United States Government Publishing OfficepublisherpbldistributordstUnited StatesNational Archives and Records AdministrationOffice of the Federal RegisterauthorautGovernment Organizationtextgovernment publicationengCFRRegulatory Information2003_cfr_21v1executive2010-09-17Office of the Federal Register, National Archives and Records Administration2003-04-01monographicannualdepositedborn digital504 p.AE 2.106/3:21/https://www.govinfo.gov/app/details/CFR-2003-title21-vol1P0b002ee18073a18d21CFRDGPO2010-09-172014-12-02CFR-2003-title21-vol1machine generatedengfdlpCFRCFR-2003-title21-vol12119parts 1 to 99falseCFR-title21-vol1falsefalse2003-04-01Food and DrugsTitle 21Volume 1Code of Federal Regulationshttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/html/CFR-2003-title21-vol1.htmhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1.xmlCode of Federal Regulations Title 21, Volume 1, April 1, 2003Food and Drugshttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol121 CFR Title 2121CFRTitle 21; Food and DrugsNODECFR-2003-title21-vol11Title 21title21 Food Safety and Inspection Service, Department of Agriculture: 9 CFR chapter III.falseCode of Federal RegulationsTitle 1 Part I1 CFR Part Iid-CFR-2003-title21-vol1Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-toc-id2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-toc-id2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-toc-id2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-toc-id2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-toc-id2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-toc-id2.xml21 CFR Toc21CFRToc; Table Of ContentsTOCCFR-2003-title21-vol1-toc-id22Toctocid-CFR-2003-title21-vol1FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESD09002ee18a5cbbf0-CFR-2003-title21-vol1-chapI.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-chapI.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-chapIhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-chapIhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-chapI.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-chapI.xml21 CFR Chapter I21CFRChapter I; FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-chapI3Chapter IchapterI trueFor nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994 and 66 FR 56035, Nov. 6, 2001.Federal RegisterVolume 59 Page 1436659 FR 14366Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-chapITable Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-chapI-toc-id4.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-chapI-toc-id4.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-chapI-toc-id4https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-chapI-toc-id4https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-chapI-toc-id4.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-chapI-toc-id4.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESTOCCFR-2003-title21-vol1-chapI-toc-id44Toctocid-CFR-2003-title21-vol1-chapIGENERALD09002ee18a5cbbf0-CFR-2003-title21-vol1-chapI-subchapA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-chapI-subchapA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-chapI-subchapAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-chapI-subchapAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-chapI-subchapA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-chapI-subchapA.xml21 CFR Subchapter A21CFRSubchapter A; GENERALChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-chapI-subchapA5Subchapter AsubchapA falseid-CFR-2003-title21-vol1-chapI-subchapAGENERAL ENFORCEMENT REGULATIONSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part1.xml21 CFR 121CFR1Part 1; GENERAL ENFORCEMENT REGULATIONSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part16Part 1part1 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.falseUnited States CodeTitle 15 Section 1453Title 15 Section 1454Title 15 Section 145515 U.S.C. 145315 U.S.C. 145415 U.S.C. 1455United States CodeTitle 21 Section 321Title 21 Section 343Title 21 Section 352Title 21 Section 355Title 21 Section 360bTitle 21 Section 362Title 21 Section 371Title 21 Section 374Title 21 Section 381Title 21 Section 382Title 21 Section 39321 U.S.C. 32121 U.S.C. 34321 U.S.C. 35221 U.S.C. 35521 U.S.C. 360b21 U.S.C. 36221 U.S.C. 37121 U.S.C. 37421 U.S.C. 38121 U.S.C. 38221 U.S.C. 393United States CodeTitle 42 Section 216Title 42 Section 241Title 42 Section 243Title 42 Section 262Title 42 Section 26442 U.S.C. 21642 U.S.C. 24142 U.S.C. 24342 U.S.C. 26242 U.S.C. 264Federal RegisterVolume 42 Page 1555342 FR 15553id-CFR-2003-title21-vol1-part1Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part1-toc-id7.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part1-toc-id7.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-toc-id7https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-toc-id7https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part1-toc-id7.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part1-toc-id7.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 1GENERAL ENFORCEMENT REGULATIONSTOCCFR-2003-title21-vol1-part1-toc-id77Toctocid-CFR-2003-title21-vol1-part1General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part1-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part1-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part1-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part1-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 1GENERAL ENFORCEMENT REGULATIONSNODECFR-2003-title21-vol1-part1-subpartA8Subpart AsubpartA falseid-CFR-2003-title21-vol1-part1-subpartAGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-1.xml21 CFR 1.121CFR1.1Section 1.1; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-19Section 1.1section1.1 42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993falseFederal RegisterVolume 42 Page 1555342 FR 15553Federal RegisterVolume 58 Page 1708558 FR 17085id-CFR-2003-title21-vol1-part1-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-3.xml21 CFR 1.321CFR1.3Section 1.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-310Section 1.3section1.3 falseid-CFR-2003-title21-vol1-part1-subpartAAuthority citations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-4.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-4.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-4https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-4https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-4.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-4.xml21 CFR 1.421CFR1.4Section 1.4; Authority citations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-411Section 1.4section1.4 54 FR 39630, Sept. 27, 1989falseUnited States CodeTitle 5 Section 5525 U.S.C. 552United States CodeTitle 21 Section 37121 U.S.C. 371Federal RegisterVolume 54 Page 3963054 FR 39630id-CFR-2003-title21-vol1-part1General Labeling RequirementsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part1-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part1-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part1-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part1-subpartB.xml21 CFR B21CFRSubpart B; General Labeling RequirementsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 1GENERAL ENFORCEMENT REGULATIONSNODECFR-2003-title21-vol1-part1-subpartB12Subpart BsubpartB falseid-CFR-2003-title21-vol1-part1-subpartBPresence of mandatory label information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-20.xml21 CFR 1.2021CFR1.20Section 1.20; Presence of mandatory label information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Labeling RequirementsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-2013Section 1.20section1.20 falseUnited States CodeTitle 15 Section 231-233Title 15 Section 234-236Title 15 Section 251-256Title 15 Section 257-257i15 U.S.C. 231-23315 U.S.C. 234-23615 U.S.C. 251-25615 U.S.C. 257-257iUnited States Statutes at LargeVolume 37 Page 25037 Stat. 250United States Statutes at LargeVolume 38 Page 118638 Stat. 1186United States Statutes at LargeVolume 39 Page 67339 Stat. 673United States Statutes at LargeVolume 45 Page 63545 Stat. 635id-CFR-2003-title21-vol1-part1-subpartBFailure to reveal material facts.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-21.xml21 CFR 1.2121CFR1.21Section 1.21; Failure to reveal material facts.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Labeling RequirementsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-2114Section 1.21section1.21 falseid-CFR-2003-title21-vol1-part1-subpartBProcedures for requesting variations and exemptions from required label statements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-23.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-23.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-23https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-23https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-23.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-23.xml21 CFR 1.2321CFR1.23Section 1.23; Procedures for requesting variations and exemptions from required label statements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Labeling RequirementsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-2315Section 1.23section1.23 falseid-CFR-2003-title21-vol1-part1-subpartBExemptions from required label statements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-24.xml21 CFR 1.2421CFR1.24Section 1.24; Exemptions from required label statements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Labeling RequirementsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-2416Section 1.24section1.24 42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47 FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3, 1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001falseUnited States Statutes at LargeVolume 42 Page 150042 Stat. 1500Federal RegisterVolume 42 Page 1555342 FR 15553Federal RegisterVolume 47 Page 3242147 FR 32421Federal RegisterVolume 47 Page 94647 FR 946Federal RegisterVolume 49 Page 1333949 FR 13339Federal RegisterVolume 54 Page 903354 FR 9033Federal RegisterVolume 58 Page 217458 FR 2174Federal RegisterVolume 61 Page 1447861 FR 14478Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part1ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part1-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part1-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part1-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part1-subpartC.xml21 CFR C21CFRSubparts C-D; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 1GENERAL ENFORCEMENT REGULATIONSNODECFR-2003-title21-vol1-part1-subpartC17Subparts C-DsubpartC falseid-CFR-2003-title21-vol1-part1Imports and ExportsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part1-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part1-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part1-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part1-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part1-subpartE.xml21 CFR E21CFRSubpart E; Imports and ExportsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 1GENERAL ENFORCEMENT REGULATIONSNODECFR-2003-title21-vol1-part1-subpartE18Subpart EsubpartE falseid-CFR-2003-title21-vol1-part1-subpartEDefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-83.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-83.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-83https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-83https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-83.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-83.xml21 CFR 1.8321CFR1.83Section 1.83; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-8319Section 1.83section1.83 falseUnited States CodeTitle 19 Section 1483Title 19 Section 1484Title 19 Section 148519 U.S.C. 148319 U.S.C. 148419 U.S.C. 1485id-CFR-2003-title21-vol1-part1-subpartENotice of sampling.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-90.xml21 CFR 1.9021CFR1.90Section 1.90; Notice of sampling.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9020Section 1.90section1.90 falseid-CFR-2003-title21-vol1-part1-subpartEPayment for samples.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-91.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-91.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-91https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-91https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-91.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-91.xml21 CFR 1.9121CFR1.91Section 1.91; Payment for samples.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9121Section 1.91section1.91 falseid-CFR-2003-title21-vol1-part1-subpartEHearing on refusal of admission.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-94.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-94.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-94https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-94https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-94.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-94.xml21 CFR 1.9421CFR1.94Section 1.94; Hearing on refusal of admission.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9422Section 1.94section1.94 falseid-CFR-2003-title21-vol1-part1-subpartEApplication for authorization to relabel and recondition.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-95.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-95.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-95https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-95https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-95.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-95.xml21 CFR 1.9521CFR1.95Section 1.95; Application for authorization to relabel and recondition.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9523Section 1.95section1.95 falseid-CFR-2003-title21-vol1-part1-subpartEGranting of authorization to relabel and recondition.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-96.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-96.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-96https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-96https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-96.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-96.xml21 CFR 1.9621CFR1.96Section 1.96; Granting of authorization to relabel and recondition.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9624Section 1.96section1.96 42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989falseFederal RegisterVolume 42 Page 1555342 FR 15553Federal RegisterVolume 54 Page 903354 FR 9033id-CFR-2003-title21-vol1-part1-subpartEBonds.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-97.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-97.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-97https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-97https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-97.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-97.xml21 CFR 1.9721CFR1.97Section 1.97; Bonds.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9725Section 1.97section1.97 falseid-CFR-2003-title21-vol1-part1-subpartECosts chargeable in connection with relabeling and reconditioning inadmissible imports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-99.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-99.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-99https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-99https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-99.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-99.xml21 CFR 1.9921CFR1.99Section 1.99; Costs chargeable in connection with relabeling and reconditioning inadmissible imports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-9926Section 1.99section1.99 falseUnited States CodeTitle 19 Section 26719 U.S.C. 267United States Statutes at LargeVolume 36 Page 90136 Stat. 901id-CFR-2003-title21-vol1-part1-subpartENotification and recordkeeping.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec1-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec1-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec1-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec1-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec1-101.xml21 CFR 1.10121CFR1.101Section 1.101; Notification and recordkeeping.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EImports and ExportsPart 1GENERAL ENFORCEMENT REGULATIONSCONTENTCFR-2003-title21-vol1-sec1-10127Section 1.101section1.101 66 FR 65447, Dec. 19, 2001falseUnited States CodeTitle 18 Section 100118 U.S.C. 1001United States CodeTitle 21 Section 381Title 21 Section 38221 U.S.C. 38121 U.S.C. 382United States CodeTitle 42 Section 26242 U.S.C. 262Federal RegisterVolume 66 Page 6544766 FR 65447id-CFR-2003-title21-vol1-chapI-subchapAGENERAL ADMINISTRATIVE RULINGS AND DECISIONSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2.xml21 CFR 221CFR2Part 2; GENERAL ADMINISTRATIVE RULINGS AND DECISIONSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part228Part 2part2 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671 et seq.falseUnited States CodeTitle 15 Section 402Title 15 Section 40915 U.S.C. 40215 U.S.C. 409United States CodeTitle 21 Section 321Title 21 Section 331Title 21 Section 335Title 21 Section 342Title 21 Section 343Title 21 Section 346aTitle 21 Section 348Title 21 Section 351Title 21 Section 352Title 21 Section 355Title 21 Section 360bTitle 21 Section 361Title 21 Section 362Title 21 Section 371Title 21 Section 372Title 21 Section 37421 U.S.C. 32121 U.S.C. 33121 U.S.C. 33521 U.S.C. 34221 U.S.C. 34321 U.S.C. 346a21 U.S.C. 34821 U.S.C. 35121 U.S.C. 35221 U.S.C. 35521 U.S.C. 360b21 U.S.C. 36121 U.S.C. 36221 U.S.C. 37121 U.S.C. 37221 U.S.C. 374United States CodeTitle 42 Section 7671et seq.42 U.S.C. 7671et seq.Federal RegisterVolume 42 Page 1555942 FR 15559id-CFR-2003-title21-vol1-part2Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2-toc-id29.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2-toc-id29.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-toc-id29https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-toc-id29https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2-toc-id29.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2-toc-id29.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSTOCCFR-2003-title21-vol1-part2-toc-id2929Toctocid-CFR-2003-title21-vol1-part2General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSNODECFR-2003-title21-vol1-part2-subpartA30Subpart AsubpartA falseid-CFR-2003-title21-vol1-part2-subpartAImminent hazard to the public health.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-5.xml21 CFR 2.521CFR2.5Section 2.5; Imminent hazard to the public health.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-531Section 2.5section2.5 falseid-CFR-2003-title21-vol1-part2-subpartAExamination and investigation samples.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-10.xml21 CFR 2.1021CFR2.10Section 2.10; Examination and investigation samples.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-1032Section 2.10section2.10 42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998falseFederal RegisterVolume 42 Page 1555942 FR 15559Federal RegisterVolume 63 Page 5129963 FR 51299id-CFR-2003-title21-vol1-part2-subpartAMethods of analysis.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-19.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-19.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-19https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-19https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-19.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-19.xml21 CFR 2.1921CFR2.19Section 2.19; Methods of analysis.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-1933Section 2.19section2.19 42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54 FR 9034, Mar. 3, 1989falseFederal RegisterVolume 42 Page 1555942 FR 15559Federal RegisterVolume 47 Page 94647 FR 946Federal RegisterVolume 54 Page 903454 FR 9034id-CFR-2003-title21-vol1-part2Human and Animal FoodsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2-subpartB.xml21 CFR B21CFRSubpart B; Human and Animal FoodsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSNODECFR-2003-title21-vol1-part2-subpartB34Subpart BsubpartB falseid-CFR-2003-title21-vol1-part2-subpartBGrain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-25.xml21 CFR 2.2521CFR2.25Section 2.25; Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BHuman and Animal FoodsPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-2535Section 2.25section2.25 falseUnited States CodeTitle 7 Section 1551et seq.7 U.S.C. 1551et seq.United States Statutes at LargeVolume 53 Page 127553 Stat. 1275United States Statutes at LargeVolume 72 Page 47672 Stat. 476id-CFR-2003-title21-vol1-part2-subpartBUse of secondhand containers for the shipment or storage of food and animal feed.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-35.xml21 CFR 2.3521CFR2.35Section 2.35; Use of secondhand containers for the shipment or storage of food and animal feed.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BHuman and Animal FoodsPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-3536Section 2.35section2.35 falseid-CFR-2003-title21-vol1-part2ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2-subpartC.xml21 CFR C21CFRSubparts C-E; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSNODECFR-2003-title21-vol1-part2-subpartC37Subparts C-EsubpartC falseid-CFR-2003-title21-vol1-part2Caustic PoisonsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2-subpartF.xml21 CFR F21CFRSubpart F; Caustic PoisonsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSNODECFR-2003-title21-vol1-part2-subpartF38Subpart FsubpartF falseid-CFR-2003-title21-vol1-part2-subpartFDefinition of ammonia under Federal Caustic Poison Act.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-110.xml21 CFR 2.11021CFR2.110Section 2.110; Definition of ammonia under Federal Caustic Poison Act.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FCaustic PoisonsPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-11039Section 2.110section2.110 falseid-CFR-2003-title21-vol1-part2Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic ActD09002ee18a5cbbf0-CFR-2003-title21-vol1-part2-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part2-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part2-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part2-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part2-subpartG.xml21 CFR G21CFRSubpart G; Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic ActChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSNODECFR-2003-title21-vol1-part2-subpartG40Subpart GsubpartG falseid-CFR-2003-title21-vol1-part2-subpartGUse of ozone-depleting substances in foods, drugs, devices, or cosmetics.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec2-125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec2-125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec2-125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec2-125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec2-125.xml21 CFR 2.12521CFR2.125Section 2.125; Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GProvisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic ActPart 2GENERAL ADMINISTRATIVE RULINGS AND DECISIONSCONTENTCFR-2003-title21-vol1-sec2-12541Section 2.125section2.125 67 FR 48384, July 24, 2002falseCode of Federal RegulationsTitle 0 Part 820 CFR Part 82Federal RegisterVolume 67 Page 4838467 FR 48384id-CFR-2003-title21-vol1-chapI-subchapAPRODUCT JURISDICTIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part3.xml21 CFR 321CFR3Part 3; PRODUCT JURISDICTIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part342Part 3part3 21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262.falseUnited States CodeTitle 21 Section 321Title 21 Section 351Title 21 Section 352Title 21 Section 353Title 21 Section 355Title 21 Section 360c-360fTitle 21 Section 360Title 21 Section 360gg-360ssTitle 21 Section 360h-360jTitle 21 Section 371(a)Title 21 Section 379eTitle 21 Section 381Title 21 Section 39421 U.S.C. 32121 U.S.C. 35121 U.S.C. 35221 U.S.C. 35321 U.S.C. 35521 U.S.C. 360c-360f21 U.S.C. 36021 U.S.C. 360gg-360ss21 U.S.C. 360h-360j21 U.S.C. 371(a)21 U.S.C. 379e21 U.S.C. 38121 U.S.C. 394United States CodeTitle 42 Section 216Title 42 Section 26242 U.S.C. 21642 U.S.C. 262Federal RegisterVolume 56 Page 5875656 FR 58756id-CFR-2003-title21-vol1-part3Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part3-toc-id43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part3-toc-id43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3-toc-id43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3-toc-id43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part3-toc-id43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part3-toc-id43.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 3PRODUCT JURISDICTIONTOCCFR-2003-title21-vol1-part3-toc-id4343Toctocid-CFR-2003-title21-vol1-part3Assignment of Agency Component for Review of Premarket ApplicationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part3-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part3-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part3-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part3-subpartA.xml21 CFR A21CFRSubpart A; Assignment of Agency Component for Review of Premarket ApplicationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 3PRODUCT JURISDICTIONNODECFR-2003-title21-vol1-part3-subpartA44Subpart AsubpartA falseid-CFR-2003-title21-vol1-part3-subpartAPurpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-1.xml21 CFR 3.121CFR3.1Section 3.1; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-145Section 3.1section3.1 falseUnited States Public Law 629 (101st Congress)Public Law 101-629id-CFR-2003-title21-vol1-part3-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-2.xml21 CFR 3.221CFR3.2Section 3.2; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-246Section 3.2section3.2 56 FR 58756, Nov. 21, 1991 as amended at 64 FR 398, Jan. 5, 1999; 64 FR 56447, Oct. 20, 1999falseUnited States CodeTitle 42 Section 262(a)42 U.S.C. 262(a)Federal RegisterVolume 56 Page 5875656 FR 58756Federal RegisterVolume 64 Page 39864 FR 398Federal RegisterVolume 64 Page 5644764 FR 56447id-CFR-2003-title21-vol1-part3-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-3.xml21 CFR 3.321CFR3.3Section 3.3; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-347Section 3.3section3.3 falseid-CFR-2003-title21-vol1-part3-subpartADesignated agency component.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-4.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-4.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-4https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-4https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-4.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-4.xml21 CFR 3.421CFR3.4Section 3.4; Designated agency component.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-448Section 3.4section3.4 falseid-CFR-2003-title21-vol1-part3-subpartAProcedures for identifying the designated agency component.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-5.xml21 CFR 3.521CFR3.5Section 3.5; Procedures for identifying the designated agency component.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-549Section 3.5section3.5 falseid-CFR-2003-title21-vol1-part3-subpartAProduct jurisdiction officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-6.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-6.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-6https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-6https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-6.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-6.xml21 CFR 3.621CFR3.6Section 3.6; Product jurisdiction officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-650Section 3.6section3.6 falseid-CFR-2003-title21-vol1-part3-subpartARequest for designation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-7.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-7.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-7https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-7https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-7.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-7.xml21 CFR 3.721CFR3.7Section 3.7; Request for designation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-751Section 3.7section3.7 falseid-CFR-2003-title21-vol1-part3-subpartALetter of designation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-8.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-8.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-8https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-8https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-8.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-8.xml21 CFR 3.821CFR3.8Section 3.8; Letter of designation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-852Section 3.8section3.8 falseid-CFR-2003-title21-vol1-part3-subpartAEffect of letter of designation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-9.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-9.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-9https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-9https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-9.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-9.xml21 CFR 3.921CFR3.9Section 3.9; Effect of letter of designation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-953Section 3.9section3.9 falseid-CFR-2003-title21-vol1-part3-subpartAStay of review time.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec3-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec3-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec3-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec3-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec3-10.xml21 CFR 3.1021CFR3.10Section 3.10; Stay of review time.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AAssignment of Agency Component for Review of Premarket ApplicationsPart 3PRODUCT JURISDICTIONCONTENTCFR-2003-title21-vol1-sec3-1054Section 3.10section3.10 falseid-CFR-2003-title21-vol1-part3ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part3-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part3-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part3-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part3-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part3-subpartB.xml21 CFR B21CFRSubpart B; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 3PRODUCT JURISDICTIONNODECFR-2003-title21-vol1-part3-subpartB55Subpart BsubpartB falseid-CFR-2003-title21-vol1-chapI-subchapADELEGATIONS OF AUTHORITY AND ORGANIZATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5.xml21 CFR 521CFR5Part 5; DELEGATIONS OF AUTHORITY AND ORGANIZATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part556Part 5part5 5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 15 U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C., 61-63, 141-149, 301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 1395y, 4332, 4831(a), 10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.falseUnited States CodeTitle 5 Section 504Title 5 Section 5525 U.S.C. 5045 U.S.C. 552United States CodeTitle 5 Section 504Title 5 Section 552Title 5 Section 605(b)5 U.S.C. 5045 U.S.C. 5525 U.S.C. 605(b)United States CodeTitle 7 Section 138aTitle 7 Section 22177 U.S.C. 138a7 U.S.C. 2217United States CodeTitle 15 Section 1261-1282Title 15 Section 1451-1461Title 15 Section 3701-3711aTitle 15 Section 63815 U.S.C. 1261-128215 U.S.C. 1451-146115 U.S.C. 3701-3711a15 U.S.C. 638United States CodeTitle 21 Section 1031-1309Title 21 Section 1401-1403Title 21 Section 141-149Title 21 Section 301-394Title 21 Section 467fTitle 21 Section 61-63Title 21 Section 679(b)Title 21 Section 801-88621 U.S.C. 1031-130921 U.S.C. 1401-140321 U.S.C. 141-14921 U.S.C. 301-39421 U.S.C. 467f21 U.S.C. 61-6321 U.S.C. 679(b)21 U.S.C. 801-886United States CodeTitle 35 Section 15635 U.S.C. 156United States CodeTitle 42 Section 10007-10008Title 42 Section 1395yTitle 42 Section 238Title 42 Section 241Title 42 Section 242aTitle 42 Section 242Title 42 Section 242lTitle 42 Section 242nTitle 42 Section 242oTitle 42 Section 243Title 42 Section 262Title 42 Section 263Title 42 Section 264Title 42 Section 265Title 42 Section 300aa-1Title 42 Section 300ar-25-28Title 42 Section 300ccTitle 42 Section 300ffTitle 42 Section 300u-300u-5Title 42 Section 4332Title 42 Section 4831(a)42 U.S.C. 10007-1000842 U.S.C. 1395y42 U.S.C. 23842 U.S.C. 24142 U.S.C. 242a42 U.S.C. 24242 U.S.C. 242l42 U.S.C. 242n42 U.S.C. 242o42 U.S.C. 24342 U.S.C. 26242 U.S.C. 26342 U.S.C. 26442 U.S.C. 26542 U.S.C. 300aa-142 U.S.C. 300ar-25-2842 U.S.C. 300cc42 U.S.C. 300ff42 U.S.C. 300u-300u-542 U.S.C. 433242 U.S.C. 4831(a)Federal RegisterVolume 41 Page 2429441 FR 24294Federal RegisterVolume 52 Page 1341452 FR 13414Federal RegisterVolume 66 Page 3099366 FR 30993id-CFR-2003-title21-vol1-part5Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-toc-id57.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-toc-id57.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-toc-id57https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-toc-id57https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-toc-id57.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-toc-id57.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONTOCCFR-2003-title21-vol1-part5-toc-id5757Toctocid-CFR-2003-title21-vol1-part5Delegations of Authority to the Commissioner of Food and DrugsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartA.xml21 CFR A21CFRSubpart A; Delegations of Authority to the Commissioner of Food and DrugsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartA58Subpart AsubpartA falseid-CFR-2003-title21-vol1-part5-subpartADelegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-10.xml21 CFR 5.1021CFR5.10Section 5.10; Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ADelegations of Authority to the Commissioner of Food and DrugsPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1059Section 5.10section5.10 falseUnited States CodeTitle 5 Section 504Title 5 Section 552bTitle 5 Section 552b(c)5 U.S.C. 5045 U.S.C. 552b5 U.S.C. 552b(c)United States CodeTitle 7 Section 138aTitle 7 Section 22177 U.S.C. 138a7 U.S.C. 2217United States CodeTitle 15 Section 1451et seq.Title 15 Section 3701et seq.Title 15 Section 3710a(a)(2)Title 15 Section 3710a(b)(3)(C)Title 15 Section 3710a(b)(3)(D)Title 15 Section 3710a(c)(3)(A)Title 15 Section 3710a(c)(3)(B)Title 15 Section 3710a(c)(5)(A)Title 15 Section 3710c(a)(1)Title 15 Section 3710c(a)(1)(A)(i)Title 15 Section 3710c(a)(2)Title 15 Section 63815 U.S.C. 1451et seq.15 U.S.C. 3701et seq.15 U.S.C. 3710a(a)(2)15 U.S.C. 3710a(b)(3)(C)15 U.S.C. 3710a(b)(3)(D)15 U.S.C. 3710a(c)(3)(A)15 U.S.C. 3710a(c)(3)(B)15 U.S.C. 3710a(c)(5)(A)15 U.S.C. 3710c(a)(1)15 U.S.C. 3710c(a)(1)(A)(i)15 U.S.C. 3710c(a)(2)15 U.S.C. 638United States CodeTitle 21 Section 1031et seq.Title 21 Section 1401-1403Title 21 Section 141et seq.Title 21 Section 144Title 21 Section 301et seq.Title 21 Section 335Title 21 Section 360cnoteTitle 21 Section 360inoteTitle 21 Section 360jnoteTitle 21 Section 467f(b)Title 21 Section 61-63Title 21 Section 679(b)Title 21 Section 801et seq.Title 21 Section 811(h)(4)Title 21 Section 823(f)21 U.S.C. 1031et seq.21 U.S.C. 1401-140321 U.S.C. 141et seq.21 U.S.C. 14421 U.S.C. 301et seq.21 U.S.C. 33521 U.S.C. 360cnote21 U.S.C. 360inote21 U.S.C. 360jnote21 U.S.C. 467f(b)21 U.S.C. 61-6321 U.S.C. 679(b)21 U.S.C. 801et seq.21 U.S.C. 811(h)(4)21 U.S.C. 823(f)United States CodeTitle 35 Section 156Title 35 Section 20335 U.S.C. 15635 U.S.C. 203United States CodeTitle 42 Section 10007Title 42 Section 10008Title 42 Section 238Title 42 Section 241Title 42 Section 242aTitle 42 Section 242(a)Title 42 Section 242lTitle 42 Section 242oTitle 42 Section 243Title 42 Section 262Title 42 Section 262et seq.Title 42 Section 263Title 42 Section 264Title 42 Section 265Title 42 Section 300aa-1noteTitle 42 Section 300aa-25Title 42 Section 300aa-25et seq.Title 42 Section 300aa-27Title 42 Section 300aa-28Title 42 Section 300cc-12(a)(1)Title 42 Section 300ff-72(a)(1)(A)Title 42 Section 300u-1(a)Title 42 Section 300uet seq.Title 42 Section 4831(a)42 U.S.C. 1000742 U.S.C. 1000842 U.S.C. 23842 U.S.C. 24142 U.S.C. 242a42 U.S.C. 242(a)42 U.S.C. 242l42 U.S.C. 242o42 U.S.C. 24342 U.S.C. 26242 U.S.C. 262et seq.42 U.S.C. 26342 U.S.C. 26442 U.S.C. 26542 U.S.C. 300aa-1note42 U.S.C. 300aa-2542 U.S.C. 300aa-25et seq.42 U.S.C. 300aa-2742 U.S.C. 300aa-2842 U.S.C. 300cc-12(a)(1)42 U.S.C. 300ff-72(a)(1)(A)42 U.S.C. 300u-1(a)42 U.S.C. 300uet seq.42 U.S.C. 4831(a)United States Statutes at LargeVolume 44 Page 140644 Stat. 1406United States Statutes at LargeVolume 84 Page 124184 Stat. 1241Presidential Executive Order Number 11490Executive Order 11490United States Public Law 613 (86th Congress)Public Law 86-613United States Public Law 513 (91st Congress)Public Law 91-513United States Public Law 463 (92nd Congress)Public Law 92-463United States Public Law 317 (94th Congress)Public Law 94-317United States Public Law 629 (101st Congress)Public Law 101-629United States Public Law 180 (104th Congress)Public Law 104-180Code of Federal RegulationsTitle 1 Part 101-61 CFR Part 101-6Code of Federal RegulationsTitle 2 Part 722 CFR Part 72Code of Federal RegulationsTitle 5 Part 55 CFR Part 5Code of Federal RegulationsTitle 5 Part 115 CFR Part 11Code of Federal RegulationsTitle 5 Part 135 CFR Part 13Code of Federal RegulationsTitle 5 Part 55 CFR Part 5id-CFR-2003-title21-vol1-part5-subpartAReservation of authority.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-11.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-11.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-11https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-11https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-11.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-11.xml21 CFR 5.1121CFR5.11Section 5.11; Reservation of authority.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ADelegations of Authority to the Commissioner of Food and DrugsPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1160Section 5.11section5.11 falseid-CFR-2003-title21-vol1-part5General Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartB.xml21 CFR B21CFRSubpart B; General Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartB61Subpart BsubpartB falseid-CFR-2003-title21-vol1-part5-subpartBGeneral redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-20.xml21 CFR 5.2021CFR5.20Section 5.20; General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2062Section 5.20section5.20 falseUnited States CodeTitle 5 Section 552(b)Title 5 Section 605(b)5 U.S.C. 552(b)5 U.S.C. 605(b)United States CodeTitle 18 Section 208(b)(3)18 U.S.C. 208(b)(3)United States CodeTitle 21 Section 379hTitle 21 Section 379h(d)(1)(C)21 U.S.C. 379h21 U.S.C. 379h(d)(1)(C)id-CFR-2003-title21-vol1-part5-subpartBEmergency functions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-21.xml21 CFR 5.2121CFR5.21Section 5.21; Emergency functions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2163Section 5.21section5.21 falseid-CFR-2003-title21-vol1-part5-subpartBCertification of true copies and use of Department seal.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-22.xml21 CFR 5.2221CFR5.22Section 5.22; Certification of true copies and use of Department seal.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2264Section 5.22section5.22 falseid-CFR-2003-title21-vol1-part5-subpartBDisclosure of official records and authorization of testimony.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-23.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-23.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-23https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-23https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-23.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-23.xml21 CFR 5.2321CFR5.23Section 5.23; Disclosure of official records and authorization of testimony.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2365Section 5.23section5.23 falseid-CFR-2003-title21-vol1-part5-subpartBAuthority relating to technology transfer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-24.xml21 CFR 5.2421CFR5.24Section 5.24; Authority relating to technology transfer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2466Section 5.24section5.24 falseUnited States CodeTitle 15 Section 3701et seq.Title 15 Section 3710a(a)Title 15 Section 3710a(c)(5)Title 15 Section 3710a(c)(5)(A)15 U.S.C. 3701et seq.15 U.S.C. 3710a(a)15 U.S.C. 3710a(c)(5)15 U.S.C. 3710a(c)(5)(A)Presidential Executive Order Number 12591Executive Order 12591id-CFR-2003-title21-vol1-part5-subpartBResearch, investigation, and testing programs and health information and promotion programs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-25.xml21 CFR 5.2521CFR5.25Section 5.25; Research, investigation, and testing programs and health information and promotion programs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2567Section 5.25section5.25 falseUnited States CodeTitle 21 Section 360ii21 U.S.C. 360iiUnited States CodeTitle 42 Section 241Title 42 Section 242lTitle 42 Section 243Title 42 Section 300u-1Title 42 Section 300u-2Title 42 Section 300u-3Title 42 Section 300u42 U.S.C. 24142 U.S.C. 242l42 U.S.C. 24342 U.S.C. 300u-142 U.S.C. 300u-242 U.S.C. 300u-342 U.S.C. 300uUnited States Public Law 622 (95th Congress)Public Law 95-622id-CFR-2003-title21-vol1-part5-subpartBService fellowships.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-26.xml21 CFR 5.2621CFR5.26Section 5.26; Service fellowships.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2668Section 5.26section5.26 falseUnited States CodeTitle 42 Section 209(g)Title 42 Section 210(f)42 U.S.C. 209(g)42 U.S.C. 210(f)id-CFR-2003-title21-vol1-part5-subpartBPatent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-27.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-27.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-27https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-27https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-27.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-27.xml21 CFR 5.2721CFR5.27Section 5.27; Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2769Section 5.27section5.27 falseUnited States CodeTitle 35 Section 156Title 35 Section 156(d)(2)(B)Title 35 Section 156(d)(2)(B)(ii)35 U.S.C. 15635 U.S.C. 156(d)(2)(B)35 U.S.C. 156(d)(2)(B)(ii)id-CFR-2003-title21-vol1-part5-subpartBHearings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-28.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-28.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-28https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-28https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-28.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-28.xml21 CFR 5.2821CFR5.28Section 5.28; Hearings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2870Section 5.28section5.28 66 FR 30993, June 8, 2001, as amended at 67 FR 53306, Aug. 15, 2002falseUnited States CodeTitle 7 Section 22177 U.S.C. 2217United States CodeTitle 15 Section 145515 U.S.C. 1455United States CodeTitle 21 Section 145Title 21 Section 335Title 21 Section 344(b)Title 21 Section 381(a)21 U.S.C. 14521 U.S.C. 33521 U.S.C. 344(b)21 U.S.C. 381(a)United States Statutes at LargeVolume 43 Page 80343 Stat. 803United States Statutes at LargeVolume 44 Page 140644 Stat. 1406United States Public Law 613 (86th Congress)Public Law 86-613Federal RegisterVolume 66 Page 3099366 FR 30993Federal RegisterVolume 67 Page 5330667 FR 53306id-CFR-2003-title21-vol1-part5-subpartBPetitions under part 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-29.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-29.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-29https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-29https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-29.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-29.xml21 CFR 5.2921CFR5.29Section 5.29; Petitions under part 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-2971Section 5.29section5.29 falseid-CFR-2003-title21-vol1-part5-subpartBAuthority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-30.xml21 CFR 5.3021CFR5.30Section 5.30; Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-3072Section 5.30section5.30 falseUnited States CodeTitle 18 Section 208(b)(1)18 U.S.C. 208(b)(1)id-CFR-2003-title21-vol1-part5-subpartBEnforcement activities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-31.xml21 CFR 5.3121CFR5.31Section 5.31; Enforcement activities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-3173Section 5.31section5.31 falseUnited States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 141-149Title 21 Section 334Title 21 Section 334(a)(2)Title 21 Section 372Title 21 Section 372(e)(1)Title 21 Section 61-6421 U.S.C. 141-14921 U.S.C. 33421 U.S.C. 334(a)(2)21 U.S.C. 37221 U.S.C. 372(e)(1)21 U.S.C. 61-64United States CodeTitle 42 Section 262Title 42 Section 26442 U.S.C. 26242 U.S.C. 264United States Statutes at LargeVolume 43 Page 80343 Stat. 803United States Statutes at LargeVolume 44 Page 140b44 Stat. 140bUnited States Public Law 613 (86th Congress)Public Law 86-613id-CFR-2003-title21-vol1-part5-subpartBCertification following inspections.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-32.xml21 CFR 5.3221CFR5.32Section 5.32; Certification following inspections.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-3274Section 5.32section5.32 falseid-CFR-2003-title21-vol1-part5-subpartBIssuance of reports of minor violations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-33.xml21 CFR 5.3321CFR5.33Section 5.33; Issuance of reports of minor violations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-3375Section 5.33section5.33 falseUnited States CodeTitle 21 Section 336Title 21 Section 360pp(d)21 U.S.C. 33621 U.S.C. 360pp(d)id-CFR-2003-title21-vol1-part5-subpartBIssuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-34.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-34.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-34https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-34https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-34.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-34.xml21 CFR 5.3421CFR5.34Section 5.34; Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-3476Section 5.34section5.34 falseUnited States CodeTitle 21 Section 335aTitle 21 Section 335a(c)(2)(B)Title 21 Section 335u(d)(3)21 U.S.C. 335a21 U.S.C. 335a(c)(2)(B)21 U.S.C. 335u(d)(3)id-CFR-2003-title21-vol1-part5-subpartBOfficials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-35.xml21 CFR 5.3521CFR5.35Section 5.35; Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-3577Section 5.35section5.35 falseUnited States CodeTitle 5 Section 605(b)5 U.S.C. 605(b)id-CFR-2003-title21-vol1-part5Human Drugs; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartC.xml21 CFR C21CFRSubpart C; Human Drugs; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartC78Subpart CsubpartC falseid-CFR-2003-title21-vol1-part5-subpartCIssuance of notices implementing the provisions of the Drug Amendments of 1962.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-100.xml21 CFR 5.10021CFR5.100Section 5.100; Issuance of notices implementing the provisions of the Drug Amendments of 1962.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10079Section 5.100section5.100 falseUnited States CodeTitle 21 Section 35521 U.S.C. 355United States Public Law 781 (87th Congress)Public Law 87-781id-CFR-2003-title21-vol1-part5-subpartCTermination of exemptions for new drugs for investigational use in human beings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-101.xml21 CFR 5.10121CFR5.101Section 5.101; Termination of exemptions for new drugs for investigational use in human beings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10180Section 5.101section5.101 falseid-CFR-2003-title21-vol1-part5-subpartCAuthority to approve and to withdraw approval of a charge for investigational new drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-102.xml21 CFR 5.10221CFR5.102Section 5.102; Authority to approve and to withdraw approval of a charge for investigational new drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10281Section 5.102section5.102 falseid-CFR-2003-title21-vol1-part5-subpartCApproval of new drug applications and their supplements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-103.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-103.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-103https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-103https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-103.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-103.xml21 CFR 5.10321CFR5.103Section 5.103; Approval of new drug applications and their supplements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10382Section 5.103section5.103 falseUnited States CodeTitle 21 Section 355Title 21 Section 355(b)(2)21 U.S.C. 35521 U.S.C. 355(b)(2)id-CFR-2003-title21-vol1-part5-subpartCResponses to Drug Enforcement Administration temporary scheduling notices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-104.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-104.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-104https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-104https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-104.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-104.xml21 CFR 5.10421CFR5.104Section 5.104; Responses to Drug Enforcement Administration temporary scheduling notices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10483Section 5.104section5.104 falseUnited States CodeTitle 21 Section 811(h)(4)21 U.S.C. 811(h)(4)id-CFR-2003-title21-vol1-part5-subpartCIssuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-105.xml21 CFR 5.10521CFR5.105Section 5.105; Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10584Section 5.105section5.105 falseUnited States CodeTitle 21 Section 35521 U.S.C. 355id-CFR-2003-title21-vol1-part5-subpartCSubmission of and effective approval dates for abbreviated new drug applications and certain new drug applications.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-106.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-106.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-106https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-106https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-106.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-106.xml21 CFR 5.10621CFR5.106Section 5.106; Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10685Section 5.106section5.106 falseUnited States CodeTitle 21 Section 355(b)(1)Title 21 Section 355(b)(2)Title 21 Section 355(c)(3)(D)Title 21 Section 355(j)21 U.S.C. 355(b)(1)21 U.S.C. 355(b)(2)21 U.S.C. 355(c)(3)(D)21 U.S.C. 355(j)id-CFR-2003-title21-vol1-part5-subpartCExtensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-107.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-107.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-107https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-107https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-107.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-107.xml21 CFR 5.10721CFR5.107Section 5.107; Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10786Section 5.107section5.107 falseid-CFR-2003-title21-vol1-part5-subpartCAuthority relating to waivers or reductions of prescription drug user fees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-108.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-108.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-108https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-108https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-108.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-108.xml21 CFR 5.10821CFR5.108Section 5.108; Authority relating to waivers or reductions of prescription drug user fees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10887Section 5.108section5.108 falseUnited States CodeTitle 21 Section 379h(a)(1)(G)Title 21 Section 379h(d)(1)(A)Title 21 Section 379h(d)(1)(B)Title 21 Section 379h(d)(1)(C)Title 21 Section 379h(d)(1)(D)Title 21 Section 379h(d)(1)(E)21 U.S.C. 379h(a)(1)(G)21 U.S.C. 379h(d)(1)(A)21 U.S.C. 379h(d)(1)(B)21 U.S.C. 379h(d)(1)(C)21 U.S.C. 379h(d)(1)(D)21 U.S.C. 379h(d)(1)(E)id-CFR-2003-title21-vol1-part5-subpartCIssuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-109.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-109.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-109https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-109https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-109.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-109.xml21 CFR 5.10921CFR5.109Section 5.109; Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CHuman Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-10988Section 5.109section5.109 falseUnited States CodeTitle 21 Section 355(e)21 U.S.C. 355(e)id-CFR-2003-title21-vol1-part5Biologics; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartD.xml21 CFR D21CFRSubpart D; Biologics; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartD89Subpart DsubpartD falseid-CFR-2003-title21-vol1-part5-subpartDFunctions pertaining to safer vaccines.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-200.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-200.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-200https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-200https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-200.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-200.xml21 CFR 5.20021CFR5.200Section 5.200; Functions pertaining to safer vaccines.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DBiologics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-20090Section 5.200section5.200 falseUnited States CodeTitle 42 Section 300aa-1noteTitle 42 Section 300aa-25Title 42 Section 300aa-25et seq.Title 42 Section 300aa-27Title 42 Section 300aa-2842 U.S.C. 300aa-1note42 U.S.C. 300aa-2542 U.S.C. 300aa-25et seq.42 U.S.C. 300aa-2742 U.S.C. 300aa-28id-CFR-2003-title21-vol1-part5-subpartDRedelegation of the Center for Biologics Evaluation and Research Director's program authorities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-201.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-201.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-201https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-201https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-201.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-201.xml21 CFR 5.20121CFR5.201Section 5.201; Redelegation of the Center for Biologics Evaluation and Research Director's program authorities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DBiologics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-20191Section 5.201section5.201 falseid-CFR-2003-title21-vol1-part5-subpartDIssuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses, suspension of licenses, or revocation of licenses and certain notices of revocation of licenses.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-202.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-202.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-202https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-202https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-202.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-202.xml21 CFR 5.20221CFR5.202Section 5.202; Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses, suspension of licenses, or revocation of licenses and certain notices of revocation of licenses.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DBiologics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-20292Section 5.202section5.202 falseid-CFR-2003-title21-vol1-part5-subpartDIssuance and revocation of licenses for the propagation or manufacture and preparation of biological products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-203.xml21 CFR 5.20321CFR5.203Section 5.203; Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DBiologics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-20393Section 5.203section5.203 falseUnited States CodeTitle 42 Section 26242 U.S.C. 262id-CFR-2003-title21-vol1-part5-subpartDNotification of release for distribution of biological products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-204.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-204.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-204https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-204https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-204.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-204.xml21 CFR 5.20421CFR5.204Section 5.204; Notification of release for distribution of biological products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DBiologics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-20494Section 5.204section5.204 falseid-CFR-2003-title21-vol1-part5Food and Cosmetics; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartE.xml21 CFR E21CFRSubpart E; Food and Cosmetics; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartE95Subpart EsubpartE falseid-CFR-2003-title21-vol1-part5-subpartEFood standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-300.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-300.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-300https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-300https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-300.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-300.xml21 CFR 5.30021CFR5.300Section 5.300; Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EFood and Cosmetics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-30096Section 5.300section5.300 falseUnited States CodeTitle 21 Section 341Title 21 Section 343(r)(4)Title 21 Section 348Title 21 Section 348(c)(2)Title 21 Section 348(e)Title 21 Section 348(h)Title 21 Section 348(h)(5)Title 21 Section 379eTitle 21 Section 379e(d)(1)21 U.S.C. 34121 U.S.C. 343(r)(4)21 U.S.C. 34821 U.S.C. 348(c)(2)21 U.S.C. 348(e)21 U.S.C. 348(h)21 U.S.C. 348(h)(5)21 U.S.C. 379e21 U.S.C. 379e(d)(1)id-CFR-2003-title21-vol1-part5-subpartEIssuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-301.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-301.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-301https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-301https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-301.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-301.xml21 CFR 5.30121CFR5.301Section 5.301; Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EFood and Cosmetics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-30197Section 5.301section5.301 falseUnited States CodeTitle 21 Section 371(e)21 U.S.C. 371(e)id-CFR-2003-title21-vol1-part5-subpartEDetention of meat, poultry, eggs, and related products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-302.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-302.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-302https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-302https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-302.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-302.xml21 CFR 5.30221CFR5.302Section 5.302; Detention of meat, poultry, eggs, and related products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EFood and Cosmetics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-30298Section 5.302section5.302 falseUnited States CodeTitle 21 Section 1031et seq.Title 21 Section 467f(b)Title 21 Section 679(b)21 U.S.C. 1031et seq.21 U.S.C. 467f(b)21 U.S.C. 679(b)id-CFR-2003-title21-vol1-part5-subpartEEstablishing standards and approving accrediting bodies under the National Laboratory Accreditation Program.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-303.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-303.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-303https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-303https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-303.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-303.xml21 CFR 5.30321CFR5.303Section 5.303; Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EFood and Cosmetics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-30399Section 5.303section5.303 falseUnited States CodeTitle 7 Section 138a7 U.S.C. 138aid-CFR-2003-title21-vol1-part5-subpartEApproval of schools providing food-processing instruction.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-304.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-304.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-304https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-304https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-304.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-304.xml21 CFR 5.30421CFR5.304Section 5.304; Approval of schools providing food-processing instruction.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EFood and Cosmetics; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-304100Section 5.304section5.304 falseid-CFR-2003-title21-vol1-part5Medical Devices and Radiological Health; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartF.xml21 CFR F21CFRSubpart F; Medical Devices and Radiological Health; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartF101Subpart FsubpartF falseid-CFR-2003-title21-vol1-part5-subpartFIssuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-400.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-400.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-400https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-400https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-400.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-400.xml21 CFR 5.40021CFR5.400Section 5.400; Issuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-400102Section 5.400section5.400 falseUnited States CodeTitle 21 Section 360d(c)21 U.S.C. 360d(c)id-CFR-2003-title21-vol1-part5-subpartFIssuance of Federal Register documents pertaining to exemptions from premarket notification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-401.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-401.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-401https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-401https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-401.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-401.xml21 CFR 5.40121CFR5.401Section 5.401; Issuance of Federal Register documents pertaining to exemptions from premarket notification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-401103Section 5.401section5.401 falseUnited States CodeTitle 21 Section 360(m)21 U.S.C. 360(m)id-CFR-2003-title21-vol1-part5-subpartFDetention of adulterated or misbranded medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-402.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-402.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-402https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-402https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-402.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-402.xml21 CFR 5.40221CFR5.402Section 5.402; Detention of adulterated or misbranded medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-402104Section 5.402section5.402 falseUnited States CodeTitle 21 Section 334(g)21 U.S.C. 334(g)id-CFR-2003-title21-vol1-part5-subpartFAuthorization to use alternative evidence for determination of the effectiveness of medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-403.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-403.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-403https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-403https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-403.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-403.xml21 CFR 5.40321CFR5.403Section 5.403; Authorization to use alternative evidence for determination of the effectiveness of medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-403105Section 5.403section5.403 falseUnited States CodeTitle 21 Section 360cTitle 21 Section 360c(a)(3)(B)Title 21 Section 360dTitle 21 Section 360e21 U.S.C. 360c21 U.S.C. 360c(a)(3)(B)21 U.S.C. 360d21 U.S.C. 360eid-CFR-2003-title21-vol1-part5-subpartFNotification to petitioners of determinations made on petitions for reclassification of medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-404.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-404.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-404https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-404https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-404.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-404.xml21 CFR 5.40421CFR5.404Section 5.404; Notification to petitioners of determinations made on petitions for reclassification of medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-404106Section 5.404section5.404 falseUnited States CodeTitle 21 Section 360c(e)Title 21 Section 360c(f)Title 21 Section 360d(b)Title 21 Section 360Title 21 Section 360e(b)21 U.S.C. 360c(e)21 U.S.C. 360c(f)21 U.S.C. 360d(b)21 U.S.C. 36021 U.S.C. 360e(b)id-CFR-2003-title21-vol1-part5-subpartFDetermination of classification of devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-405.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-405.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-405https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-405https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-405.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-405.xml21 CFR 5.40521CFR5.405Section 5.405; Determination of classification of devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-405107Section 5.405section5.405 falseUnited States CodeTitle 21 Section 360c(d)Title 21 Section 360c(f)(1)(A)Title 21 Section 360c(f)(2)(B)Title 21 Section 360c(f)(2)(C)21 U.S.C. 360c(d)21 U.S.C. 360c(f)(1)(A)21 U.S.C. 360c(f)(2)(B)21 U.S.C. 360c(f)(2)(C)id-CFR-2003-title21-vol1-part5-subpartFNotification to sponsors of deficiencies in petitions for reclassification of medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-406.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-406.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-406https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-406https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-406.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-406.xml21 CFR 5.40621CFR5.406Section 5.406; Notification to sponsors of deficiencies in petitions for reclassification of medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-406108Section 5.406section5.406 falseUnited States CodeTitle 21 Section 360c(f)Title 21 Section 360j(l)21 U.S.C. 360c(f)21 U.S.C. 360j(l)id-CFR-2003-title21-vol1-part5-subpartFApproval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-407.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-407.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-407https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-407https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-407.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-407.xml21 CFR 5.40721CFR5.407Section 5.407; Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-407109Section 5.407section5.407 falseUnited States CodeTitle 21 Section 360eTitle 21 Section 360e(f)Title 21 Section 360j(l)21 U.S.C. 360e21 U.S.C. 360e(f)21 U.S.C. 360j(l)id-CFR-2003-title21-vol1-part5-subpartFDeterminations concerning the type of valid scientific evidence submitted in a premarket approval application.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-408.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-408.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-408https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-408https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-408.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-408.xml21 CFR 5.40821CFR5.408Section 5.408; Determinations concerning the type of valid scientific evidence submitted in a premarket approval application.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-408110Section 5.408section5.408 falseUnited States CodeTitle 21 Section 360c(a)(3)(D)21 U.S.C. 360c(a)(3)(D)id-CFR-2003-title21-vol1-part5-subpartFDeterminations that medical devices present unreasonable risk of substantial harm.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-409.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-409.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-409https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-409https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-409.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-409.xml21 CFR 5.40921CFR5.409Section 5.409; Determinations that medical devices present unreasonable risk of substantial harm.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-409111Section 5.409section5.409 falseUnited States CodeTitle 21 Section 360h(a)21 U.S.C. 360h(a)id-CFR-2003-title21-vol1-part5-subpartFOrders to repair or replace, or make refunds for, medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-410.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-410.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-410https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-410https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-410.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-410.xml21 CFR 5.41021CFR5.410Section 5.410; Orders to repair or replace, or make refunds for, medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-410112Section 5.410section5.410 falseUnited States CodeTitle 21 Section 360h(b)21 U.S.C. 360h(b)id-CFR-2003-title21-vol1-part5-subpartFMedical device recall authority.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-411.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-411.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-411https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-411https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-411.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-411.xml21 CFR 5.41121CFR5.411Section 5.411; Medical device recall authority.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-411113Section 5.411section5.411 falseUnited States CodeTitle 21 Section 360h(e)21 U.S.C. 360h(e)id-CFR-2003-title21-vol1-part5-subpartFTemporary suspension of a medical device application.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-412.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-412.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-412https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-412https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-412.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-412.xml21 CFR 5.41221CFR5.412Section 5.412; Temporary suspension of a medical device application.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-412114Section 5.412section5.412 falseUnited States CodeTitle 21 Section 360e(e)21 U.S.C. 360e(e)id-CFR-2003-title21-vol1-part5-subpartFApproval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-413.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-413.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-413https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-413https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-413.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-413.xml21 CFR 5.41321CFR5.413Section 5.413; Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-413115Section 5.413section5.413 falseUnited States CodeTitle 21 Section 360j(g)Title 21 Section 360j(g)(7)Title 21 Section 360j(y)21 U.S.C. 360j(g)21 U.S.C. 360j(g)(7)21 U.S.C. 360j(y)id-CFR-2003-title21-vol1-part5-subpartFPostmarket surveillance.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-414.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-414.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-414https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-414https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-414.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-414.xml21 CFR 5.41421CFR5.414Section 5.414; Postmarket surveillance.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-414116Section 5.414section5.414 falseid-CFR-2003-title21-vol1-part5-subpartFAuthority relating to medical device reporting procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-415.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-415.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-415https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-415https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-415.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-415.xml21 CFR 5.41521CFR5.415Section 5.415; Authority relating to medical device reporting procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-415117Section 5.415section5.415 falseid-CFR-2003-title21-vol1-part5-subpartFMedical device tracking.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-416.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-416.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-416https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-416https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-416.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-416.xml21 CFR 5.41621CFR5.416Section 5.416; Medical device tracking.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-416118Section 5.416section5.416 falseUnited States CodeTitle 21 Section 360i(e)21 U.S.C. 360i(e)id-CFR-2003-title21-vol1-part5-subpartFAuthority pertaining to accreditation functions for medical devices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-417.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-417.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-417https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-417https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-417.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-417.xml21 CFR 5.41721CFR5.417Section 5.417; Authority pertaining to accreditation functions for medical devices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FMedical Devices and Radiological Health; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-417119Section 5.417section5.417 falseUnited States CodeTitle 21 Section 360c(f)(1)Title 21 Section 360(k)Title 21 Section 360mTitle 21 Section 360m(a)(1)Title 21 Section 360m(a)(2)(B)Title 21 Section 360m(b)(2)(B)Title 21 Section 360m(b)(2)(c)21 U.S.C. 360c(f)(1)21 U.S.C. 360(k)21 U.S.C. 360m21 U.S.C. 360m(a)(1)21 U.S.C. 360m(a)(2)(B)21 U.S.C. 360m(b)(2)(B)21 U.S.C. 360m(b)(2)(c)id-CFR-2003-title21-vol1-part5Animal Drugs; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartG.xml21 CFR G21CFRSubpart G; Animal Drugs; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartG120Subpart GsubpartG falseid-CFR-2003-title21-vol1-part5-subpartGIssuance of Federal Register documents pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical method, and prohibition of certain extralabel drug use.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-500.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-500.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-500https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-500https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-500.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-500.xml21 CFR 5.50021CFR5.500Section 5.500; Issuance of Federal Register documents pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical method, and prohibition of certain extralabel drug use.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GAnimal Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-500121Section 5.500section5.500 falseUnited States CodeTitle 21 Section 360b(a)(4)21 U.S.C. 360b(a)(4)id-CFR-2003-title21-vol1-part5-subpartGApproval of new animal drug applications, medicated feed mill license applications and their supplements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-501.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-501.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-501https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-501https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-501.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-501.xml21 CFR 5.50121CFR5.501Section 5.501; Approval of new animal drug applications, medicated feed mill license applications and their supplements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GAnimal Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-501122Section 5.501section5.501 falseUnited States CodeTitle 21 Section 360bTitle 21 Section 360b(m)21 U.S.C. 360b21 U.S.C. 360b(m)United States Public Law 250 (104th Congress)Public Law 104-250id-CFR-2003-title21-vol1-part5-subpartGIssuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-502.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-502.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-502https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-502https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-502.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-502.xml21 CFR 5.50221CFR5.502Section 5.502; Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GAnimal Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-502123Section 5.502section5.502 falseUnited States CodeTitle 21 Section 360b(m)21 U.S.C. 360b(m)United States Public Law 250 (104th Congress)Public Law 104-250id-CFR-2003-title21-vol1-part5-subpartGSubmission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-503.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-503.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-503https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-503https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-503.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-503.xml21 CFR 5.50321CFR5.503Section 5.503; Submission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GAnimal Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-503124Section 5.503section5.503 falseUnited States CodeTitle 21 Section 360b(b)(1)Title 21 Section 360b(b)(2)Title 21 Section 360b(c)(2)(D)(iv)21 U.S.C. 360b(b)(1)21 U.S.C. 360b(b)(2)21 U.S.C. 360b(c)(2)(D)(iv)id-CFR-2003-title21-vol1-part5-subpartGIssuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new animal drugs and feeds bearing or containing new animal drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-504.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-504.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-504https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-504https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-504.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-504.xml21 CFR 5.50421CFR5.504Section 5.504; Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new animal drugs and feeds bearing or containing new animal drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GAnimal Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-504125Section 5.504section5.504 falseUnited States CodeTitle 21 Section 360b(e)21 U.S.C. 360b(e)id-CFR-2003-title21-vol1-part5-subpartGTermination of exemptions for new drugs for investigational use in animals.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-505.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-505.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-505https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-505https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-505.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-505.xml21 CFR 5.50521CFR5.505Section 5.505; Termination of exemptions for new drugs for investigational use in animals.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GAnimal Drugs; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-505126Section 5.505section5.505 falseid-CFR-2003-title21-vol1-part5Radiation Control; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartH.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartH.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartHhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartHhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartH.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartH.xml21 CFR H21CFRSubpart H; Radiation Control; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartH127Subpart HsubpartH falseid-CFR-2003-title21-vol1-part5-subpartHVariances from performance standards for electronic products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-600.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-600.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-600https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-600https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-600.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-600.xml21 CFR 5.60021CFR5.600Section 5.600; Variances from performance standards for electronic products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-600128Section 5.600section5.600 falseid-CFR-2003-title21-vol1-part5-subpartHExemption of electronic products from performance standards and prohibited acts.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-601.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-601.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-601https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-601https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-601.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-601.xml21 CFR 5.60121CFR5.601Section 5.601; Exemption of electronic products from performance standards and prohibited acts.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-601129Section 5.601section5.601 falseUnited States CodeTitle 21 Section 360kk(a)(5)Title 21 Section 360oo(a)Title 21 Section 360oo(b)21 U.S.C. 360kk(a)(5)21 U.S.C. 360oo(a)21 U.S.C. 360oo(b)id-CFR-2003-title21-vol1-part5-subpartHTesting programs and methods of certification and identification for electronic products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-602.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-602.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-602https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-602https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-602.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-602.xml21 CFR 5.60221CFR5.602Section 5.602; Testing programs and methods of certification and identification for electronic products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-602130Section 5.602section5.602 falseUnited States CodeTitle 21 Section 360kk(g)Title 21 Section 360kk(h)21 U.S.C. 360kk(g)21 U.S.C. 360kk(h)id-CFR-2003-title21-vol1-part5-subpartHNotification of defects in, and repair or replacement of, electronic products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-603.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-603.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-603https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-603https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-603.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-603.xml21 CFR 5.60321CFR5.603Section 5.603; Notification of defects in, and repair or replacement of, electronic products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-603131Section 5.603section5.603 falseUnited States CodeTitle 21 Section 360kkTitle 21 Section 360ll(e)21 U.S.C. 360kk21 U.S.C. 360ll(e)id-CFR-2003-title21-vol1-part5-subpartHManufacturers requirement to provide data to ultimate purchasers of electronic products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-604.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-604.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-604https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-604https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-604.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-604.xml21 CFR 5.60421CFR5.604Section 5.604; Manufacturers requirement to provide data to ultimate purchasers of electronic products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-604132Section 5.604section5.604 falseUnited States CodeTitle 21 Section 360nn(c)21 U.S.C. 360nn(c)id-CFR-2003-title21-vol1-part5-subpartHDealer and distributor direction to provide data to manufacturers of electronic products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-605.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-605.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-605https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-605https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-605.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-605.xml21 CFR 5.60521CFR5.605Section 5.605; Dealer and distributor direction to provide data to manufacturers of electronic products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-605133Section 5.605section5.605 falseUnited States CodeTitle 21 Section 360nn(f)21 U.S.C. 360nn(f)id-CFR-2003-title21-vol1-part5-subpartHAcceptance of assistance from State and Local authorities for enforcement of radiation control legislation and regulations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-606.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-606.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-606https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-606https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-606.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-606.xml21 CFR 5.60621CFR5.606Section 5.606; Acceptance of assistance from State and Local authorities for enforcement of radiation control legislation and regulations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HRadiation Control; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-606134Section 5.606section5.606 falseUnited States CodeTitle 21 Section 360rr21 U.S.C. 360rrid-CFR-2003-title21-vol1-part5Product Designation; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartI.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartI.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartIhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartIhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartI.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartI.xml21 CFR I21CFRSubpart I; Product Designation; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartI135Subpart IsubpartI falseid-CFR-2003-title21-vol1-part5-subpartIAuthority relating to determination of product primary jurisdiction.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-700.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-700.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-700https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-700https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-700.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-700.xml21 CFR 5.70021CFR5.700Section 5.700; Authority relating to determination of product primary jurisdiction.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart IProduct Designation; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-700136Section 5.700section5.700 falseUnited States CodeTitle 21 Section 353(g)Title 21 Section 360bbb-221 U.S.C. 353(g)21 U.S.C. 360bbb-2id-CFR-2003-title21-vol1-part5-subpartIPremarket approval of a product that is or contains a biologic, a device, or a drug.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-701.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-701.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-701https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-701https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-701.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-701.xml21 CFR 5.70121CFR5.701Section 5.701; Premarket approval of a product that is or contains a biologic, a device, or a drug.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart IProduct Designation; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-701137Section 5.701section5.701 falseid-CFR-2003-title21-vol1-part5Imports and Exports; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartJ.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartJ.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartJhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartJhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartJ.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartJ.xml21 CFR J21CFRSubpart J; Imports and Exports; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartJ138Subpart JsubpartJ falseid-CFR-2003-title21-vol1-part5-subpartJImports and exports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-800.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-800.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-800https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-800https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-800.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-800.xml21 CFR 5.80021CFR5.800Section 5.800; Imports and exports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart JImports and Exports; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-800139Section 5.800section5.800 falseUnited States CodeTitle 21 Section 360kkTitle 21 Section 360kk(h)Title 21 Section 360mmTitle 21 Section 360oo(b)Title 21 Section 381Title 21 Section 381(d)(2)Title 21 Section 381(e)21 U.S.C. 360kk21 U.S.C. 360kk(h)21 U.S.C. 360mm21 U.S.C. 360oo(b)21 U.S.C. 38121 U.S.C. 381(d)(2)21 U.S.C. 381(e)United States CodeTitle 42 Section 26542 U.S.C. 265id-CFR-2003-title21-vol1-part5-subpartJExport of unapproved drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-801.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-801.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-801https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-801https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-801.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-801.xml21 CFR 5.80121CFR5.801Section 5.801; Export of unapproved drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart JImports and Exports; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-801140Section 5.801section5.801 falseUnited States CodeTitle 21 Section 382(b)(2)Title 21 Section 382(e)21 U.S.C. 382(b)(2)21 U.S.C. 382(e)United States CodeTitle 42 Section 262(h)42 U.S.C. 262(h)id-CFR-2003-title21-vol1-part5-subpartJManufacturer's resident import agents.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-802.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-802.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-802https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-802https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-802.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-802.xml21 CFR 5.80221CFR5.802Section 5.802; Manufacturer's resident import agents.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart JImports and Exports; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-802141Section 5.802section5.802 falseid-CFR-2003-title21-vol1-part5Orphan Products; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartK.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartK.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartKhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartKhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartK.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartK.xml21 CFR K21CFRSubpart K; Orphan Products; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartK142Subpart KsubpartK falseid-CFR-2003-title21-vol1-part5-subpartKOrphan products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-900.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-900.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-900https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-900https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-900.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-900.xml21 CFR 5.90021CFR5.900Section 5.900; Orphan products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KOrphan Products; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-900143Section 5.900section5.900 falseUnited States CodeTitle 21 Section 360aa(a)Title 21 Section 360bb(a)Title 21 Section 360cc(b)(1)Title 21 Section 360dd21 U.S.C. 360aa(a)21 U.S.C. 360bb(a)21 U.S.C. 360cc(b)(1)21 U.S.C. 360ddid-CFR-2003-title21-vol1-part5Mammography Facilities; Redelegations of AuthorityD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartL.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartL.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartLhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartLhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartL.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartL.xml21 CFR L21CFRSubpart L; Mammography Facilities; Redelegations of AuthorityChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartL144Subpart LsubpartL falseid-CFR-2003-title21-vol1-part5-subpartLAuthority to ensure that mammography facilities meet quality standards.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-1000.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-1000.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1000https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1000https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-1000.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-1000.xml21 CFR 5.100021CFR5.1000Section 5.1000; Authority to ensure that mammography facilities meet quality standards.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart LMammography Facilities; Redelegations of AuthorityPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1000145Section 5.1000section5.1000 falseUnited States CodeTitle 41 Section 263b(e)(6)(A)41 U.S.C. 263b(e)(6)(A)United States CodeTitle 42 Section 263b(b)Title 42 Section 263b(c)Title 42 Section 263b(d)(1)Title 42 Section 263b(e)(1)(A)Title 42 Section 263b(e)(1)(c)Title 42 Section 263b(e)(2)(A)Title 42 Section 263b(e)(2)(B)Title 42 Section 263b(e)(3)Title 42 Section 263b(e)(4)Title 42 Section 263b(g)Title 42 Section 263b(g)(1)Title 42 Section 263b(g)(4)Title 42 Section 263b(h)(2)Title 42 Section 263b(h)(3)Title 42 Section 263b(h)(l)Title 42 Section 263b(i)Title 42 Section 263b(i)(1)Title 42 Section 263b(i)(3)Title 42 Section 263b(l)Title 42 Section 263b(o)42 U.S.C. 263b(b)42 U.S.C. 263b(c)42 U.S.C. 263b(d)(1)42 U.S.C. 263b(e)(1)(A)42 U.S.C. 263b(e)(1)(c)42 U.S.C. 263b(e)(2)(A)42 U.S.C. 263b(e)(2)(B)42 U.S.C. 263b(e)(3)42 U.S.C. 263b(e)(4)42 U.S.C. 263b(g)42 U.S.C. 263b(g)(1)42 U.S.C. 263b(g)(4)42 U.S.C. 263b(h)(2)42 U.S.C. 263b(h)(3)42 U.S.C. 263b(h)(l)42 U.S.C. 263b(i)42 U.S.C. 263b(i)(1)42 U.S.C. 263b(i)(3)42 U.S.C. 263b(l)42 U.S.C. 263b(o)id-CFR-2003-title21-vol1-part5OrganizationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part5-subpartM.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part5-subpartM.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartMhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part5-subpartMhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part5-subpartM.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part5-subpartM.xml21 CFR M21CFRSubpart M; OrganizationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONNODECFR-2003-title21-vol1-part5-subpartM146Subpart MsubpartM falseid-CFR-2003-title21-vol1-part5-subpartMHeadquarters.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-1100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-1100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-1100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-1100.xml21 CFR 5.110021CFR5.1100Section 5.1100; Headquarters.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart MOrganizationPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1100147Section 5.1100section5.1100 66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001falseFederal RegisterVolume 66 Page 3099366 FR 30993Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part5-subpartMChief Counsel, Food and Drug Administration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-1105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-1105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-1105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-1105.xml21 CFR 5.110521CFR5.1105Section 5.1105; Chief Counsel, Food and Drug Administration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart MOrganizationPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1105148Section 5.1105section5.1105 falseid-CFR-2003-title21-vol1-part5-subpartMFood and Drug Administration Public Information Offices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-1110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-1110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-1110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-1110.xml21 CFR 5.111021CFR5.1110Section 5.1110; Food and Drug Administration Public Information Offices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart MOrganizationPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1110149Section 5.1110section5.1110 66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001falseFederal RegisterVolume 66 Page 3099366 FR 30993Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part5-subpartMField structure.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec5-1115.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec5-1115.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1115https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec5-1115https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec5-1115.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec5-1115.xml21 CFR 5.111521CFR5.1115Section 5.1115; Field structure.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart MOrganizationPart 5DELEGATIONS OF AUTHORITY AND ORGANIZATIONCONTENTCFR-2003-title21-vol1-sec5-1115150Section 5.1115section5.1115 falseid-CFR-2003-title21-vol1-chapI-subchapAENFORCEMENT POLICYD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7.xml21 CFR 721CFR7Part 7; ENFORCEMENT POLICYChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part7151Part 7part7 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.falseUnited States CodeTitle 21 Section 321-39321 U.S.C. 321-393United States CodeTitle 42 Section 241Title 42 Section 262Title 42 Section 263b-263nTitle 42 Section 26442 U.S.C. 24142 U.S.C. 26242 U.S.C. 263b-263n42 U.S.C. 264Federal RegisterVolume 42 Page 1556742 FR 15567id-CFR-2003-title21-vol1-part7Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7-toc-id152.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7-toc-id152.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-toc-id152https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-toc-id152https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7-toc-id152.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7-toc-id152.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 7ENFORCEMENT POLICYTOCCFR-2003-title21-vol1-part7-toc-id152152Toctocid-CFR-2003-title21-vol1-part7General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 7ENFORCEMENT POLICYNODECFR-2003-title21-vol1-part7-subpartA153Subpart AsubpartA falseid-CFR-2003-title21-vol1-part7-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-1.xml21 CFR 7.121CFR7.1Section 7.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-1154Section 7.1section7.1 43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000falseUnited States CodeTitle 21 Section 301et seq.21 U.S.C. 301et seq.Federal RegisterVolume 43 Page 2621843 FR 26218Federal RegisterVolume 65 Page 5647665 FR 56476id-CFR-2003-title21-vol1-part7-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-3.xml21 CFR 7.321CFR7.3Section 7.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-3155Section 7.3section7.3 42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, 1979falseFederal RegisterVolume 42 Page 1556742 FR 15567Federal RegisterVolume 43 Page 2621843 FR 26218Federal RegisterVolume 44 Page 1216744 FR 12167id-CFR-2003-title21-vol1-part7-subpartAGuaranty.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-12.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-12.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-12https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-12https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-12.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-12.xml21 CFR 7.1221CFR7.12Section 7.12; Guaranty.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-12156Section 7.12section7.12 falseid-CFR-2003-title21-vol1-part7-subpartASuggested forms of guaranty.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-13.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-13.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-13https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-13https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-13.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-13.xml21 CFR 7.1321CFR7.13Section 7.13; Suggested forms of guaranty.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-13157Section 7.13section7.13 falseid-CFR-2003-title21-vol1-part7ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7-subpartB.xml21 CFR B21CFRSubpart B; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 7ENFORCEMENT POLICYNODECFR-2003-title21-vol1-part7-subpartB158Subpart BsubpartB falseid-CFR-2003-title21-vol1-part7Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7-subpartC.xml21 CFR C21CFRSubpart C; Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 7ENFORCEMENT POLICYNODECFR-2003-title21-vol1-part7-subpartC159Subpart CsubpartC falseFederal RegisterVolume 43 Page 2621843 FR 26218id-CFR-2003-title21-vol1-part7-subpartCRecall policy.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-40.xml21 CFR 7.4021CFR7.40Section 7.40; Recall policy.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-40160Section 7.40section7.40 43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000falseFederal RegisterVolume 43 Page 2621843 FR 26218Federal RegisterVolume 65 Page 5647665 FR 56476id-CFR-2003-title21-vol1-part7-subpartCHealth hazard evaluation and recall classification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-41.xml21 CFR 7.4121CFR7.41Section 7.41; Health hazard evaluation and recall classification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-41161Section 7.41section7.41 falseid-CFR-2003-title21-vol1-part7-subpartCRecall strategy.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-42.xml21 CFR 7.4221CFR7.42Section 7.42; Recall strategy.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-42162Section 7.42section7.42 43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, 1994falseFederal RegisterVolume 43 Page 2621843 FR 26218Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 59 Page 1436359 FR 14363id-CFR-2003-title21-vol1-part7-subpartCFood and Drug Administration-requested recall.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-45.xml21 CFR 7.4521CFR7.45Section 7.45; Food and Drug Administration-requested recall.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-45163Section 7.45section7.45 falseid-CFR-2003-title21-vol1-part7-subpartCFirm-initiated recall.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-46.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-46.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-46https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-46https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-46.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-46.xml21 CFR 7.4621CFR7.46Section 7.46; Firm-initiated recall.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-46164Section 7.46section7.46 falseid-CFR-2003-title21-vol1-part7-subpartCRecall communications.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-49.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-49.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-49https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-49https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-49.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-49.xml21 CFR 7.4921CFR7.49Section 7.49; Recall communications.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-49165Section 7.49section7.49 falseid-CFR-2003-title21-vol1-part7-subpartCPublic notification of recall.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-50.xml21 CFR 7.5021CFR7.50Section 7.50; Public notification of recall.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-50166Section 7.50section7.50 falseid-CFR-2003-title21-vol1-part7-subpartCRecall status reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-53.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-53.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-53https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-53https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-53.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-53.xml21 CFR 7.5321CFR7.53Section 7.53; Recall status reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-53167Section 7.53section7.53 falseid-CFR-2003-title21-vol1-part7-subpartCTermination of a recall.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-55.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-55.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-55https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-55https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-55.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-55.xml21 CFR 7.5521CFR7.55Section 7.55; Termination of a recall.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-55168Section 7.55section7.55 falseid-CFR-2003-title21-vol1-part7-subpartCGeneral industry guidance.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-59.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-59.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-59https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-59https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-59.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-59.xml21 CFR 7.5921CFR7.59Section 7.59; General industry guidance.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry ResponsibilitiesPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-59169Section 7.59section7.59 falseid-CFR-2003-title21-vol1-part7ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7-subpartD.xml21 CFR D21CFRSubpart D; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 7ENFORCEMENT POLICYNODECFR-2003-title21-vol1-part7-subpartD170Subpart DsubpartD falseid-CFR-2003-title21-vol1-part7Criminal ViolationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part7-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part7-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part7-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part7-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part7-subpartE.xml21 CFR E21CFRSubpart E; Criminal ViolationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 7ENFORCEMENT POLICYNODECFR-2003-title21-vol1-part7-subpartE171Subpart EsubpartE falseid-CFR-2003-title21-vol1-part7-subpartEOpportunity for presentation of views before report of criminal violation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-84.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-84.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-84https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-84https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-84.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-84.xml21 CFR 7.8421CFR7.84Section 7.84; Opportunity for presentation of views before report of criminal violation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ECriminal ViolationsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-84172Section 7.84section7.84 44 FR 12167, Mar. 6, 1979falseFederal RegisterVolume 44 Page 1216744 FR 12167id-CFR-2003-title21-vol1-part7-subpartEConduct of a presentation of views before report of criminal violation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-85.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-85.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-85https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-85https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-85.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-85.xml21 CFR 7.8521CFR7.85Section 7.85; Conduct of a presentation of views before report of criminal violation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ECriminal ViolationsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-85173Section 7.85section7.85 44 FR 12168, Mar. 6, 1979falseUnited States CodeTitle 21 Section 333(c)21 U.S.C. 333(c)Federal RegisterVolume 44 Page 1216844 FR 12168id-CFR-2003-title21-vol1-part7-subpartERecords related to opportunities for presentation of views conducted before report of criminal violation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec7-87.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec7-87.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-87https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec7-87https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec7-87.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec7-87.xml21 CFR 7.8721CFR7.87Section 7.87; Records related to opportunities for presentation of views conducted before report of criminal violation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ECriminal ViolationsPart 7ENFORCEMENT POLICYCONTENTCFR-2003-title21-vol1-sec7-87174Section 7.87section7.87 44 FR 12168, Mar. 6, 1979falseFederal RegisterVolume 44 Page 1216844 FR 12168id-CFR-2003-title21-vol1-chapI-subchapAADMINISTRATIVE PRACTICES AND PROCEDURESD09002ee18a5cbbf0-CFR-2003-title21-vol1-part10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part10.xml21 CFR 1021CFR10Part 10; ADMINISTRATIVE PRACTICES AND PROCEDURESChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part10175Part 10part10 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.falseUnited States CodeTitle 5 Section 551-558Title 5 Section 701-7065 U.S.C. 551-5585 U.S.C. 701-706United States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 1034Title 21 Section 141-149Title 21 Section 321-397Title 21 Section 467fTitle 21 Section 679Title 21 Section 82121 U.S.C. 103421 U.S.C. 141-14921 U.S.C. 321-39721 U.S.C. 467f21 U.S.C. 67921 U.S.C. 821United States CodeTitle 28 Section 211228 U.S.C. 2112United States CodeTitle 42 Section 201Title 42 Section 262Title 42 Section 263bTitle 42 Section 26442 U.S.C. 20142 U.S.C. 26242 U.S.C. 263b42 U.S.C. 264Federal RegisterVolume 44 Page 2232344 FR 22323id-CFR-2003-title21-vol1-part10Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part10-toc-id176.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part10-toc-id176.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-toc-id176https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-toc-id176https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part10-toc-id176.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part10-toc-id176.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESTOCCFR-2003-title21-vol1-part10-toc-id176176Toctocid-CFR-2003-title21-vol1-part10General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part10-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part10-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part10-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part10-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESNODECFR-2003-title21-vol1-part10-subpartA177Subpart AsubpartA falseid-CFR-2003-title21-vol1-part10-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-1.xml21 CFR 10.121CFR10.1Section 10.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-1178Section 10.1section10.1 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 54 Page 903454 FR 9034id-CFR-2003-title21-vol1-part10-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-3.xml21 CFR 10.321CFR10.3Section 10.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-3179Section 10.3section10.3 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 FR 8994, Mar. 6, 1985; 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28, 1994falseUnited States CodeTitle 5 Section 31055 U.S.C. 3105Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 50 Page 899450 FR 8994Federal RegisterVolume 54 Page 688654 FR 6886Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 59 Page 1436359 FR 14363id-CFR-2003-title21-vol1-part10-subpartASummaries of administrative practices and procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-10.xml21 CFR 10.1021CFR10.10Section 10.10; Summaries of administrative practices and procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-10180Section 10.10section10.10 falseid-CFR-2003-title21-vol1-part10-subpartAWaiver, suspension, or modification of procedural requirements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-19.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-19.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-19https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-19https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-19.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-19.xml21 CFR 10.1921CFR10.19Section 10.19; Waiver, suspension, or modification of procedural requirements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-19181Section 10.19section10.19 falseid-CFR-2003-title21-vol1-part10General Administrative ProceduresD09002ee18a5cbbf0-CFR-2003-title21-vol1-part10-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part10-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part10-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part10-subpartB.xml21 CFR B21CFRSubpart B; General Administrative ProceduresChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESNODECFR-2003-title21-vol1-part10-subpartB182Subpart BsubpartB falseid-CFR-2003-title21-vol1-part10-subpartBSubmission of documents to Dockets Management Branch; computation of time; availability for public disclosure.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-20.xml21 CFR 10.2021CFR10.20Section 10.20; Submission of documents to Dockets Management Branch; computation of time; availability for public disclosure.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-20183Section 10.20section10.20 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 49 FR 7363, Feb. 29, 1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28, 1994; 64 FR 69190, Dec. 10, 1999; 65 FR 56477, Sept. 19, 2000; 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001falseUnited States CodeTitle 18 Section 100118 U.S.C. 1001Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 49 Page 736349 FR 7363Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 59 Page 1436359 FR 14363Federal RegisterVolume 64 Page 6919064 FR 69190Federal RegisterVolume 65 Page 5647765 FR 56477Federal RegisterVolume 66 Page 5603566 FR 56035Federal RegisterVolume 66 Page 6674266 FR 66742id-CFR-2003-title21-vol1-part10-subpartBInitiation of administrative proceedings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-25.xml21 CFR 10.2521CFR10.25Section 10.25; Initiation of administrative proceedings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-25184Section 10.25section10.25 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 54 Page 903454 FR 9034id-CFR-2003-title21-vol1-part10-subpartBCitizen petition.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-30.xml21 CFR 10.3021CFR10.30Section 10.30; Citizen petition.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-30185Section 10.30section10.30 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001falseCode of Federal RegulationsTitle 1 Part 5.101 CFR Part 5.10Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 57 Page 1798057 FR 17980Federal RegisterVolume 59 Page 1436459 FR 14364Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 66 Page 1284866 FR 12848Federal RegisterVolume 66 Page 646766 FR 6467id-CFR-2003-title21-vol1-part10-subpartBAdministrative reconsideration of action.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-33.xml21 CFR 10.3321CFR10.33Section 10.33; Administrative reconsideration of action.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-33186Section 10.33section10.33 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 59 Page 1436459 FR 14364Federal RegisterVolume 66 Page 1284866 FR 12848Federal RegisterVolume 66 Page 646766 FR 6467id-CFR-2003-title21-vol1-part10-subpartBAdministrative stay of action.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-35.xml21 CFR 10.3521CFR10.35Section 10.35; Administrative stay of action.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-35187Section 10.35section10.35 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54 FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 59 Page 1436459 FR 14364Federal RegisterVolume 66 Page 1284866 FR 12848Federal RegisterVolume 66 Page 646866 FR 6468id-CFR-2003-title21-vol1-part10-subpartBPromulgation of regulations for the efficient enforcement of the law.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-40.xml21 CFR 10.4021CFR10.40Section 10.40; Promulgation of regulations for the efficient enforcement of the law.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-40188Section 10.40section10.40 44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001falseUnited States CodeTitle 5 Section 551Title 5 Section 552Title 5 Section 5535 U.S.C. 5515 U.S.C. 5525 U.S.C. 553Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 52 Page 3640152 FR 36401Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 56 Page 1375856 FR 13758Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 66 Page 1284866 FR 12848Federal RegisterVolume 66 Page 646866 FR 6468id-CFR-2003-title21-vol1-part10-subpartBCourt review of final administrative action; exhaustion of administrative remedies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-45.xml21 CFR 10.4521CFR10.45Section 10.45; Court review of final administrative action; exhaustion of administrative remedies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-45189Section 10.45section10.45 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 65 FR 56477, Sept. 19, 2000falseUnited States CodeTitle 5 Section 701et seq.5 U.S.C. 701et seq.United States CodeTitle 28 Section 1404(a)Title 28 Section 2112(a)Title 28 Section 220128 U.S.C. 1404(a)28 U.S.C. 2112(a)28 U.S.C. 2201Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 54 Page 688654 FR 6886Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 57 Page 1798057 FR 17980Federal RegisterVolume 65 Page 5647765 FR 56477id-CFR-2003-title21-vol1-part10-subpartBPromulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-50.xml21 CFR 10.5021CFR10.50Section 10.50; Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-50190Section 10.50section10.50 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58 FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May 13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR 4906, Feb. 1, 2002falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 54 Page 903454 FR 9034Federal RegisterVolume 58 Page 4919058 FR 49190Federal RegisterVolume 60 Page 3862660 FR 38626Federal RegisterVolume 63 Page 2669763 FR 26697Federal RegisterVolume 64 Page 39864 FR 398Federal RegisterVolume 64 Page 5644864 FR 56448Federal RegisterVolume 67 Page 490667 FR 4906id-CFR-2003-title21-vol1-part10-subpartBSeparation of functions; ex parte communications.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-55.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-55.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-55https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-55https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-55.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-55.xml21 CFR 10.5521CFR10.55Section 10.55; Separation of functions; ex parte communications.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-55191Section 10.55section10.55 44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 50 Page 899450 FR 8994Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 64 Page 39864 FR 398id-CFR-2003-title21-vol1-part10-subpartBReferral by court.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-60.xml21 CFR 10.6021CFR10.60Section 10.60; Referral by court.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-60192Section 10.60section10.60 falseid-CFR-2003-title21-vol1-part10-subpartBMeetings and correspondence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-65.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-65.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-65https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-65https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-65.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-65.xml21 CFR 10.6521CFR10.65Section 10.65; Meetings and correspondence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-65193Section 10.65section10.65 66 FR 6468, Jan. 22, 2001falseFederal RegisterVolume 66 Page 646866 FR 6468id-CFR-2003-title21-vol1-part10-subpartBDocumentation of significant decisions in administrative file.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-70.xml21 CFR 10.7021CFR10.70Section 10.70; Documentation of significant decisions in administrative file.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-70194Section 10.70section10.70 falseid-CFR-2003-title21-vol1-part10-subpartBInternal agency review of decisions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-75.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-75.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-75https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-75https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-75.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-75.xml21 CFR 10.7521CFR10.75Section 10.75; Internal agency review of decisions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-75195Section 10.75section10.75 44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63 FR 63982, Nov. 18, 1998falseUnited States CodeTitle 42 Section 26242 U.S.C. 262Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 50 Page 899450 FR 8994Federal RegisterVolume 63 Page 6398263 FR 63982id-CFR-2003-title21-vol1-part10-subpartBDissemination of draft Federal Register notices and regulations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-80.xml21 CFR 10.8021CFR10.80Section 10.80; Dissemination of draft Federal Register notices and regulations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-80196Section 10.80section10.80 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999falseUnited States CodeTitle 42 Section 263f42 U.S.C. 263fFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 64 Page 39864 FR 398id-CFR-2003-title21-vol1-part10-subpartBAdvisory opinions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-85.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-85.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-85https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-85https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-85.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-85.xml21 CFR 10.8521CFR10.85Section 10.85; Advisory opinions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-85197Section 10.85section10.85 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 65 FR 56477, Sept. 19, 2000falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 59 Page 1436459 FR 14364Federal RegisterVolume 65 Page 5647765 FR 56477id-CFR-2003-title21-vol1-part10-subpartBFood and Drug Administration regulations, recommendations, and agreements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-90.xml21 CFR 10.9021CFR10.90Section 10.90; Food and Drug Administration regulations, recommendations, and agreements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-90198Section 10.90section10.90 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 FR 56477, Sept. 19, 2000falseUnited States CodeTitle 42 Section 243Title 42 Section 263d(b)42 U.S.C. 24342 U.S.C. 263d(b)Federal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 65 Page 5647765 FR 56477id-CFR-2003-title21-vol1-part10-subpartBParticipation in outside standard-setting activities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-95.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-95.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-95https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-95https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-95.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-95.xml21 CFR 10.9521CFR10.95Section 10.95; Participation in outside standard-setting activities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-95199Section 10.95section10.95 44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 52 FR 35064, Sept. 17, 1987; 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2232344 FR 22323Federal RegisterVolume 46 Page 845546 FR 8455Federal RegisterVolume 52 Page 3506452 FR 35064Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part10-subpartBPublic calendar.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-100.xml21 CFR 10.10021CFR10.100Section 10.100; Public calendar.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-100200Section 10.100section10.100 66 FR 6468, Jan. 22, 2001falseFederal RegisterVolume 66 Page 646866 FR 6468id-CFR-2003-title21-vol1-part10-subpartBRepresentation by an organization.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-105.xml21 CFR 10.10521CFR10.105Section 10.105; Representation by an organization.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-105201Section 10.105section10.105 falseid-CFR-2003-title21-vol1-part10-subpartBSettlement proposals.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-110.xml21 CFR 10.11021CFR10.110Section 10.110; Settlement proposals.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-110202Section 10.110section10.110 falseid-CFR-2003-title21-vol1-part10-subpartBGood guidance practices.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-115.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-115.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-115https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-115https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-115.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-115.xml21 CFR 10.11521CFR10.115Section 10.115; Good guidance practices.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral Administrative ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-115203Section 10.115section10.115 65 FR 56477, Sept. 19, 2000falseFederal RegisterVolume 65 Page 5647765 FR 56477id-CFR-2003-title21-vol1-part10Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresD09002ee18a5cbbf0-CFR-2003-title21-vol1-part10-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part10-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part10-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part10-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part10-subpartC.xml21 CFR C21CFRSubpart C; Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESNODECFR-2003-title21-vol1-part10-subpartC204Subpart CsubpartC falseFederal RegisterVolume 49 Page 1472649 FR 14726id-CFR-2003-title21-vol1-part10-subpartCScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-200.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-200.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-200https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-200https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-200.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-200.xml21 CFR 10.20021CFR10.200Section 10.200; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-200205Section 10.200section10.200 falseid-CFR-2003-title21-vol1-part10-subpartCDefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-203.xml21 CFR 10.20321CFR10.203Section 10.203; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-203206Section 10.203section10.203 49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 49 Page 1472649 FR 14726Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part10-subpartCGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-204.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-204.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-204https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-204https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-204.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-204.xml21 CFR 10.20421CFR10.204Section 10.204; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-204207Section 10.204section10.204 falseid-CFR-2003-title21-vol1-part10-subpartCElectronic media coverage of public administrative proceedings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-205.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-205.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-205https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-205https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-205.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-205.xml21 CFR 10.20521CFR10.205Section 10.205; Electronic media coverage of public administrative proceedings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-205208Section 10.205section10.205 falseid-CFR-2003-title21-vol1-part10-subpartCProcedures for electronic media coverage of agency public administrative proceedings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec10-206.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec10-206.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-206https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec10-206https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec10-206.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec10-206.xml21 CFR 10.20621CFR10.206Section 10.206; Procedures for electronic media coverage of agency public administrative proceedings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and ProceduresPart 10ADMINISTRATIVE PRACTICES AND PROCEDURESCONTENTCFR-2003-title21-vol1-sec10-206209Section 10.206section10.206 49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 49 Page 1472649 FR 14726Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-chapI-subchapAELECTRONIC RECORDS; ELECTRONIC SIGNATURESD09002ee18a5cbbf0-CFR-2003-title21-vol1-part11.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part11.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part11.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part11.xml21 CFR 1121CFR11Part 11; ELECTRONIC RECORDS; ELECTRONIC SIGNATURESChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part11210Part 11part11 21 U.S.C. 321-393; 42 U.S.C. 262.falseUnited States CodeTitle 21 Section 321-39321 U.S.C. 321-393United States CodeTitle 42 Section 26242 U.S.C. 262Federal RegisterVolume 62 Page 1346462 FR 13464id-CFR-2003-title21-vol1-part11Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part11-toc-id211.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part11-toc-id211.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-toc-id211https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-toc-id211https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part11-toc-id211.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part11-toc-id211.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESTOCCFR-2003-title21-vol1-part11-toc-id211211Toctocid-CFR-2003-title21-vol1-part11General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part11-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part11-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part11-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part11-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESNODECFR-2003-title21-vol1-part11-subpartA212Subpart AsubpartA falseid-CFR-2003-title21-vol1-part11-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-1.xml21 CFR 11.121CFR11.1Section 11.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-1213Section 11.1section11.1 falseid-CFR-2003-title21-vol1-part11-subpartAImplementation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-2.xml21 CFR 11.221CFR11.2Section 11.2; Implementation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-2214Section 11.2section11.2 falseid-CFR-2003-title21-vol1-part11-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-3.xml21 CFR 11.321CFR11.3Section 11.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-3215Section 11.3section11.3 falseUnited States CodeTitle 21 Section 321-39321 U.S.C. 321-393id-CFR-2003-title21-vol1-part11Electronic RecordsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part11-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part11-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part11-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part11-subpartB.xml21 CFR B21CFRSubpart B; Electronic RecordsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESNODECFR-2003-title21-vol1-part11-subpartB216Subpart BsubpartB falseid-CFR-2003-title21-vol1-part11-subpartBControls for closed systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-10.xml21 CFR 11.1021CFR11.10Section 11.10; Controls for closed systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BElectronic RecordsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-10217Section 11.10section11.10 falseid-CFR-2003-title21-vol1-part11-subpartBControls for open systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-30.xml21 CFR 11.3021CFR11.30Section 11.30; Controls for open systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BElectronic RecordsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-30218Section 11.30section11.30 falseid-CFR-2003-title21-vol1-part11-subpartBSignature manifestations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-50.xml21 CFR 11.5021CFR11.50Section 11.50; Signature manifestations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BElectronic RecordsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-50219Section 11.50section11.50 falseid-CFR-2003-title21-vol1-part11-subpartBSignature/record linking.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-70.xml21 CFR 11.7021CFR11.70Section 11.70; Signature/record linking.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BElectronic RecordsPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-70220Section 11.70section11.70 falseid-CFR-2003-title21-vol1-part11Electronic SignaturesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part11-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part11-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part11-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part11-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part11-subpartC.xml21 CFR C21CFRSubpart C; Electronic SignaturesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESNODECFR-2003-title21-vol1-part11-subpartC221Subpart CsubpartC falseid-CFR-2003-title21-vol1-part11-subpartCGeneral requirements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-100.xml21 CFR 11.10021CFR11.100Section 11.100; General requirements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic SignaturesPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-100222Section 11.100section11.100 falseid-CFR-2003-title21-vol1-part11-subpartCElectronic signature components and controls.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-200.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-200.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-200https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-200https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-200.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-200.xml21 CFR 11.20021CFR11.200Section 11.200; Electronic signature components and controls.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic SignaturesPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-200223Section 11.200section11.200 falseid-CFR-2003-title21-vol1-part11-subpartCControls for identification codes/passwords.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec11-300.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec11-300.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-300https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec11-300https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec11-300.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec11-300.xml21 CFR 11.30021CFR11.300Section 11.300; Controls for identification codes/passwords.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CElectronic SignaturesPart 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURESCONTENTCFR-2003-title21-vol1-sec11-300224Section 11.300section11.300 falseid-CFR-2003-title21-vol1-chapI-subchapAFORMAL EVIDENTIARY PUBLIC HEARINGD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12.xml21 CFR 1221CFR12Part 12; FORMAL EVIDENTIARY PUBLIC HEARINGChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part12225Part 12part12 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.falseUnited States CodeTitle 5 Section 551-558Title 5 Section 701-7215 U.S.C. 551-5585 U.S.C. 701-721United States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 1034Title 21 Section 141-149Title 21 Section 321-393Title 21 Section 467fTitle 21 Section 679Title 21 Section 82121 U.S.C. 103421 U.S.C. 141-14921 U.S.C. 321-39321 U.S.C. 467f21 U.S.C. 67921 U.S.C. 821United States CodeTitle 28 Section 211228 U.S.C. 2112United States CodeTitle 42 Section 201Title 42 Section 262Title 42 Section 263b-263nTitle 42 Section 26442 U.S.C. 20142 U.S.C. 26242 U.S.C. 263b-263n42 U.S.C. 264Federal RegisterVolume 44 Page 2233944 FR 22339id-CFR-2003-title21-vol1-part12Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-toc-id226.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-toc-id226.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-toc-id226https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-toc-id226https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-toc-id226.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-toc-id226.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGTOCCFR-2003-title21-vol1-part12-toc-id226226Toctocid-CFR-2003-title21-vol1-part12General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartA227Subpart AsubpartA falseid-CFR-2003-title21-vol1-part12-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-1.xml21 CFR 12.121CFR12.1Section 12.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-1228Section 12.1section12.1 falseid-CFR-2003-title21-vol1-part12Initiation of ProceedingsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartB.xml21 CFR B21CFRSubpart B; Initiation of ProceedingsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartB229Subpart BsubpartB falseid-CFR-2003-title21-vol1-part12-subpartBInitiation of a hearing involving the issuance, amendment, or revocation of a regulation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-20.xml21 CFR 12.2021CFR12.20Section 12.20; Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-20230Section 12.20section12.20 44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part12-subpartBInitiation of a hearing involving the issuance, amendment, or revocation of an order.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-21.xml21 CFR 12.2121CFR12.21Section 12.21; Initiation of a hearing involving the issuance, amendment, or revocation of an order.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-21231Section 12.21section12.21 44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982; 54 FR 9035, Mar. 3, 1989falseUnited States CodeTitle 5 Section 504Title 5 Section 504note5 U.S.C. 5045 U.S.C. 504noteCode of Federal RegulationsTitle 5 Part 135 CFR Part 13Federal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 47 Page 2573447 FR 25734Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part12-subpartBFiling objections and requests for a hearing on a regulation or order.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-22.xml21 CFR 12.2221CFR12.22Section 12.22; Filing objections and requests for a hearing on a regulation or order.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-22232Section 12.22section12.22 44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10, 1999falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 64 Page 6919064 FR 69190id-CFR-2003-title21-vol1-part12-subpartBNotice of filing of objections.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-23.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-23.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-23https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-23https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-23.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-23.xml21 CFR 12.2321CFR12.23Section 12.23; Notice of filing of objections.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-23233Section 12.23section12.23 falseid-CFR-2003-title21-vol1-part12-subpartBRuling on objections and requests for hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-24.xml21 CFR 12.2421CFR12.24Section 12.24; Ruling on objections and requests for hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-24234Section 12.24section12.24 44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part12-subpartBModification or revocation of regulation or order.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-26.xml21 CFR 12.2621CFR12.26Section 12.26; Modification or revocation of regulation or order.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-26235Section 12.26section12.26 falseid-CFR-2003-title21-vol1-part12-subpartBDenial of hearing in whole or in part.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-28.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-28.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-28https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-28https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-28.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-28.xml21 CFR 12.2821CFR12.28Section 12.28; Denial of hearing in whole or in part.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-28236Section 12.28section12.28 falseUnited States CodeTitle 28 Section 2112(a)28 U.S.C. 2112(a)id-CFR-2003-title21-vol1-part12-subpartBJudicial review after waiver of hearing on a regulation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-30.xml21 CFR 12.3021CFR12.30Section 12.30; Judicial review after waiver of hearing on a regulation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-30237Section 12.30section12.30 falseid-CFR-2003-title21-vol1-part12-subpartBRequest for alternative form of hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-32.xml21 CFR 12.3221CFR12.32Section 12.32; Request for alternative form of hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-32238Section 12.32section12.32 falseid-CFR-2003-title21-vol1-part12-subpartBNotice of hearing; stay of action.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-35.xml21 CFR 12.3521CFR12.35Section 12.35; Notice of hearing; stay of action.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-35239Section 12.35section12.35 44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 47 Page 2637547 FR 26375id-CFR-2003-title21-vol1-part12-subpartBEffective date of a regulation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-37.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-37.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-37https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-37https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-37.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-37.xml21 CFR 12.3721CFR12.37Section 12.37; Effective date of a regulation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-37240Section 12.37section12.37 falseid-CFR-2003-title21-vol1-part12-subpartBEffective date of an order.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-38.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-38.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-38https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-38https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-38.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-38.xml21 CFR 12.3821CFR12.38Section 12.38; Effective date of an order.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-38241Section 12.38section12.38 falseid-CFR-2003-title21-vol1-part12Appearance and ParticipationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartC.xml21 CFR C21CFRSubpart C; Appearance and ParticipationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartC242Subpart CsubpartC falseid-CFR-2003-title21-vol1-part12-subpartCAppearance.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-40.xml21 CFR 12.4021CFR12.40Section 12.40; Appearance.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CAppearance and ParticipationPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-40243Section 12.40section12.40 falseid-CFR-2003-title21-vol1-part12-subpartCNotice of participation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-45.xml21 CFR 12.4521CFR12.45Section 12.45; Notice of participation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CAppearance and ParticipationPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-45244Section 12.45section12.45 44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994falseCode of Federal RegulationsTitle 1 Part 12.85,1 CFR Part 12.85,Code of Federal RegulationsTitle 1 Part 13.251 CFR Part 13.25Code of Federal RegulationsTitle 1 Part 121 CFR Part 12Federal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 46 Page 845646 FR 8456Federal RegisterVolume 59 Page 1436459 FR 14364id-CFR-2003-title21-vol1-part12-subpartCAdvice on public participation in hearings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-50.xml21 CFR 12.5021CFR12.50Section 12.50; Advice on public participation in hearings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CAppearance and ParticipationPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-50245Section 12.50section12.50 44 FR 22329, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989; 58 FR 17096, Apr. 1, 1993falseFederal RegisterVolume 44 Page 2232944 FR 22329Federal RegisterVolume 50 Page 899450 FR 8994Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 58 Page 1709658 FR 17096id-CFR-2003-title21-vol1-part12Presiding OfficerD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartD.xml21 CFR D21CFRSubpart D; Presiding OfficerChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartD246Subpart DsubpartD falseid-CFR-2003-title21-vol1-part12-subpartDPresiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-60.xml21 CFR 12.6021CFR12.60Section 12.60; Presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPresiding OfficerPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-60247Section 12.60section12.60 falseUnited States CodeTitle 5 Section 31055 U.S.C. 3105id-CFR-2003-title21-vol1-part12-subpartDCommencement of functions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-62.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-62.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-62https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-62https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-62.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-62.xml21 CFR 12.6221CFR12.62Section 12.62; Commencement of functions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPresiding OfficerPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-62248Section 12.62section12.62 falseid-CFR-2003-title21-vol1-part12-subpartDAuthority of presiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-70.xml21 CFR 12.7021CFR12.70Section 12.70; Authority of presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPresiding OfficerPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-70249Section 12.70section12.70 falseid-CFR-2003-title21-vol1-part12-subpartDDisqualification of presiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-75.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-75.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-75https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-75https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-75.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-75.xml21 CFR 12.7521CFR12.75Section 12.75; Disqualification of presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPresiding OfficerPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-75250Section 12.75section12.75 falseid-CFR-2003-title21-vol1-part12-subpartDUnavailability of presiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-78.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-78.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-78https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-78https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-78.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-78.xml21 CFR 12.7821CFR12.78Section 12.78; Unavailability of presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPresiding OfficerPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-78251Section 12.78section12.78 falseid-CFR-2003-title21-vol1-part12Hearing ProceduresD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartE.xml21 CFR E21CFRSubpart E; Hearing ProceduresChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartE252Subpart EsubpartE falseid-CFR-2003-title21-vol1-part12-subpartEFiling and service of submissions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-80.xml21 CFR 12.8021CFR12.80Section 12.80; Filing and service of submissions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-80253Section 12.80section12.80 falseid-CFR-2003-title21-vol1-part12-subpartEPetition to participate in forma pauperis.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-82.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-82.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-82https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-82https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-82.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-82.xml21 CFR 12.8221CFR12.82Section 12.82; Petition to participate in forma pauperis.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-82254Section 12.82section12.82 falseid-CFR-2003-title21-vol1-part12-subpartEAdvisory opinions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-83.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-83.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-83https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-83https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-83.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-83.xml21 CFR 12.8321CFR12.83Section 12.83; Advisory opinions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-83255Section 12.83section12.83 falseid-CFR-2003-title21-vol1-part12-subpartEDisclosure of data and information by the participants.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-85.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-85.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-85https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-85https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-85.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-85.xml21 CFR 12.8521CFR12.85Section 12.85; Disclosure of data and information by the participants.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-85256Section 12.85section12.85 44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part12-subpartEPurpose; oral and written testimony; burden of proof.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-87.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-87.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-87https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-87https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-87.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-87.xml21 CFR 12.8721CFR12.87Section 12.87; Purpose; oral and written testimony; burden of proof.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-87257Section 12.87section12.87 44 FR 22339, Apr. 13, 1979 as amended at 64 FR 399, Jan. 5, 1999falseUnited States CodeTitle 5 Section 556(d)5 U.S.C. 556(d)Federal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part12-subpartEParticipation of nonparties.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-89.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-89.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-89https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-89https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-89.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-89.xml21 CFR 12.8921CFR12.89Section 12.89; Participation of nonparties.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-89258Section 12.89section12.89 44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 48 Page 5177048 FR 51770id-CFR-2003-title21-vol1-part12-subpartEConduct at oral hearings or conferences.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-90.xml21 CFR 12.9021CFR12.90Section 12.90; Conduct at oral hearings or conferences.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-90259Section 12.90section12.90 falseid-CFR-2003-title21-vol1-part12-subpartETime and place of prehearing conference.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-91.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-91.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-91https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-91https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-91.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-91.xml21 CFR 12.9121CFR12.91Section 12.91; Time and place of prehearing conference.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-91260Section 12.91section12.91 falseid-CFR-2003-title21-vol1-part12-subpartEPrehearing conference procedure.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-92.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-92.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-92https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-92https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-92.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-92.xml21 CFR 12.9221CFR12.92Section 12.92; Prehearing conference procedure.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-92261Section 12.92section12.92 falseid-CFR-2003-title21-vol1-part12-subpartESummary decisions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-93.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-93.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-93https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-93https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-93.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-93.xml21 CFR 12.9321CFR12.93Section 12.93; Summary decisions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-93262Section 12.93section12.93 falseid-CFR-2003-title21-vol1-part12-subpartEReceipt of evidence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-94.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-94.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-94https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-94https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-94.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-94.xml21 CFR 12.9421CFR12.94Section 12.94; Receipt of evidence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-94263Section 12.94section12.94 falseid-CFR-2003-title21-vol1-part12-subpartEOfficial notice.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-95.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-95.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-95https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-95https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-95.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-95.xml21 CFR 12.9521CFR12.95Section 12.95; Official notice.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-95264Section 12.95section12.95 falseid-CFR-2003-title21-vol1-part12-subpartEBriefs and arguments.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-96.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-96.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-96https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-96https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-96.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-96.xml21 CFR 12.9621CFR12.96Section 12.96; Briefs and arguments.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-96265Section 12.96section12.96 falseid-CFR-2003-title21-vol1-part12-subpartEInterlocutory appeal from ruling of presiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-97.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-97.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-97https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-97https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-97.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-97.xml21 CFR 12.9721CFR12.97Section 12.97; Interlocutory appeal from ruling of presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-97266Section 12.97section12.97 falseid-CFR-2003-title21-vol1-part12-subpartEOfficial transcript.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-98.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-98.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-98https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-98https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-98.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-98.xml21 CFR 12.9821CFR12.98Section 12.98; Official transcript.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-98267Section 12.98section12.98 falseid-CFR-2003-title21-vol1-part12-subpartEMotions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-99.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-99.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-99https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-99https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-99.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-99.xml21 CFR 12.9921CFR12.99Section 12.99; Motions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EHearing ProceduresPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-99268Section 12.99section12.99 falseid-CFR-2003-title21-vol1-part12Administrative RecordD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartF.xml21 CFR F21CFRSubpart F; Administrative RecordChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartF269Subpart FsubpartF falseid-CFR-2003-title21-vol1-part12-subpartFAdministrative record of a hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-100.xml21 CFR 12.10021CFR12.100Section 12.100; Administrative record of a hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAdministrative RecordPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-100270Section 12.100section12.100 falseid-CFR-2003-title21-vol1-part12-subpartFExamination of record.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-105.xml21 CFR 12.10521CFR12.105Section 12.105; Examination of record.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAdministrative RecordPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-105271Section 12.105section12.105 falseid-CFR-2003-title21-vol1-part12Initial and Final DecisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartG.xml21 CFR G21CFRSubpart G; Initial and Final DecisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartG272Subpart GsubpartG falseid-CFR-2003-title21-vol1-part12-subpartGInitial decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-120.xml21 CFR 12.12021CFR12.120Section 12.120; Initial decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GInitial and Final DecisionsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-120273Section 12.120section12.120 falseid-CFR-2003-title21-vol1-part12-subpartGAppeal from or review of initial decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-125.xml21 CFR 12.12521CFR12.125Section 12.125; Appeal from or review of initial decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GInitial and Final DecisionsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-125274Section 12.125section12.125 44 FR 22339, Apr. 13, 1979, as amended at 53 FR 29453, Aug. 5, 1988falseFederal RegisterVolume 44 Page 2233944 FR 22339Federal RegisterVolume 53 Page 2945353 FR 29453id-CFR-2003-title21-vol1-part12-subpartGDecision by Commissioner on appeal or review of initial decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-130.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-130.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-130https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-130https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-130.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-130.xml21 CFR 12.13021CFR12.130Section 12.130; Decision by Commissioner on appeal or review of initial decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GInitial and Final DecisionsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-130275Section 12.130section12.130 falseid-CFR-2003-title21-vol1-part12-subpartGReconsideration and stay of action.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-139.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-139.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-139https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-139https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-139.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-139.xml21 CFR 12.13921CFR12.139Section 12.139; Reconsideration and stay of action.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GInitial and Final DecisionsPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-139276Section 12.139section12.139 falseid-CFR-2003-title21-vol1-part12Judicial ReviewD09002ee18a5cbbf0-CFR-2003-title21-vol1-part12-subpartH.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part12-subpartH.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartHhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part12-subpartHhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part12-subpartH.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part12-subpartH.xml21 CFR H21CFRSubpart H; Judicial ReviewChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 12FORMAL EVIDENTIARY PUBLIC HEARINGNODECFR-2003-title21-vol1-part12-subpartH277Subpart HsubpartH falseid-CFR-2003-title21-vol1-part12-subpartHReview by the courts.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-140.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-140.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-140https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-140https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-140.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-140.xml21 CFR 12.14021CFR12.140Section 12.140; Review by the courts.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HJudicial ReviewPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-140278Section 12.140section12.140 falseUnited States CodeTitle 28 Section 2112(a)28 U.S.C. 2112(a)id-CFR-2003-title21-vol1-part12-subpartHCopies of petitions for judicial review.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec12-159.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec12-159.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-159https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec12-159https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec12-159.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec12-159.xml21 CFR 12.15921CFR12.159Section 12.159; Copies of petitions for judicial review.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HJudicial ReviewPart 12FORMAL EVIDENTIARY PUBLIC HEARINGCONTENTCFR-2003-title21-vol1-sec12-159279Section 12.159section12.159 falseid-CFR-2003-title21-vol1-chapI-subchapAPUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYD09002ee18a5cbbf0-CFR-2003-title21-vol1-part13.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part13.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part13.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part13.xml21 CFR 1321CFR13Part 13; PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part13280Part 13part13 5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-263n, 264.falseUnited States CodeTitle 5 Section 551-558Title 5 Section 701-7215 U.S.C. 551-5585 U.S.C. 701-721United States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 1034Title 21 Section 141-149Title 21 Section 321-393Title 21 Section 467fTitle 21 Section 679Title 21 Section 82121 U.S.C. 103421 U.S.C. 141-14921 U.S.C. 321-39321 U.S.C. 467f21 U.S.C. 67921 U.S.C. 821United States CodeTitle 28 Section 211228 U.S.C. 2112United States CodeTitle 42 Section 201Title 42 Section 262Title 42 Section 263b-263nTitle 42 Section 26442 U.S.C. 20142 U.S.C. 26242 U.S.C. 263b-263n42 U.S.C. 264Federal RegisterVolume 44 Page 2234844 FR 22348id-CFR-2003-title21-vol1-part13Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part13-toc-id281.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part13-toc-id281.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-toc-id281https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-toc-id281https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part13-toc-id281.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part13-toc-id281.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYTOCCFR-2003-title21-vol1-part13-toc-id281281Toctocid-CFR-2003-title21-vol1-part13General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part13-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part13-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part13-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part13-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYNODECFR-2003-title21-vol1-part13-subpartA282Subpart AsubpartA falseid-CFR-2003-title21-vol1-part13-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-1.xml21 CFR 13.121CFR13.1Section 13.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-1283Section 13.1section13.1 falseid-CFR-2003-title21-vol1-part13-subpartANotice of a hearing before a Board.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-5.xml21 CFR 13.521CFR13.5Section 13.5; Notice of a hearing before a Board.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-5284Section 13.5section13.5 44 FR 22348, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982falseFederal RegisterVolume 44 Page 2234844 FR 22348Federal RegisterVolume 47 Page 2637547 FR 26375id-CFR-2003-title21-vol1-part13-subpartAMembers of a Board.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-10.xml21 CFR 13.1021CFR13.10Section 13.10; Members of a Board.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-10285Section 13.10section13.10 44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985falseFederal RegisterVolume 44 Page 2234844 FR 22348Federal RegisterVolume 50 Page 899450 FR 8994id-CFR-2003-title21-vol1-part13-subpartASeparation of functions; ex parte communications; administrative support.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-15.xml21 CFR 13.1521CFR13.15Section 13.15; Separation of functions; ex parte communications; administrative support.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-15286Section 13.15section13.15 44 FR 22348, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2234844 FR 22348Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part13Hearing ProceduresD09002ee18a5cbbf0-CFR-2003-title21-vol1-part13-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part13-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part13-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part13-subpartB.xml21 CFR B21CFRSubpart B; Hearing ProceduresChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYNODECFR-2003-title21-vol1-part13-subpartB287Subpart BsubpartB falseid-CFR-2003-title21-vol1-part13-subpartBSubmissions to a Board.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-20.xml21 CFR 13.2021CFR13.20Section 13.20; Submissions to a Board.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BHearing ProceduresPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-20288Section 13.20section13.20 falseid-CFR-2003-title21-vol1-part13-subpartBDisclosure of data and information by the participants.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-25.xml21 CFR 13.2521CFR13.25Section 13.25; Disclosure of data and information by the participants.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BHearing ProceduresPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-25289Section 13.25section13.25 44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2234844 FR 22348Federal RegisterVolume 50 Page 899450 FR 8994Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part13-subpartBProceedings of a Board.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-30.xml21 CFR 13.3021CFR13.30Section 13.30; Proceedings of a Board.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BHearing ProceduresPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-30290Section 13.30section13.30 falseid-CFR-2003-title21-vol1-part13Records of a Hearing Before a BoardD09002ee18a5cbbf0-CFR-2003-title21-vol1-part13-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part13-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part13-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part13-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part13-subpartC.xml21 CFR C21CFRSubpart C; Records of a Hearing Before a BoardChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYNODECFR-2003-title21-vol1-part13-subpartC291Subpart CsubpartC falseid-CFR-2003-title21-vol1-part13-subpartCAdministrative record of a Board.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-40.xml21 CFR 13.4021CFR13.40Section 13.40; Administrative record of a Board.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecords of a Hearing Before a BoardPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-40292Section 13.40section13.40 falseid-CFR-2003-title21-vol1-part13-subpartCExamination of administrative record.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-45.xml21 CFR 13.4521CFR13.45Section 13.45; Examination of administrative record.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecords of a Hearing Before a BoardPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-45293Section 13.45section13.45 falseid-CFR-2003-title21-vol1-part13-subpartCRecord for administrative decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec13-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec13-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec13-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec13-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec13-50.xml21 CFR 13.5021CFR13.50Section 13.50; Record for administrative decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecords of a Hearing Before a BoardPart 13PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRYCONTENTCFR-2003-title21-vol1-sec13-50294Section 13.50section13.50 falseid-CFR-2003-title21-vol1-chapI-subchapAPUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEED09002ee18a5cbbf0-CFR-2003-title21-vol1-part14.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14.xml21 CFR 1421CFR14Part 14; PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEEChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part14295Part 14part14 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.falseUnited States CodeTitle 5 Appendix 25 U.S.C. App. 2United States CodeTitle 5 Appendix 25 U.S.C. App. 2United States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 1034Title 21 Section 141-149Title 21 Section 321-394Title 21 Section 41-50Title 21 Section 467fTitle 21 Section 679Title 21 Section 82121 U.S.C. 103421 U.S.C. 141-14921 U.S.C. 321-39421 U.S.C. 41-5021 U.S.C. 467f21 U.S.C. 67921 U.S.C. 821United States CodeTitle 28 Section 211228 U.S.C. 2112United States CodeTitle 42 Section 201Title 42 Section 262Title 42 Section 263bTitle 42 Section 26442 U.S.C. 20142 U.S.C. 26242 U.S.C. 263b42 U.S.C. 264Federal RegisterVolume 44 Page 2235144 FR 22351id-CFR-2003-title21-vol1-part14Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-toc-id296.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-toc-id296.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-toc-id296https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-toc-id296https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-toc-id296.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-toc-id296.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEETOCCFR-2003-title21-vol1-part14-toc-id296296Toctocid-CFR-2003-title21-vol1-part14General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartA297Subpart AsubpartA falseid-CFR-2003-title21-vol1-part14-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-1.xml21 CFR 14.121CFR14.1Section 14.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-1298Section 14.1section14.1 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part14-subpartAPurpose of proceedings before an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-5.xml21 CFR 14.521CFR14.5Section 14.5; Purpose of proceedings before an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-5299Section 14.5section14.5 falseid-CFR-2003-title21-vol1-part14-subpartAAdministrative remedies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-7.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-7.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-7https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-7https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-7.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-7.xml21 CFR 14.721CFR14.7Section 14.7; Administrative remedies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-7300Section 14.7section14.7 44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990falseCode of Federal RegulationsTitle 5 Part 5.345 CFR Part 5.34Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 55 Page 140455 FR 1404id-CFR-2003-title21-vol1-part14-subpartAApplicability to Congress.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-10.xml21 CFR 14.1021CFR14.10Section 14.10; Applicability to Congress.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-10301Section 14.10section14.10 falseid-CFR-2003-title21-vol1-part14-subpartACommittees working under a contract with FDA.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-15.xml21 CFR 14.1521CFR14.15Section 14.15; Committees working under a contract with FDA.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-15302Section 14.15section14.15 falseid-CFR-2003-title21-vol1-part14Meeting ProceduresD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartB.xml21 CFR B21CFRSubpart B; Meeting ProceduresChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartB303Subpart BsubpartB falseid-CFR-2003-title21-vol1-part14-subpartBNotice of hearing before an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-20.xml21 CFR 14.2021CFR14.20Section 14.20; Notice of hearing before an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-20304Section 14.20section14.20 44 FR 22351, Apr. 13, 1979, as amended at 47 FR 26375, June 1, 1982; 54 FR 9035, Mar. 3, 1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 47 Page 2637547 FR 26375Federal RegisterVolume 54 Page 903554 FR 9035Federal RegisterVolume 66 Page 1285066 FR 12850Federal RegisterVolume 66 Page 646966 FR 6469id-CFR-2003-title21-vol1-part14-subpartBMeetings of an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-22.xml21 CFR 14.2221CFR14.22Section 14.22; Meetings of an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-22305Section 14.22section14.22 44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 48 Page 4088748 FR 40887Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part14-subpartBPortions of advisory committee meetings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-25.xml21 CFR 14.2521CFR14.25Section 14.25; Portions of advisory committee meetings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-25306Section 14.25section14.25 falseid-CFR-2003-title21-vol1-part14-subpartBDetermination to close portions of advisory committee meetings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-27.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-27.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-27https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-27https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-27.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-27.xml21 CFR 14.2721CFR14.27Section 14.27; Determination to close portions of advisory committee meetings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-27307Section 14.27section14.27 44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000falseUnited States CodeTitle 5 Section 552b(c)5 U.S.C. 552b(c)Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 65 Page 5647965 FR 56479id-CFR-2003-title21-vol1-part14-subpartBConduct of a hearing before an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-29.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-29.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-29https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-29https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-29.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-29.xml21 CFR 14.2921CFR14.29Section 14.29; Conduct of a hearing before an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-29308Section 14.29section14.29 falseid-CFR-2003-title21-vol1-part14-subpartBChairman of an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-30.xml21 CFR 14.3021CFR14.30Section 14.30; Chairman of an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-30309Section 14.30section14.30 falseid-CFR-2003-title21-vol1-part14-subpartBConsultation by an advisory committee with other persons.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-31.xml21 CFR 14.3121CFR14.31Section 14.31; Consultation by an advisory committee with other persons.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-31310Section 14.31section14.31 44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990falseUnited States CodeTitle 18 Section 1905Title 18 Section 20818 U.S.C. 190518 U.S.C. 208United States CodeTitle 21 Section 331(j)21 U.S.C. 331(j)Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 55 Page 4270355 FR 42703id-CFR-2003-title21-vol1-part14-subpartBCompilation of materials for members of an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-33.xml21 CFR 14.3321CFR14.33Section 14.33; Compilation of materials for members of an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-33311Section 14.33section14.33 44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 65 Page 5647965 FR 56479id-CFR-2003-title21-vol1-part14-subpartBWritten submissions to an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-35.xml21 CFR 14.3521CFR14.35Section 14.35; Written submissions to an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-35312Section 14.35section14.35 falseid-CFR-2003-title21-vol1-part14-subpartBAdditional rules for a particular advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-39.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-39.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-39https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-39https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-39.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-39.xml21 CFR 14.3921CFR14.39Section 14.39; Additional rules for a particular advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BMeeting ProceduresPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-39313Section 14.39section14.39 falseid-CFR-2003-title21-vol1-part14Establishment of Advisory CommitteesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartC.xml21 CFR C21CFRSubpart C; Establishment of Advisory CommitteesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartC314Subpart CsubpartC falseid-CFR-2003-title21-vol1-part14-subpartCEstablishment and renewal of advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-40.xml21 CFR 14.4021CFR14.40Section 14.40; Establishment and renewal of advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CEstablishment of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-40315Section 14.40section14.40 44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990falseCode of Federal RegulationsTitle 5 Part 11and5 CFR Part 11andFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 55 Page 4270355 FR 42703id-CFR-2003-title21-vol1-part14-subpartCTermination of advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-55.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-55.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-55https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-55https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-55.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-55.xml21 CFR 14.5521CFR14.55Section 14.55; Termination of advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CEstablishment of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-55316Section 14.55section14.55 falseUnited States CodeTitle 21 Section 4221 U.S.C. 42United States CodeTitle 42 Section 263f(f)(1)(A)42 U.S.C. 263f(f)(1)(A)id-CFR-2003-title21-vol1-part14Records of Meetings and Hearings Before Advisory CommitteesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartD.xml21 CFR D21CFRSubpart D; Records of Meetings and Hearings Before Advisory CommitteesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartD317Subpart DsubpartD falseid-CFR-2003-title21-vol1-part14-subpartDMinutes and reports of advisory committee meetings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-60.xml21 CFR 14.6021CFR14.60Section 14.60; Minutes and reports of advisory committee meetings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DRecords of Meetings and Hearings Before Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-60318Section 14.60section14.60 44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980falseUnited States CodeTitle 5 Section 552(b)5 U.S.C. 552(b)Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 45 Page 8572545 FR 85725id-CFR-2003-title21-vol1-part14-subpartDTranscripts of advisory committee meetings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-61.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-61.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-61https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-61https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-61.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-61.xml21 CFR 14.6121CFR14.61Section 14.61; Transcripts of advisory committee meetings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DRecords of Meetings and Hearings Before Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-61319Section 14.61section14.61 falseid-CFR-2003-title21-vol1-part14-subpartDPublic inquiries and requests for advisory committee records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-65.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-65.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-65https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-65https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-65.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-65.xml21 CFR 14.6521CFR14.65Section 14.65; Public inquiries and requests for advisory committee records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DRecords of Meetings and Hearings Before Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-65320Section 14.65section14.65 44 FR 22351, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 46 Page 845646 FR 8456id-CFR-2003-title21-vol1-part14-subpartDAdministrative record of a public hearing before an advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-70.xml21 CFR 14.7021CFR14.70Section 14.70; Administrative record of a public hearing before an advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DRecords of Meetings and Hearings Before Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-70321Section 14.70section14.70 falseid-CFR-2003-title21-vol1-part14-subpartDExamination of administrative record and other advisory committee records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-75.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-75.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-75https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-75https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-75.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-75.xml21 CFR 14.7521CFR14.75Section 14.75; Examination of administrative record and other advisory committee records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DRecords of Meetings and Hearings Before Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-75322Section 14.75section14.75 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part14Members of Advisory CommitteesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartE.xml21 CFR E21CFRSubpart E; Members of Advisory CommitteesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartE323Subpart EsubpartE falseid-CFR-2003-title21-vol1-part14-subpartEQualifications for members of standing policy and technical advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-80.xml21 CFR 14.8021CFR14.80Section 14.80; Qualifications for members of standing policy and technical advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EMembers of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-80324Section 14.80section14.80 44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988; 54 FR 9035, Mar. 3, 1989falseUnited States CodeTitle 18 Section 208(a)Title 18 Section 208(b)18 U.S.C. 208(a)18 U.S.C. 208(b)Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 53 Page 5094953 FR 50949Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part14-subpartENominations of voting members of standing advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-82.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-82.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-82https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-82https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-82.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-82.xml21 CFR 14.8221CFR14.82Section 14.82; Nominations of voting members of standing advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EMembers of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-82325Section 14.82section14.82 falseid-CFR-2003-title21-vol1-part14-subpartENominations and selection of nonvoting members of standing technical advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-84.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-84.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-84https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-84https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-84.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-84.xml21 CFR 14.8421CFR14.84Section 14.84; Nominations and selection of nonvoting members of standing technical advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EMembers of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-84326Section 14.84section14.84 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989falseUnited States CodeTitle 18 Section 208(a)Title 18 Section 208(b)18 U.S.C. 208(a)18 U.S.C. 208(b)Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 54 Page 903554 FR 9035id-CFR-2003-title21-vol1-part14-subpartERights and responsibilities of nonvoting members of advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-86.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-86.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-86https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-86https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-86.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-86.xml21 CFR 14.8621CFR14.86Section 14.86; Rights and responsibilities of nonvoting members of advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EMembers of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-86327Section 14.86section14.86 falseid-CFR-2003-title21-vol1-part14-subpartEAd hoc advisory committee members.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-90.xml21 CFR 14.9021CFR14.90Section 14.90; Ad hoc advisory committee members.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EMembers of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-90328Section 14.90section14.90 falseid-CFR-2003-title21-vol1-part14-subpartECompensation of advisory committee members.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-95.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-95.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-95https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-95https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-95.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-95.xml21 CFR 14.9521CFR14.95Section 14.95; Compensation of advisory committee members.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EMembers of Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-95329Section 14.95section14.95 44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 53 Page 5094953 FR 50949id-CFR-2003-title21-vol1-part14Standing Advisory CommitteesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartF.xml21 CFR F21CFRSubpart F; Standing Advisory CommitteesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartF330Subpart FsubpartF falseid-CFR-2003-title21-vol1-part14-subpartFList of standing advisory committees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-100.xml21 CFR 14.10021CFR14.100Section 14.100; List of standing advisory committees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FStanding Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-100331Section 14.100section14.100 For Federal Register citations affecting § 14.100, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.54 FR 9036, Mar. 3, 1989falseUnited States CodeTitle 21 Section 4221 U.S.C. 42United States CodeTitle 42 Section 263f(f)(1)(A)42 U.S.C. 263f(f)(1)(A)Federal RegisterVolume 54 Page 903654 FR 9036id-CFR-2003-title21-vol1-part14Technical Electronic Products Radiation Safety Standards CommitteeD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartG.xml21 CFR G21CFRSubpart G; Technical Electronic Products Radiation Safety Standards CommitteeChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartG332Subpart GsubpartG falseid-CFR-2003-title21-vol1-part14-subpartGEstablishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-120.xml21 CFR 14.12021CFR14.120Section 14.120; Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GTechnical Electronic Products Radiation Safety Standards CommitteePart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-120333Section 14.120section14.120 falseUnited States CodeTitle 42 Section 263f(f)(1)(A)42 U.S.C. 263f(f)(1)(A)id-CFR-2003-title21-vol1-part14-subpartGFunctions of TEPRSSC.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-122.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-122.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-122https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-122https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-122.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-122.xml21 CFR 14.12221CFR14.122Section 14.122; Functions of TEPRSSC.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GTechnical Electronic Products Radiation Safety Standards CommitteePart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-122334Section 14.122section14.122 falseUnited States CodeTitle 42 Section 263f42 U.S.C. 263fid-CFR-2003-title21-vol1-part14-subpartGProcedures of TEPRSSC.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-125.xml21 CFR 14.12521CFR14.125Section 14.125; Procedures of TEPRSSC.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GTechnical Electronic Products Radiation Safety Standards CommitteePart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-125335Section 14.125section14.125 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989falseUnited States CodeTitle 42 Section 263f(f)(1)(A)42 U.S.C. 263f(f)(1)(A)Federal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 54 Page 903754 FR 9037id-CFR-2003-title21-vol1-part14-subpartGMembership of TEPRSSC.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-127.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-127.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-127https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-127https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-127.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-127.xml21 CFR 14.12721CFR14.127Section 14.127; Membership of TEPRSSC.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GTechnical Electronic Products Radiation Safety Standards CommitteePart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-127336Section 14.127section14.127 falseUnited States CodeTitle 42 Section 210(c)42 U.S.C. 210(c)id-CFR-2003-title21-vol1-part14-subpartGConduct of TEPRSSC meeting; availability of TEPRSSC records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-130.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-130.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-130https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-130https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-130.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-130.xml21 CFR 14.13021CFR14.130Section 14.130; Conduct of TEPRSSC meeting; availability of TEPRSSC records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GTechnical Electronic Products Radiation Safety Standards CommitteePart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-130337Section 14.130section14.130 falseUnited States CodeTitle 42 Section 263f(f)(1)(B)42 U.S.C. 263f(f)(1)(B)id-CFR-2003-title21-vol1-part14Color Additive Advisory CommitteesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartH.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartH.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartHhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartHhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartH.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartH.xml21 CFR H21CFRSubpart H; Color Additive Advisory CommitteesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartH338Subpart HsubpartH falseid-CFR-2003-title21-vol1-part14-subpartHEstablishment of a color additive advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-140.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-140.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-140https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-140https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-140.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-140.xml21 CFR 14.14021CFR14.140Section 14.140; Establishment of a color additive advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HColor Additive Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-140339Section 14.140section14.140 falseid-CFR-2003-title21-vol1-part14-subpartHFunctions of a color additive advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-142.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-142.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-142https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-142https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-142.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-142.xml21 CFR 14.14221CFR14.142Section 14.142; Functions of a color additive advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HColor Additive Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-142340Section 14.142section14.142 falseid-CFR-2003-title21-vol1-part14-subpartHProcedures of a color additive advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-145.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-145.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-145https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-145https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-145.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-145.xml21 CFR 14.14521CFR14.145Section 14.145; Procedures of a color additive advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HColor Additive Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-145341Section 14.145section14.145 falseid-CFR-2003-title21-vol1-part14-subpartHMembership of a color additive advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-147.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-147.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-147https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-147https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-147.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-147.xml21 CFR 14.14721CFR14.147Section 14.147; Membership of a color additive advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HColor Additive Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-147342Section 14.147section14.147 falseid-CFR-2003-title21-vol1-part14-subpartHFees and compensation pertaining to a color additive advisory committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-155.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-155.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-155https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-155https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-155.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-155.xml21 CFR 14.15521CFR14.155Section 14.155; Fees and compensation pertaining to a color additive advisory committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart HColor Additive Advisory CommitteesPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-155343Section 14.155section14.155 falseid-CFR-2003-title21-vol1-part14Advisory Committees for Human Prescription DrugsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part14-subpartI.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part14-subpartI.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartIhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part14-subpartIhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part14-subpartI.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part14-subpartI.xml21 CFR I21CFRSubpart I; Advisory Committees for Human Prescription DrugsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEENODECFR-2003-title21-vol1-part14-subpartI344Subpart IsubpartI falseid-CFR-2003-title21-vol1-part14-subpartIEstablishment of standing technical advisory committees for human prescription drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-160.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-160.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-160https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-160https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-160.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-160.xml21 CFR 14.16021CFR14.160Section 14.160; Establishment of standing technical advisory committees for human prescription drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart IAdvisory Committees for Human Prescription DrugsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-160345Section 14.160section14.160 falseid-CFR-2003-title21-vol1-part14-subpartIUtilization of an advisory committee on the initiative of FDA.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-171.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-171.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-171https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-171https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-171.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-171.xml21 CFR 14.17121CFR14.171Section 14.171; Utilization of an advisory committee on the initiative of FDA.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart IAdvisory Committees for Human Prescription DrugsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-171346Section 14.171section14.171 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2235144 FR 22351Federal RegisterVolume 54 Page 903754 FR 9037id-CFR-2003-title21-vol1-part14-subpartIUtilization of an advisory committee at the request of an interested person.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-172.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-172.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-172https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-172https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-172.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-172.xml21 CFR 14.17221CFR14.172Section 14.172; Utilization of an advisory committee at the request of an interested person.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart IAdvisory Committees for Human Prescription DrugsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-172347Section 14.172section14.172 falseid-CFR-2003-title21-vol1-part14-subpartIAdvice and recommendations in writing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec14-174.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec14-174.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-174https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec14-174https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec14-174.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec14-174.xml21 CFR 14.17421CFR14.174Section 14.174; Advice and recommendations in writing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart IAdvisory Committees for Human Prescription DrugsPart 14PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEECONTENTCFR-2003-title21-vol1-sec14-174348Section 14.174section14.174 falseid-CFR-2003-title21-vol1-chapI-subchapAPUBLIC HEARING BEFORE THE COMMISSIONERD09002ee18a5cbbf0-CFR-2003-title21-vol1-part15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part15.xml21 CFR 1521CFR15Part 15; PUBLIC HEARING BEFORE THE COMMISSIONERChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part15349Part 15part15 5 U.S.C. 553; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-263n, 264.falseUnited States CodeTitle 5 Section 5535 U.S.C. 553United States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 1034Title 21 Section 141-149Title 21 Section 321-393Title 21 Section 467fTitle 21 Section 679Title 21 Section 82121 U.S.C. 103421 U.S.C. 141-14921 U.S.C. 321-39321 U.S.C. 467f21 U.S.C. 67921 U.S.C. 821United States CodeTitle 28 Section 211228 U.S.C. 2112United States CodeTitle 42 Section 201Title 42 Section 262Title 42 Section 263b-263nTitle 42 Section 26442 U.S.C. 20142 U.S.C. 26242 U.S.C. 263b-263n42 U.S.C. 264Federal RegisterVolume 44 Page 2236644 FR 22366id-CFR-2003-title21-vol1-part15Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part15-toc-id350.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part15-toc-id350.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-toc-id350https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-toc-id350https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part15-toc-id350.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part15-toc-id350.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 15PUBLIC HEARING BEFORE THE COMMISSIONERTOCCFR-2003-title21-vol1-part15-toc-id350350Toctocid-CFR-2003-title21-vol1-part15General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part15-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part15-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part15-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part15-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 15PUBLIC HEARING BEFORE THE COMMISSIONERNODECFR-2003-title21-vol1-part15-subpartA351Subpart AsubpartA falseid-CFR-2003-title21-vol1-part15-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-1.xml21 CFR 15.121CFR15.1Section 15.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-1352Section 15.1section15.1 falseid-CFR-2003-title21-vol1-part15Procedures for Public Hearing Before the CommissionerD09002ee18a5cbbf0-CFR-2003-title21-vol1-part15-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part15-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part15-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part15-subpartB.xml21 CFR B21CFRSubpart B; Procedures for Public Hearing Before the CommissionerChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 15PUBLIC HEARING BEFORE THE COMMISSIONERNODECFR-2003-title21-vol1-part15-subpartB353Subpart BsubpartB falseid-CFR-2003-title21-vol1-part15-subpartBNotice of a public hearing before the Commissioner.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-20.xml21 CFR 15.2021CFR15.20Section 15.20; Notice of a public hearing before the Commissioner.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BProcedures for Public Hearing Before the CommissionerPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-20354Section 15.20section15.20 44 FR 22366, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982falseFederal RegisterVolume 44 Page 2236644 FR 22366Federal RegisterVolume 47 Page 2637547 FR 26375id-CFR-2003-title21-vol1-part15-subpartBNotice of participation; schedule for hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-21.xml21 CFR 15.2121CFR15.21Section 15.21; Notice of participation; schedule for hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BProcedures for Public Hearing Before the CommissionerPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-21355Section 15.21section15.21 falseid-CFR-2003-title21-vol1-part15-subpartBWritten submissions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-25.xml21 CFR 15.2521CFR15.25Section 15.25; Written submissions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BProcedures for Public Hearing Before the CommissionerPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-25356Section 15.25section15.25 falseid-CFR-2003-title21-vol1-part15-subpartBConduct of a public hearing before the Commissioner.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-30.xml21 CFR 15.3021CFR15.30Section 15.30; Conduct of a public hearing before the Commissioner.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BProcedures for Public Hearing Before the CommissionerPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-30357Section 15.30section15.30 falseid-CFR-2003-title21-vol1-part15Records of a Public Hearing Before the CommissionerD09002ee18a5cbbf0-CFR-2003-title21-vol1-part15-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part15-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part15-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part15-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part15-subpartC.xml21 CFR C21CFRSubpart C; Records of a Public Hearing Before the CommissionerChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 15PUBLIC HEARING BEFORE THE COMMISSIONERNODECFR-2003-title21-vol1-part15-subpartC358Subpart CsubpartC falseid-CFR-2003-title21-vol1-part15-subpartCAdministrative record.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-40.xml21 CFR 15.4021CFR15.40Section 15.40; Administrative record.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecords of a Public Hearing Before the CommissionerPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-40359Section 15.40section15.40 falseid-CFR-2003-title21-vol1-part15-subpartCExamination of administrative record.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec15-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec15-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec15-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec15-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec15-45.xml21 CFR 15.4521CFR15.45Section 15.45; Examination of administrative record.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRecords of a Public Hearing Before the CommissionerPart 15PUBLIC HEARING BEFORE THE COMMISSIONERCONTENTCFR-2003-title21-vol1-sec15-45360Section 15.45section15.45 falseid-CFR-2003-title21-vol1-chapI-subchapAREGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part16.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16.xml21 CFR 1621CFR16Part 16; REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part16361Part 16part16 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.falseUnited States CodeTitle 15 Section 1451-146115 U.S.C. 1451-1461United States CodeTitle 21 Section 1034Title 21 Section 141-149Title 21 Section 321-394Title 21 Section 467fTitle 21 Section 679Title 21 Section 82121 U.S.C. 103421 U.S.C. 141-14921 U.S.C. 321-39421 U.S.C. 467f21 U.S.C. 67921 U.S.C. 821United States CodeTitle 28 Section 211228 U.S.C. 2112United States CodeTitle 42 Section 201-262Title 42 Section 263bTitle 42 Section 36442 U.S.C. 201-26242 U.S.C. 263b42 U.S.C. 364Federal RegisterVolume 44 Page 2236744 FR 22367id-CFR-2003-title21-vol1-part16Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-toc-id362.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-toc-id362.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-toc-id362https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-toc-id362https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-toc-id362.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-toc-id362.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONTOCCFR-2003-title21-vol1-part16-toc-id362362Toctocid-CFR-2003-title21-vol1-part16General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartA363Subpart AsubpartA falseid-CFR-2003-title21-vol1-part16-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-1.xml21 CFR 16.121CFR16.1Section 16.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-1364Section 16.1section16.1 44 FR 22367, Apr. 13, 1979, as amended at 45 FR 3750, Jan 18, 1980; 45 FR 10332, Feb. 15, 1980; 46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 51 FR 26364, July 22, 1986; 54 FR 9037, Mar. 3, 1989; 57 FR 58403, Dec. 10, 1992; 58 FR 65520, Dec. 14, 1993; 62 FR 40444, July 29, 1997; 62 FR 55976, Oct. 28, 1997; 63 FR 26697, May 13, 1998; 63 FR 64581, Nov. 20, 1998; 67 FR 5467, Feb. 6, 2002falseFederal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 45 Page 1033245 FR 10332Federal RegisterVolume 45 Page 375045 FR 3750Federal RegisterVolume 46 Page 1434046 FR 14340Federal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 51 Page 2636451 FR 26364Federal RegisterVolume 54 Page 903754 FR 9037Federal RegisterVolume 57 Page 5840357 FR 58403Federal RegisterVolume 58 Page 6552058 FR 65520Federal RegisterVolume 62 Page 4044462 FR 40444Federal RegisterVolume 62 Page 5597662 FR 55976Federal RegisterVolume 63 Page 2669763 FR 26697Federal RegisterVolume 63 Page 6458163 FR 64581Federal RegisterVolume 67 Page 546767 FR 5467id-CFR-2003-title21-vol1-part16-subpartAInapplicability and limited applicability.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-5.xml21 CFR 16.521CFR16.5Section 16.5; Inapplicability and limited applicability.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-5365Section 16.5section16.5 44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5, 2000falseUnited States CodeTitle 42 Section 26442 U.S.C. 264Federal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 57 Page 5840357 FR 58403Federal RegisterVolume 65 Page 7611065 FR 76110id-CFR-2003-title21-vol1-part16Initiation of ProceedingsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartB.xml21 CFR B21CFRSubpart B; Initiation of ProceedingsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartB366Subpart BsubpartB falseid-CFR-2003-title21-vol1-part16-subpartBInitiation of regulatory hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-22.xml21 CFR 16.2221CFR16.22Section 16.22; Initiation of regulatory hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-22367Section 16.22section16.22 44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984falseCode of Federal RegulationsTitle 1 Part 101 CFR Part 10Federal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 49 Page 3217349 FR 32173id-CFR-2003-title21-vol1-part16-subpartBRegulatory hearing required by the act or a regulation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-24.xml21 CFR 16.2421CFR16.24Section 16.24; Regulatory hearing required by the act or a regulation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-24368Section 16.24section16.24 44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982; 54 FR 9037, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 47 Page 2637547 FR 26375Federal RegisterVolume 54 Page 903754 FR 9037id-CFR-2003-title21-vol1-part16-subpartBDenial of hearing and summary decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-26.xml21 CFR 16.2621CFR16.26Section 16.26; Denial of hearing and summary decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInitiation of ProceedingsPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-26369Section 16.26section16.26 53 FR 4615, Feb. 17, 1988falseFederal RegisterVolume 53 Page 461553 FR 4615id-CFR-2003-title21-vol1-part16Commissioner and Presiding OfficerD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartC.xml21 CFR C21CFRSubpart C; Commissioner and Presiding OfficerChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartC370Subpart CsubpartC falseid-CFR-2003-title21-vol1-part16-subpartCCommissioner.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-40.xml21 CFR 16.4021CFR16.40Section 16.40; Commissioner.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCommissioner and Presiding OfficerPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-40371Section 16.40section16.40 44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 54 Page 903754 FR 9037id-CFR-2003-title21-vol1-part16-subpartCPresiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-42.xml21 CFR 16.4221CFR16.42Section 16.42; Presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCommissioner and Presiding OfficerPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-42372Section 16.42section16.42 44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 67 FR 53306, Aug. 15, 2002falseCode of Federal RegulationsTitle 5 Part 930.209(b) or5 CFR Part 930.209(b) orFederal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 54 Page 903754 FR 9037Federal RegisterVolume 67 Page 5330667 FR 53306id-CFR-2003-title21-vol1-part16-subpartCCommunication to presiding officer and Commissioner.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-44.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-44.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-44https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-44https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-44.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-44.xml21 CFR 16.4421CFR16.44Section 16.44; Communication to presiding officer and Commissioner.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCommissioner and Presiding OfficerPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-44373Section 16.44section16.44 falseid-CFR-2003-title21-vol1-part16Procedures for Regulatory HearingD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartD.xml21 CFR D21CFRSubpart D; Procedures for Regulatory HearingChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartD374Subpart DsubpartD falseid-CFR-2003-title21-vol1-part16-subpartDHearing procedure.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-60.xml21 CFR 16.6021CFR16.60Section 16.60; Hearing procedure.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Regulatory HearingPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-60375Section 16.60section16.60 44 FR 22367, Apr. 13, 1979, as amended at 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001falseFederal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 66 Page 1285066 FR 12850Federal RegisterVolume 66 Page 646966 FR 6469id-CFR-2003-title21-vol1-part16-subpartDRight to counsel.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-62.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-62.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-62https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-62https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-62.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-62.xml21 CFR 16.6221CFR16.62Section 16.62; Right to counsel.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Regulatory HearingPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-62376Section 16.62section16.62 falseid-CFR-2003-title21-vol1-part16Administrative Record and DecisionD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartE.xml21 CFR E21CFRSubpart E; Administrative Record and DecisionChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartE377Subpart EsubpartE falseid-CFR-2003-title21-vol1-part16-subpartEAdministrative record of a regulatory hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-80.xml21 CFR 16.8021CFR16.80Section 16.80; Administrative record of a regulatory hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Record and DecisionPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-80378Section 16.80section16.80 falseid-CFR-2003-title21-vol1-part16-subpartEExamination of administrative record.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-85.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-85.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-85https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-85https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-85.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-85.xml21 CFR 16.8521CFR16.85Section 16.85; Examination of administrative record.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Record and DecisionPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-85379Section 16.85section16.85 falseid-CFR-2003-title21-vol1-part16-subpartEAdministrative decision and record for decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-95.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-95.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-95https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-95https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-95.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-95.xml21 CFR 16.9521CFR16.95Section 16.95; Administrative decision and record for decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Record and DecisionPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-95380Section 16.95section16.95 falseid-CFR-2003-title21-vol1-part16Reconsideration and StayD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartF.xml21 CFR F21CFRSubpart F; Reconsideration and StayChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartF381Subpart FsubpartF falseid-CFR-2003-title21-vol1-part16-subpartFReconsideration and stay of action.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-119.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-119.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-119https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-119https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-119.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-119.xml21 CFR 16.11921CFR16.119Section 16.119; Reconsideration and stay of action.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FReconsideration and StayPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-119382Section 16.119section16.119 44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989falseFederal RegisterVolume 44 Page 2236744 FR 22367Federal RegisterVolume 54 Page 903754 FR 9037id-CFR-2003-title21-vol1-part16Judicial ReviewD09002ee18a5cbbf0-CFR-2003-title21-vol1-part16-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part16-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part16-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part16-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part16-subpartG.xml21 CFR G21CFRSubpart G; Judicial ReviewChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONNODECFR-2003-title21-vol1-part16-subpartG383Subpart GsubpartG falseid-CFR-2003-title21-vol1-part16-subpartGJudicial review.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec16-120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec16-120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec16-120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec16-120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec16-120.xml21 CFR 16.12021CFR16.120Section 16.120; Judicial review.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GJudicial ReviewPart 16REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATIONCONTENTCFR-2003-title21-vol1-sec16-120384Section 16.120section16.120 falseid-CFR-2003-title21-vol1-chapI-subchapACIVIL MONEY PENALTIES HEARINGSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part17.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part17.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part17https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part17https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part17.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part17.xml21 CFR 1721CFR17Part 17; CIVIL MONEY PENALTIES HEARINGSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part17385Part 17part17 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554, 555, 556, 557.falseUnited States CodeTitle 5 Section 554Title 5 Section 555Title 5 Section 556Title 5 Section 5575 U.S.C. 5545 U.S.C. 5555 U.S.C. 5565 U.S.C. 557United States CodeTitle 21 Section 331Title 21 Section 333Title 21 Section 337Title 21 Section 351Title 21 Section 352Title 21 Section 355Title 21 Section 360cTitle 21 Section 360Title 21 Section 360fTitle 21 Section 360iTitle 21 Section 360jTitle 21 Section 37121 U.S.C. 33121 U.S.C. 33321 U.S.C. 33721 U.S.C. 35121 U.S.C. 35221 U.S.C. 35521 U.S.C. 360c21 U.S.C. 36021 U.S.C. 360f21 U.S.C. 360i21 U.S.C. 360j21 U.S.C. 371United States CodeTitle 42 Section 262Title 42 Section 263bTitle 42 Section 300aa-2842 U.S.C. 26242 U.S.C. 263b42 U.S.C. 300aa-28Federal RegisterVolume 60 Page 3862660 FR 38626id-CFR-2003-title21-vol1-part17Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part17-toc-id386.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part17-toc-id386.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part17-toc-id386https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part17-toc-id386https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part17-toc-id386.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part17-toc-id386.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSTOCCFR-2003-title21-vol1-part17-toc-id386386Toctocid-CFR-2003-title21-vol1-part17Scope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-1.xml21 CFR 17.121CFR17.1Section 17.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-1387Section 17.1section17.1 falseid-CFR-2003-title21-vol1-part17Definitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-3.xml21 CFR 17.321CFR17.3Section 17.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-3388Section 17.3section17.3 falseUnited States CodeTitle 5 Section 31055 U.S.C. 3105United States CodeTitle 21 Section 333(g)(1)Title 21 Section 333(g)(1)(B)(i)Title 21 Section 333(g)(1)(B)(ii)Title 21 Section 333(g)(1)(B)(iii)21 U.S.C. 333(g)(1)21 U.S.C. 333(g)(1)(B)(i)21 U.S.C. 333(g)(1)(B)(ii)21 U.S.C. 333(g)(1)(B)(iii)id-CFR-2003-title21-vol1-part17Complaint.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-5.xml21 CFR 17.521CFR17.5Section 17.5; Complaint.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-5389Section 17.5section17.5 falseid-CFR-2003-title21-vol1-part17Service of complaint.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-7.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-7.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-7https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-7https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-7.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-7.xml21 CFR 17.721CFR17.7Section 17.7; Service of complaint.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-7390Section 17.7section17.7 falseid-CFR-2003-title21-vol1-part17Answer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-9.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-9.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-9https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-9https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-9.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-9.xml21 CFR 17.921CFR17.9Section 17.9; Answer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-9391Section 17.9section17.9 falseid-CFR-2003-title21-vol1-part17Default upon failure to file an answer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-11.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-11.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-11https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-11https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-11.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-11.xml21 CFR 17.1121CFR17.11Section 17.11; Default upon failure to file an answer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-11392Section 17.11section17.11 falseid-CFR-2003-title21-vol1-part17Notice of hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-13.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-13.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-13https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-13https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-13.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-13.xml21 CFR 17.1321CFR17.13Section 17.13; Notice of hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-13393Section 17.13section17.13 falseid-CFR-2003-title21-vol1-part17Parties to the hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-15.xml21 CFR 17.1521CFR17.15Section 17.15; Parties to the hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-15394Section 17.15section17.15 falseid-CFR-2003-title21-vol1-part17Summary decisions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-17.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-17.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-17https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-17https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-17.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-17.xml21 CFR 17.1721CFR17.17Section 17.17; Summary decisions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-17395Section 17.17section17.17 falseid-CFR-2003-title21-vol1-part17Interlocutory appeal from ruling of presiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-18.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-18.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-18https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-18https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-18.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-18.xml21 CFR 17.1821CFR17.18Section 17.18; Interlocutory appeal from ruling of presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-18396Section 17.18section17.18 falseid-CFR-2003-title21-vol1-part17Authority of the presiding officer.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-19.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-19.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-19https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-19https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-19.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-19.xml21 CFR 17.1921CFR17.19Section 17.19; Authority of the presiding officer.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-19397Section 17.19section17.19 falseid-CFR-2003-title21-vol1-part17Ex parte contacts.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-20.xml21 CFR 17.2021CFR17.20Section 17.20; Ex parte contacts.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-20398Section 17.20section17.20 falseid-CFR-2003-title21-vol1-part17Prehearing conferences.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-21.xml21 CFR 17.2121CFR17.21Section 17.21; Prehearing conferences.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-21399Section 17.21section17.21 falseid-CFR-2003-title21-vol1-part17Discovery.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-23.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-23.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-23https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-23https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-23.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-23.xml21 CFR 17.2321CFR17.23Section 17.23; Discovery.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-23400Section 17.23section17.23 falseid-CFR-2003-title21-vol1-part17Exchange of witness lists, witness statements, and exhibits.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-25.xml21 CFR 17.2521CFR17.25Section 17.25; Exchange of witness lists, witness statements, and exhibits.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-25401Section 17.25section17.25 falseid-CFR-2003-title21-vol1-part17Hearing subpoenas.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-27.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-27.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-27https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-27https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-27.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-27.xml21 CFR 17.2721CFR17.27Section 17.27; Hearing subpoenas.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-27402Section 17.27section17.27 falseid-CFR-2003-title21-vol1-part17Protective order.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-28.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-28.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-28https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-28https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-28.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-28.xml21 CFR 17.2821CFR17.28Section 17.28; Protective order.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-28403Section 17.28section17.28 falseCode of Federal RegulationsTitle 1 Part 201 CFR Part 20id-CFR-2003-title21-vol1-part17Fees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-29.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-29.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-29https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-29https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-29.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-29.xml21 CFR 17.2921CFR17.29Section 17.29; Fees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-29404Section 17.29section17.29 falseid-CFR-2003-title21-vol1-part17Computation of time.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-30.xml21 CFR 17.3021CFR17.30Section 17.30; Computation of time.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-30405Section 17.30section17.30 falseid-CFR-2003-title21-vol1-part17Form, filing, and service of papers.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-31.xml21 CFR 17.3121CFR17.31Section 17.31; Form, filing, and service of papers.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-31406Section 17.31section17.31 falseid-CFR-2003-title21-vol1-part17Motions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-32.xml21 CFR 17.3221CFR17.32Section 17.32; Motions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-32407Section 17.32section17.32 falseid-CFR-2003-title21-vol1-part17The hearing and burden of proof.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-33.xml21 CFR 17.3321CFR17.33Section 17.33; The hearing and burden of proof.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-33408Section 17.33section17.33 falseid-CFR-2003-title21-vol1-part17Determining the amount of penalties and assessments.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-34.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-34.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-34https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-34https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-34.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-34.xml21 CFR 17.3421CFR17.34Section 17.34; Determining the amount of penalties and assessments.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-34409Section 17.34section17.34 falseid-CFR-2003-title21-vol1-part17Sanctions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-35.xml21 CFR 17.3521CFR17.35Section 17.35; Sanctions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-35410Section 17.35section17.35 falseid-CFR-2003-title21-vol1-part17Witnesses.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-37.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-37.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-37https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-37https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-37.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-37.xml21 CFR 17.3721CFR17.37Section 17.37; Witnesses.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-37411Section 17.37section17.37 falseid-CFR-2003-title21-vol1-part17Evidence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-39.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-39.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-39https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-39https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-39.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-39.xml21 CFR 17.3921CFR17.39Section 17.39; Evidence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-39412Section 17.39section17.39 falseid-CFR-2003-title21-vol1-part17The administrative record.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-41.xml21 CFR 17.4121CFR17.41Section 17.41; The administrative record.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-41413Section 17.41section17.41 falseid-CFR-2003-title21-vol1-part17Posthearing briefs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-43.xml21 CFR 17.4321CFR17.43Section 17.43; Posthearing briefs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-43414Section 17.43section17.43 falseid-CFR-2003-title21-vol1-part17Initial decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-45.xml21 CFR 17.4521CFR17.45Section 17.45; Initial decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-45415Section 17.45section17.45 falseid-CFR-2003-title21-vol1-part17Appeals.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-47.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-47.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-47https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-47https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-47.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-47.xml21 CFR 17.4721CFR17.47Section 17.47; Appeals.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-47416Section 17.47section17.47 falseid-CFR-2003-title21-vol1-part17Harmless error.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-48.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-48.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-48https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-48https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-48.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-48.xml21 CFR 17.4821CFR17.48Section 17.48; Harmless error.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-48417Section 17.48section17.48 falseid-CFR-2003-title21-vol1-part17Judicial review.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-51.xml21 CFR 17.5121CFR17.51Section 17.51; Judicial review.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-51418Section 17.51section17.51 falseid-CFR-2003-title21-vol1-part17Deposit in the Treasury of the United States.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec17-54.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec17-54.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-54https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec17-54https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec17-54.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec17-54.xml21 CFR 17.5421CFR17.54Section 17.54; Deposit in the Treasury of the United States.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 17CIVIL MONEY PENALTIES HEARINGSCONTENTCFR-2003-title21-vol1-sec17-54419Section 17.54section17.54 falseid-CFR-2003-title21-vol1-chapI-subchapASTANDARDS OF CONDUCT AND CONFLICTS OF INTERESTD09002ee18a5cbbf0-CFR-2003-title21-vol1-part19.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part19.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part19.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part19.xml21 CFR 1921CFR19Part 19; STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part19420Part 19part19 21 U.S.C. 371.falseUnited States CodeTitle 21 Section 37121 U.S.C. 371Federal RegisterVolume 42 Page 1561542 FR 15615id-CFR-2003-title21-vol1-part19Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part19-toc-id421.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part19-toc-id421.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-toc-id421https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-toc-id421https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part19-toc-id421.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part19-toc-id421.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTTOCCFR-2003-title21-vol1-part19-toc-id421421Toctocid-CFR-2003-title21-vol1-part19General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part19-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part19-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part19-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part19-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTNODECFR-2003-title21-vol1-part19-subpartA422Subpart AsubpartA falseid-CFR-2003-title21-vol1-part19-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-1.xml21 CFR 19.121CFR19.1Section 19.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-1423Section 19.1section19.1 falseid-CFR-2003-title21-vol1-part19-subpartAReference to Department regulations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-5.xml21 CFR 19.521CFR19.5Section 19.5; Reference to Department regulations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-5424Section 19.5section19.5 falseCode of Federal RegulationsTitle 5 Part 735 CFR Part 73Code of Federal RegulationsTitle 5 Part 735 CFR Part 73id-CFR-2003-title21-vol1-part19-subpartACode of ethics for government service.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-6.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-6.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-6https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-6https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-6.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-6.xml21 CFR 19.621CFR19.6Section 19.6; Code of ethics for government service.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-6425Section 19.6section19.6 falseid-CFR-2003-title21-vol1-part19-subpartAFood and Drug Administration Conflict of Interest Review Board.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-10.xml21 CFR 19.1021CFR19.10Section 19.10; Food and Drug Administration Conflict of Interest Review Board.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-10426Section 19.10section19.10 42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985; 55 FR 1404, Jan. 16, 1990; 65 FR 56479, Sept. 19, 2000falseFederal RegisterVolume 42 Page 1561542 FR 15615Federal RegisterVolume 46 Page 845646 FR 8456Federal RegisterVolume 50 Page 5227850 FR 52278Federal RegisterVolume 55 Page 140455 FR 1404Federal RegisterVolume 65 Page 5647965 FR 56479id-CFR-2003-title21-vol1-part19Reporting of ViolationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part19-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part19-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part19-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part19-subpartB.xml21 CFR B21CFRSubpart B; Reporting of ViolationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTNODECFR-2003-title21-vol1-part19-subpartB427Subpart BsubpartB falseid-CFR-2003-title21-vol1-part19-subpartBDuty to report violations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-21.xml21 CFR 19.2121CFR19.21Section 19.21; Duty to report violations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BReporting of ViolationsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-21428Section 19.21section19.21 42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985; 60 FR 47478, Sept. 13, 1995falseCode of Federal RegulationsTitle 5 Part 735 CFR Part 73Code of Federal RegulationsTitle 5 Part 73or 735 CFR Part 73or 73Federal RegisterVolume 42 Page 1561542 FR 15615Federal RegisterVolume 46 Page 845646 FR 8456Federal RegisterVolume 50 Page 5227850 FR 52278Federal RegisterVolume 60 Page 4747860 FR 47478id-CFR-2003-title21-vol1-part19Disqualification ConditionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part19-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part19-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part19-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part19-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part19-subpartC.xml21 CFR C21CFRSubpart C; Disqualification ConditionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTNODECFR-2003-title21-vol1-part19-subpartC429Subpart CsubpartC falseid-CFR-2003-title21-vol1-part19-subpartCTemporary disqualification of former employees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-45.xml21 CFR 19.4521CFR19.45Section 19.45; Temporary disqualification of former employees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDisqualification ConditionsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-45430Section 19.45section19.45 falseid-CFR-2003-title21-vol1-part19-subpartCPermanent disqualification of former employees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec19-55.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec19-55.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-55https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec19-55https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec19-55.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec19-55.xml21 CFR 19.5521CFR19.55Section 19.55; Permanent disqualification of former employees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDisqualification ConditionsPart 19STANDARDS OF CONDUCT AND CONFLICTS OF INTERESTCONTENTCFR-2003-title21-vol1-sec19-55431Section 19.55section19.55 falseid-CFR-2003-title21-vol1-chapI-subchapAPUBLIC INFORMATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20.xml21 CFR 2021CFR20Part 20; PUBLIC INFORMATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part20432Part 20part20 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.falseUnited States CodeTitle 5 Section 5525 U.S.C. 552United States CodeTitle 18 Section 190518 U.S.C. 1905United States CodeTitle 19 Section 2531-258219 U.S.C. 2531-2582United States CodeTitle 21 Section 1401-1403Title 21 Section 321-39321 U.S.C. 1401-140321 U.S.C. 321-393United States CodeTitle 21 Section 1401-1403Title 21 Section 321-393Title 21 Section 372(a)21 U.S.C. 1401-140321 U.S.C. 321-39321 U.S.C. 372(a)United States CodeTitle 42 Section 241Title 42 Section 242aTitle 42 Section 242Title 42 Section 242lTitle 42 Section 242nTitle 42 Section 243Title 42 Section 262Title 42 Section 263b-263nTitle 42 Section 263Title 42 Section 264Title 42 Section 265Title 42 Section 300aa-1Title 42 Section 300u-300u-542 U.S.C. 24142 U.S.C. 242a42 U.S.C. 24242 U.S.C. 242l42 U.S.C. 242n42 U.S.C. 24342 U.S.C. 26242 U.S.C. 263b-263n42 U.S.C. 26342 U.S.C. 26442 U.S.C. 26542 U.S.C. 300aa-142 U.S.C. 300u-300u-5Federal RegisterVolume 42 Page 1561642 FR 15616id-CFR-2003-title21-vol1-part20Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-toc-id433.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-toc-id433.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-toc-id433https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-toc-id433https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-toc-id433.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-toc-id433.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONTOCCFR-2003-title21-vol1-part20-toc-id433433Toctocid-CFR-2003-title21-vol1-part20Official Testimony and InformationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-subpartA.xml21 CFR A21CFRSubpart A; Official Testimony and InformationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONNODECFR-2003-title21-vol1-part20-subpartA434Subpart AsubpartA falseid-CFR-2003-title21-vol1-part20-subpartATestimony by Food and Drug Administration employees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-1.xml21 CFR 20.121CFR20.1Section 20.1; Testimony by Food and Drug Administration employees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AOfficial Testimony and InformationPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-1435Section 20.1section20.1 falseid-CFR-2003-title21-vol1-part20-subpartAProduction of records by Food and Drug Administration employees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-2.xml21 CFR 20.221CFR20.2Section 20.2; Production of records by Food and Drug Administration employees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AOfficial Testimony and InformationPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-2436Section 20.2section20.2 falseid-CFR-2003-title21-vol1-part20-subpartACertification and authentication of Food and Drug Administration records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-3.xml21 CFR 20.321CFR20.3Section 20.3; Certification and authentication of Food and Drug Administration records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AOfficial Testimony and InformationPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-3437Section 20.3section20.3 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845646 FR 8456id-CFR-2003-title21-vol1-part20General PolicyD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-subpartB.xml21 CFR B21CFRSubpart B; General PolicyChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONNODECFR-2003-title21-vol1-part20-subpartB438Subpart BsubpartB falseid-CFR-2003-title21-vol1-part20-subpartBPolicy on disclosure of Food and Drug Administration records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-20.xml21 CFR 20.2021CFR20.20Section 20.20; Policy on disclosure of Food and Drug Administration records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-20439Section 20.20section20.20 falseid-CFR-2003-title21-vol1-part20-subpartBUniform access to records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-21.xml21 CFR 20.2121CFR20.21Section 20.21; Uniform access to records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-21440Section 20.21section20.21 42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9037, Mar. 3, 1989falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 54 Page 903754 FR 9037id-CFR-2003-title21-vol1-part20-subpartBPartial disclosure of records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-22.xml21 CFR 20.2221CFR20.22Section 20.22; Partial disclosure of records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-22441Section 20.22section20.22 falseid-CFR-2003-title21-vol1-part20-subpartBRequest for existing records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-23.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-23.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-23https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-23https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-23.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-23.xml21 CFR 20.2321CFR20.23Section 20.23; Request for existing records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-23442Section 20.23section20.23 falseid-CFR-2003-title21-vol1-part20-subpartBPreparation of new records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-24.xml21 CFR 20.2421CFR20.24Section 20.24; Preparation of new records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-24443Section 20.24section20.24 falseid-CFR-2003-title21-vol1-part20-subpartBRetroactive application of regulations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-25.xml21 CFR 20.2521CFR20.25Section 20.25; Retroactive application of regulations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-25444Section 20.25section20.25 falseid-CFR-2003-title21-vol1-part20-subpartBIndexes of certain records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-26.xml21 CFR 20.2621CFR20.26Section 20.26; Indexes of certain records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-26445Section 20.26section20.26 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845646 FR 8456id-CFR-2003-title21-vol1-part20-subpartBSubmission of records marked as confidential.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-27.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-27.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-27https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-27https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-27.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-27.xml21 CFR 20.2721CFR20.27Section 20.27; Submission of records marked as confidential.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-27446Section 20.27section20.27 falseid-CFR-2003-title21-vol1-part20-subpartBFood and Drug Administration determinations of confidentiality.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-28.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-28.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-28https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-28https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-28.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-28.xml21 CFR 20.2821CFR20.28Section 20.28; Food and Drug Administration determinations of confidentiality.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-28447Section 20.28section20.28 falseid-CFR-2003-title21-vol1-part20-subpartBProhibition on withdrawal of records from Food and Drug Administration files.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-29.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-29.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-29https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-29https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-29.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-29.xml21 CFR 20.2921CFR20.29Section 20.29; Prohibition on withdrawal of records from Food and Drug Administration files.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-29448Section 20.29section20.29 falseid-CFR-2003-title21-vol1-part20-subpartBFood and Drug Administration Freedom of Information Staff.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-30.xml21 CFR 20.3021CFR20.30Section 20.30; Food and Drug Administration Freedom of Information Staff.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-30449Section 20.30section20.30 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845646 FR 8456id-CFR-2003-title21-vol1-part20-subpartBRetention schedule of requests for Food and Drug Administration records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-31.xml21 CFR 20.3121CFR20.31Section 20.31; Retention schedule of requests for Food and Drug Administration records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-31450Section 20.31section20.31 47 FR 24277, June 4, 1982falseFederal RegisterVolume 47 Page 2427747 FR 24277id-CFR-2003-title21-vol1-part20-subpartBDisclosure of Food and Drug Administration employee names.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-32.xml21 CFR 20.3221CFR20.32Section 20.32; Disclosure of Food and Drug Administration employee names.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BGeneral PolicyPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-32451Section 20.32section20.32 falseid-CFR-2003-title21-vol1-part20Procedures and FeesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-subpartC.xml21 CFR C21CFRSubpart C; Procedures and FeesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONNODECFR-2003-title21-vol1-part20-subpartC452Subpart CsubpartC falseid-CFR-2003-title21-vol1-part20-subpartCFiling a request for records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-40.xml21 CFR 20.4021CFR20.40Section 20.40; Filing a request for records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-40453Section 20.40section20.40 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845646 FR 8456id-CFR-2003-title21-vol1-part20-subpartCTime limitations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-41.xml21 CFR 20.4121CFR20.41Section 20.41; Time limitations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-41454Section 20.41section20.41 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 55 FR 1405, Jan. 16, 1990; 59 FR 533, Jan. 5, 1994falseCode of Federal RegulationsTitle 5 Part 5.345 CFR Part 5.34Federal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845646 FR 8456Federal RegisterVolume 55 Page 140555 FR 1405Federal RegisterVolume 59 Page 53359 FR 533id-CFR-2003-title21-vol1-part20-subpartCFees to be charged.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-42.xml21 CFR 20.4221CFR20.42Section 20.42; Fees to be charged.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-42455Section 20.42section20.42 59 FR 533, Jan. 5, 1994falseCode of Federal RegulationsTitle 5 Part 305 CFR Part 30Federal RegisterVolume 59 Page 53359 FR 533id-CFR-2003-title21-vol1-part20-subpartCWaiver or reduction of fees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-43.xml21 CFR 20.4321CFR20.43Section 20.43; Waiver or reduction of fees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-43456Section 20.43section20.43 59 FR 534, Jan. 5, 1994falseFederal RegisterVolume 59 Page 53459 FR 534id-CFR-2003-title21-vol1-part20-subpartCPresubmission review of request for confidentiality of voluntarily submitted data or information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-44.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-44.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-44https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-44https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-44.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-44.xml21 CFR 20.4421CFR20.44Section 20.44; Presubmission review of request for confidentiality of voluntarily submitted data or information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-44457Section 20.44section20.44 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 FR 8995, Mar. 6, 1985falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845746 FR 8457Federal RegisterVolume 50 Page 899550 FR 8995id-CFR-2003-title21-vol1-part20-subpartCSituations in which confidentiality is uncertain.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-45.xml21 CFR 20.4521CFR20.45Section 20.45; Situations in which confidentiality is uncertain.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-45458Section 20.45section20.45 falseid-CFR-2003-title21-vol1-part20-subpartCJudicial review of proposed disclosure.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-46.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-46.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-46https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-46https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-46.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-46.xml21 CFR 20.4621CFR20.46Section 20.46; Judicial review of proposed disclosure.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-46459Section 20.46section20.46 falseUnited States CodeTitle 5 Chapter 75 U.S.C. Chapter 7id-CFR-2003-title21-vol1-part20-subpartCDenial of a request for records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-47.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-47.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-47https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-47https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-47.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-47.xml21 CFR 20.4721CFR20.47Section 20.47; Denial of a request for records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-47460Section 20.47section20.47 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 55 FR 1405, Jan. 16, 1990falseCode of Federal RegulationsTitle 5 Part 5.345 CFR Part 5.34Federal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845746 FR 8457Federal RegisterVolume 55 Page 140555 FR 1405id-CFR-2003-title21-vol1-part20-subpartCNonspecific and overly burdensome requests.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-48.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-48.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-48https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-48https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-48.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-48.xml21 CFR 20.4821CFR20.48Section 20.48; Nonspecific and overly burdensome requests.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-48461Section 20.48section20.48 falseid-CFR-2003-title21-vol1-part20-subpartCReferral to primary source of records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-49.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-49.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-49https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-49https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-49.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-49.xml21 CFR 20.4921CFR20.49Section 20.49; Referral to primary source of records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-49462Section 20.49section20.49 falseid-CFR-2003-title21-vol1-part20-subpartCAvailability of records at National Technical Information Service.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-50.xml21 CFR 20.5021CFR20.50Section 20.50; Availability of records at National Technical Information Service.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-50463Section 20.50section20.50 42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 54 Page 903854 FR 9038id-CFR-2003-title21-vol1-part20-subpartCUse of private contractor for copying.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-51.xml21 CFR 20.5121CFR20.51Section 20.51; Use of private contractor for copying.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-51464Section 20.51section20.51 falseid-CFR-2003-title21-vol1-part20-subpartCRequest for review without copying.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-52.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-52.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-52https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-52https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-52.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-52.xml21 CFR 20.5221CFR20.52Section 20.52; Request for review without copying.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-52465Section 20.52section20.52 falseid-CFR-2003-title21-vol1-part20-subpartCIndexing trade secrets and confidential commercial or financial information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-53.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-53.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-53https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-53https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-53.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-53.xml21 CFR 20.5321CFR20.53Section 20.53; Indexing trade secrets and confidential commercial or financial information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CProcedures and FeesPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-53466Section 20.53section20.53 42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 59 Page 53559 FR 535id-CFR-2003-title21-vol1-part20ExemptionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-subpartD.xml21 CFR D21CFRSubpart D; ExemptionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONNODECFR-2003-title21-vol1-part20-subpartD467Subpart DsubpartD falseid-CFR-2003-title21-vol1-part20-subpartDApplicability of exemptions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-60.xml21 CFR 20.6021CFR20.60Section 20.60; Applicability of exemptions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-60468Section 20.60section20.60 falseid-CFR-2003-title21-vol1-part20-subpartDTrade secrets and commercial or financial information which is privileged or confidential.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-61.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-61.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-61https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-61https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-61.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-61.xml21 CFR 20.6121CFR20.61Section 20.61; Trade secrets and commercial or financial information which is privileged or confidential.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-61469Section 20.61section20.61 42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 59 Page 53559 FR 535id-CFR-2003-title21-vol1-part20-subpartDInter- or intra-agency memoranda or letters.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-62.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-62.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-62https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-62https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-62.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-62.xml21 CFR 20.6221CFR20.62Section 20.62; Inter- or intra-agency memoranda or letters.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-62470Section 20.62section20.62 falseid-CFR-2003-title21-vol1-part20-subpartDPersonnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-63.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-63.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-63https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-63https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-63.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-63.xml21 CFR 20.6321CFR20.63Section 20.63; Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-63471Section 20.63section20.63 42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 60 Page 1696860 FR 16968id-CFR-2003-title21-vol1-part20-subpartDRecords or information compiled for law enforcement purposes.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-64.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-64.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-64https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-64https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-64.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-64.xml21 CFR 20.6421CFR20.64Section 20.64; Records or information compiled for law enforcement purposes.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-64472Section 20.64section20.64 42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 59 Page 53659 FR 536id-CFR-2003-title21-vol1-part20Limitations on ExemptionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-subpartE.xml21 CFR E21CFRSubpart E; Limitations on ExemptionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONNODECFR-2003-title21-vol1-part20-subpartE473Subpart EsubpartE falseid-CFR-2003-title21-vol1-part20-subpartEApplicability of limitations on exemptions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-80.xml21 CFR 20.8021CFR20.80Section 20.80; Applicability of limitations on exemptions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-80474Section 20.80section20.80 falseid-CFR-2003-title21-vol1-part20-subpartEData and information previously disclosed to the public.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-81.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-81.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-81https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-81https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-81.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-81.xml21 CFR 20.8121CFR20.81Section 20.81; Data and information previously disclosed to the public.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-81475Section 20.81section20.81 42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 59 FR 536, Jan. 5, 1994falseUnited States CodeTitle 18 Section 100118 U.S.C. 1001Federal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 54 Page 903854 FR 9038Federal RegisterVolume 59 Page 53659 FR 536id-CFR-2003-title21-vol1-part20-subpartEDiscretionary disclosure by the Commissioner.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-82.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-82.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-82https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-82https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-82.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-82.xml21 CFR 20.8221CFR20.82Section 20.82; Discretionary disclosure by the Commissioner.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-82476Section 20.82section20.82 falseUnited States CodeTitle 5 Section 552a(b)5 U.S.C. 552a(b)United States CodeTitle 18 Section 190518 U.S.C. 1905United States CodeTitle 21 Section 331(j)21 U.S.C. 331(j)United States CodeTitle 42 Section 263g(d)Title 42 Section 263i42 U.S.C. 263g(d)42 U.S.C. 263iid-CFR-2003-title21-vol1-part20-subpartEDisclosure required by court order.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-83.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-83.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-83https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-83https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-83.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-83.xml21 CFR 20.8321CFR20.83Section 20.83; Disclosure required by court order.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-83477Section 20.83section20.83 falseid-CFR-2003-title21-vol1-part20-subpartEDisclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-84.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-84.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-84https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-84https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-84.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-84.xml21 CFR 20.8421CFR20.84Section 20.84; Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-84478Section 20.84section20.84 falseUnited States CodeTitle 21 Section 372(a)21 U.S.C. 372(a)id-CFR-2003-title21-vol1-part20-subpartEDisclosure to other Federal government departments and agencies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-85.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-85.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-85https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-85https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-85.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-85.xml21 CFR 20.8521CFR20.85Section 20.85; Disclosure to other Federal government departments and agencies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-85479Section 20.85section20.85 47 FR 10804, Mar. 12, 1982, as amended at 59 FR 536, Jan. 5, 1994falseUnited States CodeTitle 21 Section 331(j)Title 21 Section 360(j)(c)21 U.S.C. 331(j)21 U.S.C. 360(j)(c)United States CodeTitle 42 Section 263g(d)Title 42 Section 263i(e)42 U.S.C. 263g(d)42 U.S.C. 263i(e)Federal RegisterVolume 47 Page 1080447 FR 10804Federal RegisterVolume 59 Page 53659 FR 536id-CFR-2003-title21-vol1-part20-subpartEDisclosure in administrative or court proceedings.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-86.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-86.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-86https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-86https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-86.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-86.xml21 CFR 20.8621CFR20.86Section 20.86; Disclosure in administrative or court proceedings.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-86480Section 20.86section20.86 42 FR 15616, Mar. 22, 1977, as amended at 60 FR 38633, July 27, 1995falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 60 Page 3863360 FR 38633id-CFR-2003-title21-vol1-part20-subpartEDisclosure to Congress.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-87.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-87.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-87https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-87https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-87.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-87.xml21 CFR 20.8721CFR20.87Section 20.87; Disclosure to Congress.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-87481Section 20.87section20.87 42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 59 Page 53659 FR 536id-CFR-2003-title21-vol1-part20-subpartECommunications with State and local government officials.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-88.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-88.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-88https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-88https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-88.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-88.xml21 CFR 20.8821CFR20.88Section 20.88; Communications with State and local government officials.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-88482Section 20.88section20.88 42 FR 15616, Mar. 22, 1977, as amended at 60 FR 63381, Dec. 8, 1995; 65 FR 11887, Mar. 7, 2000falseUnited States CodeTitle 21 Section 372(a)21 U.S.C. 372(a)Federal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 60 Page 6338160 FR 63381Federal RegisterVolume 65 Page 1188765 FR 11887id-CFR-2003-title21-vol1-part20-subpartECommunications with foreign government officials.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-89.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-89.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-89https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-89https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-89.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-89.xml21 CFR 20.8921CFR20.89Section 20.89; Communications with foreign government officials.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-89483Section 20.89section20.89 42 FR 15616, Mar. 22, 1977, as amended at 58 FR 61603, Nov. 19, 1993; 60 FR 63382, Dec. 8, 1995; 65 FR 11888, Mar. 7, 2000falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 58 Page 6160358 FR 61603Federal RegisterVolume 60 Page 6338260 FR 63382Federal RegisterVolume 65 Page 1188865 FR 11888id-CFR-2003-title21-vol1-part20-subpartEDisclosure to contractors.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-90.xml21 CFR 20.9021CFR20.90Section 20.90; Disclosure to contractors.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-90484Section 20.90section20.90 falseid-CFR-2003-title21-vol1-part20-subpartEUse of data or information for administrative or court enforcement action.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-91.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-91.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-91https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-91https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-91.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-91.xml21 CFR 20.9121CFR20.91Section 20.91; Use of data or information for administrative or court enforcement action.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ELimitations on ExemptionsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-91485Section 20.91section20.91 falseid-CFR-2003-title21-vol1-part20Availability of Specific Categories of RecordsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part20-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part20-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part20-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part20-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part20-subpartF.xml21 CFR F21CFRSubpart F; Availability of Specific Categories of RecordsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 20PUBLIC INFORMATIONNODECFR-2003-title21-vol1-part20-subpartF486Subpart FsubpartF falseid-CFR-2003-title21-vol1-part20-subpartFApplicability; cross-reference to other regulations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-100.xml21 CFR 20.10021CFR20.100Section 20.100; Applicability; cross-reference to other regulations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-100487Section 20.100section20.100 42 FR 15616, Mar. 22, 1977, as amended at 42 FR 19989, Apr. 15, 1977; 42 FR 42526, Aug. 28, 1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993, July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR 9038, Mar. 3, 1989; 58 FR 2533, Jan. 6, 1993; 59 FR 536, Jan. 5, 1994; 61 FR 33244, June 26, 1996; 62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, 1999; 67 FR 13717, Mar. 26, 2002; 67 FR 35729, May 21, 2002falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 42 Page 1998942 FR 19989Federal RegisterVolume 42 Page 4252642 FR 42526Federal RegisterVolume 42 Page 5888942 FR 58889Federal RegisterVolume 43 Page 3299343 FR 32993Federal RegisterVolume 51 Page 2247551 FR 22475Federal RegisterVolume 54 Page 903854 FR 9038Federal RegisterVolume 58 Page 253358 FR 2533Federal RegisterVolume 59 Page 53659 FR 536Federal RegisterVolume 61 Page 3324461 FR 33244Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 64 Page 5644864 FR 56448Federal RegisterVolume 67 Page 1371767 FR 13717Federal RegisterVolume 67 Page 3572967 FR 35729id-CFR-2003-title21-vol1-part20-subpartFAdministrative enforcement records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-101.xml21 CFR 20.10121CFR20.101Section 20.101; Administrative enforcement records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-101488Section 20.101section20.101 falseid-CFR-2003-title21-vol1-part20-subpartFCourt enforcement records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-102.xml21 CFR 20.10221CFR20.102Section 20.102; Court enforcement records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-102489Section 20.102section20.102 falseid-CFR-2003-title21-vol1-part20-subpartFCorrespondence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-103.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-103.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-103https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-103https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-103.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-103.xml21 CFR 20.10321CFR20.103Section 20.103; Correspondence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-103490Section 20.103section20.103 42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 54 Page 903854 FR 9038id-CFR-2003-title21-vol1-part20-subpartFSummaries of oral discussions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-104.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-104.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-104https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-104https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-104.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-104.xml21 CFR 20.10421CFR20.104Section 20.104; Summaries of oral discussions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-104491Section 20.104section20.104 falseid-CFR-2003-title21-vol1-part20-subpartFTesting and research conducted by or with funds provided by the Food and Drug Administration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-105.xml21 CFR 20.10521CFR20.105Section 20.105; Testing and research conducted by or with funds provided by the Food and Drug Administration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-105492Section 20.105section20.105 falseid-CFR-2003-title21-vol1-part20-subpartFStudies and reports prepared by or with funds provided by the Food and Drug Administration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-106.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-106.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-106https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-106https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-106.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-106.xml21 CFR 20.10621CFR20.106Section 20.106; Studies and reports prepared by or with funds provided by the Food and Drug Administration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-106493Section 20.106section20.106 42 FR FR 15616, Mar. 22, 1977, as amended at 50 FR 8995, Mar. 6, 1985falseFederal RegisterVolume 50 Page 899550 FR 8995id-CFR-2003-title21-vol1-part20-subpartFFood and Drug Administration manuals.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-107.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-107.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-107https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-107https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-107.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-107.xml21 CFR 20.10721CFR20.107Section 20.107; Food and Drug Administration manuals.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-107494Section 20.107section20.107 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 1434046 FR 14340Federal RegisterVolume 46 Page 845746 FR 8457id-CFR-2003-title21-vol1-part20-subpartFAgreements between the Food and Drug Administration and other departments, agencies, and organizations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-108.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-108.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-108https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-108https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-108.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-108.xml21 CFR 20.10821CFR20.108Section 20.108; Agreements between the Food and Drug Administration and other departments, agencies, and organizations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-108495Section 20.108section20.108 42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 58 FR 48794, 48796, Sept. 20, 1993falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 46 Page 845746 FR 8457Federal RegisterVolume 58 Page 4879458 FR 48794id-CFR-2003-title21-vol1-part20-subpartFData and information obtained by contract.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-109.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-109.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-109https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-109https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-109.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-109.xml21 CFR 20.10921CFR20.109Section 20.109; Data and information obtained by contract.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-109496Section 20.109section20.109 falseid-CFR-2003-title21-vol1-part20-subpartFData and information about Food and Drug Administration employees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-110.xml21 CFR 20.11021CFR20.110Section 20.110; Data and information about Food and Drug Administration employees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-110497Section 20.110section20.110 falseid-CFR-2003-title21-vol1-part20-subpartFData and information submitted voluntarily to the Food and Drug Administration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-111.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-111.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-111https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-111https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-111.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-111.xml21 CFR 20.11121CFR20.111Section 20.111; Data and information submitted voluntarily to the Food and Drug Administration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-111498Section 20.111section20.111 falseid-CFR-2003-title21-vol1-part20-subpartFVoluntary drug experience reports submitted by physicians and hospitals.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-112.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-112.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-112https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-112https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-112.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-112.xml21 CFR 20.11221CFR20.112Section 20.112; Voluntary drug experience reports submitted by physicians and hospitals.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-112499Section 20.112section20.112 42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62 FR 52249, Oct. 7, 1997falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 54 Page 903854 FR 9038Federal RegisterVolume 62 Page 5224962 FR 52249id-CFR-2003-title21-vol1-part20-subpartFVoluntary product defect reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-113.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-113.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-113https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-113https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-113.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-113.xml21 CFR 20.11321CFR20.113Section 20.113; Voluntary product defect reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-113500Section 20.113section20.113 falseid-CFR-2003-title21-vol1-part20-subpartFData and information submitted pursuant to cooperative quality assurance agreements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-114.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-114.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-114https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-114https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-114.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-114.xml21 CFR 20.11421CFR20.114Section 20.114; Data and information submitted pursuant to cooperative quality assurance agreements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-114501Section 20.114section20.114 falseid-CFR-2003-title21-vol1-part20-subpartFProduct codes for manufacturing or sales dates.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-115.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-115.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-115https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-115https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-115.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-115.xml21 CFR 20.11521CFR20.115Section 20.115; Product codes for manufacturing or sales dates.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-115502Section 20.115section20.115 falseid-CFR-2003-title21-vol1-part20-subpartFDrug and device listing information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-116.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-116.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-116https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-116https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-116.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-116.xml21 CFR 20.11621CFR20.116Section 20.116; Drug and device listing information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-116503Section 20.116section20.116 42 FR 42526, Aug. 23, 1977falseFederal RegisterVolume 42 Page 4252642 FR 42526id-CFR-2003-title21-vol1-part20-subpartFNew drug information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-117.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-117.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-117https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-117https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-117.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-117.xml21 CFR 20.11721CFR20.117Section 20.117; New drug information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-117504Section 20.117section20.117 42 FR 15616, Mar. 22, 1977, as amended at 45 FR 72608, Oct. 31, 1980; 46 FR 8457, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999falseFederal RegisterVolume 42 Page 1561642 FR 15616Federal RegisterVolume 45 Page 7260845 FR 72608Federal RegisterVolume 46 Page 845746 FR 8457Federal RegisterVolume 54 Page 903854 FR 9038Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part20-subpartFAdvisory committee records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-118.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-118.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-118https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-118https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-118.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-118.xml21 CFR 20.11821CFR20.118Section 20.118; Advisory committee records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-118505Section 20.118section20.118 falseid-CFR-2003-title21-vol1-part20-subpartFLists of names and addresses.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec20-119.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec20-119.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-119https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec20-119https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec20-119.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec20-119.xml21 CFR 20.11921CFR20.119Section 20.119; Lists of names and addresses.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FAvailability of Specific Categories of RecordsPart 20PUBLIC INFORMATIONCONTENTCFR-2003-title21-vol1-sec20-119506Section 20.119section20.119 falseid-CFR-2003-title21-vol1-chapI-subchapAPROTECTION OF PRIVACYD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21.xml21 CFR 2121CFR21Part 21; PROTECTION OF PRIVACYChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part21507Part 21part21 21 U.S.C. 371; 5 U.S.C. 552, 552a.falseUnited States CodeTitle 5 Section 552aTitle 5 Section 5525 U.S.C. 552a5 U.S.C. 552United States CodeTitle 21 Section 37121 U.S.C. 371Federal RegisterVolume 42 Page 1562642 FR 15626id-CFR-2003-title21-vol1-part21Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-toc-id508.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-toc-id508.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-toc-id508https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-toc-id508https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-toc-id508.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-toc-id508.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYTOCCFR-2003-title21-vol1-part21-toc-id508508Toctocid-CFR-2003-title21-vol1-part21General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartA509Subpart AsubpartA falseid-CFR-2003-title21-vol1-part21-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-1.xml21 CFR 21.121CFR21.1Section 21.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-1510Section 21.1section21.1 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985falseUnited States CodeTitle 5 Section 552a5 U.S.C. 552aCode of Federal RegulationsTitle 5 Part 293294, and 2975 CFR Part 293294, and 297Federal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845746 FR 8457Federal RegisterVolume 50 Page 5227850 FR 52278id-CFR-2003-title21-vol1-part21-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-3.xml21 CFR 21.321CFR21.3Section 21.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-3511Section 21.3section21.3 falseid-CFR-2003-title21-vol1-part21-subpartAPolicy concerning records about individuals.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-10.xml21 CFR 21.1021CFR21.10Section 21.10; Policy concerning records about individuals.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-10512Section 21.10section21.10 falseid-CFR-2003-title21-vol1-part21Food and Drug Administration Privacy Act Record SystemsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartB.xml21 CFR B21CFRSubpart B; Food and Drug Administration Privacy Act Record SystemsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartB513Subpart BsubpartB falseid-CFR-2003-title21-vol1-part21-subpartBProcedures for notice of Food and Drug Administration Privacy Act Record Systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-20.xml21 CFR 21.2021CFR21.20Section 21.20; Procedures for notice of Food and Drug Administration Privacy Act Record Systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFood and Drug Administration Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-20514Section 21.20section21.20 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845746 FR 8457id-CFR-2003-title21-vol1-part21-subpartBChanges in systems and new systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-21.xml21 CFR 21.2121CFR21.21Section 21.21; Changes in systems and new systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFood and Drug Administration Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-21515Section 21.21section21.21 falseid-CFR-2003-title21-vol1-part21Requirements for Specific Categories of RecordsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartC.xml21 CFR C21CFRSubpart C; Requirements for Specific Categories of RecordsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartC516Subpart CsubpartC falseid-CFR-2003-title21-vol1-part21-subpartCRecords of contractors.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-30.xml21 CFR 21.3021CFR21.30Section 21.30; Records of contractors.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRequirements for Specific Categories of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-30517Section 21.30section21.30 falseUnited States CodeTitle 5 Section 552aTitle 5 Section 552a(i)5 U.S.C. 552a5 U.S.C. 552a(i)Code of Federal RegulationsTitle 1 Part 21and1 CFR Part 21andid-CFR-2003-title21-vol1-part21-subpartCRecords stored by the National Archives and Records Administration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-31.xml21 CFR 21.3121CFR21.31Section 21.31; Records stored by the National Archives and Records Administration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRequirements for Specific Categories of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-31518Section 21.31section21.31 42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985falseUnited States CodeTitle 44 Section 310344 U.S.C. 3103Federal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 50 Page 5227850 FR 52278id-CFR-2003-title21-vol1-part21-subpartCPersonnel records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-32.xml21 CFR 21.3221CFR21.32Section 21.32; Personnel records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRequirements for Specific Categories of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-32519Section 21.32section21.32 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985falseCode of Federal RegulationsTitle 5 Part 297.106,5 CFR Part 297.106,Code of Federal RegulationsTitle 5 Part 297.108(g)(3) and 297.113(b)5 CFR Part 297.108(g)(3) and 297.113(b)Code of Federal RegulationsTitle 5 Part 297.1115 CFR Part 297.111Code of Federal RegulationsTitle 5 Part 293294, and 2975 CFR Part 293294, and 297Federal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845746 FR 8457Federal RegisterVolume 50 Page 5227850 FR 52278id-CFR-2003-title21-vol1-part21-subpartCMedical records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-33.xml21 CFR 21.3321CFR21.33Section 21.33; Medical records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRequirements for Specific Categories of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-33520Section 21.33section21.33 falseid-CFR-2003-title21-vol1-part21Procedures for Notification of and Access to Records in Privacy Act Record SystemsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartD.xml21 CFR D21CFRSubpart D; Procedures for Notification of and Access to Records in Privacy Act Record SystemsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartD521Subpart DsubpartD falseid-CFR-2003-title21-vol1-part21-subpartDProcedures for submitting requests for notification and access.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-40.xml21 CFR 21.4021CFR21.40Section 21.40; Procedures for submitting requests for notification and access.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Notification of and Access to Records in Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-40522Section 21.40section21.40 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845846 FR 8458Federal RegisterVolume 50 Page 5227850 FR 52278id-CFR-2003-title21-vol1-part21-subpartDProcessing of requests.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-41.xml21 CFR 21.4121CFR21.41Section 21.41; Processing of requests.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Notification of and Access to Records in Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-41523Section 21.41section21.41 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845846 FR 8458id-CFR-2003-title21-vol1-part21-subpartDResponses to requests.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-42.xml21 CFR 21.4221CFR21.42Section 21.42; Responses to requests.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Notification of and Access to Records in Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-42524Section 21.42section21.42 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845846 FR 8458id-CFR-2003-title21-vol1-part21-subpartDAccess to requested records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-43.xml21 CFR 21.4321CFR21.43Section 21.43; Access to requested records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Notification of and Access to Records in Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-43525Section 21.43section21.43 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845846 FR 8458id-CFR-2003-title21-vol1-part21-subpartDVerification of identity.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-44.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-44.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-44https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-44https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-44.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-44.xml21 CFR 21.4421CFR21.44Section 21.44; Verification of identity.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Notification of and Access to Records in Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-44526Section 21.44section21.44 falseid-CFR-2003-title21-vol1-part21-subpartDFees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-45.xml21 CFR 21.4521CFR21.45Section 21.45; Fees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DProcedures for Notification of and Access to Records in Privacy Act Record SystemsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-45527Section 21.45section21.45 42 FR 15626, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 54 Page 903854 FR 9038id-CFR-2003-title21-vol1-part21Procedures for Requests for Amendment of RecordsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartE.xml21 CFR E21CFRSubpart E; Procedures for Requests for Amendment of RecordsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartE528Subpart EsubpartE falseid-CFR-2003-title21-vol1-part21-subpartEProcedures for submitting requests for amendment of records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-50.xml21 CFR 21.5021CFR21.50Section 21.50; Procedures for submitting requests for amendment of records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EProcedures for Requests for Amendment of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-50529Section 21.50section21.50 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845946 FR 8459id-CFR-2003-title21-vol1-part21-subpartEResponses to requests for amendment of records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-51.xml21 CFR 21.5121CFR21.51Section 21.51; Responses to requests for amendment of records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EProcedures for Requests for Amendment of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-51530Section 21.51section21.51 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981falseFederal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845946 FR 8459id-CFR-2003-title21-vol1-part21-subpartEAdministrative appeals of refusals to amend records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-52.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-52.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-52https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-52https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-52.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-52.xml21 CFR 21.5221CFR21.52Section 21.52; Administrative appeals of refusals to amend records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EProcedures for Requests for Amendment of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-52531Section 21.52section21.52 42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985falseUnited States CodeTitle 18 Section 100118 U.S.C. 1001Federal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 50 Page 5227850 FR 52278id-CFR-2003-title21-vol1-part21-subpartENotation and disclosure of disputed records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-53.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-53.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-53https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-53https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-53.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-53.xml21 CFR 21.5321CFR21.53Section 21.53; Notation and disclosure of disputed records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EProcedures for Requests for Amendment of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-53532Section 21.53section21.53 falseid-CFR-2003-title21-vol1-part21-subpartEAmended or disputed records received from other agencies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-54.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-54.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-54https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-54https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-54.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-54.xml21 CFR 21.5421CFR21.54Section 21.54; Amended or disputed records received from other agencies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EProcedures for Requests for Amendment of RecordsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-54533Section 21.54section21.54 falseid-CFR-2003-title21-vol1-part21ExemptionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartF.xml21 CFR F21CFRSubpart F; ExemptionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartF534Subpart FsubpartF falseid-CFR-2003-title21-vol1-part21-subpartFPolicy.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-60.xml21 CFR 21.6021CFR21.60Section 21.60; Policy.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FExemptionsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-60535Section 21.60section21.60 falseid-CFR-2003-title21-vol1-part21-subpartFExempt systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-61.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-61.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-61https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-61https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-61.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-61.xml21 CFR 21.6121CFR21.61Section 21.61; Exempt systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FExemptionsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-61536Section 21.61section21.61 42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985falseUnited States CodeTitle 5 Section 552aTitle 5 Section 552a(c)(3)Title 5 Section 552a(d)(1)Title 5 Section 552a(e)(3)Title 5 Section 552a(e)(4)(G)Title 5 Section 552a(j)(2)Title 5 Section 552a(k)(2)Title 5 Section 552a(k)(5)5 U.S.C. 552a5 U.S.C. 552a(c)(3)5 U.S.C. 552a(d)(1)5 U.S.C. 552a(e)(3)5 U.S.C. 552a(e)(4)(G)5 U.S.C. 552a(j)(2)5 U.S.C. 552a(k)(2)5 U.S.C. 552a(k)(5)Federal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 46 Page 845946 FR 8459Federal RegisterVolume 50 Page 5227850 FR 52278id-CFR-2003-title21-vol1-part21-subpartFAccess to records in exempt systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-65.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-65.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-65https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-65https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-65.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-65.xml21 CFR 21.6521CFR21.65Section 21.65; Access to records in exempt systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FExemptionsPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-65537Section 21.65section21.65 falseUnited States CodeTitle 5 Section 552a(j)(2)Title 5 Section 552a(k)(2)5 U.S.C. 552a(j)(2)5 U.S.C. 552a(k)(2)id-CFR-2003-title21-vol1-part21Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualD09002ee18a5cbbf0-CFR-2003-title21-vol1-part21-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part21-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part21-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part21-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part21-subpartG.xml21 CFR G21CFRSubpart G; Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 21PROTECTION OF PRIVACYNODECFR-2003-title21-vol1-part21-subpartG538Subpart GsubpartG falseid-CFR-2003-title21-vol1-part21-subpartGDisclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-70.xml21 CFR 21.7021CFR21.70Section 21.70; Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GDisclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-70539Section 21.70section21.70 falseid-CFR-2003-title21-vol1-part21-subpartGDisclosure of records in Privacy Act Record Systems; accounting required.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-71.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-71.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-71https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-71https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-71.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-71.xml21 CFR 21.7121CFR21.71Section 21.71; Disclosure of records in Privacy Act Record Systems; accounting required.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GDisclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-71540Section 21.71section21.71 42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985; 54 FR 9038, Mar. 3, 1989falseUnited States CodeTitle 5 Section 552a(i)(3)5 U.S.C. 552a(i)(3)United States CodeTitle 18 Section 100118 U.S.C. 1001United States CodeTitle 31 Section 952(d)31 U.S.C. 952(d)Federal RegisterVolume 42 Page 1562642 FR 15626Federal RegisterVolume 50 Page 5227850 FR 52278Federal RegisterVolume 54 Page 903854 FR 9038id-CFR-2003-title21-vol1-part21-subpartGIndividual consent to disclosure of records to other persons.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-72.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-72.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-72https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-72https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-72.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-72.xml21 CFR 21.7221CFR21.72Section 21.72; Individual consent to disclosure of records to other persons.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GDisclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-72541Section 21.72section21.72 falseid-CFR-2003-title21-vol1-part21-subpartGAccuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-73.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-73.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-73https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-73https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-73.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-73.xml21 CFR 21.7321CFR21.73Section 21.73; Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GDisclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-73542Section 21.73section21.73 falseid-CFR-2003-title21-vol1-part21-subpartGProviding notice that a record is disputed.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-74.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-74.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-74https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-74https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-74.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-74.xml21 CFR 21.7421CFR21.74Section 21.74; Providing notice that a record is disputed.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GDisclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-74543Section 21.74section21.74 falseid-CFR-2003-title21-vol1-part21-subpartGRights of legal guardians.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec21-75.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec21-75.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-75https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec21-75https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec21-75.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec21-75.xml21 CFR 21.7521CFR21.75Section 21.75; Rights of legal guardians.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GDisclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject IndividualPart 21PROTECTION OF PRIVACYCONTENTCFR-2003-title21-vol1-sec21-75544Section 21.75section21.75 falseid-CFR-2003-title21-vol1-chapI-subchapAENVIRONMENTAL IMPACT CONSIDERATIONSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25.xml21 CFR 2521CFR25Part 25; ENVIRONMENTAL IMPACT CONSIDERATIONSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part25545Part 25part25 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.falseUnited States CodeTitle 21 Section 321-39321 U.S.C. 321-393United States CodeTitle 42 Section 262Title 42 Section 263b-264Title 42 Section 4321Title 42 Section 433242 U.S.C. 26242 U.S.C. 263b-26442 U.S.C. 432142 U.S.C. 4332Code of Federal RegulationsTitle 0 Part 1500-15080 CFR Part 1500-1508Code of Federal RegulationsTitle 0 Part 1500-15080 CFR Part 1500-1508Federal RegisterVolume 35 Page 424735 FR 4247Federal RegisterVolume 42 Page 2696742 FR 26967Federal RegisterVolume 44 Page 195744 FR 1957Federal RegisterVolume 62 Page 4059262 FR 40592id-CFR-2003-title21-vol1-part25Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-toc-id546.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-toc-id546.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-toc-id546https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-toc-id546https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-toc-id546.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-toc-id546.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSTOCCFR-2003-title21-vol1-part25-toc-id546546Toctocid-CFR-2003-title21-vol1-part25General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSNODECFR-2003-title21-vol1-part25-subpartA547Subpart AsubpartA falseid-CFR-2003-title21-vol1-part25-subpartAPurpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-1.xml21 CFR 25.121CFR25.1Section 25.1; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-1548Section 25.1section25.1 falseCode of Federal RegulationsTitle 0 Part 1500through 1508 and0 CFR Part 1500through 1508 andFederal RegisterVolume 45 Page 7651945 FR 76519id-CFR-2003-title21-vol1-part25-subpartATerminology.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-5.xml21 CFR 25.521CFR25.5Section 25.5; Terminology.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-5549Section 25.5section25.5 62 FR 40592, July 29, 1997, as amended at 64 FR 399, Jan. 5, 1999falseCode of Federal RegulationsTitle 0 Part 1508.100 CFR Part 1508.10Code of Federal RegulationsTitle 0 Part 1508.110 CFR Part 1508.11Code of Federal RegulationsTitle 0 Part 1508.120 CFR Part 1508.12Code of Federal RegulationsTitle 0 Part 1508.130 CFR Part 1508.13Code of Federal RegulationsTitle 0 Part 1508.140 CFR Part 1508.14Code of Federal RegulationsTitle 0 Part 1508.160 CFR Part 1508.16Code of Federal RegulationsTitle 0 Part 1508.170 CFR Part 1508.17Code of Federal RegulationsTitle 0 Part 1508.180 CFR Part 1508.18Code of Federal RegulationsTitle 0 Part 1508.200 CFR Part 1508.20Code of Federal RegulationsTitle 0 Part 1508.210 CFR Part 1508.21Code of Federal RegulationsTitle 0 Part 1508.220 CFR Part 1508.22Code of Federal RegulationsTitle 0 Part 1508.230 CFR Part 1508.23Code of Federal RegulationsTitle 0 Part 1508.250 CFR Part 1508.25Code of Federal RegulationsTitle 0 Part 1508.270 CFR Part 1508.27Code of Federal RegulationsTitle 0 Part 1508.40 CFR Part 1508.4Code of Federal RegulationsTitle 0 Part 1508.50 CFR Part 1508.5Code of Federal RegulationsTitle 0 Part 1508.70 CFR Part 1508.7Code of Federal RegulationsTitle 0 Part 1508.80 CFR Part 1508.8Code of Federal RegulationsTitle 0 Part 1508.90 CFR Part 1508.9Code of Federal RegulationsTitle 0 Part 15080 CFR Part 1508Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part25-subpartAPolicies and NEPA planning.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-10.xml21 CFR 25.1021CFR25.10Section 25.10; Policies and NEPA planning.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-10550Section 25.10section25.10 falseCode of Federal RegulationsTitle 0 Part 1502.25 and0 CFR Part 1502.25 andid-CFR-2003-title21-vol1-part25Agency Actions Requiring Environmental ConsiderationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-subpartB.xml21 CFR B21CFRSubpart B; Agency Actions Requiring Environmental ConsiderationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSNODECFR-2003-title21-vol1-part25-subpartB551Subpart BsubpartB falseid-CFR-2003-title21-vol1-part25-subpartBGeneral procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-15.xml21 CFR 25.1521CFR25.15Section 25.15; General procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAgency Actions Requiring Environmental ConsiderationPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-15552Section 25.15section25.15 falseid-CFR-2003-title21-vol1-part25-subpartBPublic health and safety emergencies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-16.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-16.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-16https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-16https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-16.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-16.xml21 CFR 25.1621CFR25.16Section 25.16; Public health and safety emergencies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAgency Actions Requiring Environmental ConsiderationPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-16553Section 25.16section25.16 falseid-CFR-2003-title21-vol1-part25-subpartBActions requiring preparation of an environmental assessment.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-20.xml21 CFR 25.2021CFR25.20Section 25.20; Actions requiring preparation of an environmental assessment.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAgency Actions Requiring Environmental ConsiderationPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-20554Section 25.20section25.20 62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000falseUnited States CodeTitle 21 Section 348(h)21 U.S.C. 348(h)Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 65 Page 3035565 FR 30355id-CFR-2003-title21-vol1-part25-subpartBExtraordinary circumstances.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-21.xml21 CFR 25.2121CFR25.21Section 25.21; Extraordinary circumstances.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAgency Actions Requiring Environmental ConsiderationPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-21555Section 25.21section25.21 falseCode of Federal RegulationsTitle 0 Part 1508.270 CFR Part 1508.27Code of Federal RegulationsTitle 0 Part 1508.4,0 CFR Part 1508.4,id-CFR-2003-title21-vol1-part25-subpartBActions requiring the preparation of an environmental impact statement.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-22.xml21 CFR 25.2221CFR25.22Section 25.22; Actions requiring the preparation of an environmental impact statement.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAgency Actions Requiring Environmental ConsiderationPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-22556Section 25.22section25.22 falseid-CFR-2003-title21-vol1-part25Categorical ExclusionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-subpartC.xml21 CFR C21CFRSubpart C; Categorical ExclusionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSNODECFR-2003-title21-vol1-part25-subpartC557Subpart CsubpartC falseid-CFR-2003-title21-vol1-part25-subpartCGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-30.xml21 CFR 25.3021CFR25.30Section 25.30; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCategorical ExclusionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-30558Section 25.30section25.30 62 FR 40592, July 29, 1997, as amended at 65 FR 56479, Sept. 19, 2000falseCode of Federal RegulationsTitle 0 Part 61.20 CFR Part 61.2Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 65 Page 5647965 FR 56479id-CFR-2003-title21-vol1-part25-subpartCHuman drugs and biologics.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-31.xml21 CFR 25.3121CFR25.31Section 25.31; Human drugs and biologics.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCategorical ExclusionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-31559Section 25.31section25.31 62 FR 40592, July 29, 1997, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999falseFederal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 63 Page 2669763 FR 26697Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part25-subpartCFoods, food additives, and color additives.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-32.xml21 CFR 25.3221CFR25.32Section 25.32; Foods, food additives, and color additives.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCategorical ExclusionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-32560Section 25.32section25.32 62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000falseUnited States CodeTitle 21 Section 348(h)21 U.S.C. 348(h)Federal RegisterVolume 62 Page 4059262 FR 40592Federal RegisterVolume 65 Page 3035565 FR 30355id-CFR-2003-title21-vol1-part25-subpartCAnimal drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-33.xml21 CFR 25.3321CFR25.33Section 25.33; Animal drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCategorical ExclusionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-33561Section 25.33section25.33 falseid-CFR-2003-title21-vol1-part25-subpartCDevices and electronic products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-34.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-34.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-34https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-34https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-34.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-34.xml21 CFR 25.3421CFR25.34Section 25.34; Devices and electronic products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCategorical ExclusionsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-34562Section 25.34section25.34 falseid-CFR-2003-title21-vol1-part25Preparation of Environmental DocumentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-subpartD.xml21 CFR D21CFRSubpart D; Preparation of Environmental DocumentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSNODECFR-2003-title21-vol1-part25-subpartD563Subpart DsubpartD falseid-CFR-2003-title21-vol1-part25-subpartDEnvironmental assessments.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-40.xml21 CFR 25.4021CFR25.40Section 25.40; Environmental assessments.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPreparation of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-40564Section 25.40section25.40 falseCode of Federal RegulationsTitle 0 Part 1500.4(j) and 1502.21,0 CFR Part 1500.4(j) and 1502.21,Code of Federal RegulationsTitle 0 Part 1508.9,0 CFR Part 1508.9,id-CFR-2003-title21-vol1-part25-subpartDFindings of no significant impact.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-41.xml21 CFR 25.4121CFR25.41Section 25.41; Findings of no significant impact.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPreparation of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-41565Section 25.41section25.41 falseCode of Federal RegulationsTitle 0 Part 1508.130 CFR Part 1508.13id-CFR-2003-title21-vol1-part25-subpartDEnvironmental impact statements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-42.xml21 CFR 25.4221CFR25.42Section 25.42; Environmental impact statements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPreparation of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-42566Section 25.42section25.42 falseCode of Federal RegulationsTitle 0 Part 1501.7 and0 CFR Part 1501.7 andCode of Federal RegulationsTitle 0 Part 1502.9,0 CFR Part 1502.9,Code of Federal RegulationsTitle 0 Part 1508.110 CFR Part 1508.11id-CFR-2003-title21-vol1-part25-subpartDRecords of decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-43.xml21 CFR 25.4321CFR25.43Section 25.43; Records of decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPreparation of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-43567Section 25.43section25.43 falseid-CFR-2003-title21-vol1-part25-subpartDLead and cooperating agencies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-44.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-44.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-44https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-44https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-44.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-44.xml21 CFR 25.4421CFR25.44Section 25.44; Lead and cooperating agencies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPreparation of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-44568Section 25.44section25.44 falseCode of Federal RegulationsTitle 0 Part 1501.5 and 1501.6,0 CFR Part 1501.5 and 1501.6,id-CFR-2003-title21-vol1-part25-subpartDResponsible agency official.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-45.xml21 CFR 25.4521CFR25.45Section 25.45; Responsible agency official.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DPreparation of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-45569Section 25.45section25.45 falseCode of Federal RegulationsTitle 0 Part 1505.20 CFR Part 1505.2id-CFR-2003-title21-vol1-part25Public Participation and Notification of Environmental DocumentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-subpartE.xml21 CFR E21CFRSubpart E; Public Participation and Notification of Environmental DocumentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSNODECFR-2003-title21-vol1-part25-subpartE570Subpart EsubpartE falseid-CFR-2003-title21-vol1-part25-subpartEGeneral information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-50.xml21 CFR 25.5021CFR25.50Section 25.50; General information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EPublic Participation and Notification of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-50571Section 25.50section25.50 falseUnited States CodeTitle 18 Section 1905Title 18 Section 301(j)18 U.S.C. 190518 U.S.C. 301(j)id-CFR-2003-title21-vol1-part25-subpartEEnvironmental assessments and findings of no significant impact.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-51.xml21 CFR 25.5121CFR25.51Section 25.51; Environmental assessments and findings of no significant impact.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EPublic Participation and Notification of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-51572Section 25.51section25.51 falseUnited States CodeTitle 18 Section 190518 U.S.C. 1905United States CodeTitle 21 Section 331(j)21 U.S.C. 331(j)Code of Federal RegulationsTitle 0 Part 1501.4(e)0 CFR Part 1501.4(e)Code of Federal RegulationsTitle 0 Part 1506.60 CFR Part 1506.6id-CFR-2003-title21-vol1-part25-subpartEEnvironmental impact statements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-52.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-52.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-52https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-52https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-52.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-52.xml21 CFR 25.5221CFR25.52Section 25.52; Environmental impact statements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EPublic Participation and Notification of Environmental DocumentsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-52573Section 25.52section25.52 falseCode of Federal RegulationsTitle 0 Part 1506.6 and0 CFR Part 1506.6 andCode of Federal RegulationsTitle 0 Part 1506.60 CFR Part 1506.6Code of Federal RegulationsTitle 0 Part 1502and 1506.6(f)0 CFR Part 1502and 1506.6(f)id-CFR-2003-title21-vol1-part25Other RequirementsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part25-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part25-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part25-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part25-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part25-subpartF.xml21 CFR F21CFRSubpart F; Other RequirementsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSNODECFR-2003-title21-vol1-part25-subpartF574Subpart FsubpartF falseid-CFR-2003-title21-vol1-part25-subpartFEnvironmental effects abroad of major agency actions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec25-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec25-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec25-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec25-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec25-60.xml21 CFR 25.6021CFR25.60Section 25.60; Environmental effects abroad of major agency actions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FOther RequirementsPart 25ENVIRONMENTAL IMPACT CONSIDERATIONSCONTENTCFR-2003-title21-vol1-sec25-60575Section 25.60section25.60 falsePresidential Executive Order Number 12114Executive Order 12114Federal RegisterVolume 44 Page 195744 FR 1957id-CFR-2003-title21-vol1-chapI-subchapAMUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26.xml21 CFR 2621CFR26Part 26; MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part26576Part 26part26 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.falseUnited States CodeTitle 5 Section 5525 U.S.C. 552United States CodeTitle 15 Section 1453Title 15 Section 1454Title 15 Section 145515 U.S.C. 145315 U.S.C. 145415 U.S.C. 1455United States CodeTitle 18 Section 190518 U.S.C. 1905United States CodeTitle 21 Section 321Title 21 Section 331Title 21 Section 351Title 21 Section 352Title 21 Section 355Title 21 Section 360bTitle 21 Section 360cTitle 21 Section 360dTitle 21 Section 360Title 21 Section 360eTitle 21 Section 360fTitle 21 Section 360gTitle 21 Section 360hTitle 21 Section 360iTitle 21 Section 360jTitle 21 Section 360lTitle 21 Section 360mTitle 21 Section 371Title 21 Section 374Title 21 Section 381Title 21 Section 382Title 21 Section 383Title 21 Section 39321 U.S.C. 32121 U.S.C. 33121 U.S.C. 35121 U.S.C. 35221 U.S.C. 35521 U.S.C. 360b21 U.S.C. 360c21 U.S.C. 360d21 U.S.C. 36021 U.S.C. 360e21 U.S.C. 360f21 U.S.C. 360g21 U.S.C. 360h21 U.S.C. 360i21 U.S.C. 360j21 U.S.C. 360l21 U.S.C. 360m21 U.S.C. 37121 U.S.C. 37421 U.S.C. 38121 U.S.C. 38221 U.S.C. 38321 U.S.C. 393United States CodeTitle 42 Section 216Title 42 Section 241Title 42 Section 242lTitle 42 Section 262Title 42 Section 264Title 42 Section 26542 U.S.C. 21642 U.S.C. 24142 U.S.C. 242l42 U.S.C. 26242 U.S.C. 26442 U.S.C. 265Federal RegisterVolume 63 Page 6014163 FR 60141id-CFR-2003-title21-vol1-part26Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-toc-id577.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-toc-id577.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-toc-id577https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-toc-id577https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-toc-id577.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-toc-id577.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYTOCCFR-2003-title21-vol1-part26-toc-id577577Toctocid-CFR-2003-title21-vol1-part26General.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-0.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-0.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-0https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-0https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-0.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-0.xml21 CFR 26.021CFR26.0Section 26.0; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-0578Section 26.0section26.0 falseid-CFR-2003-title21-vol1-part26Specific Sector Provisions for Pharmaceutical Good Manufacturing PracticesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartA.xml21 CFR A21CFRSubpart A; Specific Sector Provisions for Pharmaceutical Good Manufacturing PracticesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYNODECFR-2003-title21-vol1-part26-subpartA579Subpart AsubpartA falseid-CFR-2003-title21-vol1-part26-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-1.xml21 CFR 26.121CFR26.1Section 26.1; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-1580Section 26.1section26.1 63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999falseFederal RegisterVolume 63 Page 6014163 FR 60141Federal RegisterVolume 64 Page 1634864 FR 16348id-CFR-2003-title21-vol1-part26-subpartAPurpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-2.xml21 CFR 26.221CFR26.2Section 26.2; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-2581Section 26.2section26.2 falseid-CFR-2003-title21-vol1-part26-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-3.xml21 CFR 26.321CFR26.3Section 26.3; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-3582Section 26.3section26.3 falseid-CFR-2003-title21-vol1-part26-subpartAProduct coverage.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-4.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-4.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-4https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-4https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-4.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-4.xml21 CFR 26.421CFR26.4Section 26.4; Product coverage.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-4583Section 26.4section26.4 falseid-CFR-2003-title21-vol1-part26-subpartALength of transition period.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-5.xml21 CFR 26.521CFR26.5Section 26.5; Length of transition period.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-5584Section 26.5section26.5 falseid-CFR-2003-title21-vol1-part26-subpartAEquivalence assessment.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-6.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-6.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-6https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-6https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-6.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-6.xml21 CFR 26.621CFR26.6Section 26.6; Equivalence assessment.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-6585Section 26.6section26.6 falseid-CFR-2003-title21-vol1-part26-subpartAParticipation in the equivalence assessment and determination.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-7.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-7.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-7https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-7https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-7.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-7.xml21 CFR 26.721CFR26.7Section 26.7; Participation in the equivalence assessment and determination.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-7586Section 26.7section26.7 falseid-CFR-2003-title21-vol1-part26-subpartAOther transition activities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-8.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-8.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-8https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-8https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-8.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-8.xml21 CFR 26.821CFR26.8Section 26.8; Other transition activities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-8587Section 26.8section26.8 falseid-CFR-2003-title21-vol1-part26-subpartAEquivalence determination.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-9.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-9.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-9https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-9https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-9.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-9.xml21 CFR 26.921CFR26.9Section 26.9; Equivalence determination.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-9588Section 26.9section26.9 falseid-CFR-2003-title21-vol1-part26-subpartARegulatory authorities not listed as currently equivalent.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-10.xml21 CFR 26.1021CFR26.10Section 26.10; Regulatory authorities not listed as currently equivalent.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-10589Section 26.10section26.10 falseid-CFR-2003-title21-vol1-part26-subpartAStart of operational period.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-11.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-11.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-11https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-11https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-11.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-11.xml21 CFR 26.1121CFR26.11Section 26.11; Start of operational period.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-11590Section 26.11section26.11 falseid-CFR-2003-title21-vol1-part26-subpartANature of recognition of inspection reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-12.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-12.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-12https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-12https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-12.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-12.xml21 CFR 26.1221CFR26.12Section 26.12; Nature of recognition of inspection reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-12591Section 26.12section26.12 falseid-CFR-2003-title21-vol1-part26-subpartATransmission of postapproval inspection reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-13.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-13.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-13https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-13https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-13.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-13.xml21 CFR 26.1321CFR26.13Section 26.13; Transmission of postapproval inspection reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-13592Section 26.13section26.13 falseid-CFR-2003-title21-vol1-part26-subpartATransmission of preapproval inspection reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-14.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-14.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-14https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-14https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-14.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-14.xml21 CFR 26.1421CFR26.14Section 26.14; Transmission of preapproval inspection reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-14593Section 26.14section26.14 falseid-CFR-2003-title21-vol1-part26-subpartAMonitoring continued equivalence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-15.xml21 CFR 26.1521CFR26.15Section 26.15; Monitoring continued equivalence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-15594Section 26.15section26.15 falseid-CFR-2003-title21-vol1-part26-subpartASuspension.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-16.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-16.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-16https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-16https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-16.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-16.xml21 CFR 26.1621CFR26.16Section 26.16; Suspension.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-16595Section 26.16section26.16 falseid-CFR-2003-title21-vol1-part26-subpartARole and composition of the Joint Sectoral Committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-17.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-17.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-17https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-17https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-17.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-17.xml21 CFR 26.1721CFR26.17Section 26.17; Role and composition of the Joint Sectoral Committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-17596Section 26.17section26.17 falseid-CFR-2003-title21-vol1-part26-subpartARegulatory collaboration.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-18.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-18.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-18https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-18https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-18.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-18.xml21 CFR 26.1821CFR26.18Section 26.18; Regulatory collaboration.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-18597Section 26.18section26.18 falseid-CFR-2003-title21-vol1-part26-subpartAInformation relating to quality aspects.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-19.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-19.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-19https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-19https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-19.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-19.xml21 CFR 26.1921CFR26.19Section 26.19; Information relating to quality aspects.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-19598Section 26.19section26.19 falseid-CFR-2003-title21-vol1-part26-subpartAAlert system.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-20.xml21 CFR 26.2021CFR26.20Section 26.20; Alert system.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-20599Section 26.20section26.20 falseid-CFR-2003-title21-vol1-part26-subpartASafeguard clause.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-21.xml21 CFR 26.2121CFR26.21Section 26.21; Safeguard clause.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-21600Section 26.21section26.21 falseid-CFR-2003-title21-vol1-part26-subpartAList of Applicable Laws, Regulations, and Administrative ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartA-appA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartA-appA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartA-appA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartA-appA.xml21 CFR Appendix A to Subpart A of Part 2621CFRAppendix A to Subpart A of Part 26; List of Applicable Laws, Regulations, and Administrative ProvisionsAppendix A to Subpart A of Part 26List of Applicable Laws, Regulations, and Administrative ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartA-appA601Appendix A to Subpart A of Part 26appendixA falseid-CFR-2003-title21-vol1-part26-subpartAList of AuthoritiesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartA-appB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartA-appB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartA-appB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartA-appB.xml21 CFR Appendix B to Subpart A of Part 2621CFRAppendix B to Subpart A of Part 26; List of AuthoritiesAppendix B to Subpart A of Part 26List of AuthoritiesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartA-appB602Appendix B to Subpart A of Part 26appendixB falseid-CFR-2003-title21-vol1-part26-subpartAIndicative List of Products Covered by Subpart AD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartA-appC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartA-appC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartA-appC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartA-appC.xml21 CFR Appendix C to Subpart A of Part 2621CFRAppendix C to Subpart A of Part 26; Indicative List of Products Covered by Subpart AAppendix C to Subpart A of Part 26Indicative List of Products Covered by Subpart AChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartA-appC603Appendix C to Subpart A of Part 26appendixC falseid-CFR-2003-title21-vol1-part26-subpartACriteria for Assessing Equivalence for Post- and PreapprovalD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartA-appD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartA-appD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartA-appD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartA-appD.xml21 CFR Appendix D to Subpart A of Part 2621CFRAppendix D to Subpart A of Part 26; Criteria for Assessing Equivalence for Post- and PreapprovalAppendix D to Subpart A of Part 26Criteria for Assessing Equivalence for Post- and PreapprovalChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartA-appD604Appendix D to Subpart A of Part 26appendixD falseid-CFR-2003-title21-vol1-part26-subpartAElements to be Considered in Developing a Two-Way Alert SystemD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartA-appE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartA-appE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartA-appEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartA-appE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartA-appE.xml21 CFR Appendix E to Subpart A of Part 2621CFRAppendix E to Subpart A of Part 26; Elements to be Considered in Developing a Two-Way Alert SystemAppendix E to Subpart A of Part 26Elements to be Considered in Developing a Two-Way Alert SystemChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ASpecific Sector Provisions for Pharmaceutical Good Manufacturing PracticesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartA-appE605Appendix E to Subpart A of Part 26appendixE falseid-CFR-2003-title21-vol1-part26Specific Sector Provisions for Medical DevicesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartB.xml21 CFR B21CFRSubpart B; Specific Sector Provisions for Medical DevicesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYNODECFR-2003-title21-vol1-part26-subpartB606Subpart BsubpartB falseid-CFR-2003-title21-vol1-part26-subpartBPurpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-31.xml21 CFR 26.3121CFR26.31Section 26.31; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-31607Section 26.31section26.31 falseid-CFR-2003-title21-vol1-part26-subpartBScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-32.xml21 CFR 26.3221CFR26.32Section 26.32; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-32608Section 26.32section26.32 falseid-CFR-2003-title21-vol1-part26-subpartBProduct coverage.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-33.xml21 CFR 26.3321CFR26.33Section 26.33; Product coverage.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-33609Section 26.33section26.33 falseid-CFR-2003-title21-vol1-part26-subpartBRegulatory authorities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-34.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-34.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-34https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-34https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-34.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-34.xml21 CFR 26.3421CFR26.34Section 26.34; Regulatory authorities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-34610Section 26.34section26.34 falseid-CFR-2003-title21-vol1-part26-subpartBLength and purpose of transition period.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-35.xml21 CFR 26.3521CFR26.35Section 26.35; Length and purpose of transition period.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-35611Section 26.35section26.35 falseid-CFR-2003-title21-vol1-part26-subpartBListing of CAB's.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-36.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-36.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-36https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-36https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-36.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-36.xml21 CFR 26.3621CFR26.36Section 26.36; Listing of CAB's.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-36612Section 26.36section26.36 falseid-CFR-2003-title21-vol1-part26-subpartBConfidence building activities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-37.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-37.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-37https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-37https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-37.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-37.xml21 CFR 26.3721CFR26.37Section 26.37; Confidence building activities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-37613Section 26.37section26.37 falseid-CFR-2003-title21-vol1-part26-subpartBOther transition period activities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-38.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-38.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-38https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-38https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-38.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-38.xml21 CFR 26.3821CFR26.38Section 26.38; Other transition period activities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-38614Section 26.38section26.38 falseid-CFR-2003-title21-vol1-part26-subpartBEquivalence assessment.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-39.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-39.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-39https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-39https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-39.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-39.xml21 CFR 26.3921CFR26.39Section 26.39; Equivalence assessment.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-39615Section 26.39section26.39 falseid-CFR-2003-title21-vol1-part26-subpartBStart of the operational period.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-40.xml21 CFR 26.4021CFR26.40Section 26.40; Start of the operational period.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-40616Section 26.40section26.40 falseid-CFR-2003-title21-vol1-part26-subpartBExchange and endorsement of quality system evaluation reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-41.xml21 CFR 26.4121CFR26.41Section 26.41; Exchange and endorsement of quality system evaluation reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-41617Section 26.41section26.41 falseid-CFR-2003-title21-vol1-part26-subpartBExchange and endorsement of product evaluation reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-42.xml21 CFR 26.4221CFR26.42Section 26.42; Exchange and endorsement of product evaluation reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-42618Section 26.42section26.42 falseid-CFR-2003-title21-vol1-part26-subpartBTransmission of quality system evaluation reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-43.xml21 CFR 26.4321CFR26.43Section 26.43; Transmission of quality system evaluation reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-43619Section 26.43section26.43 falseid-CFR-2003-title21-vol1-part26-subpartBTransmission of product evaluation reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-44.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-44.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-44https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-44https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-44.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-44.xml21 CFR 26.4421CFR26.44Section 26.44; Transmission of product evaluation reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-44620Section 26.44section26.44 falseid-CFR-2003-title21-vol1-part26-subpartBMonitoring continued equivalence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-45.xml21 CFR 26.4521CFR26.45Section 26.45; Monitoring continued equivalence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-45621Section 26.45section26.45 falseid-CFR-2003-title21-vol1-part26-subpartBListing of additional CAB's.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-46.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-46.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-46https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-46https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-46.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-46.xml21 CFR 26.4621CFR26.46Section 26.46; Listing of additional CAB's.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-46622Section 26.46section26.46 falseid-CFR-2003-title21-vol1-part26-subpartBRole and composition of the Joint Sectoral Committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-47.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-47.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-47https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-47https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-47.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-47.xml21 CFR 26.4721CFR26.47Section 26.47; Role and composition of the Joint Sectoral Committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-47623Section 26.47section26.47 falseid-CFR-2003-title21-vol1-part26-subpartBHarmonization.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-48.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-48.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-48https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-48https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-48.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-48.xml21 CFR 26.4821CFR26.48Section 26.48; Harmonization.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-48624Section 26.48section26.48 falseid-CFR-2003-title21-vol1-part26-subpartBRegulatory cooperation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-49.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-49.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-49https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-49https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-49.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-49.xml21 CFR 26.4921CFR26.49Section 26.49; Regulatory cooperation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-49625Section 26.49section26.49 falseid-CFR-2003-title21-vol1-part26-subpartBAlert system and exchange of postmarket vigilance reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-50.xml21 CFR 26.5021CFR26.50Section 26.50; Alert system and exchange of postmarket vigilance reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-50626Section 26.50section26.50 falseid-CFR-2003-title21-vol1-part26-subpartBRelevant Legislation, Regulations, and Procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartB-appA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartB-appA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartB-appAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartB-appAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartB-appA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartB-appA.xml21 CFR Appendix A to Subpart B of Part 2621CFRAppendix A to Subpart B of Part 26; Relevant Legislation, Regulations, and Procedures.Appendix A to Subpart B of Part 26Relevant Legislation, Regulations, and Procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartB-appA627Appendix A to Subpart B of Part 26appendixA falseUnited States CodeTitle 21 Section 321et seq.21 U.S.C. 321et seq.United States CodeTitle 42 Section 201et seq.42 U.S.C. 201et seq.Federal RegisterVolume 61 Page 1478961 FR 14789Federal RegisterVolume 63 Page 2839263 FR 28392Federal RegisterVolume 63 Page 3624063 FR 36240Federal RegisterVolume 63 Page 956163 FR 9561id-CFR-2003-title21-vol1-part26-subpartBScope of Product CoverageD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartB-appB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartB-appB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartB-appBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartB-appBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartB-appB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartB-appB.xml21 CFR Appendix B to Subpart B of Part 2621CFRAppendix B to Subpart B of Part 26; Scope of Product CoverageAppendix B to Subpart B of Part 26Scope of Product CoverageChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartB-appB628Appendix B to Subpart B of Part 26appendixB 63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999falseCode of Federal RegulationsTitle 1 Part 8681 CFR Part 868Code of Federal RegulationsTitle 1 Part 8721 CFR Part 872Code of Federal RegulationsTitle 1 Part 8741 CFR Part 874Code of Federal RegulationsTitle 1 Part 8761 CFR Part 876Code of Federal RegulationsTitle 1 Part 8781 CFR Part 878Code of Federal RegulationsTitle 1 Part 8801 CFR Part 880Code of Federal RegulationsTitle 1 Part 8821 CFR Part 882Code of Federal RegulationsTitle 1 Part 8861 CFR Part 886Code of Federal RegulationsTitle 1 Part 8881 CFR Part 888Code of Federal RegulationsTitle 1 Part 8901 CFR Part 890Code of Federal RegulationsTitle 1 Part 8921 CFR Part 892Federal RegisterVolume 63 Page 6014163 FR 60141Federal RegisterVolume 64 Page 1634864 FR 16348id-CFR-2003-title21-vol1-part26-subpartB[Reserved]D09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartB-appC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartB-appC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartB-appChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartB-appChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartB-appC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartB-appC.xml21 CFR Appendixes C-F to Subpart B of Part 2621CFRAppendixes C-F to Subpart B of Part 26; [Reserved]Appendixes C-F to Subpart B of Part 26[Reserved]Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BSpecific Sector Provisions for Medical DevicesPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYAPPENDIXCFR-2003-title21-vol1-part26-subpartB-appC629Appendixes C-F to Subpart B of Part 26appendixC falseid-CFR-2003-title21-vol1-part26“Framework” ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part26-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part26-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part26-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part26-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part26-subpartC.xml21 CFR C21CFRSubpart C; “Framework” ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYNODECFR-2003-title21-vol1-part26-subpartC630Subpart CsubpartC falseid-CFR-2003-title21-vol1-part26-subpartCDefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-60.xml21 CFR 26.6021CFR26.60Section 26.60; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-60631Section 26.60section26.60 falseUnited States CodeTitle 5 Section 1Title 5 Section 552(a)5 U.S.C. 15 U.S.C. 552(a)Code of Federal RegulationsTitle 1 Part 511 CFR Part 51id-CFR-2003-title21-vol1-part26-subpartCPurpose of this part.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-61.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-61.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-61https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-61https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-61.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-61.xml21 CFR 26.6121CFR26.61Section 26.61; Purpose of this part.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-61632Section 26.61section26.61 falseid-CFR-2003-title21-vol1-part26-subpartCGeneral obligations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-62.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-62.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-62https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-62https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-62.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-62.xml21 CFR 26.6221CFR26.62Section 26.62; General obligations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-62633Section 26.62section26.62 falseid-CFR-2003-title21-vol1-part26-subpartCGeneral coverage of this part.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-63.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-63.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-63https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-63https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-63.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-63.xml21 CFR 26.6321CFR26.63Section 26.63; General coverage of this part.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-63634Section 26.63section26.63 falseid-CFR-2003-title21-vol1-part26-subpartCTransitional arrangements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-64.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-64.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-64https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-64https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-64.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-64.xml21 CFR 26.6421CFR26.64Section 26.64; Transitional arrangements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-64635Section 26.64section26.64 falseid-CFR-2003-title21-vol1-part26-subpartCDesignating authorities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-65.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-65.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-65https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-65https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-65.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-65.xml21 CFR 26.6521CFR26.65Section 26.65; Designating authorities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-65636Section 26.65section26.65 falseid-CFR-2003-title21-vol1-part26-subpartCDesignation and listing procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-66.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-66.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-66https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-66https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-66.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-66.xml21 CFR 26.6621CFR26.66Section 26.66; Designation and listing procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-66637Section 26.66section26.66 falseid-CFR-2003-title21-vol1-part26-subpartCSuspension of listed conformity assessment bodies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-67.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-67.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-67https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-67https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-67.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-67.xml21 CFR 26.6721CFR26.67Section 26.67; Suspension of listed conformity assessment bodies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-67638Section 26.67section26.67 falseid-CFR-2003-title21-vol1-part26-subpartCWithdrawal of listed conformity assessment bodies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-68.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-68.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-68https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-68https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-68.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-68.xml21 CFR 26.6821CFR26.68Section 26.68; Withdrawal of listed conformity assessment bodies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-68639Section 26.68section26.68 falseid-CFR-2003-title21-vol1-part26-subpartCMonitoring of conformity assessment bodies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-69.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-69.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-69https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-69https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-69.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-69.xml21 CFR 26.6921CFR26.69Section 26.69; Monitoring of conformity assessment bodies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-69640Section 26.69section26.69 falseid-CFR-2003-title21-vol1-part26-subpartCConformity assessment bodies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-70.xml21 CFR 26.7021CFR26.70Section 26.70; Conformity assessment bodies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-70641Section 26.70section26.70 falseid-CFR-2003-title21-vol1-part26-subpartCExchange of information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-71.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-71.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-71https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-71https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-71.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-71.xml21 CFR 26.7121CFR26.71Section 26.71; Exchange of information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-71642Section 26.71section26.71 falseid-CFR-2003-title21-vol1-part26-subpartCSectoral contact points.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-72.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-72.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-72https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-72https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-72.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-72.xml21 CFR 26.7221CFR26.72Section 26.72; Sectoral contact points.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-72643Section 26.72section26.72 falseid-CFR-2003-title21-vol1-part26-subpartCJoint Committee.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-73.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-73.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-73https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-73https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-73.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-73.xml21 CFR 26.7321CFR26.73Section 26.73; Joint Committee.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-73644Section 26.73section26.73 falseid-CFR-2003-title21-vol1-part26-subpartCPreservation of regulatory authority.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-74.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-74.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-74https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-74https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-74.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-74.xml21 CFR 26.7421CFR26.74Section 26.74; Preservation of regulatory authority.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-74645Section 26.74section26.74 falseid-CFR-2003-title21-vol1-part26-subpartCSuspension of recognition obligations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-75.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-75.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-75https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-75https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-75.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-75.xml21 CFR 26.7521CFR26.75Section 26.75; Suspension of recognition obligations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-75646Section 26.75section26.75 falseid-CFR-2003-title21-vol1-part26-subpartCConfidentiality.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-76.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-76.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-76https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-76https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-76.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-76.xml21 CFR 26.7621CFR26.76Section 26.76; Confidentiality.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-76647Section 26.76section26.76 falseid-CFR-2003-title21-vol1-part26-subpartCFees.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-77.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-77.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-77https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-77https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-77.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-77.xml21 CFR 26.7721CFR26.77Section 26.77; Fees.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-77648Section 26.77section26.77 falseid-CFR-2003-title21-vol1-part26-subpartCAgreements with other countries.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-78.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-78.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-78https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-78https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-78.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-78.xml21 CFR 26.7821CFR26.78Section 26.78; Agreements with other countries.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-78649Section 26.78section26.78 falseid-CFR-2003-title21-vol1-part26-subpartCTerritorial application.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-79.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-79.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-79https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-79https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-79.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-79.xml21 CFR 26.7921CFR26.79Section 26.79; Territorial application.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-79650Section 26.79section26.79 falseid-CFR-2003-title21-vol1-part26-subpartCEntry into force, amendment, and termination.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-80.xml21 CFR 26.8021CFR26.80Section 26.80; Entry into force, amendment, and termination.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-80651Section 26.80section26.80 falseid-CFR-2003-title21-vol1-part26-subpartCFinal provisions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec26-81.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec26-81.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-81https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec26-81https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec26-81.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec26-81.xml21 CFR 26.8121CFR26.81Section 26.81; Final provisions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart C“Framework” ProvisionsPart 26MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITYCONTENTCFR-2003-title21-vol1-sec26-81652Section 26.81section26.81 falseid-CFR-2003-title21-vol1-chapI-subchapAPROTECTION OF HUMAN SUBJECTSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part50.xml21 CFR 5021CFR50Part 50; PROTECTION OF HUMAN SUBJECTSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part50653Part 50part50 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.falseUnited States CodeTitle 21 Section 321Title 21 Section 343Title 21 Section 346aTitle 21 Section 346Title 21 Section 348Title 21 Section 350aTitle 21 Section 350bTitle 21 Section 352Title 21 Section 353Title 21 Section 355Title 21 Section 360c-360fTitle 21 Section 360Title 21 Section 360h-360jTitle 21 Section 371Title 21 Section 379eTitle 21 Section 38121 U.S.C. 32121 U.S.C. 34321 U.S.C. 346a21 U.S.C. 34621 U.S.C. 34821 U.S.C. 350a21 U.S.C. 350b21 U.S.C. 35221 U.S.C. 35321 U.S.C. 35521 U.S.C. 360c-360f21 U.S.C. 36021 U.S.C. 360h-360j21 U.S.C. 37121 U.S.C. 379e21 U.S.C. 381United States CodeTitle 42 Section 216Title 42 Section 241Title 42 Section 262Title 42 Section 263b-263n42 U.S.C. 21642 U.S.C. 24142 U.S.C. 26242 U.S.C. 263b-263nFederal RegisterVolume 45 Page 3639045 FR 36390id-CFR-2003-title21-vol1-part50Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part50-toc-id654.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part50-toc-id654.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-toc-id654https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-toc-id654https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part50-toc-id654.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part50-toc-id654.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 50PROTECTION OF HUMAN SUBJECTSTOCCFR-2003-title21-vol1-part50-toc-id654654Toctocid-CFR-2003-title21-vol1-part50General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part50-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part50-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part50-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part50-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 50PROTECTION OF HUMAN SUBJECTSNODECFR-2003-title21-vol1-part50-subpartA655Subpart AsubpartA falseid-CFR-2003-title21-vol1-part50-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-1.xml21 CFR 50.121CFR50.1Section 50.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-1656Section 50.1section50.1 45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24, 2001falseFederal RegisterVolume 45 Page 3639045 FR 36390Federal RegisterVolume 46 Page 897946 FR 8979Federal RegisterVolume 63 Page 2669763 FR 26697Federal RegisterVolume 64 Page 39964 FR 399Federal RegisterVolume 66 Page 2059766 FR 20597id-CFR-2003-title21-vol1-part50-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-3.xml21 CFR 50.321CFR50.3Section 50.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-3657Section 50.3section50.3 45 FR 36390, May 30, 1980, as amended at 46 FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2, 1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 66 FR 20597, Apr. 24, 2001falseUnited States CodeTitle 21 Section 321-39221 U.S.C. 321-392United States CodeTitle 42 Section 262Title 42 Section 263b-263n42 U.S.C. 26242 U.S.C. 263b-263nUnited States Statutes at LargeVolume 52 Page 1040 et seq.52 Stat. 1040 et seq.Federal RegisterVolume 45 Page 3639045 FR 36390Federal RegisterVolume 46 Page 895046 FR 8950Federal RegisterVolume 54 Page 903854 FR 9038Federal RegisterVolume 56 Page 2802856 FR 28028Federal RegisterVolume 61 Page 5152861 FR 51528Federal RegisterVolume 62 Page 3944062 FR 39440Federal RegisterVolume 64 Page 39964 FR 399Federal RegisterVolume 64 Page 5644864 FR 56448Federal RegisterVolume 66 Page 2059766 FR 20597id-CFR-2003-title21-vol1-part50Informed Consent of Human SubjectsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part50-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part50-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part50-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part50-subpartB.xml21 CFR B21CFRSubpart B; Informed Consent of Human SubjectsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 50PROTECTION OF HUMAN SUBJECTSNODECFR-2003-title21-vol1-part50-subpartB658Subpart BsubpartB falseFederal RegisterVolume 46 Page 895146 FR 8951id-CFR-2003-title21-vol1-part50-subpartBGeneral requirements for informed consent.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-20.xml21 CFR 50.2021CFR50.20Section 50.20; General requirements for informed consent.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformed Consent of Human SubjectsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-20659Section 50.20section50.20 46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999falseFederal RegisterVolume 46 Page 895146 FR 8951Federal RegisterVolume 64 Page 1094264 FR 10942id-CFR-2003-title21-vol1-part50-subpartBException from general requirements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-23.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-23.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-23https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-23https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-23.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-23.xml21 CFR 50.2321CFR50.23Section 50.23; Exception from general requirements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformed Consent of Human SubjectsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-23660Section 50.23section50.23 46 FR 8951, Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999; 64 FR 54188, Oct. 5, 1999falseUnited States CodeTitle 10 Section 1107(d)Title 10 Section 1107(f)10 U.S.C. 1107(d)10 U.S.C. 1107(f)United States CodeTitle 21 Section 355(i)(4)21 U.S.C. 355(i)(4)Federal RegisterVolume 46 Page 895146 FR 8951Federal RegisterVolume 55 Page 5281755 FR 52817Federal RegisterVolume 64 Page 39964 FR 399Federal RegisterVolume 64 Page 5418864 FR 54188id-CFR-2003-title21-vol1-part50-subpartBException from informed consent requirements for emergency research.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-24.xml21 CFR 50.2421CFR50.24Section 50.24; Exception from informed consent requirements for emergency research.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformed Consent of Human SubjectsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-24661Section 50.24section50.24 61 FR 51528, Oct. 2, 1996falseFederal RegisterVolume 61 Page 5152861 FR 51528id-CFR-2003-title21-vol1-part50-subpartBElements of informed consent.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-25.xml21 CFR 50.2521CFR50.25Section 50.25; Elements of informed consent.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformed Consent of Human SubjectsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-25662Section 50.25section50.25 falseid-CFR-2003-title21-vol1-part50-subpartBDocumentation of informed consent.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-27.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-27.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-27https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-27https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-27.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-27.xml21 CFR 50.2721CFR50.27Section 50.27; Documentation of informed consent.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformed Consent of Human SubjectsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-27663Section 50.27section50.27 46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996falseFederal RegisterVolume 46 Page 895146 FR 8951Federal RegisterVolume 61 Page 5728061 FR 57280id-CFR-2003-title21-vol1-part50ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part50-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part50-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part50-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part50-subpartC.xml21 CFR C21CFRSubpart C; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 50PROTECTION OF HUMAN SUBJECTSNODECFR-2003-title21-vol1-part50-subpartC664Subpart CsubpartC falseid-CFR-2003-title21-vol1-part50Additional Safeguards for Children in Clinical InvestigationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part50-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part50-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part50-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part50-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part50-subpartD.xml21 CFR D21CFRSubpart D; Additional Safeguards for Children in Clinical InvestigationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 50PROTECTION OF HUMAN SUBJECTSNODECFR-2003-title21-vol1-part50-subpartD665Subpart DsubpartD falseFederal RegisterVolume 66 Page 2059866 FR 20598id-CFR-2003-title21-vol1-part50-subpartDIRB duties.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-50.xml21 CFR 50.5021CFR50.50Section 50.50; IRB duties.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-50666Section 50.50section50.50 falseid-CFR-2003-title21-vol1-part50-subpartDClinical investigations not involving greater than minimal risk.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-51.xml21 CFR 50.5121CFR50.51Section 50.51; Clinical investigations not involving greater than minimal risk.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-51667Section 50.51section50.51 falseid-CFR-2003-title21-vol1-part50-subpartDClinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-52.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-52.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-52https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-52https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-52.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-52.xml21 CFR 50.5221CFR50.52Section 50.52; Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-52668Section 50.52section50.52 falseid-CFR-2003-title21-vol1-part50-subpartDClinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-53.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-53.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-53https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-53https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-53.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-53.xml21 CFR 50.5321CFR50.53Section 50.53; Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-53669Section 50.53section50.53 falseid-CFR-2003-title21-vol1-part50-subpartDClinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-54.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-54.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-54https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-54https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-54.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-54.xml21 CFR 50.5421CFR50.54Section 50.54; Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-54670Section 50.54section50.54 falseid-CFR-2003-title21-vol1-part50-subpartDRequirements for permission by parents or guardians and for assent by children.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-55.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-55.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-55https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-55https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-55.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-55.xml21 CFR 50.5521CFR50.55Section 50.55; Requirements for permission by parents or guardians and for assent by children.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-55671Section 50.55section50.55 falseid-CFR-2003-title21-vol1-part50-subpartDWards.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec50-56.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec50-56.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-56https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec50-56https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec50-56.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec50-56.xml21 CFR 50.5621CFR50.56Section 50.56; Wards.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DAdditional Safeguards for Children in Clinical InvestigationsPart 50PROTECTION OF HUMAN SUBJECTSCONTENTCFR-2003-title21-vol1-sec50-56672Section 50.56section50.56 falseid-CFR-2003-title21-vol1-chapI-subchapAFINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part54.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part54.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part54https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part54https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part54.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part54.xml21 CFR 5421CFR54Part 54; FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part54673Part 54part54 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c-360j, 371, 372, 373, 374, 375, 376, 379; 42 U.S.C. 262.falseUnited States CodeTitle 21 Section 321Title 21 Section 331Title 21 Section 351Title 21 Section 352Title 21 Section 353Title 21 Section 355Title 21 Section 360c-360jTitle 21 Section 360Title 21 Section 371Title 21 Section 372Title 21 Section 373Title 21 Section 374Title 21 Section 375Title 21 Section 376Title 21 Section 37921 U.S.C. 32121 U.S.C. 33121 U.S.C. 35121 U.S.C. 35221 U.S.C. 35321 U.S.C. 35521 U.S.C. 360c-360j21 U.S.C. 36021 U.S.C. 37121 U.S.C. 37221 U.S.C. 37321 U.S.C. 37421 U.S.C. 37521 U.S.C. 37621 U.S.C. 379United States CodeTitle 42 Section 26242 U.S.C. 262Federal RegisterVolume 63 Page 525063 FR 5250id-CFR-2003-title21-vol1-part54Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part54-toc-id674.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part54-toc-id674.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part54-toc-id674https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part54-toc-id674https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part54-toc-id674.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part54-toc-id674.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSTOCCFR-2003-title21-vol1-part54-toc-id674674Toctocid-CFR-2003-title21-vol1-part54Purpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec54-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec54-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec54-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec54-1.xml21 CFR 54.121CFR54.1Section 54.1; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSCONTENTCFR-2003-title21-vol1-sec54-1675Section 54.1section54.1 falseid-CFR-2003-title21-vol1-part54Definitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec54-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec54-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec54-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec54-2.xml21 CFR 54.221CFR54.2Section 54.2; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSCONTENTCFR-2003-title21-vol1-sec54-2676Section 54.2section54.2 63 FR 5250, Feb. 2, 1998, as amended at 63 FR 72181, Dec. 31, 1998falseFederal RegisterVolume 63 Page 525063 FR 5250Federal RegisterVolume 63 Page 7218163 FR 72181id-CFR-2003-title21-vol1-part54Scope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec54-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec54-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec54-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec54-3.xml21 CFR 54.321CFR54.3Section 54.3; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSCONTENTCFR-2003-title21-vol1-sec54-3677Section 54.3section54.3 falseid-CFR-2003-title21-vol1-part54Certification and disclosure requirements.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec54-4.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec54-4.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-4https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-4https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec54-4.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec54-4.xml21 CFR 54.421CFR54.4Section 54.4; Certification and disclosure requirements.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSCONTENTCFR-2003-title21-vol1-sec54-4678Section 54.4section54.4 63 FR 5250, Feb. 2, 1998; 63 FR 35134, June 29, 1998, as amended at 64 FR 399, Jan. 5, 1999falseFederal RegisterVolume 63 Page 3513463 FR 35134Federal RegisterVolume 63 Page 525063 FR 5250Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part54Agency evaluation of financial interests.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec54-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec54-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec54-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec54-5.xml21 CFR 54.521CFR54.5Section 54.5; Agency evaluation of financial interests.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSCONTENTCFR-2003-title21-vol1-sec54-5679Section 54.5section54.5 falseid-CFR-2003-title21-vol1-part54Recordkeeping and record retention.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec54-6.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec54-6.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-6https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec54-6https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec54-6.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec54-6.xml21 CFR 54.621CFR54.6Section 54.6; Recordkeeping and record retention.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORSCONTENTCFR-2003-title21-vol1-sec54-6680Section 54.6section54.6 falseid-CFR-2003-title21-vol1-chapI-subchapAINSTITUTIONAL REVIEW BOARDSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56.xml21 CFR 5621CFR56Part 56; INSTITUTIONAL REVIEW BOARDSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part56681Part 56part56 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.falseUnited States CodeTitle 21 Section 321Title 21 Section 343Title 21 Section 346aTitle 21 Section 346Title 21 Section 348Title 21 Section 350aTitle 21 Section 350bTitle 21 Section 351Title 21 Section 352Title 21 Section 353Title 21 Section 355Title 21 Section 360c-360fTitle 21 Section 360Title 21 Section 360h-360jTitle 21 Section 371Title 21 Section 379eTitle 21 Section 38121 U.S.C. 32121 U.S.C. 34321 U.S.C. 346a21 U.S.C. 34621 U.S.C. 34821 U.S.C. 350a21 U.S.C. 350b21 U.S.C. 35121 U.S.C. 35221 U.S.C. 35321 U.S.C. 35521 U.S.C. 360c-360f21 U.S.C. 36021 U.S.C. 360h-360j21 U.S.C. 37121 U.S.C. 379e21 U.S.C. 381United States CodeTitle 42 Section 216Title 42 Section 241Title 42 Section 262Title 42 Section 263b-263n42 U.S.C. 21642 U.S.C. 24142 U.S.C. 26242 U.S.C. 263b-263nFederal RegisterVolume 46 Page 897546 FR 8975id-CFR-2003-title21-vol1-part56Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56-toc-id682.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56-toc-id682.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-toc-id682https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-toc-id682https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56-toc-id682.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56-toc-id682.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 56INSTITUTIONAL REVIEW BOARDSTOCCFR-2003-title21-vol1-part56-toc-id682682Toctocid-CFR-2003-title21-vol1-part56General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 56INSTITUTIONAL REVIEW BOARDSNODECFR-2003-title21-vol1-part56-subpartA683Subpart AsubpartA falseid-CFR-2003-title21-vol1-part56-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-101.xml21 CFR 56.10121CFR56.101Section 56.101; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-101684Section 56.101section56.101 46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 64 Page 39964 FR 399Federal RegisterVolume 66 Page 2059966 FR 20599id-CFR-2003-title21-vol1-part56-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-102.xml21 CFR 56.10221CFR56.102Section 56.102; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-102685Section 56.102section56.102 46 FR 8975, Jan. 27, 1981, as amended at 54 FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599, Apr. 24, 2001falseUnited States CodeTitle 21 Section 321-39221 U.S.C. 321-392United States Statutes at LargeVolume 52 Page 1040 et seq.52 Stat. 1040 et seq.Federal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 54 Page 903854 FR 9038Federal RegisterVolume 56 Page 2802856 FR 28028Federal RegisterVolume 64 Page 39964 FR 399Federal RegisterVolume 64 Page 5644864 FR 56448Federal RegisterVolume 65 Page 5230265 FR 52302Federal RegisterVolume 66 Page 2059966 FR 20599id-CFR-2003-title21-vol1-part56-subpartACircumstances in which IRB review is required.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-103.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-103.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-103https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-103https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-103.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-103.xml21 CFR 56.10321CFR56.103Section 56.103; Circumstances in which IRB review is required.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-103686Section 56.103section56.103 46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981falseFederal RegisterVolume 46 Page 1434046 FR 14340Federal RegisterVolume 46 Page 897546 FR 8975id-CFR-2003-title21-vol1-part56-subpartAExemptions from IRB requirement.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-104.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-104.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-104https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-104https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-104.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-104.xml21 CFR 56.10421CFR56.104Section 56.104; Exemptions from IRB requirement.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-104687Section 56.104section56.104 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 56 Page 2802856 FR 28028id-CFR-2003-title21-vol1-part56-subpartAWaiver of IRB requirement.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-105.xml21 CFR 56.10521CFR56.105Section 56.105; Waiver of IRB requirement.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-105688Section 56.105section56.105 falseid-CFR-2003-title21-vol1-part56Organization and PersonnelD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56-subpartB.xml21 CFR B21CFRSubpart B; Organization and PersonnelChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 56INSTITUTIONAL REVIEW BOARDSNODECFR-2003-title21-vol1-part56-subpartB689Subpart BsubpartB falseid-CFR-2003-title21-vol1-part56-subpartBIRB membership.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-107.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-107.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-107https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-107https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-107.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-107.xml21 CFR 56.10721CFR56.107Section 56.107; IRB membership.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BOrganization and PersonnelPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-107690Section 56.107section56.107 46 FR 8975, Jan 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56 FR 29756, June 28, 1991falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 56 Page 2802856 FR 28028Federal RegisterVolume 56 Page 2975656 FR 29756id-CFR-2003-title21-vol1-part56IRB Functions and OperationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56-subpartC.xml21 CFR C21CFRSubpart C; IRB Functions and OperationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 56INSTITUTIONAL REVIEW BOARDSNODECFR-2003-title21-vol1-part56-subpartC691Subpart CsubpartC falseid-CFR-2003-title21-vol1-part56-subpartCIRB functions and operations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-108.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-108.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-108https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-108https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-108.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-108.xml21 CFR 56.10821CFR56.108Section 56.108; IRB functions and operations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-108692Section 56.108section56.108 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 56 Page 2802856 FR 28028Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part56-subpartCIRB review of research.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-109.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-109.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-109https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-109https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-109.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-109.xml21 CFR 56.10921CFR56.109Section 56.109; IRB review of research.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-109693Section 56.109section56.109 46 FR 8975, Jan. 27, 1981, as amended at 61 FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24, 2001falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 61 Page 5152961 FR 51529Federal RegisterVolume 66 Page 2059966 FR 20599id-CFR-2003-title21-vol1-part56-subpartCExpedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-110.xml21 CFR 56.11021CFR56.110Section 56.110; Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-110694Section 56.110section56.110 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 56 Page 2802956 FR 28029id-CFR-2003-title21-vol1-part56-subpartCCriteria for IRB approval of research.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-111.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-111.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-111https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-111https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-111.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-111.xml21 CFR 56.11121CFR56.111Section 56.111; Criteria for IRB approval of research.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-111695Section 56.111section56.111 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 66 FR 20599, Apr. 24, 2001falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 56 Page 2802956 FR 28029Federal RegisterVolume 66 Page 2059966 FR 20599id-CFR-2003-title21-vol1-part56-subpartCReview by institution.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-112.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-112.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-112https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-112https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-112.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-112.xml21 CFR 56.11221CFR56.112Section 56.112; Review by institution.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-112696Section 56.112section56.112 falseid-CFR-2003-title21-vol1-part56-subpartCSuspension or termination of IRB approval of research.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-113.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-113.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-113https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-113https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-113.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-113.xml21 CFR 56.11321CFR56.113Section 56.113; Suspension or termination of IRB approval of research.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-113697Section 56.113section56.113 falseid-CFR-2003-title21-vol1-part56-subpartCCooperative research.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-114.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-114.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-114https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-114https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-114.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-114.xml21 CFR 56.11421CFR56.114Section 56.114; Cooperative research.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CIRB Functions and OperationsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-114698Section 56.114section56.114 falseid-CFR-2003-title21-vol1-part56Records and ReportsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56-subpartD.xml21 CFR D21CFRSubpart D; Records and ReportsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 56INSTITUTIONAL REVIEW BOARDSNODECFR-2003-title21-vol1-part56-subpartD699Subpart DsubpartD falseid-CFR-2003-title21-vol1-part56-subpartDIRB records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-115.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-115.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-115https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-115https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-115.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-115.xml21 CFR 56.11521CFR56.115Section 56.115; IRB records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DRecords and ReportsPart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-115700Section 56.115section56.115 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 46 Page 897546 FR 8975Federal RegisterVolume 56 Page 2802956 FR 28029Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part56Administrative Actions for NoncomplianceD09002ee18a5cbbf0-CFR-2003-title21-vol1-part56-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part56-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part56-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part56-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part56-subpartE.xml21 CFR E21CFRSubpart E; Administrative Actions for NoncomplianceChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 56INSTITUTIONAL REVIEW BOARDSNODECFR-2003-title21-vol1-part56-subpartE701Subpart EsubpartE falseid-CFR-2003-title21-vol1-part56-subpartELesser administrative actions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-120.xml21 CFR 56.12021CFR56.120Section 56.120; Lesser administrative actions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Actions for NoncompliancePart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-120702Section 56.120section56.120 falseid-CFR-2003-title21-vol1-part56-subpartEDisqualification of an IRB or an institution.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-121.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-121.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-121https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-121https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-121.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-121.xml21 CFR 56.12121CFR56.121Section 56.121; Disqualification of an IRB or an institution.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Actions for NoncompliancePart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-121703Section 56.121section56.121 falseid-CFR-2003-title21-vol1-part56-subpartEPublic disclosure of information regarding revocation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-122.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-122.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-122https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-122https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-122.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-122.xml21 CFR 56.12221CFR56.122Section 56.122; Public disclosure of information regarding revocation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Actions for NoncompliancePart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-122704Section 56.122section56.122 falseid-CFR-2003-title21-vol1-part56-subpartEReinstatement of an IRB or an institution.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-123.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-123.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-123https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-123https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-123.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-123.xml21 CFR 56.12321CFR56.123Section 56.123; Reinstatement of an IRB or an institution.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Actions for NoncompliancePart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-123705Section 56.123section56.123 falseid-CFR-2003-title21-vol1-part56-subpartEActions alternative or additional to disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec56-124.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec56-124.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-124https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec56-124https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec56-124.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec56-124.xml21 CFR 56.12421CFR56.124Section 56.124; Actions alternative or additional to disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EAdministrative Actions for NoncompliancePart 56INSTITUTIONAL REVIEW BOARDSCONTENTCFR-2003-title21-vol1-sec56-124706Section 56.124section56.124 falseid-CFR-2003-title21-vol1-chapI-subchapAGOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58.xml21 CFR 5821CFR58Part 58; GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part58707Part 58part58 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.falseUnited States CodeTitle 21 Section 342Title 21 Section 346aTitle 21 Section 346Title 21 Section 348Title 21 Section 351Title 21 Section 352Title 21 Section 353Title 21 Section 355Title 21 Section 360b-360fTitle 21 Section 360Title 21 Section 360h-360jTitle 21 Section 371Title 21 Section 379eTitle 21 Section 38121 U.S.C. 34221 U.S.C. 346a21 U.S.C. 34621 U.S.C. 34821 U.S.C. 35121 U.S.C. 35221 U.S.C. 35321 U.S.C. 35521 U.S.C. 360b-360f21 U.S.C. 36021 U.S.C. 360h-360j21 U.S.C. 37121 U.S.C. 379e21 U.S.C. 381United States CodeTitle 42 Section 216Title 42 Section 262Title 42 Section 263b-263n42 U.S.C. 21642 U.S.C. 26242 U.S.C. 263b-263nFederal RegisterVolume 43 Page 6001343 FR 60013id-CFR-2003-title21-vol1-part58Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-toc-id708.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-toc-id708.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-toc-id708https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-toc-id708https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-toc-id708.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-toc-id708.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESTOCCFR-2003-title21-vol1-part58-toc-id708708Toctocid-CFR-2003-title21-vol1-part58General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartA709Subpart AsubpartA falseid-CFR-2003-title21-vol1-part58-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-1.xml21 CFR 58.121CFR58.1Section 58.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-1710Section 58.1section58.1 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3377952 FR 33779Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part58-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-3.xml21 CFR 58.321CFR58.3Section 58.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-3711Section 58.3section58.3 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 21, 2002falseUnited States CodeTitle 21 Section 321-39221 U.S.C. 321-392United States Statutes at LargeVolume 52 Page 1040 et seq.52 Stat. 1040 et seq.Federal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3377952 FR 33779Federal RegisterVolume 54 Page 903954 FR 9039Federal RegisterVolume 64 Page 5644864 FR 56448Federal RegisterVolume 67 Page 3572967 FR 35729id-CFR-2003-title21-vol1-part58-subpartAApplicability to studies performed under grants and contracts.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-10.xml21 CFR 58.1021CFR58.10Section 58.10; Applicability to studies performed under grants and contracts.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-10712Section 58.10section58.10 falseid-CFR-2003-title21-vol1-part58-subpartAInspection of a testing facility.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-15.xml21 CFR 58.1521CFR58.15Section 58.15; Inspection of a testing facility.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-15713Section 58.15section58.15 falseid-CFR-2003-title21-vol1-part58Organization and PersonnelD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartB.xml21 CFR B21CFRSubpart B; Organization and PersonnelChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartB714Subpart BsubpartB falseid-CFR-2003-title21-vol1-part58-subpartBPersonnel.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-29.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-29.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-29https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-29https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-29.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-29.xml21 CFR 58.2921CFR58.29Section 58.29; Personnel.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BOrganization and PersonnelPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-29715Section 58.29section58.29 falseid-CFR-2003-title21-vol1-part58-subpartBTesting facility management.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-31.xml21 CFR 58.3121CFR58.31Section 58.31; Testing facility management.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BOrganization and PersonnelPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-31716Section 58.31section58.31 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartBStudy director.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-33.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-33.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-33https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-33https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-33.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-33.xml21 CFR 58.3321CFR58.33Section 58.33; Study director.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BOrganization and PersonnelPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-33717Section 58.33section58.33 43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 44 Page 1765744 FR 17657id-CFR-2003-title21-vol1-part58-subpartBQuality assurance unit.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-35.xml21 CFR 58.3521CFR58.35Section 58.35; Quality assurance unit.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BOrganization and PersonnelPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-35718Section 58.35section58.35 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58FacilitiesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartC.xml21 CFR C21CFRSubpart C; FacilitiesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartC719Subpart CsubpartC falseid-CFR-2003-title21-vol1-part58-subpartCGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-41.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-41.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-41https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-41https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-41.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-41.xml21 CFR 58.4121CFR58.41Section 58.41; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CFacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-41720Section 58.41section58.41 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartCAnimal care facilities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-43.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-43.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-43https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-43https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-43.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-43.xml21 CFR 58.4321CFR58.43Section 58.43; Animal care facilities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CFacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-43721Section 58.43section58.43 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartCAnimal supply facilities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-45.xml21 CFR 58.4521CFR58.45Section 58.45; Animal supply facilities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CFacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-45722Section 58.45section58.45 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartCFacilities for handling test and control articles.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-47.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-47.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-47https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-47https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-47.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-47.xml21 CFR 58.4721CFR58.47Section 58.47; Facilities for handling test and control articles.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CFacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-47723Section 58.47section58.47 falseid-CFR-2003-title21-vol1-part58-subpartCLaboratory operation areas.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-49.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-49.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-49https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-49https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-49.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-49.xml21 CFR 58.4921CFR58.49Section 58.49; Laboratory operation areas.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CFacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-49724Section 58.49section58.49 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartCSpecimen and data storage facilities.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-51.xml21 CFR 58.5121CFR58.51Section 58.51; Specimen and data storage facilities.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CFacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-51725Section 58.51section58.51 falseid-CFR-2003-title21-vol1-part58EquipmentD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartD.xml21 CFR D21CFRSubpart D; EquipmentChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartD726Subpart DsubpartD falseid-CFR-2003-title21-vol1-part58-subpartDEquipment design.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-61.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-61.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-61https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-61https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-61.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-61.xml21 CFR 58.6121CFR58.61Section 58.61; Equipment design.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DEquipmentPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-61727Section 58.61section58.61 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartDMaintenance and calibration of equipment.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-63.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-63.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-63https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-63https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-63.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-63.xml21 CFR 58.6321CFR58.63Section 58.63; Maintenance and calibration of equipment.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DEquipmentPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-63728Section 58.63section58.63 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58Testing Facilities OperationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartE.xml21 CFR E21CFRSubpart E; Testing Facilities OperationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartE729Subpart EsubpartE falseid-CFR-2003-title21-vol1-part58-subpartEStandard operating procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-81.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-81.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-81https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-81https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-81.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-81.xml21 CFR 58.8121CFR58.81Section 58.81; Standard operating procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ETesting Facilities OperationPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-81730Section 58.81section58.81 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780id-CFR-2003-title21-vol1-part58-subpartEReagents and solutions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-83.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-83.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-83https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-83https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-83.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-83.xml21 CFR 58.8321CFR58.83Section 58.83; Reagents and solutions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ETesting Facilities OperationPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-83731Section 58.83section58.83 falseid-CFR-2003-title21-vol1-part58-subpartEAnimal care.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-90.xml21 CFR 58.9021CFR58.90Section 58.90; Animal care.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ETesting Facilities OperationPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-90732Section 58.90section58.90 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 54 FR 15924, Apr. 20, 1989; 56 FR 32088, July 15, 1991; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378052 FR 33780Federal RegisterVolume 54 Page 1592454 FR 15924Federal RegisterVolume 56 Page 3208856 FR 32088Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58Test and Control ArticlesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartF.xml21 CFR F21CFRSubpart F; Test and Control ArticlesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartF733Subpart FsubpartF falseid-CFR-2003-title21-vol1-part58-subpartFTest and control article characterization.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-105.xml21 CFR 58.10521CFR58.105Section 58.105; Test and control article characterization.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FTest and Control ArticlesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-105734Section 58.105section58.105 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378152 FR 33781Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58-subpartFTest and control article handling.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-107.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-107.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-107https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-107https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-107.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-107.xml21 CFR 58.10721CFR58.107Section 58.107; Test and control article handling.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FTest and Control ArticlesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-107735Section 58.107section58.107 falseid-CFR-2003-title21-vol1-part58-subpartFMixtures of articles with carriers.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-113.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-113.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-113https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-113https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-113.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-113.xml21 CFR 58.11321CFR58.113Section 58.113; Mixtures of articles with carriers.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FTest and Control ArticlesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-113736Section 58.113section58.113 43 FR 60013, Dec. 22, 1978, as amended at 45 FR 24865, Apr. 11, 1980; 52 FR 33781, Sept. 4, 1987falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 45 Page 2486545 FR 24865Federal RegisterVolume 52 Page 3378152 FR 33781id-CFR-2003-title21-vol1-part58Protocol for and Conduct of a Nonclinical Laboratory StudyD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartG.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartG.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartGhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartGhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartG.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartG.xml21 CFR G21CFRSubpart G; Protocol for and Conduct of a Nonclinical Laboratory StudyChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartG737Subpart GsubpartG falseid-CFR-2003-title21-vol1-part58-subpartGProtocol.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-120.xml21 CFR 58.12021CFR58.120Section 58.120; Protocol.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GProtocol for and Conduct of a Nonclinical Laboratory StudyPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-120738Section 58.120section58.120 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378152 FR 33781Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58-subpartGConduct of a nonclinical laboratory study.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-130.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-130.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-130https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-130https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-130.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-130.xml21 CFR 58.13021CFR58.130Section 58.130; Conduct of a nonclinical laboratory study.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart GProtocol for and Conduct of a Nonclinical Laboratory StudyPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-130739Section 58.130section58.130 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378152 FR 33781Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58ReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartH.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartH.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartHhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartHhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartH.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartH.xml21 CFR H21CFRSubparts H-I; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartH740Subparts H-IsubpartH falseid-CFR-2003-title21-vol1-part58Records and ReportsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartJ.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartJ.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartJhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartJhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartJ.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartJ.xml21 CFR J21CFRSubpart J; Records and ReportsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartJ741Subpart JsubpartJ falseid-CFR-2003-title21-vol1-part58-subpartJReporting of nonclinical laboratory study results.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-185.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-185.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-185https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-185https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-185.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-185.xml21 CFR 58.18521CFR58.185Section 58.185; Reporting of nonclinical laboratory study results.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart JRecords and ReportsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-185742Section 58.185section58.185 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378152 FR 33781id-CFR-2003-title21-vol1-part58-subpartJStorage and retrieval of records and data.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-190.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-190.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-190https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-190https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-190.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-190.xml21 CFR 58.19021CFR58.190Section 58.190; Storage and retrieval of records and data.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart JRecords and ReportsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-190743Section 58.190section58.190 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378152 FR 33781Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part58-subpartJRetention of records.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-195.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-195.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-195https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-195https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-195.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-195.xml21 CFR 58.19521CFR58.195Section 58.195; Retention of records.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart JRecords and ReportsPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-195744Section 58.195section58.195 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 52 Page 3378152 FR 33781Federal RegisterVolume 54 Page 903954 FR 9039id-CFR-2003-title21-vol1-part58Disqualification of Testing FacilitiesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part58-subpartK.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part58-subpartK.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartKhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part58-subpartKhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part58-subpartK.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part58-subpartK.xml21 CFR K21CFRSubpart K; Disqualification of Testing FacilitiesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESNODECFR-2003-title21-vol1-part58-subpartK745Subpart KsubpartK falseid-CFR-2003-title21-vol1-part58-subpartKPurpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-200.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-200.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-200https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-200https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-200.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-200.xml21 CFR 58.20021CFR58.200Section 58.200; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-200746Section 58.200section58.200 falseid-CFR-2003-title21-vol1-part58-subpartKGrounds for disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-202.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-202.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-202https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-202https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-202.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-202.xml21 CFR 58.20221CFR58.202Section 58.202; Grounds for disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-202747Section 58.202section58.202 falseid-CFR-2003-title21-vol1-part58-subpartKNotice of and opportunity for hearing on proposed disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-204.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-204.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-204https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-204https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-204.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-204.xml21 CFR 58.20421CFR58.204Section 58.204; Notice of and opportunity for hearing on proposed disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-204748Section 58.204section58.204 falseid-CFR-2003-title21-vol1-part58-subpartKFinal order on disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-206.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-206.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-206https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-206https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-206.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-206.xml21 CFR 58.20621CFR58.206Section 58.206; Final order on disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-206749Section 58.206section58.206 falseid-CFR-2003-title21-vol1-part58-subpartKActions upon disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-210.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-210.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-210https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-210https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-210.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-210.xml21 CFR 58.21021CFR58.210Section 58.210; Actions upon disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-210750Section 58.210section58.210 43 FR 60013, Dec. 22, 1978, as amended at 59 FR 13200, Mar. 21, 1994falseFederal RegisterVolume 43 Page 6001343 FR 60013Federal RegisterVolume 59 Page 1320059 FR 13200id-CFR-2003-title21-vol1-part58-subpartKPublic disclosure of information regarding disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-213.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-213.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-213https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-213https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-213.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-213.xml21 CFR 58.21321CFR58.213Section 58.213; Public disclosure of information regarding disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-213751Section 58.213section58.213 falseid-CFR-2003-title21-vol1-part58-subpartKAlternative or additional actions to disqualification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-215.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-215.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-215https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-215https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-215.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-215.xml21 CFR 58.21521CFR58.215Section 58.215; Alternative or additional actions to disqualification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-215752Section 58.215section58.215 falseid-CFR-2003-title21-vol1-part58-subpartKSuspension or termination of a testing facility by a sponsor.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-217.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-217.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-217https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-217https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-217.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-217.xml21 CFR 58.21721CFR58.217Section 58.217; Suspension or termination of a testing facility by a sponsor.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-217753Section 58.217section58.217 43 FR FR 60013, Dec. 22, 1978, as amended at 50 FR 8995, Mar. 6, 1985falseFederal RegisterVolume 50 Page 899550 FR 8995id-CFR-2003-title21-vol1-part58-subpartKReinstatement of a disqualified testing facility.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec58-219.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec58-219.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-219https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec58-219https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec58-219.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec58-219.xml21 CFR 58.21921CFR58.219Section 58.219; Reinstatement of a disqualified testing facility.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart KDisqualification of Testing FacilitiesPart 58GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESCONTENTCFR-2003-title21-vol1-sec58-219754Section 58.219section58.219 falseid-CFR-2003-title21-vol1-chapI-subchapAPATENT TERM RESTORATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part60.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60.xml21 CFR 6021CFR60Part 60; PATENT TERM RESTORATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part60755Part 60part60 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.falseUnited States CodeTitle 21 Section 348Title 21 Section 355Title 21 Section 360eTitle 21 Section 360jTitle 21 Section 371Title 21 Section 379e21 U.S.C. 34821 U.S.C. 35521 U.S.C. 360e21 U.S.C. 360j21 U.S.C. 37121 U.S.C. 379eUnited States CodeTitle 35 Section 15635 U.S.C. 156United States CodeTitle 42 Section 26242 U.S.C. 262Federal RegisterVolume 53 Page 730553 FR 7305id-CFR-2003-title21-vol1-part60Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part60-toc-id756.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60-toc-id756.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-toc-id756https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-toc-id756https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60-toc-id756.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60-toc-id756.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 60PATENT TERM RESTORATIONTOCCFR-2003-title21-vol1-part60-toc-id756756Toctocid-CFR-2003-title21-vol1-part60General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part60-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 60PATENT TERM RESTORATIONNODECFR-2003-title21-vol1-part60-subpartA757Subpart AsubpartA falseid-CFR-2003-title21-vol1-part60-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-1.xml21 CFR 60.121CFR60.1Section 60.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-1758Section 60.1section60.1 53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992falseUnited States CodeTitle 35 Section 156Title 35 Section 156(f)(2)35 U.S.C. 15635 U.S.C. 156(f)(2)Federal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 57 Page 5626157 FR 56261id-CFR-2003-title21-vol1-part60-subpartAPurpose.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-2.xml21 CFR 60.221CFR60.2Section 60.2; Purpose.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-2759Section 60.2section60.2 falseid-CFR-2003-title21-vol1-part60-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-3.xml21 CFR 60.321CFR60.3Section 60.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-3760Section 60.3section60.3 53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992; 64 FR 399, Jan. 5, 1999falseUnited States CodeTitle 21 Section 301-39221 U.S.C. 301-392United States CodeTitle 35 Section 15635 U.S.C. 156United States Statutes at LargeVolume 52 Page 1040 et seq.52 Stat. 1040 et seq.Federal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 57 Page 5626157 FR 56261Federal RegisterVolume 64 Page 39964 FR 399id-CFR-2003-title21-vol1-part60Eligibility AssistanceD09002ee18a5cbbf0-CFR-2003-title21-vol1-part60-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60-subpartB.xml21 CFR B21CFRSubpart B; Eligibility AssistanceChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 60PATENT TERM RESTORATIONNODECFR-2003-title21-vol1-part60-subpartB761Subpart BsubpartB falseid-CFR-2003-title21-vol1-part60-subpartBFDA assistance on eligibility.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-10.xml21 CFR 60.1021CFR60.10Section 60.10; FDA assistance on eligibility.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BEligibility AssistancePart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-10762Section 60.10section60.10 57 FR 56261, Nov. 27, 1992falseFederal RegisterVolume 57 Page 5626157 FR 56261id-CFR-2003-title21-vol1-part60Regulatory Review Period DeterminationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part60-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60-subpartC.xml21 CFR C21CFRSubpart C; Regulatory Review Period DeterminationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 60PATENT TERM RESTORATIONNODECFR-2003-title21-vol1-part60-subpartC763Subpart CsubpartC falseid-CFR-2003-title21-vol1-part60-subpartCFDA action on regulatory review period determinations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-20.xml21 CFR 60.2021CFR60.20Section 60.20; FDA action on regulatory review period determinations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRegulatory Review Period DeterminationsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-20764Section 60.20section60.20 53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994falseUnited States CodeTitle 35 Section 15635 U.S.C. 156Federal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 59 Page 1436459 FR 14364id-CFR-2003-title21-vol1-part60-subpartCRegulatory review period determinations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-22.xml21 CFR 60.2221CFR60.22Section 60.22; Regulatory review period determinations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRegulatory Review Period DeterminationsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-22765Section 60.22section60.22 53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56262, Nov. 27, 1992; 64 FR 400, Jan. 5, 1999falseFederal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 57 Page 5626257 FR 56262Federal RegisterVolume 64 Page 40064 FR 400id-CFR-2003-title21-vol1-part60-subpartCRevision of regulatory review period determinations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-24.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-24.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-24https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-24https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-24.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-24.xml21 CFR 60.2421CFR60.24Section 60.24; Revision of regulatory review period determinations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRegulatory Review Period DeterminationsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-24766Section 60.24section60.24 53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 59 Page 1436459 FR 14364Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part60-subpartCFinal action on regulatory review period determinations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-26.xml21 CFR 60.2621CFR60.26Section 60.26; Final action on regulatory review period determinations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRegulatory Review Period DeterminationsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-26767Section 60.26section60.26 53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994falseFederal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 59 Page 1436459 FR 14364id-CFR-2003-title21-vol1-part60-subpartCTime frame for determining regulatory review periods.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-28.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-28.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-28https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-28https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-28.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-28.xml21 CFR 60.2821CFR60.28Section 60.28; Time frame for determining regulatory review periods.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CRegulatory Review Period DeterminationsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-28768Section 60.28section60.28 falseid-CFR-2003-title21-vol1-part60Due Diligence PetitionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part60-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60-subpartD.xml21 CFR D21CFRSubpart D; Due Diligence PetitionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 60PATENT TERM RESTORATIONNODECFR-2003-title21-vol1-part60-subpartD769Subpart DsubpartD falseid-CFR-2003-title21-vol1-part60-subpartDFiling, format, and content of petitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-30.xml21 CFR 60.3021CFR60.30Section 60.30; Filing, format, and content of petitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DDue Diligence PetitionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-30770Section 60.30section60.30 53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part60-subpartDApplicant response to petition.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-32.xml21 CFR 60.3221CFR60.32Section 60.32; Applicant response to petition.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DDue Diligence PetitionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-32771Section 60.32section60.32 falseid-CFR-2003-title21-vol1-part60-subpartDFDA action on petitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-34.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-34.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-34https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-34https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-34.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-34.xml21 CFR 60.3421CFR60.34Section 60.34; FDA action on petitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DDue Diligence PetitionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-34772Section 60.34section60.34 falseid-CFR-2003-title21-vol1-part60-subpartDStandard of due diligence.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-36.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-36.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-36https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-36https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-36.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-36.xml21 CFR 60.3621CFR60.36Section 60.36; Standard of due diligence.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DDue Diligence PetitionsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-36773Section 60.36section60.36 falseid-CFR-2003-title21-vol1-part60Due Diligence HearingsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part60-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part60-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part60-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part60-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part60-subpartE.xml21 CFR E21CFRSubpart E; Due Diligence HearingsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 60PATENT TERM RESTORATIONNODECFR-2003-title21-vol1-part60-subpartE774Subpart EsubpartE falseid-CFR-2003-title21-vol1-part60-subpartERequest for hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-40.xml21 CFR 60.4021CFR60.40Section 60.40; Request for hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EDue Diligence HearingsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-40775Section 60.40section60.40 53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002falseFederal RegisterVolume 53 Page 730553 FR 7305Federal RegisterVolume 67 Page 958567 FR 9585id-CFR-2003-title21-vol1-part60-subpartENotice of hearing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-42.xml21 CFR 60.4221CFR60.42Section 60.42; Notice of hearing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EDue Diligence HearingsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-42776Section 60.42section60.42 falseid-CFR-2003-title21-vol1-part60-subpartEHearing procedures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-44.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-44.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-44https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-44https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-44.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-44.xml21 CFR 60.4421CFR60.44Section 60.44; Hearing procedures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EDue Diligence HearingsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-44777Section 60.44section60.44 falseid-CFR-2003-title21-vol1-part60-subpartEAdministrative decision.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec60-46.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec60-46.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-46https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec60-46https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec60-46.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec60-46.xml21 CFR 60.4621CFR60.46Section 60.46; Administrative decision.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart EDue Diligence HearingsPart 60PATENT TERM RESTORATIONCONTENTCFR-2003-title21-vol1-sec60-46778Section 60.46section60.46 falseid-CFR-2003-title21-vol1-chapI-subchapACOLOR ADDITIVESD09002ee18a5cbbf0-CFR-2003-title21-vol1-part70.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part70.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part70.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part70.xml21 CFR 7021CFR70Part 70; COLOR ADDITIVESChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part70779Part 70part70 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 379e.falseUnited States CodeTitle 21 Section 321Title 21 Section 341Title 21 Section 342Title 21 Section 343Title 21 Section 348Title 21 Section 351Title 21 Section 360bTitle 21 Section 361Title 21 Section 371Title 21 Section 379e21 U.S.C. 32121 U.S.C. 34121 U.S.C. 34221 U.S.C. 34321 U.S.C. 34821 U.S.C. 35121 U.S.C. 360b21 U.S.C. 36121 U.S.C. 37121 U.S.C. 379eFederal RegisterVolume 42 Page 1563642 FR 15636id-CFR-2003-title21-vol1-part70Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part70-toc-id780.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part70-toc-id780.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-toc-id780https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-toc-id780https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part70-toc-id780.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part70-toc-id780.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 70COLOR ADDITIVESTOCCFR-2003-title21-vol1-part70-toc-id780780Toctocid-CFR-2003-title21-vol1-part70General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part70-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part70-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part70-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part70-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 70COLOR ADDITIVESNODECFR-2003-title21-vol1-part70-subpartA781Subpart AsubpartA falseid-CFR-2003-title21-vol1-part70-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-3.xml21 CFR 70.321CFR70.3Section 70.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-3782Section 70.3section70.3 42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996falseFederal RegisterVolume 42 Page 1563642 FR 15636Federal RegisterVolume 61 Page 1447861 FR 14478id-CFR-2003-title21-vol1-part70-subpartAGeneral restrictions on use of color additives.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-5.xml21 CFR 70.521CFR70.5Section 70.5; General restrictions on use of color additives.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-5783Section 70.5section70.5 falseid-CFR-2003-title21-vol1-part70-subpartAColor additives in standardized foods and new drugs.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-10.xml21 CFR 70.1021CFR70.10Section 70.10; Color additives in standardized foods and new drugs.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-10784Section 70.10section70.10 42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999falseFederal RegisterVolume 42 Page 1563642 FR 15636Federal RegisterVolume 64 Page 40064 FR 400id-CFR-2003-title21-vol1-part70-subpartARelated substances.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-11.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-11.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-11https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-11https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-11.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-11.xml21 CFR 70.1121CFR70.11Section 70.11; Related substances.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-11785Section 70.11section70.11 falseid-CFR-2003-title21-vol1-part70-subpartAFees for listing.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-19.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-19.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-19https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-19https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-19.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-19.xml21 CFR 70.1921CFR70.19Section 70.19; Fees for listing.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-19786Section 70.19section70.19 42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001falseUnited States CodeTitle 21 Section 379e21 U.S.C. 379eUnited States Statutes at LargeVolume 74 Page 40474 Stat. 404United States Public Law 618 (86th Congress)Public Law 86-618Federal RegisterVolume 42 Page 1563642 FR 15636Federal RegisterVolume 54 Page 2489054 FR 24890Federal RegisterVolume 61 Page 1447861 FR 14478Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part70Packaging and LabelingD09002ee18a5cbbf0-CFR-2003-title21-vol1-part70-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part70-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part70-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part70-subpartB.xml21 CFR B21CFRSubpart B; Packaging and LabelingChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 70COLOR ADDITIVESNODECFR-2003-title21-vol1-part70-subpartB787Subpart BsubpartB falseid-CFR-2003-title21-vol1-part70-subpartBPackaging requirements for straight colors (other than hair dyes).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-20.xml21 CFR 70.2021CFR70.20Section 70.20; Packaging requirements for straight colors (other than hair dyes).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BPackaging and LabelingPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-20788Section 70.20section70.20 falseid-CFR-2003-title21-vol1-part70-subpartBLabeling requirements for color additives (other than hair dyes).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-25.xml21 CFR 70.2521CFR70.25Section 70.25; Labeling requirements for color additives (other than hair dyes).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BPackaging and LabelingPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-25789Section 70.25section70.25 falseid-CFR-2003-title21-vol1-part70Safety EvaluationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part70-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part70-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part70-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part70-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part70-subpartC.xml21 CFR C21CFRSubpart C; Safety EvaluationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 70COLOR ADDITIVESNODECFR-2003-title21-vol1-part70-subpartC790Subpart CsubpartC falseid-CFR-2003-title21-vol1-part70-subpartCSafety factors to be considered.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-40.xml21 CFR 70.4021CFR70.40Section 70.40; Safety factors to be considered.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CSafety EvaluationPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-40791Section 70.40section70.40 falseid-CFR-2003-title21-vol1-part70-subpartCCriteria for evaluating the safety of color additives.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-42.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-42.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-42https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-42https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-42.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-42.xml21 CFR 70.4221CFR70.42Section 70.42; Criteria for evaluating the safety of color additives.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CSafety EvaluationPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-42792Section 70.42section70.42 falseid-CFR-2003-title21-vol1-part70-subpartCAllocation of color additives.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-45.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-45.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-45https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-45https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-45.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-45.xml21 CFR 70.4521CFR70.45Section 70.45; Allocation of color additives.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CSafety EvaluationPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-45793Section 70.45section70.45 falseid-CFR-2003-title21-vol1-part70-subpartCApplication of the cancer clause of section 721 of the act.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-50.xml21 CFR 70.5021CFR70.50Section 70.50; Application of the cancer clause of section 721 of the act.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CSafety EvaluationPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-50794Section 70.50section70.50 42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 1987falseFederal RegisterVolume 42 Page 1563642 FR 15636Federal RegisterVolume 43 Page 2267543 FR 22675Federal RegisterVolume 52 Page 4958652 FR 49586id-CFR-2003-title21-vol1-part70-subpartCAdvisory committee on the applicability of the anticancer clause.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-51.xml21 CFR 70.5121CFR70.51Section 70.51; Advisory committee on the applicability of the anticancer clause.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CSafety EvaluationPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-51795Section 70.51section70.51 falseid-CFR-2003-title21-vol1-part70-subpartCRequest for scientific studies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec70-55.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec70-55.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-55https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec70-55https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec70-55.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec70-55.xml21 CFR 70.5521CFR70.55Section 70.55; Request for scientific studies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CSafety EvaluationPart 70COLOR ADDITIVESCONTENTCFR-2003-title21-vol1-sec70-55796Section 70.55section70.55 falseid-CFR-2003-title21-vol1-chapI-subchapACOLOR ADDITIVE PETITIONSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part71.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part71.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part71.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part71.xml21 CFR 7121CFR71Part 71; COLOR ADDITIVE PETITIONSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part71797Part 71part71 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.falseUnited States CodeTitle 21 Section 321Title 21 Section 342Title 21 Section 348Title 21 Section 351Title 21 Section 355Title 21 Section 360b-360fTitle 21 Section 360Title 21 Section 360h-360jTitle 21 Section 361Title 21 Section 371Title 21 Section 379eTitle 21 Section 38121 U.S.C. 32121 U.S.C. 34221 U.S.C. 34821 U.S.C. 35121 U.S.C. 35521 U.S.C. 360b-360f21 U.S.C. 36021 U.S.C. 360h-360j21 U.S.C. 36121 U.S.C. 37121 U.S.C. 379e21 U.S.C. 381United States CodeTitle 42 Section 216Title 42 Section 26242 U.S.C. 21642 U.S.C. 262Federal RegisterVolume 42 Page 1563942 FR 15639id-CFR-2003-title21-vol1-part71Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part71-toc-id798.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part71-toc-id798.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71-toc-id798https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71-toc-id798https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part71-toc-id798.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part71-toc-id798.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 71COLOR ADDITIVE PETITIONSTOCCFR-2003-title21-vol1-part71-toc-id798798Toctocid-CFR-2003-title21-vol1-part71General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part71-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part71-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part71-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part71-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 71COLOR ADDITIVE PETITIONSNODECFR-2003-title21-vol1-part71-subpartA799Subpart AsubpartA falseid-CFR-2003-title21-vol1-part71-subpartAPetitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-1.xml21 CFR 71.121CFR71.1Section 71.1; Petitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-1800Section 71.1section71.1 42 FR 15639, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 62 FR 40598, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6, 2001falseUnited States CodeTitle 21 Section 451et seq.Title 21 Section 601et seq.21 U.S.C. 451et seq.21 U.S.C. 601et seq.Federal RegisterVolume 42 Page 1563942 FR 15639Federal RegisterVolume 43 Page 6002143 FR 60021Federal RegisterVolume 46 Page 895246 FR 8952Federal RegisterVolume 50 Page 1666850 FR 16668Federal RegisterVolume 50 Page 749150 FR 7491Federal RegisterVolume 54 Page 2489054 FR 24890Federal RegisterVolume 61 Page 1447861 FR 14478Federal RegisterVolume 62 Page 4059862 FR 40598Federal RegisterVolume 65 Page 5176265 FR 51762Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part71-subpartANotice of filing of petition.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-2.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-2.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-2https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-2https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-2.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-2.xml21 CFR 71.221CFR71.2Section 71.2; Notice of filing of petition.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-2801Section 71.2section71.2 42 FR 15639, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999falseFederal RegisterVolume 42 Page 1563942 FR 15639Federal RegisterVolume 64 Page 40064 FR 400id-CFR-2003-title21-vol1-part71-subpartASamples; additional information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-4.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-4.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-4https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-4https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-4.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-4.xml21 CFR 71.421CFR71.4Section 71.4; Samples; additional information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-4802Section 71.4section71.4 falseid-CFR-2003-title21-vol1-part71-subpartAExtension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-6.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-6.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-6https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-6https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-6.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-6.xml21 CFR 71.621CFR71.6Section 71.6; Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-6803Section 71.6section71.6 42 FR 15636, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985falseFederal RegisterVolume 42 Page 1563642 FR 15636Federal RegisterVolume 43 Page 6002143 FR 60021Federal RegisterVolume 46 Page 895246 FR 8952Federal RegisterVolume 50 Page 749150 FR 7491id-CFR-2003-title21-vol1-part71-subpartAConfidentiality of data and information in color additive petitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-15.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-15.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-15https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-15https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-15.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-15.xml21 CFR 71.1521CFR71.15Section 71.15; Confidentiality of data and information in color additive petitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-15804Section 71.15section71.15 falseid-CFR-2003-title21-vol1-part71-subpartAPetition for exemption from certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-18.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-18.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-18https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-18https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-18.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-18.xml21 CFR 71.1821CFR71.18Section 71.18; Petition for exemption from certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-18805Section 71.18section71.18 falseid-CFR-2003-title21-vol1-part71Administrative Action on PetitionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part71-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part71-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part71-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part71-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part71-subpartB.xml21 CFR B21CFRSubpart B; Administrative Action on PetitionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 71COLOR ADDITIVE PETITIONSNODECFR-2003-title21-vol1-part71-subpartB806Subpart BsubpartB falseid-CFR-2003-title21-vol1-part71-subpartBPublication of regulation.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-20.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-20.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-20https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-20https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-20.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-20.xml21 CFR 71.2021CFR71.20Section 71.20; Publication of regulation.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-20807Section 71.20section71.20 42 FR 15639, Mar. 22, 1977, as amended at 65 FR 51762, Aug. 25, 2000falseUnited States CodeTitle 21 Section 451et seq.Title 21 Section 601et seq.21 U.S.C. 451et seq.21 U.S.C. 601et seq.Federal RegisterVolume 42 Page 1563942 FR 15639Federal RegisterVolume 65 Page 5176265 FR 51762id-CFR-2003-title21-vol1-part71-subpartBDeception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-22.xml21 CFR 71.2221CFR71.22Section 71.22; Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-22808Section 71.22section71.22 falseid-CFR-2003-title21-vol1-part71-subpartBCondition for certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-25.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-25.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-25https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-25https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-25.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-25.xml21 CFR 71.2521CFR71.25Section 71.25; Condition for certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-25809Section 71.25section71.25 falseid-CFR-2003-title21-vol1-part71-subpartBRevocation of exemption from certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-26.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-26.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-26https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-26https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-26.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-26.xml21 CFR 71.2621CFR71.26Section 71.26; Revocation of exemption from certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-26810Section 71.26section71.26 falseid-CFR-2003-title21-vol1-part71-subpartBListing and exemption from certification on the Commissioner's initiative.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-27.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-27.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-27https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-27https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-27.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-27.xml21 CFR 71.2721CFR71.27Section 71.27; Listing and exemption from certification on the Commissioner's initiative.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-27811Section 71.27section71.27 falseid-CFR-2003-title21-vol1-part71-subpartBProcedure for filing objections to regulations.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-30.xml21 CFR 71.3021CFR71.30Section 71.30; Procedure for filing objections to regulations.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-30812Section 71.30section71.30 falseid-CFR-2003-title21-vol1-part71-subpartBExemption of color additives for investigational use.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec71-37.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec71-37.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-37https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec71-37https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec71-37.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec71-37.xml21 CFR 71.3721CFR71.37Section 71.37; Exemption of color additives for investigational use.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BAdministrative Action on PetitionsPart 71COLOR ADDITIVE PETITIONSCONTENTCFR-2003-title21-vol1-sec71-37813Section 71.37section71.37 falseid-CFR-2003-title21-vol1-chapI-subchapALISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part73.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part73.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part73.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part73.xml21 CFR 7321CFR73Part 73; LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part73814Part 73part73 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001.falseUnited States CodeTitle 21 Section 321Title 21 Section 341Title 21 Section 342Title 21 Section 343Title 21 Section 348Title 21 Section 351Title 21 Section 352Title 21 Section 355Title 21 Section 361Title 21 Section 362Title 21 Section 371Title 21 Section 379e21 U.S.C. 32121 U.S.C. 34121 U.S.C. 34221 U.S.C. 34321 U.S.C. 34821 U.S.C. 35121 U.S.C. 35221 U.S.C. 35521 U.S.C. 36121 U.S.C. 36221 U.S.C. 37121 U.S.C. 379eFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 66 Page 6674266 FR 66742id-CFR-2003-title21-vol1-part73Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part73-toc-id815.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part73-toc-id815.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-toc-id815https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-toc-id815https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part73-toc-id815.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part73-toc-id815.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONTOCCFR-2003-title21-vol1-part73-toc-id815815Toctocid-CFR-2003-title21-vol1-part73FoodsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part73-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part73-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part73-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part73-subpartA.xml21 CFR A21CFRSubpart A; FoodsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONNODECFR-2003-title21-vol1-part73-subpartA816Subpart AsubpartA falseid-CFR-2003-title21-vol1-part73-subpartADiluents in color additive mixtures for food use exempt from certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1.xml21 CFR 73.121CFR73.1Section 73.1; Diluents in color additive mixtures for food use exempt from certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1817Section 73.1section73.1 42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 57 Page 3217557 FR 32175id-CFR-2003-title21-vol1-part73-subpartAAnnatto extract.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-30.xml21 CFR 73.3021CFR73.30Section 73.30; Annatto extract.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-30818Section 73.30section73.30 falseid-CFR-2003-title21-vol1-part73-subpartAAstaxanthin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-35.xml21 CFR 73.3521CFR73.35Section 73.35; Astaxanthin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-35819Section 73.35section73.35 60 FR 18738, Apr. 13, 1995falseFederal RegisterVolume 60 Page 1873860 FR 18738id-CFR-2003-title21-vol1-part73-subpartADehydrated beets (beet powder).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-40.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-40.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-40https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-40https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-40.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-40.xml21 CFR 73.4021CFR73.40Section 73.40; Dehydrated beets (beet powder).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-40820Section 73.40section73.40 falseid-CFR-2003-title21-vol1-part73-subpartAUltramarine blue.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-50.xml21 CFR 73.5021CFR73.50Section 73.50; Ultramarine blue.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-50821Section 73.50section73.50 falseid-CFR-2003-title21-vol1-part73-subpartACanthaxanthin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-75.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-75.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-75https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-75https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-75.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-75.xml21 CFR 73.7521CFR73.75Section 73.75; Canthaxanthin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-75822Section 73.75section73.75 42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, 1998falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 50 Page 4753450 FR 47534Federal RegisterVolume 63 Page 1481763 FR 14817id-CFR-2003-title21-vol1-part73-subpartACaramel.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-85.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-85.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-85https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-85https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-85.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-85.xml21 CFR 73.8521CFR73.85Section 73.85; Caramel.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-85823Section 73.85section73.85 falseid-CFR-2003-title21-vol1-part73-subpartAβ-Apo-8′-carotenal.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-90.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-90.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-90https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-90https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-90.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-90.xml21 CFR 73.9021CFR73.90Section 73.90; β-Apo-8′-carotenal.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-90824Section 73.90section73.90 falseid-CFR-2003-title21-vol1-part73-subpartAβ-Carotene.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-95.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-95.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-95https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-95https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-95.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-95.xml21 CFR 73.9521CFR73.95Section 73.95; β-Carotene.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-95825Section 73.95section73.95 falseid-CFR-2003-title21-vol1-part73-subpartACochineal extract; carmine.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-100.xml21 CFR 73.10021CFR73.100Section 73.100; Cochineal extract; carmine.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-100826Section 73.100section73.100 falseid-CFR-2003-title21-vol1-part73-subpartASodium copper chlorophyllin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-125.xml21 CFR 73.12521CFR73.125Section 73.125; Sodium copper chlorophyllin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-125827Section 73.125section73.125 67 FR 35431, May 20, 2002falseFederal RegisterVolume 67 Page 3543167 FR 35431id-CFR-2003-title21-vol1-part73-subpartAToasted partially defatted cooked cottonseed flour.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-140.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-140.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-140https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-140https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-140.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-140.xml21 CFR 73.14021CFR73.140Section 73.140; Toasted partially defatted cooked cottonseed flour.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-140828Section 73.140section73.140 falseid-CFR-2003-title21-vol1-part73-subpartAFerrous gluconate.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-160.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-160.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-160https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-160https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-160.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-160.xml21 CFR 73.16021CFR73.160Section 73.160; Ferrous gluconate.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-160829Section 73.160section73.160 42 FR 15643, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 47 Page 94647 FR 946Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartAFerrous lactate.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-165.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-165.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-165https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-165https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-165.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-165.xml21 CFR 73.16521CFR73.165Section 73.165; Ferrous lactate.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-165830Section 73.165section73.165 61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001falseUnited States CodeTitle 5 Section 1Title 5 Section 552(a)5 U.S.C. 15 U.S.C. 552(a)Code of Federal RegulationsTitle 1 Part 511 CFR Part 51Federal RegisterVolume 61 Page 4031961 FR 40319Federal RegisterVolume 66 Page 6674266 FR 66742id-CFR-2003-title21-vol1-part73-subpartAGrape color extract.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-169.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-169.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-169https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-169https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-169.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-169.xml21 CFR 73.16921CFR73.169Section 73.169; Grape color extract.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-169831Section 73.169section73.169 46 FR 47532, Sept. 29, 1981falseFederal RegisterVolume 46 Page 4753246 FR 47532id-CFR-2003-title21-vol1-part73-subpartAGrape skin extract (enocianina).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-170.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-170.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-170https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-170https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-170.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-170.xml21 CFR 73.17021CFR73.170Section 73.170; Grape skin extract (enocianina).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-170832Section 73.170section73.170 falseid-CFR-2003-title21-vol1-part73-subpartAHaematococcus algae meal.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-185.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-185.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-185https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-185https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-185.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-185.xml21 CFR 73.18521CFR73.185Section 73.185; Haematococcus algae meal.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-185833Section 73.185section73.185 65 FR 41584, July 6, 2000falseFederal RegisterVolume 65 Page 4158465 FR 41584id-CFR-2003-title21-vol1-part73-subpartASynthetic iron oxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-200.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-200.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-200https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-200https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-200.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-200.xml21 CFR 73.20021CFR73.200Section 73.200; Synthetic iron oxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-200834Section 73.200section73.200 42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 59 Page 1057859 FR 10578id-CFR-2003-title21-vol1-part73-subpartAFruit juice.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-250.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-250.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-250https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-250https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-250.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-250.xml21 CFR 73.25021CFR73.250Section 73.250; Fruit juice.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-250835Section 73.250section73.250 42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 60 Page 5262960 FR 52629id-CFR-2003-title21-vol1-part73-subpartAVegetable juice.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-260.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-260.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-260https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-260https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-260.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-260.xml21 CFR 73.26021CFR73.260Section 73.260; Vegetable juice.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-260836Section 73.260section73.260 42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 60 Page 5262960 FR 52629id-CFR-2003-title21-vol1-part73-subpartADried algae meal.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-275.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-275.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-275https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-275https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-275.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-275.xml21 CFR 73.27521CFR73.275Section 73.275; Dried algae meal.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-275837Section 73.275section73.275 falseid-CFR-2003-title21-vol1-part73-subpartATagetes (Aztec marigold) meal and extract.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-295.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-295.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-295https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-295https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-295.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-295.xml21 CFR 73.29521CFR73.295Section 73.295; Tagetes (Aztec marigold) meal and extract.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-295838Section 73.295section73.295 falseid-CFR-2003-title21-vol1-part73-subpartACarrot oil.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-300.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-300.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-300https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-300https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-300.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-300.xml21 CFR 73.30021CFR73.300Section 73.300; Carrot oil.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-300839Section 73.300section73.300 falseid-CFR-2003-title21-vol1-part73-subpartACorn endosperm oil.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-315.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-315.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-315https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-315https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-315.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-315.xml21 CFR 73.31521CFR73.315Section 73.315; Corn endosperm oil.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-315840Section 73.315section73.315 falseid-CFR-2003-title21-vol1-part73-subpartAPaprika.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-340.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-340.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-340https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-340https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-340.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-340.xml21 CFR 73.34021CFR73.340Section 73.340; Paprika.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-340841Section 73.340section73.340 falseid-CFR-2003-title21-vol1-part73-subpartAPaprika oleoresin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-345.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-345.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-345https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-345https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-345.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-345.xml21 CFR 73.34521CFR73.345Section 73.345; Paprika oleoresin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-345842Section 73.345section73.345 falseid-CFR-2003-title21-vol1-part73-subpartAPhaffia yeast.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-355.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-355.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-355https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-355https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-355.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-355.xml21 CFR 73.35521CFR73.355Section 73.355; Phaffia yeast.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-355843Section 73.355section73.355 65 FR 41587, July 6, 2000falseFederal RegisterVolume 65 Page 4158765 FR 41587id-CFR-2003-title21-vol1-part73-subpartARiboflavin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-450.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-450.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-450https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-450https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-450.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-450.xml21 CFR 73.45021CFR73.450Section 73.450; Riboflavin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-450844Section 73.450section73.450 42 FR 15643, Mar. 22, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 47 Page 94747 FR 947Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartASaffron.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-500.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-500.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-500https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-500https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-500.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-500.xml21 CFR 73.50021CFR73.500Section 73.500; Saffron.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-500845Section 73.500section73.500 falseid-CFR-2003-title21-vol1-part73-subpartATitanium dioxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-575.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-575.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-575https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-575https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-575.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-575.xml21 CFR 73.57521CFR73.575Section 73.575; Titanium dioxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-575846Section 73.575section73.575 falseid-CFR-2003-title21-vol1-part73-subpartATurmeric.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-600.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-600.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-600https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-600https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-600.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-600.xml21 CFR 73.60021CFR73.600Section 73.600; Turmeric.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-600847Section 73.600section73.600 falseid-CFR-2003-title21-vol1-part73-subpartATurmeric oleoresin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-615.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-615.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-615https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-615https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-615.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-615.xml21 CFR 73.61521CFR73.615Section 73.615; Turmeric oleoresin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-615848Section 73.615section73.615 falseid-CFR-2003-title21-vol1-part73DrugsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part73-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part73-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part73-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part73-subpartB.xml21 CFR B21CFRSubpart B; DrugsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONNODECFR-2003-title21-vol1-part73-subpartB849Subpart BsubpartB falseid-CFR-2003-title21-vol1-part73-subpartBDiluents in color additive mixtures for drug use exempt from certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1001.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1001.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1001https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1001https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1001.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1001.xml21 CFR 73.100121CFR73.1001Section 73.1001; Diluents in color additive mixtures for drug use exempt from certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1001850Section 73.1001section73.1001 falseid-CFR-2003-title21-vol1-part73-subpartBAlumina (dried aluminum hydroxide).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1010.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1010.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1010https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1010https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1010.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1010.xml21 CFR 73.101021CFR73.1010Section 73.1010; Alumina (dried aluminum hydroxide).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1010851Section 73.1010section73.1010 falseid-CFR-2003-title21-vol1-part73-subpartBChromium-cobalt-aluminum oxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1015.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1015.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1015https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1015https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1015.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1015.xml21 CFR 73.101521CFR73.1015Section 73.1015; Chromium-cobalt-aluminum oxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1015852Section 73.1015section73.1015 42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartBFerric ammonium citrate.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1025.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1025.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1025https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1025https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1025.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1025.xml21 CFR 73.102521CFR73.1025Section 73.1025; Ferric ammonium citrate.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1025853Section 73.1025section73.1025 42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartBAnnatto extract.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1030.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1030.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1030https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1030https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1030.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1030.xml21 CFR 73.103021CFR73.1030Section 73.1030; Annatto extract.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1030854Section 73.1030section73.1030 42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 42 Page 3699442 FR 36994id-CFR-2003-title21-vol1-part73-subpartBCalcium carbonate.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1070.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1070.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1070https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1070https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1070.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1070.xml21 CFR 73.107021CFR73.1070Section 73.1070; Calcium carbonate.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1070855Section 73.1070section73.1070 42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartBCanthaxanthin.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1075.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1075.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1075https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1075https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1075.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1075.xml21 CFR 73.107521CFR73.1075Section 73.1075; Canthaxanthin.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1075856Section 73.1075section73.1075 falseid-CFR-2003-title21-vol1-part73-subpartBCaramel.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1085.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1085.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1085https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1085https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1085.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1085.xml21 CFR 73.108521CFR73.1085Section 73.1085; Caramel.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1085857Section 73.1085section73.1085 falseid-CFR-2003-title21-vol1-part73-subpartBβ-Carotene.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1095.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1095.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1095https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1095https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1095.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1095.xml21 CFR 73.109521CFR73.1095Section 73.1095; β-Carotene.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1095858Section 73.1095section73.1095 42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 42 Page 3372242 FR 33722id-CFR-2003-title21-vol1-part73-subpartBCochineal extract; carmine.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1100.xml21 CFR 73.110021CFR73.1100Section 73.1100; Cochineal extract; carmine.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1100859Section 73.1100section73.1100 falseid-CFR-2003-title21-vol1-part73-subpartBPotassium sodium copper chloropyhllin (chlorophyllin-copper complex).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1125.xml21 CFR 73.112521CFR73.1125Section 73.1125; Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1125860Section 73.1125section73.1125 falseid-CFR-2003-title21-vol1-part73-subpartBDihydroxyacetone.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1150.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1150.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1150https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1150https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1150.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1150.xml21 CFR 73.115021CFR73.1150Section 73.1150; Dihydroxyacetone.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1150861Section 73.1150section73.1150 falseid-CFR-2003-title21-vol1-part73-subpartBBismuth oxychloride.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1162.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1162.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1162https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1162https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1162.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1162.xml21 CFR 73.116221CFR73.1162Section 73.1162; Bismuth oxychloride.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1162862Section 73.1162section73.1162 42 FR 52394, Sept. 30, 1977falseFederal RegisterVolume 42 Page 5239442 FR 52394id-CFR-2003-title21-vol1-part73-subpartBSynthetic iron oxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1200.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1200.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1200https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1200https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1200.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1200.xml21 CFR 73.120021CFR73.1200Section 73.1200; Synthetic iron oxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1200863Section 73.1200section73.1200 falseid-CFR-2003-title21-vol1-part73-subpartBFerric ammonium ferrocyanide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1298.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1298.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1298https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1298https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1298.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1298.xml21 CFR 73.129821CFR73.1298Section 73.1298; Ferric ammonium ferrocyanide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1298864Section 73.1298section73.1298 42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979falseFederal RegisterVolume 42 Page 3856242 FR 38562Federal RegisterVolume 44 Page 2832244 FR 28322id-CFR-2003-title21-vol1-part73-subpartBFerric ferrocyanide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1299.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1299.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1299https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1299https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1299.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1299.xml21 CFR 73.129921CFR73.1299Section 73.1299; Ferric ferrocyanide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1299865Section 73.1299section73.1299 43 FR 54235, Nov. 21, 1978falseFederal RegisterVolume 43 Page 5423543 FR 54235id-CFR-2003-title21-vol1-part73-subpartBChromium hydroxide green.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1326.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1326.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1326https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1326https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1326.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1326.xml21 CFR 73.132621CFR73.1326Section 73.1326; Chromium hydroxide green.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1326866Section 73.1326section73.1326 42 FR 36451, July 15, 1977, as amended at 42 FR 59852, Nov. 22, 1977falseFederal RegisterVolume 42 Page 3645142 FR 36451Federal RegisterVolume 42 Page 5985242 FR 59852id-CFR-2003-title21-vol1-part73-subpartBChromium oxide greens.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1327.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1327.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1327https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1327https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1327.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1327.xml21 CFR 73.132721CFR73.1327Section 73.1327; Chromium oxide greens.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1327867Section 73.1327section73.1327 42 FR 36451, July 15, 1977falseFederal RegisterVolume 42 Page 3645142 FR 36451id-CFR-2003-title21-vol1-part73-subpartBGuanine.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1329.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1329.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1329https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1329https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1329.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1329.xml21 CFR 73.132921CFR73.1329Section 73.1329; Guanine.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1329868Section 73.1329section73.1329 42 FR 37537, July 22, 1977falseFederal RegisterVolume 42 Page 3753742 FR 37537id-CFR-2003-title21-vol1-part73-subpartBPyrogallol.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1375.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1375.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1375https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1375https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1375.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1375.xml21 CFR 73.137521CFR73.1375Section 73.1375; Pyrogallol.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1375869Section 73.1375section73.1375 42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartBPyrophyllite.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1400.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1400.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1400https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1400https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1400.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1400.xml21 CFR 73.140021CFR73.1400Section 73.1400; Pyrophyllite.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1400870Section 73.1400section73.1400 falseid-CFR-2003-title21-vol1-part73-subpartBLogwood extract.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1410.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1410.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1410https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1410https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1410.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1410.xml21 CFR 73.141021CFR73.1410Section 73.1410; Logwood extract.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1410871Section 73.1410section73.1410 42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. 10, 1978falseFederal RegisterVolume 42 Page 5239342 FR 52393Federal RegisterVolume 43 Page 149043 FR 1490id-CFR-2003-title21-vol1-part73-subpartBMica.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1496.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1496.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1496https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1496https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1496.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1496.xml21 CFR 73.149621CFR73.1496Section 73.1496; Mica.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1496872Section 73.1496section73.1496 42 FR 38561, July 29, 1977, as amended at 52 FR 29665, Aug. 11, 1987falseFederal RegisterVolume 42 Page 3856142 FR 38561Federal RegisterVolume 52 Page 2966552 FR 29665id-CFR-2003-title21-vol1-part73-subpartBTalc.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1550.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1550.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1550https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1550https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1550.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1550.xml21 CFR 73.155021CFR73.1550Section 73.1550; Talc.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1550873Section 73.1550section73.1550 42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984)falseFederal RegisterVolume 42 Page 1564342 FR 15643Federal RegisterVolume 49 Page 1008949 FR 10089id-CFR-2003-title21-vol1-part73-subpartBTitanium dioxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1575.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1575.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1575https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1575https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1575.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1575.xml21 CFR 73.157521CFR73.1575Section 73.1575; Titanium dioxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1575874Section 73.1575section73.1575 falseid-CFR-2003-title21-vol1-part73-subpartBAluminum powder.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1645.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1645.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1645https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1645https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1645.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1645.xml21 CFR 73.164521CFR73.1645Section 73.1645; Aluminum powder.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1645875Section 73.1645section73.1645 42 FR 38563, July 29, 1977falseFederal RegisterVolume 42 Page 3856342 FR 38563id-CFR-2003-title21-vol1-part73-subpartBBronze powder.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1646.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1646.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1646https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1646https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1646.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1646.xml21 CFR 73.164621CFR73.1646Section 73.1646; Bronze powder.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1646876Section 73.1646section73.1646 42 FR 33723, July 1, 1977falseFederal RegisterVolume 42 Page 3372342 FR 33723id-CFR-2003-title21-vol1-part73-subpartBCopper powder.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1647.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1647.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1647https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1647https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1647.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1647.xml21 CFR 73.164721CFR73.1647Section 73.1647; Copper powder.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1647877Section 73.1647section73.1647 42 FR 33723, July 1, 1977falseFederal RegisterVolume 42 Page 3372342 FR 33723id-CFR-2003-title21-vol1-part73-subpartBZinc oxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-1991.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-1991.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1991https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-1991https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-1991.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-1991.xml21 CFR 73.199121CFR73.1991Section 73.1991; Zinc oxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-1991878Section 73.1991section73.1991 42 FR 37537, July 22, 1977falseFederal RegisterVolume 42 Page 3753742 FR 37537id-CFR-2003-title21-vol1-part73CosmeticsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part73-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part73-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part73-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part73-subpartC.xml21 CFR C21CFRSubpart C; CosmeticsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONNODECFR-2003-title21-vol1-part73-subpartC879Subpart CsubpartC falseid-CFR-2003-title21-vol1-part73-subpartCAnnatto.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2030.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2030.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2030https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2030https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2030.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2030.xml21 CFR 73.203021CFR73.2030Section 73.2030; Annatto.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2030880Section 73.2030section73.2030 42 FR 36994, July 19, 1977falseFederal RegisterVolume 42 Page 3699442 FR 36994id-CFR-2003-title21-vol1-part73-subpartCCaramel.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2085.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2085.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2085https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2085https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2085.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2085.xml21 CFR 73.208521CFR73.2085Section 73.2085; Caramel.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2085881Section 73.2085section73.2085 46 FR 38501, July 28, 1981falseFederal RegisterVolume 46 Page 3850146 FR 38501id-CFR-2003-title21-vol1-part73-subpartCCarmine.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2087.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2087.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2087https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2087https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2087.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2087.xml21 CFR 73.208721CFR73.2087Section 73.2087; Carmine.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2087882Section 73.2087section73.2087 42 FR 32228, June 24, 1977falseFederal RegisterVolume 42 Page 3222842 FR 32228id-CFR-2003-title21-vol1-part73-subpartCβ-Carotene.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2095.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2095.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2095https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2095https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2095.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2095.xml21 CFR 73.209521CFR73.2095Section 73.2095; β-Carotene.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2095883Section 73.2095section73.2095 42 FR 33722, July 1, 1977falseFederal RegisterVolume 42 Page 3372242 FR 33722id-CFR-2003-title21-vol1-part73-subpartCBismuth citrate.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2110.xml21 CFR 73.211021CFR73.2110Section 73.2110; Bismuth citrate.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2110884Section 73.2110section73.2110 43 FR 44831, Sept. 29, 1978falseFederal RegisterVolume 43 Page 4483143 FR 44831id-CFR-2003-title21-vol1-part73-subpartCDisodium EDTA-copper.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2120.xml21 CFR 73.212021CFR73.2120Section 73.2120; Disodium EDTA-copper.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2120885Section 73.2120section73.2120 falseid-CFR-2003-title21-vol1-part73-subpartCPotassium sodium copper chlorophyllin (chlorophyllin-copper complex).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2125.xml21 CFR 73.212521CFR73.2125Section 73.2125; Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2125886Section 73.2125section73.2125 falseid-CFR-2003-title21-vol1-part73-subpartCDihydroxyacetone.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2150.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2150.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2150https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2150https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2150.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2150.xml21 CFR 73.215021CFR73.2150Section 73.2150; Dihydroxyacetone.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2150887Section 73.2150section73.2150 falseid-CFR-2003-title21-vol1-part73-subpartCBismuth oxychloride.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2162.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2162.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2162https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2162https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2162.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2162.xml21 CFR 73.216221CFR73.2162Section 73.2162; Bismuth oxychloride.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2162888Section 73.2162section73.2162 42 FR 52394, Sept. 30, 1977falseFederal RegisterVolume 42 Page 5239442 FR 52394id-CFR-2003-title21-vol1-part73-subpartCGuaiazulene.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2180.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2180.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2180https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2180https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2180.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2180.xml21 CFR 73.218021CFR73.2180Section 73.2180; Guaiazulene.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2180889Section 73.2180section73.2180 falseid-CFR-2003-title21-vol1-part73-subpartCHenna.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2190.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2190.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2190https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2190https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2190.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2190.xml21 CFR 73.219021CFR73.2190Section 73.2190; Henna.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2190890Section 73.2190section73.2190 falseid-CFR-2003-title21-vol1-part73-subpartCIron oxides.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2250.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2250.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2250https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2250https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2250.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2250.xml21 CFR 73.225021CFR73.2250Section 73.2250; Iron oxides.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2250891Section 73.2250section73.2250 falseid-CFR-2003-title21-vol1-part73-subpartCFerric ammonium ferrocyanide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2298.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2298.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2298https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2298https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2298.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2298.xml21 CFR 73.229821CFR73.2298Section 73.2298; Ferric ammonium ferrocyanide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2298892Section 73.2298section73.2298 42 FR 38562, July 29, 1977, as amended at 43 FR 6939, Feb. 17, 1978falseFederal RegisterVolume 42 Page 3856242 FR 38562Federal RegisterVolume 43 Page 693943 FR 6939id-CFR-2003-title21-vol1-part73-subpartCFerric ferrocyanide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2299.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2299.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2299https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2299https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2299.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2299.xml21 CFR 73.229921CFR73.2299Section 73.2299; Ferric ferrocyanide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2299893Section 73.2299section73.2299 43 FR 54236, Nov. 21, 1978falseFederal RegisterVolume 43 Page 5423643 FR 54236id-CFR-2003-title21-vol1-part73-subpartCChromium hydroxide green.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2326.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2326.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2326https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2326https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2326.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2326.xml21 CFR 73.232621CFR73.2326Section 73.2326; Chromium hydroxide green.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2326894Section 73.2326section73.2326 42 FR 36452, July 15, 1977falseFederal RegisterVolume 42 Page 3645242 FR 36452id-CFR-2003-title21-vol1-part73-subpartCChromium oxide greens.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2327.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2327.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2327https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2327https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2327.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2327.xml21 CFR 73.232721CFR73.2327Section 73.2327; Chromium oxide greens.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2327895Section 73.2327section73.2327 42 FR 36452, July 15, 1977falseFederal RegisterVolume 42 Page 3645242 FR 36452id-CFR-2003-title21-vol1-part73-subpartCGuanine.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2329.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2329.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2329https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2329https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2329.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2329.xml21 CFR 73.232921CFR73.2329Section 73.2329; Guanine.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2329896Section 73.2329section73.2329 42 FR 37537, July 22, 1977falseFederal RegisterVolume 42 Page 3753742 FR 37537id-CFR-2003-title21-vol1-part73-subpartCLead acetate.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2396.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2396.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2396https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2396https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2396.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2396.xml21 CFR 73.239621CFR73.2396Section 73.2396; Lead acetate.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2396897Section 73.2396section73.2396 45 FR 72117, Oct. 31, 1980falseFederal RegisterVolume 45 Page 7211745 FR 72117id-CFR-2003-title21-vol1-part73-subpartCPyrophyllite.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2400.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2400.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2400https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2400https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2400.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2400.xml21 CFR 73.240021CFR73.2400Section 73.2400; Pyrophyllite.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2400898Section 73.2400section73.2400 falseid-CFR-2003-title21-vol1-part73-subpartCMica.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2496.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2496.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2496https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2496https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2496.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2496.xml21 CFR 73.249621CFR73.2496Section 73.2496; Mica.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2496899Section 73.2496section73.2496 42 FR 38561, July 29, 1977falseFederal RegisterVolume 42 Page 3856142 FR 38561id-CFR-2003-title21-vol1-part73-subpartCSilver.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2500.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2500.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2500https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2500https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2500.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2500.xml21 CFR 73.250021CFR73.2500Section 73.2500; Silver.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2500900Section 73.2500section73.2500 44 FR 65974, Nov. 16, 1979falseFederal RegisterVolume 44 Page 6597444 FR 65974id-CFR-2003-title21-vol1-part73-subpartCTitanium dioxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2575.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2575.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2575https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2575https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2575.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2575.xml21 CFR 73.257521CFR73.2575Section 73.2575; Titanium dioxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2575901Section 73.2575section73.2575 falseid-CFR-2003-title21-vol1-part73-subpartCAluminum powder.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2645.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2645.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2645https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2645https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2645.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2645.xml21 CFR 73.264521CFR73.2645Section 73.2645; Aluminum powder.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2645902Section 73.2645section73.2645 42 FR 38563, July 29, 1977falseFederal RegisterVolume 42 Page 3856342 FR 38563id-CFR-2003-title21-vol1-part73-subpartCBronze powder.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2646.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2646.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2646https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2646https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2646.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2646.xml21 CFR 73.264621CFR73.2646Section 73.2646; Bronze powder.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2646903Section 73.2646section73.2646 42 FR 33724, July 1, 1977falseFederal RegisterVolume 42 Page 3372442 FR 33724id-CFR-2003-title21-vol1-part73-subpartCCopper powder.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2647.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2647.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2647https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2647https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2647.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2647.xml21 CFR 73.264721CFR73.2647Section 73.2647; Copper powder.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2647904Section 73.2647section73.2647 42 FR 33724, July 1, 1977falseFederal RegisterVolume 42 Page 3372442 FR 33724id-CFR-2003-title21-vol1-part73-subpartCUltramarines.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2725.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2725.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2725https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2725https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2725.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2725.xml21 CFR 73.272521CFR73.2725Section 73.2725; Ultramarines.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2725905Section 73.2725section73.2725 falseid-CFR-2003-title21-vol1-part73-subpartCManganese violet.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2775.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2775.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2775https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2775https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2775.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2775.xml21 CFR 73.277521CFR73.2775Section 73.2775; Manganese violet.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2775906Section 73.2775section73.2775 falseid-CFR-2003-title21-vol1-part73-subpartCZinc oxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2991.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2991.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2991https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2991https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2991.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2991.xml21 CFR 73.299121CFR73.2991Section 73.2991; Zinc oxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2991907Section 73.2991section73.2991 42 FR 37538, July 22, 1977falseFederal RegisterVolume 42 Page 3753842 FR 37538id-CFR-2003-title21-vol1-part73-subpartCLuminescent zinc sulfide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-2995.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-2995.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2995https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-2995https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-2995.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-2995.xml21 CFR 73.299521CFR73.2995Section 73.2995; Luminescent zinc sulfide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-2995908Section 73.2995section73.2995 65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000falseFederal RegisterVolume 65 Page 4837765 FR 48377Federal RegisterVolume 65 Page 7515865 FR 75158id-CFR-2003-title21-vol1-part73Medical DevicesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part73-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part73-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part73-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part73-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part73-subpartD.xml21 CFR D21CFRSubpart D; Medical DevicesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONNODECFR-2003-title21-vol1-part73-subpartD909Subpart DsubpartD falseid-CFR-2003-title21-vol1-part73-subpartD1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3100.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3100.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3100https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3100https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3100.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3100.xml21 CFR 73.310021CFR73.3100Section 73.3100; 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3100910Section 73.3100section73.3100 61 FR 51586, Oct. 3, 1996falseFederal RegisterVolume 61 Page 5158661 FR 51586id-CFR-2003-title21-vol1-part73-subpartD1,4-Bis[(2-methyl-phenyl)-amino]-9,10-anthra-cene-dione.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3105.xml21 CFR 73.310521CFR73.3105Section 73.3105; 1,4-Bis[(2-methyl-phenyl)-amino]-9,10-anthra-cene-dione.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3105911Section 73.3105section73.3105 49 FR 30066, July 26, 1984falseFederal RegisterVolume 49 Page 3006649 FR 30066id-CFR-2003-title21-vol1-part73-subpartD1,4-Bis[4-(2-metha-cryloxy-ethyl) phenyl-amino]anthra-quinone co-poly-mers.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3106.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3106.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3106https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3106https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3106.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3106.xml21 CFR 73.310621CFR73.3106Section 73.3106; 1,4-Bis[4-(2-metha-cryloxy-ethyl) phenyl-amino]anthra-quinone co-poly-mers.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3106912Section 73.3106section73.3106 58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995falseFederal RegisterVolume 58 Page 1750758 FR 17507Federal RegisterVolume 60 Page 1049760 FR 10497id-CFR-2003-title21-vol1-part73-subpartDCarbazole violet.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3107.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3107.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3107https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3107https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3107.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3107.xml21 CFR 73.310721CFR73.3107Section 73.3107; Carbazole violet.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3107913Section 73.3107section73.3107 53 FR 41324, Oct. 21, 1988falseFederal RegisterVolume 53 Page 4132453 FR 41324id-CFR-2003-title21-vol1-part73-subpartDChlorophyllin-copper complex, oil soluble.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3110.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3110.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3110https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3110https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3110.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3110.xml21 CFR 73.311021CFR73.3110Section 73.3110; Chlorophyllin-copper complex, oil soluble.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3110914Section 73.3110section73.3110 48 FR 56370, Dec. 21, 1983falseFederal RegisterVolume 48 Page 5637048 FR 56370id-CFR-2003-title21-vol1-part73-subpartDChromium-cobalt-aluminum oxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3110a.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3110a.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3110ahttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3110ahttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3110a.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3110a.xml21 CFR 73.3110a21CFR73.3110aSection 73.3110a; Chromium-cobalt-aluminum oxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3110a915Section 73.3110asection73.3110a 53 FR 41325, Oct. 21, 1988falseFederal RegisterVolume 53 Page 4132553 FR 41325id-CFR-2003-title21-vol1-part73-subpartDChromium oxide greens.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3111.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3111.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3111https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3111https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3111.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3111.xml21 CFR 73.311121CFR73.3111Section 73.3111; Chromium oxide greens.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3111916Section 73.3111section73.3111 51 FR 24816, July 9, 1986falseFederal RegisterVolume 51 Page 2481651 FR 24816id-CFR-2003-title21-vol1-part73-subpartDC.I. Vat Orange 1.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3112.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3112.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3112https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3112https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3112.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3112.xml21 CFR 73.311221CFR73.3112Section 73.3112; C.I. Vat Orange 1.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3112917Section 73.3112section73.3112 50 FR 20407, May 16, 1985falseFederal RegisterVolume 50 Page 2040750 FR 20407id-CFR-2003-title21-vol1-part73-subpartD2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3115.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3115.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3115https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3115https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3115.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3115.xml21 CFR 73.311521CFR73.3115Section 73.3115; 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3115918Section 73.3115section73.3115 48 FR 22706, May 20, 1983falseFederal RegisterVolume 48 Page 2270648 FR 22706id-CFR-2003-title21-vol1-part73-subpartD16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3117.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3117.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3117https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3117https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3117.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3117.xml21 CFR 73.311721CFR73.3117Section 73.3117; 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3117919Section 73.3117section73.3117 48 FR 31375, July 8, 1983falseFederal RegisterVolume 48 Page 3137548 FR 31375id-CFR-2003-title21-vol1-part73-subpartDN,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3118.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3118.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3118https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3118https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3118.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3118.xml21 CFR 73.311821CFR73.3118Section 73.3118; N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3118920Section 73.3118section73.3118 48 FR 31375, July 8, 1983falseFederal RegisterVolume 48 Page 3137548 FR 31375id-CFR-2003-title21-vol1-part73-subpartD7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3119.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3119.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3119https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3119https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3119.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3119.xml21 CFR 73.311921CFR73.3119Section 73.3119; 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3119921Section 73.3119section73.3119 48 FR 31376, July 8, 1983falseFederal RegisterVolume 48 Page 3137648 FR 31376id-CFR-2003-title21-vol1-part73-subpartD16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3120.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3120.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3120https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3120https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3120.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3120.xml21 CFR 73.312021CFR73.3120Section 73.3120; 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3120922Section 73.3120section73.3120 48 FR 31376, July 8, 1983falseFederal RegisterVolume 48 Page 3137648 FR 31376id-CFR-2003-title21-vol1-part73-subpartDPoly(hydroxyethyl methacrylate)-dye copolymers.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3121.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3121.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3121https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3121https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3121.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3121.xml21 CFR 73.312121CFR73.3121Section 73.3121; Poly(hydroxyethyl methacrylate)-dye copolymers.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3121923Section 73.3121section73.3121 49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, 1984, as amended at 50 FR 9425, Mar. 8, 1985; 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, Feb. 22, 1993falseFederal RegisterVolume 49 Page 37349 FR 373Federal RegisterVolume 49 Page 509449 FR 5094Federal RegisterVolume 50 Page 3333850 FR 33338Federal RegisterVolume 50 Page 3784550 FR 37845Federal RegisterVolume 50 Page 4599350 FR 45993Federal RegisterVolume 50 Page 942550 FR 9425Federal RegisterVolume 58 Page 954158 FR 9541id-CFR-2003-title21-vol1-part73-subpartD4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3122.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3122.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3122https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3122https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3122.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3122.xml21 CFR 73.312221CFR73.3122Section 73.3122; 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3122924Section 73.3122section73.3122 51 FR 11432, Apr. 3, 1986falseFederal RegisterVolume 51 Page 1143251 FR 11432id-CFR-2003-title21-vol1-part73-subpartD6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3123.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3123.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3123https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3123https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3123.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3123.xml21 CFR 73.312321CFR73.3123Section 73.3123; 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3123925Section 73.3123section73.3123 51 FR 11436, Apr. 3, 1986falseFederal RegisterVolume 51 Page 1143651 FR 11436id-CFR-2003-title21-vol1-part73-subpartDPhthalocyanine green.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3124.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3124.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3124https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3124https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3124.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3124.xml21 CFR 73.312421CFR73.3124Section 73.3124; Phthalocyanine green.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3124926Section 73.3124section73.3124 51 FR 11433, Apr. 3, 1986falseFederal RegisterVolume 51 Page 1143351 FR 11433id-CFR-2003-title21-vol1-part73-subpartDIron oxides.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3125.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3125.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3125https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3125https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3125.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3125.xml21 CFR 73.312521CFR73.3125Section 73.3125; Iron oxides.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3125927Section 73.3125section73.3125 51 FR 24816, July 9, 1986falseFederal RegisterVolume 51 Page 2481651 FR 24816id-CFR-2003-title21-vol1-part73-subpartDTitanium dioxide.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3126.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3126.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3126https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3126https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3126.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3126.xml21 CFR 73.312621CFR73.3126Section 73.3126; Titanium dioxide.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3126928Section 73.3126section73.3126 51 FR 24816, July 9, 1986falseFederal RegisterVolume 51 Page 2481651 FR 24816id-CFR-2003-title21-vol1-part73-subpartDVinyl alcohol/methyl methacrylate-dye reaction products.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3127.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3127.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3127https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3127https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3127.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3127.xml21 CFR 73.312721CFR73.3127Section 73.3127; Vinyl alcohol/methyl methacrylate-dye reaction products.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3127929Section 73.3127section73.3127 58 FR 3227, Jan. 8, 1993, as amended at 58 FR 17510, Apr. 5, 1993falseFederal RegisterVolume 58 Page 1751058 FR 17510Federal RegisterVolume 58 Page 322758 FR 3227id-CFR-2003-title21-vol1-part73-subpartDMica-based pearlescent pigments.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec73-3128.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec73-3128.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3128https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec73-3128https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec73-3128.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec73-3128.xml21 CFR 73.312821CFR73.3128Section 73.3128; Mica-based pearlescent pigments.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec73-3128930Section 73.3128section73.3128 67 FR 65312, Oct. 24, 2002falseFederal RegisterVolume 67 Page 6531267 FR 65312id-CFR-2003-title21-vol1-chapI-subchapALISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part74.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74.xml21 CFR 7421CFR74Part 74; LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part74931Part 74part74 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.falseUnited States CodeTitle 21 Section 321Title 21 Section 341Title 21 Section 342Title 21 Section 343Title 21 Section 348Title 21 Section 351Title 21 Section 352Title 21 Section 355Title 21 Section 361Title 21 Section 362Title 21 Section 371Title 21 Section 379e21 U.S.C. 32121 U.S.C. 34121 U.S.C. 34221 U.S.C. 34321 U.S.C. 34821 U.S.C. 35121 U.S.C. 35221 U.S.C. 35521 U.S.C. 36121 U.S.C. 36221 U.S.C. 37121 U.S.C. 379eFederal RegisterVolume 42 Page 1565442 FR 15654id-CFR-2003-title21-vol1-part74Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part74-toc-id932.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74-toc-id932.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-toc-id932https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-toc-id932https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74-toc-id932.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74-toc-id932.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONTOCCFR-2003-title21-vol1-part74-toc-id932932Toctocid-CFR-2003-title21-vol1-part74FoodsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part74-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74-subpartA.xml21 CFR A21CFRSubpart A; FoodsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONNODECFR-2003-title21-vol1-part74-subpartA933Subpart AsubpartA falseid-CFR-2003-title21-vol1-part74-subpartAFD&C Blue No. 1.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-101.xml21 CFR 74.10121CFR74.101Section 74.101; FD&C Blue No. 1.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-101934Section 74.101section74.101 42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 58 Page 1751158 FR 17511id-CFR-2003-title21-vol1-part74-subpartAFD&C Blue No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-102.xml21 CFR 74.10221CFR74.102Section 74.102; FD&C Blue No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-102935Section 74.102section74.102 48 FR 5260, Feb. 4, 1983falseFederal RegisterVolume 48 Page 526048 FR 5260id-CFR-2003-title21-vol1-part74-subpartAFD&C Green No. 3.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-203.xml21 CFR 74.20321CFR74.203Section 74.203; FD&C Green No. 3.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-203936Section 74.203section74.203 47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982falseFederal RegisterVolume 47 Page 5214347 FR 52143Federal RegisterVolume 47 Page 5648947 FR 56489id-CFR-2003-title21-vol1-part74-subpartAOrange B.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-250.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-250.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-250https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-250https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-250.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-250.xml21 CFR 74.25021CFR74.250Section 74.250; Orange B.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-250937Section 74.250section74.250 falseid-CFR-2003-title21-vol1-part74-subpartACitrus Red No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-302.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-302.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-302https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-302https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-302.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-302.xml21 CFR 74.30221CFR74.302Section 74.302; Citrus Red No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-302938Section 74.302section74.302 falseid-CFR-2003-title21-vol1-part74-subpartAFD&C Red No. 3.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-303.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-303.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-303https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-303https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-303.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-303.xml21 CFR 74.30321CFR74.303Section 74.303; FD&C Red No. 3.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-303939Section 74.303section74.303 falseid-CFR-2003-title21-vol1-part74-subpartAFD&C Red No. 40.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-340.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-340.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-340https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-340https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-340.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-340.xml21 CFR 74.34021CFR74.340Section 74.340; FD&C Red No. 40.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-340940Section 74.340section74.340 falseid-CFR-2003-title21-vol1-part74-subpartAFD&C Yellow No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-705.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-705.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-705https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-705https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-705.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-705.xml21 CFR 74.70521CFR74.705Section 74.705; FD&C Yellow No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-705941Section 74.705section74.705 42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at 44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 44 Page 1765844 FR 17658Federal RegisterVolume 44 Page 3722044 FR 37220Federal RegisterVolume 51 Page 2451951 FR 24519id-CFR-2003-title21-vol1-part74-subpartAFD&C Yellow No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-706.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-706.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-706https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-706https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-706.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-706.xml21 CFR 74.70621CFR74.706Section 74.706; FD&C Yellow No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AFoodsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-706942Section 74.706section74.706 51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988falseFederal RegisterVolume 51 Page 4178251 FR 41782Federal RegisterVolume 52 Page 2150852 FR 21508Federal RegisterVolume 53 Page 4913853 FR 49138id-CFR-2003-title21-vol1-part74DrugsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part74-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74-subpartB.xml21 CFR B21CFRSubpart B; DrugsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONNODECFR-2003-title21-vol1-part74-subpartB943Subpart BsubpartB falseid-CFR-2003-title21-vol1-part74-subpartBFD&C Blue No. 1D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1101.xml21 CFR 74.110121CFR74.1101Section 74.1101; FD&C Blue No. 1Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1101944Section 74.1101section74.1101 47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994falseFederal RegisterVolume 47 Page 4256547 FR 42565Federal RegisterVolume 59 Page 763859 FR 7638id-CFR-2003-title21-vol1-part74-subpartBFD&C Blue No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1102.xml21 CFR 74.110221CFR74.1102Section 74.1102; FD&C Blue No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1102945Section 74.1102section74.1102 48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999falseFederal RegisterVolume 48 Page 526048 FR 5260Federal RegisterVolume 49 Page 1009049 FR 10090Federal RegisterVolume 64 Page 4829064 FR 48290id-CFR-2003-title21-vol1-part74-subpartBD&C Blue No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1104.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1104.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1104https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1104https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1104.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1104.xml21 CFR 74.110421CFR74.1104Section 74.1104; D&C Blue No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1104946Section 74.1104section74.1104 falseid-CFR-2003-title21-vol1-part74-subpartBD&C Blue No. 9.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1109.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1109.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1109https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1109https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1109.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1109.xml21 CFR 74.110921CFR74.1109Section 74.1109; D&C Blue No. 9.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1109947Section 74.1109section74.1109 42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 49 Page 1009049 FR 10090Federal RegisterVolume 58 Page 1709858 FR 17098id-CFR-2003-title21-vol1-part74-subpartBFD&C Green No. 3.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1203.xml21 CFR 74.120321CFR74.1203Section 74.1203; FD&C Green No. 3.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1203948Section 74.1203section74.1203 47 FR 52144, Nov. 19, 1982falseFederal RegisterVolume 47 Page 5214447 FR 52144id-CFR-2003-title21-vol1-part74-subpartBD&C Green No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1205.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1205.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1205https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1205https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1205.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1205.xml21 CFR 74.120521CFR74.1205Section 74.1205; D&C Green No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1205949Section 74.1205section74.1205 47 FR 24284, June 4, 1982; 47 FR 27551, June 25, 1982, as amended at 59 FR 40805, Aug. 10, 1994falseFederal RegisterVolume 47 Page 2428447 FR 24284Federal RegisterVolume 47 Page 2755147 FR 27551Federal RegisterVolume 59 Page 4080559 FR 40805id-CFR-2003-title21-vol1-part74-subpartBD&C Green No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1206.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1206.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1206https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1206https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1206.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1206.xml21 CFR 74.120621CFR74.1206Section 74.1206; D&C Green No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1206950Section 74.1206section74.1206 42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr.2, 1982; 47 FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 47 Page 1414647 FR 14146Federal RegisterVolume 47 Page 2427847 FR 24278Federal RegisterVolume 51 Page 978451 FR 9784id-CFR-2003-title21-vol1-part74-subpartBD&C Green No. 8.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1208.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1208.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1208https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1208https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1208.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1208.xml21 CFR 74.120821CFR74.1208Section 74.1208; D&C Green No. 8.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1208951Section 74.1208section74.1208 falseid-CFR-2003-title21-vol1-part74-subpartBD&C Orange No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1254.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1254.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1254https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1254https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1254.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1254.xml21 CFR 74.125421CFR74.1254Section 74.1254; D&C Orange No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1254952Section 74.1254section74.1254 42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981falseFederal RegisterVolume 42 Page 5239642 FR 52396Federal RegisterVolume 43 Page 1464243 FR 14642Federal RegisterVolume 46 Page 846146 FR 8461id-CFR-2003-title21-vol1-part74-subpartBD&C Orange No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1255.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1255.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1255https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1255https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1255.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1255.xml21 CFR 74.125521CFR74.1255Section 74.1255; D&C Orange No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1255953Section 74.1255section74.1255 47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984falseFederal RegisterVolume 47 Page 4463547 FR 44635Federal RegisterVolume 49 Page 1334249 FR 13342id-CFR-2003-title21-vol1-part74-subpartBD&C Orange No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1260.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1260.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1260https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1260https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1260.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1260.xml21 CFR 74.126021CFR74.1260Section 74.1260; D&C Orange No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1260954Section 74.1260section74.1260 46 FR 18953, Mar. 27, 1981falseFederal RegisterVolume 46 Page 1895346 FR 18953id-CFR-2003-title21-vol1-part74-subpartBD&C Orange No. 11.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1261.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1261.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1261https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1261https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1261.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1261.xml21 CFR 74.126121CFR74.1261Section 74.1261; D&C Orange No. 11.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1261955Section 74.1261section74.1261 46 FR 18953, Mar. 27, 1981falseFederal RegisterVolume 46 Page 1895346 FR 18953id-CFR-2003-title21-vol1-part74-subpartBFD&C Red No. 3.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1303.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1303.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1303https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1303https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1303.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1303.xml21 CFR 74.130321CFR74.1303Section 74.1303; FD&C Red No. 3.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1303956Section 74.1303section74.1303 falseid-CFR-2003-title21-vol1-part74-subpartBFD&C Red No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1304.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1304.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1304https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1304https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1304.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1304.xml21 CFR 74.130421CFR74.1304Section 74.1304; FD&C Red No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1304957Section 74.1304section74.1304 falseid-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1306.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1306.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1306https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1306https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1306.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1306.xml21 CFR 74.130621CFR74.1306Section 74.1306; D&C Red No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1306958Section 74.1306section74.1306 47 FR 57687, Dec. 28, 1982falseFederal RegisterVolume 47 Page 5768747 FR 57687id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1307.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1307.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1307https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1307https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1307.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1307.xml21 CFR 74.130721CFR74.1307Section 74.1307; D&C Red No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1307959Section 74.1307section74.1307 47 FR 57687, Dec. 28, 1982falseFederal RegisterVolume 47 Page 5768747 FR 57687id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 17.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1317.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1317.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1317https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1317https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1317.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1317.xml21 CFR 74.131721CFR74.1317Section 74.1317; D&C Red No. 17.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1317960Section 74.1317section74.1317 42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 42 Page 2722542 FR 27225id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 21.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1321.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1321.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1321https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1321https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1321.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1321.xml21 CFR 74.132121CFR74.1321Section 74.1321; D&C Red No. 21.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1321961Section 74.1321section74.1321 47 FR 53846, Nov. 30, 1982falseFederal RegisterVolume 47 Page 5384647 FR 53846id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 22.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1322.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1322.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1322https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1322https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1322.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1322.xml21 CFR 74.132221CFR74.1322Section 74.1322; D&C Red No. 22.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1322962Section 74.1322section74.1322 47 FR 53846, Nov. 30, 1982falseFederal RegisterVolume 47 Page 5384647 FR 53846id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 27.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1327.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1327.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1327https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1327https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1327.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1327.xml21 CFR 74.132721CFR74.1327Section 74.1327; D&C Red No. 27.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1327963Section 74.1327section74.1327 47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982falseFederal RegisterVolume 47 Page 4256747 FR 42567Federal RegisterVolume 47 Page 5110647 FR 51106id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 28.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1328.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1328.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1328https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1328https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1328.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1328.xml21 CFR 74.132821CFR74.1328Section 74.1328; D&C Red No. 28.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1328964Section 74.1328section74.1328 47 FR 42568, Sept. 28, 1982falseFederal RegisterVolume 47 Page 4256847 FR 42568id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 30.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1330.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1330.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1330https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1330https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1330.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1330.xml21 CFR 74.133021CFR74.1330Section 74.1330; D&C Red No. 30.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1330965Section 74.1330section74.1330 47 FR 22510, May 25, 1982falseFederal RegisterVolume 47 Page 2251047 FR 22510id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 31.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1331.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1331.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1331https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1331https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1331.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1331.xml21 CFR 74.133121CFR74.1331Section 74.1331; D&C Red No. 31.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1331966Section 74.1331section74.1331 falseid-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 33.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1333.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1333.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1333https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1333https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1333.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1333.xml21 CFR 74.133321CFR74.1333Section 74.1333; D&C Red No. 33.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1333967Section 74.1333section74.1333 53 FR 33120, Aug. 30, 1988falseFederal RegisterVolume 53 Page 3312053 FR 33120id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 34.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1334.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1334.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1334https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1334https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1334.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1334.xml21 CFR 74.133421CFR74.1334Section 74.1334; D&C Red No. 34.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1334968Section 74.1334section74.1334 falseid-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 36.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1336.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1336.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1336https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1336https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1336.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1336.xml21 CFR 74.133621CFR74.1336Section 74.1336; D&C Red No. 36.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1336969Section 74.1336section74.1336 53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at 53 FR 52130, Dec. 27, 1988falseFederal RegisterVolume 53 Page 2903153 FR 29031Federal RegisterVolume 53 Page 3525553 FR 35255Federal RegisterVolume 53 Page 5213053 FR 52130id-CFR-2003-title21-vol1-part74-subpartBD&C Red No. 39.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1339.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1339.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1339https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1339https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1339.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1339.xml21 CFR 74.133921CFR74.1339Section 74.1339; D&C Red No. 39.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1339970Section 74.1339section74.1339 falseid-CFR-2003-title21-vol1-part74-subpartBFD&C Red No. 40.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1340.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1340.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1340https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1340https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1340.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1340.xml21 CFR 74.134021CFR74.1340Section 74.1340; FD&C Red No. 40.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1340971Section 74.1340section74.1340 42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 59 Page 763659 FR 7636id-CFR-2003-title21-vol1-part74-subpartBD&C Violet No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1602.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1602.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1602https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1602https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1602.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1602.xml21 CFR 74.160221CFR74.1602Section 74.1602; D&C Violet No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1602972Section 74.1602section74.1602 42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, 1990falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 45 Page 6297845 FR 62978Federal RegisterVolume 55 Page 1886855 FR 18868id-CFR-2003-title21-vol1-part74-subpartBFD&C Yellow No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1705.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1705.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1705https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1705https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1705.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1705.xml21 CFR 74.170521CFR74.1705Section 74.1705; FD&C Yellow No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1705973Section 74.1705section74.1705 42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 29, 1994falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 44 Page 3722044 FR 37220Federal RegisterVolume 50 Page 3578250 FR 35782Federal RegisterVolume 51 Page 2451951 FR 24519Federal RegisterVolume 59 Page 6089759 FR 60897id-CFR-2003-title21-vol1-part74-subpartBFD&C Yellow No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1706.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1706.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1706https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1706https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1706.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1706.xml21 CFR 74.170621CFR74.1706Section 74.1706; FD&C Yellow No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1706974Section 74.1706section74.1706 51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988falseFederal RegisterVolume 51 Page 4178251 FR 41782Federal RegisterVolume 52 Page 2150852 FR 21508Federal RegisterVolume 53 Page 4913853 FR 49138id-CFR-2003-title21-vol1-part74-subpartBD&C Yellow No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1707.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1707.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1707https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1707https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1707.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1707.xml21 CFR 74.170721CFR74.1707Section 74.1707; D&C Yellow No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1707975Section 74.1707section74.1707 falseid-CFR-2003-title21-vol1-part74-subpartBExt. D&C Yellow No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1707a.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1707a.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1707ahttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1707ahttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1707a.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1707a.xml21 CFR 74.1707a21CFR74.1707aSection 74.1707a; Ext. D&C Yellow No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1707a976Section 74.1707asection74.1707a falseid-CFR-2003-title21-vol1-part74-subpartBD&C Yellow No. 8.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1708.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1708.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1708https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1708https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1708.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1708.xml21 CFR 74.170821CFR74.1708Section 74.1708; D&C Yellow No. 8.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1708977Section 74.1708section74.1708 falseid-CFR-2003-title21-vol1-part74-subpartBD&C Yellow No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1710.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1710.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1710https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1710https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1710.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1710.xml21 CFR 74.171021CFR74.1710Section 74.1710; D&C Yellow No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1710978Section 74.1710section74.1710 48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984falseFederal RegisterVolume 48 Page 3921948 FR 39219Federal RegisterVolume 49 Page 843249 FR 8432id-CFR-2003-title21-vol1-part74-subpartBD&C Yellow No. 11.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-1711.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-1711.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1711https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-1711https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-1711.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-1711.xml21 CFR 74.171121CFR74.1711Section 74.1711; D&C Yellow No. 11.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BDrugsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-1711979Section 74.1711section74.1711 falseid-CFR-2003-title21-vol1-part74CosmeticsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part74-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74-subpartC.xml21 CFR C21CFRSubpart C; CosmeticsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONNODECFR-2003-title21-vol1-part74-subpartC980Subpart CsubpartC falseid-CFR-2003-title21-vol1-part74-subpartCFD&C Blue No. 1.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2101.xml21 CFR 74.210121CFR74.2101Section 74.2101; FD&C Blue No. 1.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2101981Section 74.2101section74.2101 47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, 1994falseFederal RegisterVolume 47 Page 4256547 FR 42565Federal RegisterVolume 58 Page 1751158 FR 17511Federal RegisterVolume 59 Page 763859 FR 7638id-CFR-2003-title21-vol1-part74-subpartCD&C Blue No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2104.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2104.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2104https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2104https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2104.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2104.xml21 CFR 74.210421CFR74.2104Section 74.2104; D&C Blue No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2104982Section 74.2104section74.2104 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Brown No. 1.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2151.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2151.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2151https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2151https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2151.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2151.xml21 CFR 74.215121CFR74.2151Section 74.2151; D&C Brown No. 1.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2151983Section 74.2151section74.2151 falseid-CFR-2003-title21-vol1-part74-subpartCFD&C Green No. 3.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2203.xml21 CFR 74.220321CFR74.2203Section 74.2203; FD&C Green No. 3.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2203984Section 74.2203section74.2203 47 FR 52144, Nov. 19, 1982falseFederal RegisterVolume 47 Page 5214447 FR 52144id-CFR-2003-title21-vol1-part74-subpartCD&C Green No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2205.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2205.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2205https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2205https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2205.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2205.xml21 CFR 74.220521CFR74.2205Section 74.2205; D&C Green No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2205985Section 74.2205section74.2205 47 FR 24285, June 4, 1982, as amended at 59 FR 40805, Aug. 10, 1994falseFederal RegisterVolume 47 Page 2428547 FR 24285Federal RegisterVolume 59 Page 4080559 FR 40805id-CFR-2003-title21-vol1-part74-subpartCD&C Green No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2206.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2206.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2206https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2206https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2206.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2206.xml21 CFR 74.220621CFR74.2206Section 74.2206; D&C Green No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2206986Section 74.2206section74.2206 47 FR 14146, Apr. 4, 1982, as amended at 51 FR 9784, Mar. 21, 1986falseFederal RegisterVolume 47 Page 1414647 FR 14146Federal RegisterVolume 51 Page 978451 FR 9784id-CFR-2003-title21-vol1-part74-subpartCD&C Green No. 8.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2208.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2208.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2208https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2208https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2208.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2208.xml21 CFR 74.220821CFR74.2208Section 74.2208; D&C Green No. 8.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2208987Section 74.2208section74.2208 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Orange No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2254.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2254.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2254https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2254https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2254.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2254.xml21 CFR 74.225421CFR74.2254Section 74.2254; D&C Orange No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2254988Section 74.2254section74.2254 42 FR 52396, Sept. 30, 1977falseFederal RegisterVolume 42 Page 5239642 FR 52396id-CFR-2003-title21-vol1-part74-subpartCD&C Orange No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2255.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2255.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2255https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2255https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2255.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2255.xml21 CFR 74.225521CFR74.2255Section 74.2255; D&C Orange No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2255989Section 74.2255section74.2255 47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984falseFederal RegisterVolume 47 Page 4963547 FR 49635Federal RegisterVolume 49 Page 1334249 FR 13342id-CFR-2003-title21-vol1-part74-subpartCD&C Orange No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2260.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2260.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2260https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2260https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2260.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2260.xml21 CFR 74.226021CFR74.2260Section 74.2260; D&C Orange No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2260990Section 74.2260section74.2260 46 FR 18954, Mar. 27, 1981falseFederal RegisterVolume 46 Page 1895446 FR 18954id-CFR-2003-title21-vol1-part74-subpartCD&C Orange No. 11.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2261.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2261.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2261https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2261https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2261.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2261.xml21 CFR 74.226121CFR74.2261Section 74.2261; D&C Orange No. 11.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2261991Section 74.2261section74.2261 46 FR 18954, Mar. 27, 1981falseFederal RegisterVolume 46 Page 1895446 FR 18954id-CFR-2003-title21-vol1-part74-subpartCFD&C Red No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2304.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2304.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2304https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2304https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2304.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2304.xml21 CFR 74.230421CFR74.2304Section 74.2304; FD&C Red No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2304992Section 74.2304section74.2304 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2306.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2306.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2306https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2306https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2306.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2306.xml21 CFR 74.230621CFR74.2306Section 74.2306; D&C Red No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2306993Section 74.2306section74.2306 47 FR 57688, Dec. 28, 1982falseFederal RegisterVolume 47 Page 5768847 FR 57688id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 7D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2307.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2307.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2307https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2307https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2307.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2307.xml21 CFR 74.230721CFR74.2307Section 74.2307; D&C Red No. 7Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2307994Section 74.2307section74.2307 47 FR 57688, Dec. 28, 1982falseFederal RegisterVolume 47 Page 5768847 FR 57688id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 17.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2317.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2317.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2317https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2317https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2317.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2317.xml21 CFR 74.231721CFR74.2317Section 74.2317; D&C Red No. 17.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2317995Section 74.2317section74.2317 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 21.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2321.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2321.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2321https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2321https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2321.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2321.xml21 CFR 74.232121CFR74.2321Section 74.2321; D&C Red No. 21.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2321996Section 74.2321section74.2321 47 FR 53846, Nov. 30, 1982falseFederal RegisterVolume 47 Page 5384647 FR 53846id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 22.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2322.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2322.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2322https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2322https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2322.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2322.xml21 CFR 74.232221CFR74.2322Section 74.2322; D&C Red No. 22.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2322997Section 74.2322section74.2322 47 FR 53846, Nov. 30, 1982falseFederal RegisterVolume 47 Page 5384647 FR 53846id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 27.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2327.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2327.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2327https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2327https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2327.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2327.xml21 CFR 74.232721CFR74.2327Section 74.2327; D&C Red No. 27.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2327998Section 74.2327section74.2327 47 FR 42568, Sept. 28, 1982falseFederal RegisterVolume 47 Page 4256847 FR 42568id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 28.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2328.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2328.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2328https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2328https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2328.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2328.xml21 CFR 74.232821CFR74.2328Section 74.2328; D&C Red No. 28.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2328999Section 74.2328section74.2328 47 FR 42568, Sept. 28, 1982falseFederal RegisterVolume 47 Page 4256847 FR 42568id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 30.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2330.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2330.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2330https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2330https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2330.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2330.xml21 CFR 74.233021CFR74.2330Section 74.2330; D&C Red No. 30.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-23301000Section 74.2330section74.2330 47 FR 22511, May 25, 1982falseFederal RegisterVolume 47 Page 2251147 FR 22511id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 31.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2331.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2331.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2331https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2331https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2331.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2331.xml21 CFR 74.233121CFR74.2331Section 74.2331; D&C Red No. 31.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-23311001Section 74.2331section74.2331 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 33.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2333.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2333.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2333https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2333https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2333.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2333.xml21 CFR 74.233321CFR74.2333Section 74.2333; D&C Red No. 33.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-23331002Section 74.2333section74.2333 53 FR 33120, Aug. 30, 1988falseFederal RegisterVolume 53 Page 3312053 FR 33120id-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 34.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2334.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2334.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2334https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2334https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2334.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2334.xml21 CFR 74.233421CFR74.2334Section 74.2334; D&C Red No. 34.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-23341003Section 74.2334section74.2334 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Red No. 36.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2336.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2336.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2336https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2336https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2336.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2336.xml21 CFR 74.233621CFR74.2336Section 74.2336; D&C Red No. 36.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-23361004Section 74.2336section74.2336 53 FR 29031, Aug. 2, 1988falseFederal RegisterVolume 53 Page 2903153 FR 29031id-CFR-2003-title21-vol1-part74-subpartCFD&C Red No. 40.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2340.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2340.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2340https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2340https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2340.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2340.xml21 CFR 74.234021CFR74.2340Section 74.2340; FD&C Red No. 40.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-23401005Section 74.2340section74.2340 42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994falseFederal RegisterVolume 42 Page 1565442 FR 15654Federal RegisterVolume 59 Page 763659 FR 7636id-CFR-2003-title21-vol1-part74-subpartCD&C Violet No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2602.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2602.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2602https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2602https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2602.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2602.xml21 CFR 74.260221CFR74.2602Section 74.2602; D&C Violet No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-26021006Section 74.2602section74.2602 falseid-CFR-2003-title21-vol1-part74-subpartCExt. D&C Violet No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2602a.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2602a.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2602ahttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2602ahttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2602a.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2602a.xml21 CFR 74.2602a21CFR74.2602aSection 74.2602a; Ext. D&C Violet No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2602a1007Section 74.2602asection74.2602a falseid-CFR-2003-title21-vol1-part74-subpartCFD&C Yellow No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2705.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2705.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2705https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2705https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2705.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2705.xml21 CFR 74.270521CFR74.2705Section 74.2705; FD&C Yellow No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-27051008Section 74.2705section74.2705 50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994falseFederal RegisterVolume 50 Page 3578250 FR 35782Federal RegisterVolume 51 Page 2452451 FR 24524Federal RegisterVolume 59 Page 6089859 FR 60898id-CFR-2003-title21-vol1-part74-subpartCFD&C Yellow No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2706.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2706.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2706https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2706https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2706.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2706.xml21 CFR 74.270621CFR74.2706Section 74.2706; FD&C Yellow No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-27061009Section 74.2706section74.2706 51 FR 41782, Nov. 19, 1986falseFederal RegisterVolume 51 Page 4178251 FR 41782id-CFR-2003-title21-vol1-part74-subpartCD&C Yellow No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2707.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2707.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2707https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2707https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2707.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2707.xml21 CFR 74.270721CFR74.2707Section 74.2707; D&C Yellow No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-27071010Section 74.2707section74.2707 falseid-CFR-2003-title21-vol1-part74-subpartCExt. D&C Yellow No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2707a.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2707a.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2707ahttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2707ahttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2707a.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2707a.xml21 CFR 74.2707a21CFR74.2707aSection 74.2707a; Ext. D&C Yellow No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-2707a1011Section 74.2707asection74.2707a falseid-CFR-2003-title21-vol1-part74-subpartCD&C Yellow No. 8.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2708.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2708.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2708https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2708https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2708.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2708.xml21 CFR 74.270821CFR74.2708Section 74.2708; D&C Yellow No. 8.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-27081012Section 74.2708section74.2708 falseid-CFR-2003-title21-vol1-part74-subpartCD&C Yellow No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2710.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2710.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2710https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2710https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2710.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2710.xml21 CFR 74.271021CFR74.2710Section 74.2710; D&C Yellow No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-27101013Section 74.2710section74.2710 48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984falseFederal RegisterVolume 48 Page 3922048 FR 39220Federal RegisterVolume 49 Page 843249 FR 8432id-CFR-2003-title21-vol1-part74-subpartCD&C Yellow No. 11.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-2711.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-2711.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2711https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-2711https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-2711.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-2711.xml21 CFR 74.271121CFR74.2711Section 74.2711; D&C Yellow No. 11.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CCosmeticsPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-27111014Section 74.2711section74.2711 falseid-CFR-2003-title21-vol1-part74Medical DevicesD09002ee18a5cbbf0-CFR-2003-title21-vol1-part74-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74-subpartD.xml21 CFR D21CFRSubpart D; Medical DevicesChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONNODECFR-2003-title21-vol1-part74-subpartD1015Subpart DsubpartD falseid-CFR-2003-title21-vol1-part74-subpartD[Phthalocyaninato(2-)] copper.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3045.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3045.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3045https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3045https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3045.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3045.xml21 CFR 74.304521CFR74.3045Section 74.3045; [Phthalocyaninato(2-)] copper.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-30451016Section 74.3045section74.3045 48 FR 34947, Aug. 2, 1983, as amended at 50 FR 16228, Apr. 25, 1985; 51 FR 22929, June 24, 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371, Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR 19620, May 10, 1990; 64 FR 23186, Apr. 30, 1999falseFederal RegisterVolume 48 Page 3494748 FR 34947Federal RegisterVolume 50 Page 1622850 FR 16228Federal RegisterVolume 51 Page 2292951 FR 22929Federal RegisterVolume 51 Page 2893051 FR 28930Federal RegisterVolume 51 Page 3937151 FR 39371Federal RegisterVolume 52 Page 1594552 FR 15945Federal RegisterVolume 55 Page 1962055 FR 19620Federal RegisterVolume 64 Page 2318664 FR 23186id-CFR-2003-title21-vol1-part74-subpartDFD&C Blue No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3102.xml21 CFR 74.310221CFR74.3102Section 74.3102; FD&C Blue No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-31021017Section 74.3102section74.3102 64 FR 48290, Sept. 3, 1999falseFederal RegisterVolume 64 Page 4829064 FR 48290id-CFR-2003-title21-vol1-part74-subpartDD&C Blue No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3106.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3106.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3106https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3106https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3106.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3106.xml21 CFR 74.310621CFR74.3106Section 74.3106; D&C Blue No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-31061018Section 74.3106section74.3106 49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 50 FR 30698, July 29, 1985falseFederal RegisterVolume 49 Page 2995649 FR 29956Federal RegisterVolume 49 Page 3444749 FR 34447Federal RegisterVolume 50 Page 3069850 FR 30698id-CFR-2003-title21-vol1-part74-subpartDD&C Green No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3206.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3206.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3206https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3206https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3206.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3206.xml21 CFR 74.320621CFR74.3206Section 74.3206; D&C Green No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-32061019Section 74.3206section74.3206 48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27, 1986; 58 FR 21542, Apr. 22, 1993falseFederal RegisterVolume 48 Page 1302248 FR 13022Federal RegisterVolume 51 Page 3790951 FR 37909Federal RegisterVolume 51 Page 978451 FR 9784Federal RegisterVolume 58 Page 2154258 FR 21542id-CFR-2003-title21-vol1-part74-subpartDD&C Red No. 17.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3230.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3230.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3230https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3230https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3230.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3230.xml21 CFR 74.323021CFR74.3230Section 74.3230; D&C Red No. 17.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-32301020Section 74.3230section74.3230 55 FR 22898, June 5, 1990falseFederal RegisterVolume 55 Page 2289855 FR 22898id-CFR-2003-title21-vol1-part74-subpartDD&C Violet No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3602.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3602.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3602https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3602https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3602.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3602.xml21 CFR 74.360221CFR74.3602Section 74.3602; D&C Violet No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-36021021Section 74.3602section74.3602 52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000falseFederal RegisterVolume 52 Page 1972252 FR 19722Federal RegisterVolume 55 Page 1886855 FR 18868Federal RegisterVolume 58 Page 6010958 FR 60109Federal RegisterVolume 59 Page 1172059 FR 11720Federal RegisterVolume 63 Page 2009863 FR 20098Federal RegisterVolume 64 Page 3280564 FR 32805Federal RegisterVolume 65 Page 4634465 FR 46344id-CFR-2003-title21-vol1-part74-subpartDD&C Yellow No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec74-3710.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec74-3710.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3710https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec74-3710https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec74-3710.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec74-3710.xml21 CFR 74.371021CFR74.3710Section 74.3710; D&C Yellow No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DMedical DevicesPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec74-37101022Section 74.3710section74.3710 52 FR 28690, Aug. 3, 1987falseFederal RegisterVolume 52 Page 2869052 FR 28690id-CFR-2003-title21-vol1-part74The Procedure for Determining Ether Soluble Material in D&C Red Nos. 6 and 7D09002ee18a5cbbf0-CFR-2003-title21-vol1-part74-appA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part74-appA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-appAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part74-appAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part74-appA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part74-appA.xml21 CFR Appendix A to Part 7421CFRAppendix A to Part 74; The Procedure for Determining Ether Soluble Material in D&C Red Nos. 6 and 7Appendix A to Part 74The Procedure for Determining Ether Soluble Material in D&C Red Nos. 6 and 7Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATIONAPPENDIXCFR-2003-title21-vol1-part74-appA1023Appendix A to Part 74appendixA 47 FR 57688, Dec. 28, 1982; 48 FR 3946, Jan. 28, 1983; 48 FR 7438, Feb. 22, 1983; 48 FR 10811, Mar. 15, 1983trueFederal RegisterVolume 47 Page 5768847 FR 57688Federal RegisterVolume 48 Page 1081148 FR 10811Federal RegisterVolume 48 Page 394648 FR 3946Federal RegisterVolume 48 Page 743848 FR 7438id-CFR-2003-title21-vol1-chapI-subchapACOLOR ADDITIVE CERTIFICATIOND09002ee18a5cbbf0-CFR-2003-title21-vol1-part80.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part80.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part80.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part80.xml21 CFR 8021CFR80Part 80; COLOR ADDITIVE CERTIFICATIONChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part801024Part 80part80 21 U.S.C. 371, 379e.falseUnited States CodeTitle 21 Section 371Title 21 Section 379e21 U.S.C. 37121 U.S.C. 379eFederal RegisterVolume 42 Page 1566242 FR 15662id-CFR-2003-title21-vol1-part80Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part80-toc-id1025.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part80-toc-id1025.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80-toc-id1025https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80-toc-id1025https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part80-toc-id1025.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part80-toc-id1025.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 80COLOR ADDITIVE CERTIFICATIONTOCCFR-2003-title21-vol1-part80-toc-id10251025Toctocid-CFR-2003-title21-vol1-part80General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part80-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part80-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part80-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part80-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 80COLOR ADDITIVE CERTIFICATIONNODECFR-2003-title21-vol1-part80-subpartA1026Subpart AsubpartA falseid-CFR-2003-title21-vol1-part80-subpartAFees for certification services.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-10.xml21 CFR 80.1021CFR80.10Section 80.10; Fees for certification services.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-101027Section 80.10section80.10 42 FR 15662, Mar. 22, 1977, as amended at 47 FR 24692, June 8, 1982; 54 FR 24890, June 12, 1989; 59 FR 60899, Nov. 29, 1994; 61 FR 3572, Feb. 1, 1996; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001falseFederal RegisterVolume 42 Page 1566242 FR 15662Federal RegisterVolume 47 Page 2469247 FR 24692Federal RegisterVolume 54 Page 2489054 FR 24890Federal RegisterVolume 59 Page 6089959 FR 60899Federal RegisterVolume 61 Page 1447961 FR 14479Federal RegisterVolume 61 Page 357261 FR 3572Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part80Certification ProceduresD09002ee18a5cbbf0-CFR-2003-title21-vol1-part80-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part80-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part80-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part80-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part80-subpartB.xml21 CFR B21CFRSubpart B; Certification ProceduresChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 80COLOR ADDITIVE CERTIFICATIONNODECFR-2003-title21-vol1-part80-subpartB1028Subpart BsubpartB falseid-CFR-2003-title21-vol1-part80-subpartBRequest for certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-21.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-21.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-21https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-21https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-21.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-21.xml21 CFR 80.2121CFR80.21Section 80.21; Request for certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-211029Section 80.21section80.21 42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979; 44 FR 22053, Apr. 13, 1979, as amended at 54 FR 24890, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001falseCode of Federal RegulationsTitle 1 Part 80.22 and1 CFR Part 80.22 andCode of Federal RegulationsTitle 1 Part 741 CFR Part 74Federal RegisterVolume 42 Page 1566242 FR 15662Federal RegisterVolume 44 Page 1765844 FR 17658Federal RegisterVolume 44 Page 2205344 FR 22053Federal RegisterVolume 54 Page 2489054 FR 24890Federal RegisterVolume 61 Page 1447961 FR 14479Federal RegisterVolume 66 Page 5603566 FR 56035id-CFR-2003-title21-vol1-part80-subpartBSamples to accompany requests for certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-22.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-22.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-22https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-22https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-22.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-22.xml21 CFR 80.2221CFR80.22Section 80.22; Samples to accompany requests for certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-221030Section 80.22section80.22 falseid-CFR-2003-title21-vol1-part80-subpartBCertification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-31.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-31.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-31https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-31https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-31.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-31.xml21 CFR 80.3121CFR80.31Section 80.31; Certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-311031Section 80.31section80.31 falseid-CFR-2003-title21-vol1-part80-subpartBLimitations of certificates.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-32.xml21 CFR 80.3221CFR80.32Section 80.32; Limitations of certificates.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-321032Section 80.32section80.32 falseid-CFR-2003-title21-vol1-part80-subpartBAuthority to refuse certification service.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-34.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-34.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-34https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-34https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-34.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-34.xml21 CFR 80.3421CFR80.34Section 80.34; Authority to refuse certification service.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-341033Section 80.34section80.34 falseid-CFR-2003-title21-vol1-part80-subpartBColor additive mixtures; certification and exemption from certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-35.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-35.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-35https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-35https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-35.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-35.xml21 CFR 80.3521CFR80.35Section 80.35; Color additive mixtures; certification and exemption from certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-351034Section 80.35section80.35 falseFederal RegisterVolume 29 Page 1849529 FR 18495id-CFR-2003-title21-vol1-part80-subpartBTreatment of batch pending certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-37.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-37.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-37https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-37https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-37.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-37.xml21 CFR 80.3721CFR80.37Section 80.37; Treatment of batch pending certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-371035Section 80.37section80.37 falseid-CFR-2003-title21-vol1-part80-subpartBTreatment of batch after certification.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-38.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-38.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-38https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-38https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-38.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-38.xml21 CFR 80.3821CFR80.38Section 80.38; Treatment of batch after certification.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-381036Section 80.38section80.38 falseid-CFR-2003-title21-vol1-part80-subpartBRecords of distribution.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec80-39.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec80-39.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-39https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec80-39https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec80-39.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec80-39.xml21 CFR 80.3921CFR80.39Section 80.39; Records of distribution.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BCertification ProceduresPart 80COLOR ADDITIVE CERTIFICATIONCONTENTCFR-2003-title21-vol1-sec80-391037Section 80.39section80.39 falseid-CFR-2003-title21-vol1-chapI-subchapAGENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part81.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part81.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part81https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part81https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part81.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part81.xml21 CFR 8121CFR81Part 81; GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part811038Part 81part81 21 U.S.C. 371, 379e, 379e note.falseUnited States CodeTitle 21 Section 371Title 21 Section 379eTitle 21 Section 379enote21 U.S.C. 37121 U.S.C. 379e21 U.S.C. 379enoteid-CFR-2003-title21-vol1-part81Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part81-toc-id1039.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part81-toc-id1039.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part81-toc-id1039https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part81-toc-id1039https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part81-toc-id1039.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part81-toc-id1039.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 81GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSTOCCFR-2003-title21-vol1-part81-toc-id10391039Toctocid-CFR-2003-title21-vol1-part81Provisional lists of color additives.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec81-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec81-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec81-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec81-1.xml21 CFR 81.121CFR81.1Section 81.1; Provisional lists of color additives.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 81GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSCONTENTCFR-2003-title21-vol1-sec81-11040Section 81.1section81.1 For Federal Register citations affecting § 81.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.42 FR 15665, Mar. 22, 1977falseUnited States CodeTitle 21 Section 379enote21 U.S.C. 379enoteUnited States Statutes at LargeVolume 74 Page 40574 Stat. 405Federal RegisterVolume 42 Page 1566542 FR 15665id-CFR-2003-title21-vol1-part81Termination of provisional listings of color additives.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec81-10.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec81-10.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-10https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-10https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec81-10.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec81-10.xml21 CFR 81.1021CFR81.10Section 81.10; Termination of provisional listings of color additives.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 81GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSCONTENTCFR-2003-title21-vol1-sec81-101041Section 81.10section81.10 For Federal Register citations affecting § 81.10, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.42 FR 15665, Mar. 22, 1977falseFederal RegisterVolume 42 Page 1566542 FR 15665id-CFR-2003-title21-vol1-part81Cancellation of certificates.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec81-30.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec81-30.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-30https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-30https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec81-30.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec81-30.xml21 CFR 81.3021CFR81.30Section 81.30; Cancellation of certificates.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 81GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSCONTENTCFR-2003-title21-vol1-sec81-301042Section 81.30section81.30 For Federal Register citations affecting § 81.30, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.42 FR 15665, Mar. 22, 1977falseFederal RegisterVolume 42 Page 1566542 FR 15665id-CFR-2003-title21-vol1-part81Limitation of certificates.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec81-32.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec81-32.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-32https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec81-32https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec81-32.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec81-32.xml21 CFR 81.3221CFR81.32Section 81.32; Limitation of certificates.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 81GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICSCONTENTCFR-2003-title21-vol1-sec81-321043Section 81.32section81.32 44 FR 48966, Aug. 21, 1979falseFederal RegisterVolume 44 Page 4896644 FR 48966id-CFR-2003-title21-vol1-chapI-subchapALISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSD09002ee18a5cbbf0-CFR-2003-title21-vol1-part82.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part82.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part82.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part82.xml21 CFR 8221CFR82Part 82; LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part821044Part 82part82 21 U.S.C. 371, 379e, 379e note.falseUnited States CodeTitle 21 Section 371Title 21 Section 379eTitle 21 Section 379enote21 U.S.C. 37121 U.S.C. 379e21 U.S.C. 379enoteFederal RegisterVolume 42 Page 1566942 FR 15669id-CFR-2003-title21-vol1-part82Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part82-toc-id1045.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part82-toc-id1045.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-toc-id1045https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-toc-id1045https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part82-toc-id1045.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part82-toc-id1045.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSTOCCFR-2003-title21-vol1-part82-toc-id10451045Toctocid-CFR-2003-title21-vol1-part82General ProvisionsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part82-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part82-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part82-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part82-subpartA.xml21 CFR A21CFRSubpart A; General ProvisionsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSNODECFR-2003-title21-vol1-part82-subpartA1046Subpart AsubpartA falseid-CFR-2003-title21-vol1-part82-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-3.xml21 CFR 82.321CFR82.3Section 82.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-31047Section 82.3section82.3 falseid-CFR-2003-title21-vol1-part82-subpartAGeneral specifications for straight colors.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-5.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-5.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-5https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-5https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-5.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-5.xml21 CFR 82.521CFR82.5Section 82.5; General specifications for straight colors.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-51048Section 82.5section82.5 falseid-CFR-2003-title21-vol1-part82-subpartACertifiable mixtures.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-6.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-6.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-6https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-6https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-6.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-6.xml21 CFR 82.621CFR82.6Section 82.6; Certifiable mixtures.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral ProvisionsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-61049Section 82.6section82.6 falseid-CFR-2003-title21-vol1-part82Foods, Drugs, and CosmeticsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part82-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part82-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part82-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part82-subpartB.xml21 CFR B21CFRSubpart B; Foods, Drugs, and CosmeticsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSNODECFR-2003-title21-vol1-part82-subpartB1050Subpart BsubpartB falseid-CFR-2003-title21-vol1-part82-subpartBGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-50.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-50.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-50https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-50https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-50.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-50.xml21 CFR 82.5021CFR82.50Section 82.50; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-501051Section 82.50section82.50 falseid-CFR-2003-title21-vol1-part82-subpartBLakes (FD&C).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-51.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-51.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-51https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-51https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-51.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-51.xml21 CFR 82.5121CFR82.51Section 82.51; Lakes (FD&C).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-511052Section 82.51section82.51 falseid-CFR-2003-title21-vol1-part82-subpartBFD&C Blue No. 1.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-101.xml21 CFR 82.10121CFR82.101Section 82.101; FD&C Blue No. 1.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-1011053Section 82.101section82.101 falseid-CFR-2003-title21-vol1-part82-subpartBFD&C Blue No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-102.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-102.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-102https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-102https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-102.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-102.xml21 CFR 82.10221CFR82.102Section 82.102; FD&C Blue No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-1021054Section 82.102section82.102 48 FR 5261, Feb. 4, 1983falseFederal RegisterVolume 48 Page 526148 FR 5261id-CFR-2003-title21-vol1-part82-subpartBFD&C Green No. 3.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-203.xml21 CFR 82.20321CFR82.203Section 82.203; FD&C Green No. 3.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-2031055Section 82.203section82.203 47 FR 52144, Nov. 19, 1982falseFederal RegisterVolume 47 Page 5214447 FR 52144id-CFR-2003-title21-vol1-part82-subpartBFD&C Red No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-304.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-304.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-304https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-304https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-304.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-304.xml21 CFR 82.30421CFR82.304Section 82.304; FD&C Red No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-3041056Section 82.304section82.304 falseid-CFR-2003-title21-vol1-part82-subpartBFD&C Yellow No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-705.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-705.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-705https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-705https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-705.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-705.xml21 CFR 82.70521CFR82.705Section 82.705; FD&C Yellow No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-7051057Section 82.705section82.705 51 FR 24519, July 7, 1986falseFederal RegisterVolume 51 Page 2451951 FR 24519id-CFR-2003-title21-vol1-part82-subpartBFD&C Yellow No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-706.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-706.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-706https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-706https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-706.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-706.xml21 CFR 82.70621CFR82.706Section 82.706; FD&C Yellow No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BFoods, Drugs, and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-7061058Section 82.706section82.706 52 FR 21509, June 8, 1987falseFederal RegisterVolume 52 Page 2150952 FR 21509id-CFR-2003-title21-vol1-part82Drugs and CosmeticsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part82-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part82-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part82-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part82-subpartC.xml21 CFR C21CFRSubpart C; Drugs and CosmeticsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSNODECFR-2003-title21-vol1-part82-subpartC1059Subpart CsubpartC falseid-CFR-2003-title21-vol1-part82-subpartCGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1050.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1050.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1050https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1050https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1050.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1050.xml21 CFR 82.105021CFR82.1050Section 82.1050; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-10501060Section 82.1050section82.1050 falseid-CFR-2003-title21-vol1-part82-subpartCLakes (D&C).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1051.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1051.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1051https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1051https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1051.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1051.xml21 CFR 82.105121CFR82.1051Section 82.1051; Lakes (D&C).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-10511061Section 82.1051section82.1051 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Blue No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1104.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1104.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1104https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1104https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1104.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1104.xml21 CFR 82.110421CFR82.1104Section 82.1104; D&C Blue No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-11041062Section 82.1104section82.1104 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Green No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1205.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1205.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1205https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1205https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1205.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1205.xml21 CFR 82.120521CFR82.1205Section 82.1205; D&C Green No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-12051063Section 82.1205section82.1205 47 FR 24285, June 4, 1982falseFederal RegisterVolume 47 Page 2428547 FR 24285id-CFR-2003-title21-vol1-part82-subpartCD&C Green No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1206.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1206.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1206https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1206https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1206.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1206.xml21 CFR 82.120621CFR82.1206Section 82.1206; D&C Green No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-12061064Section 82.1206section82.1206 47 FR 14147, Apr. 2, 1982, as amended at 51 FR 9785, Mar. 21, 1986falseFederal RegisterVolume 47 Page 1414747 FR 14147Federal RegisterVolume 51 Page 978551 FR 9785id-CFR-2003-title21-vol1-part82-subpartCD&C Orange No. 4.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1254.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1254.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1254https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1254https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1254.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1254.xml21 CFR 82.125421CFR82.1254Section 82.1254; D&C Orange No. 4.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-12541065Section 82.1254section82.1254 42 FR 52396, Sept. 30, 1977falseFederal RegisterVolume 42 Page 5239642 FR 52396id-CFR-2003-title21-vol1-part82-subpartCD&C Orange No. 5.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1255.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1255.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1255https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1255https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1255.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1255.xml21 CFR 82.125521CFR82.1255Section 82.1255; D&C Orange No. 5.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-12551066Section 82.1255section82.1255 49 FR 13343, Apr. 4, 1984falseFederal RegisterVolume 49 Page 1334349 FR 13343id-CFR-2003-title21-vol1-part82-subpartCD&C Orange No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1260.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1260.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1260https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1260https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1260.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1260.xml21 CFR 82.126021CFR82.1260Section 82.1260; D&C Orange No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-12601067Section 82.1260section82.1260 46 FR 18954, Mar. 27, 1981falseFederal RegisterVolume 46 Page 1895446 FR 18954id-CFR-2003-title21-vol1-part82-subpartCD&C Orange No. 11.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1261.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1261.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1261https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1261https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1261.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1261.xml21 CFR 82.126121CFR82.1261Section 82.1261; D&C Orange No. 11.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-12611068Section 82.1261section82.1261 46 FR 18954, Mar. 27, 1981falseFederal RegisterVolume 46 Page 1895446 FR 18954id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 6.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1306.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1306.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1306https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1306https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1306.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1306.xml21 CFR 82.130621CFR82.1306Section 82.1306; D&C Red No. 6.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13061069Section 82.1306section82.1306 47 FR 57691, Dec. 28, 1982falseFederal RegisterVolume 47 Page 5769147 FR 57691id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1307.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1307.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1307https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1307https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1307.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1307.xml21 CFR 82.130721CFR82.1307Section 82.1307; D&C Red No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13071070Section 82.1307section82.1307 47 FR 57691, Dec. 28, 1982falseFederal RegisterVolume 47 Page 5769147 FR 57691id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 17.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1317.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1317.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1317https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1317https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1317.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1317.xml21 CFR 82.131721CFR82.1317Section 82.1317; D&C Red No. 17.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13171071Section 82.1317section82.1317 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 21.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1321.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1321.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1321https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1321https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1321.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1321.xml21 CFR 82.132121CFR82.1321Section 82.1321; D&C Red No. 21.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13211072Section 82.1321section82.1321 47 FR 53847, Nov. 30, 1982falseFederal RegisterVolume 47 Page 5384747 FR 53847id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 22.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1322.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1322.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1322https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1322https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1322.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1322.xml21 CFR 82.132221CFR82.1322Section 82.1322; D&C Red No. 22.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13221073Section 82.1322section82.1322 47 FR 53847, Nov. 30, 1982falseFederal RegisterVolume 47 Page 5384747 FR 53847id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 27.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1327.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1327.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1327https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1327https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1327.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1327.xml21 CFR 82.132721CFR82.1327Section 82.1327; D&C Red No. 27.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13271074Section 82.1327section82.1327 47 FR 42568, Sept. 28, 1982falseFederal RegisterVolume 47 Page 4256847 FR 42568id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 28.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1328.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1328.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1328https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1328https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1328.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1328.xml21 CFR 82.132821CFR82.1328Section 82.1328; D&C Red No. 28.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13281075Section 82.1328section82.1328 47 FR 42568, Sept. 28, 1982falseFederal RegisterVolume 47 Page 4256847 FR 42568id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 30.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1330.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1330.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1330https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1330https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1330.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1330.xml21 CFR 82.133021CFR82.1330Section 82.1330; D&C Red No. 30.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13301076Section 82.1330section82.1330 47 FR 22511, May 25, 1982falseFederal RegisterVolume 47 Page 2251147 FR 22511id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 31.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1331.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1331.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1331https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1331https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1331.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1331.xml21 CFR 82.133121CFR82.1331Section 82.1331; D&C Red No. 31.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13311077Section 82.1331section82.1331 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 33.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1333.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1333.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1333https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1333https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1333.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1333.xml21 CFR 82.133321CFR82.1333Section 82.1333; D&C Red No. 33.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13331078Section 82.1333section82.1333 53 FR 33121, Aug. 30, 1988falseFederal RegisterVolume 53 Page 3312153 FR 33121id-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 34.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1334.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1334.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1334https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1334https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1334.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1334.xml21 CFR 82.133421CFR82.1334Section 82.1334; D&C Red No. 34.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13341079Section 82.1334section82.1334 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Red No. 36.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1336.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1336.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1336https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1336https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1336.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1336.xml21 CFR 82.133621CFR82.1336Section 82.1336; D&C Red No. 36.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-13361080Section 82.1336section82.1336 53 FR 29031, Aug. 2, 1988falseFederal RegisterVolume 53 Page 2903153 FR 29031id-CFR-2003-title21-vol1-part82-subpartCD&C Violet No. 2.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1602.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1602.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1602https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1602https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1602.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1602.xml21 CFR 82.160221CFR82.1602Section 82.1602; D&C Violet No. 2.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-16021081Section 82.1602section82.1602 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Yellow No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1707.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1707.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1707https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1707https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1707.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1707.xml21 CFR 82.170721CFR82.1707Section 82.1707; D&C Yellow No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-17071082Section 82.1707section82.1707 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Yellow No. 8.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1708.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1708.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1708https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1708https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1708.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1708.xml21 CFR 82.170821CFR82.1708Section 82.1708; D&C Yellow No. 8.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-17081083Section 82.1708section82.1708 falseid-CFR-2003-title21-vol1-part82-subpartCD&C Yellow No. 10.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-1710.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-1710.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1710https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-1710https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-1710.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-1710.xml21 CFR 82.171021CFR82.1710Section 82.1710; D&C Yellow No. 10.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CDrugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-17101084Section 82.1710section82.1710 48 FR 39220, Aug. 30, 1983falseFederal RegisterVolume 48 Page 3922048 FR 39220id-CFR-2003-title21-vol1-part82Externally Applied Drugs and CosmeticsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part82-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part82-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part82-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part82-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part82-subpartD.xml21 CFR D21CFRSubpart D; Externally Applied Drugs and CosmeticsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSNODECFR-2003-title21-vol1-part82-subpartD1085Subpart DsubpartD falseid-CFR-2003-title21-vol1-part82-subpartDGeneral.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-2050.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-2050.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-2050https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-2050https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-2050.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-2050.xml21 CFR 82.205021CFR82.2050Section 82.2050; General.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExternally Applied Drugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-20501086Section 82.2050section82.2050 falseid-CFR-2003-title21-vol1-part82-subpartDLakes (Ext. D&C).D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-2051.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-2051.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-2051https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-2051https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-2051.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-2051.xml21 CFR 82.205121CFR82.2051Section 82.2051; Lakes (Ext. D&C).Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExternally Applied Drugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-20511087Section 82.2051section82.2051 falseid-CFR-2003-title21-vol1-part82-subpartDExt. D&C Yellow No. 7.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec82-2707a.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec82-2707a.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-2707ahttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec82-2707ahttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec82-2707a.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec82-2707a.xml21 CFR 82.2707a21CFR82.2707aSection 82.2707a; Ext. D&C Yellow No. 7.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DExternally Applied Drugs and CosmeticsPart 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONSCONTENTCFR-2003-title21-vol1-sec82-2707a1088Section 82.2707asection82.2707a falseid-CFR-2003-title21-vol1-chapI-subchapAReservedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part83.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part83.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part83https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part83https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part83.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part83.xml21 CFR 8321CFR83Parts 83-98; ReservedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part831089Parts 83-98part83 falseid-CFR-2003-title21-vol1-chapI-subchapADISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99.xml21 CFR 9921CFR99Part 99; DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESNODECFR-2003-title21-vol1-part991090Part 99part99 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.falseUnited States CodeTitle 21 Section 321Title 21 Section 331Title 21 Section 351Title 21 Section 352Title 21 Section 355Title 21 Section 360aa-360aaa-6Title 21 Section 360cTitle 21 Section 360Title 21 Section 360eTitle 21 Section 371Title 21 Section 37421 U.S.C. 32121 U.S.C. 33121 U.S.C. 35121 U.S.C. 35221 U.S.C. 35521 U.S.C. 360aa-360aaa-621 U.S.C. 360c21 U.S.C. 36021 U.S.C. 360e21 U.S.C. 37121 U.S.C. 374United States CodeTitle 42 Section 26242 U.S.C. 262Federal RegisterVolume 63 Page 6458163 FR 64581id-CFR-2003-title21-vol1-part99Table Of ContentsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-toc-id1091.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-toc-id1091.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-toc-id1091https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-toc-id1091https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-toc-id1091.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-toc-id1091.xml21 CFR Toc21CFRToc; Table Of ContentsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESTOCCFR-2003-title21-vol1-part99-toc-id10911091Toctocid-CFR-2003-title21-vol1-part99General InformationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-subpartA.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-subpartA.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartAhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartAhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-subpartA.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-subpartA.xml21 CFR A21CFRSubpart A; General InformationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESNODECFR-2003-title21-vol1-part99-subpartA1092Subpart AsubpartA falseid-CFR-2003-title21-vol1-part99-subpartAScope.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-1.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-1.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-1https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-1https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-1.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-1.xml21 CFR 99.121CFR99.1Section 99.1; Scope.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral InformationPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-11093Section 99.1section99.1 falseid-CFR-2003-title21-vol1-part99-subpartADefinitions.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-3.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-3.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-3https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-3https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-3.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-3.xml21 CFR 99.321CFR99.3Section 99.3; Definitions.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart AGeneral InformationPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-31094Section 99.3section99.3 falseUnited States CodeTitle 29 Section 1002(1)Title 29 Section 1144(b)(2)29 U.S.C. 1002(1)29 U.S.C. 1144(b)(2)United States CodeTitle 42 Section 300e(a)42 U.S.C. 300e(a)id-CFR-2003-title21-vol1-part99Information to be DisseminatedD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-subpartB.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-subpartB.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartBhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartBhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-subpartB.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-subpartB.xml21 CFR B21CFRSubpart B; Information to be DisseminatedChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESNODECFR-2003-title21-vol1-part99-subpartB1095Subpart BsubpartB falseid-CFR-2003-title21-vol1-part99-subpartBInformation that may be disseminated.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-101.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-101.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-101https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-101https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-101.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-101.xml21 CFR 99.10121CFR99.101Section 99.101; Information that may be disseminated.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformation to be DisseminatedPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-1011096Section 99.101section99.101 falseid-CFR-2003-title21-vol1-part99-subpartBMandatory statements and information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-103.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-103.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-103https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-103https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-103.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-103.xml21 CFR 99.10321CFR99.103Section 99.103; Mandatory statements and information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformation to be DisseminatedPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-1031097Section 99.103section99.103 falseid-CFR-2003-title21-vol1-part99-subpartBRecipients of information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-105.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-105.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-105https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-105https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-105.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-105.xml21 CFR 99.10521CFR99.105Section 99.105; Recipients of information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart BInformation to be DisseminatedPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-1051098Section 99.105section99.105 falseid-CFR-2003-title21-vol1-part99Manufacturer's Submissions, Requests, and ApplicationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-subpartC.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-subpartC.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartChttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartChttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-subpartC.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-subpartC.xml21 CFR C21CFRSubpart C; Manufacturer's Submissions, Requests, and ApplicationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESNODECFR-2003-title21-vol1-part99-subpartC1099Subpart CsubpartC falseid-CFR-2003-title21-vol1-part99-subpartCManufacturer's submission to the agency.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-201.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-201.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-201https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-201https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-201.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-201.xml21 CFR 99.20121CFR99.201Section 99.201; Manufacturer's submission to the agency.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CManufacturer's Submissions, Requests, and ApplicationsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-2011100Section 99.201section99.201 falseid-CFR-2003-title21-vol1-part99-subpartCRequest to extend the time for completing planned studies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-203.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-203.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-203https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-203https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-203.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-203.xml21 CFR 99.20321CFR99.203Section 99.203; Request to extend the time for completing planned studies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CManufacturer's Submissions, Requests, and ApplicationsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-2031101Section 99.203section99.203 falseid-CFR-2003-title21-vol1-part99-subpartCApplication for exemption from the requirement to file a supplemental application.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-205.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-205.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-205https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-205https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-205.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-205.xml21 CFR 99.20521CFR99.205Section 99.205; Application for exemption from the requirement to file a supplemental application.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart CManufacturer's Submissions, Requests, and ApplicationsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-2051102Section 99.205section99.205 falseid-CFR-2003-title21-vol1-part99FDA Action on Submissions, Requests, and ApplicationsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-subpartD.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-subpartD.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartDhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartDhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-subpartD.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-subpartD.xml21 CFR D21CFRSubpart D; FDA Action on Submissions, Requests, and ApplicationsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESNODECFR-2003-title21-vol1-part99-subpartD1103Subpart DsubpartD falseid-CFR-2003-title21-vol1-part99-subpartDAgency action on a submission.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-301.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-301.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-301https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-301https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-301.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-301.xml21 CFR 99.30121CFR99.301Section 99.301; Agency action on a submission.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DFDA Action on Submissions, Requests, and ApplicationsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-3011104Section 99.301section99.301 falseid-CFR-2003-title21-vol1-part99-subpartDExtension of time for completing planned studies.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-303.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-303.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-303https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-303https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-303.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-303.xml21 CFR 99.30321CFR99.303Section 99.303; Extension of time for completing planned studies.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DFDA Action on Submissions, Requests, and ApplicationsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-3031105Section 99.303section99.303 falseid-CFR-2003-title21-vol1-part99-subpartDExemption from the requirement to file a supplemental application.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-305.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-305.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-305https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-305https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-305.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-305.xml21 CFR 99.30521CFR99.305Section 99.305; Exemption from the requirement to file a supplemental application.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart DFDA Action on Submissions, Requests, and ApplicationsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-3051106Section 99.305section99.305 falseid-CFR-2003-title21-vol1-part99Corrective Actions and Cessation of DisseminationD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-subpartE.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-subpartE.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartEhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartEhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-subpartE.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-subpartE.xml21 CFR E21CFRSubpart E; Corrective Actions and Cessation of DisseminationChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESNODECFR-2003-title21-vol1-part99-subpartE1107Subpart EsubpartE falseid-CFR-2003-title21-vol1-part99-subpartECorrective actions and cessation of dissemination of information.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-401.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-401.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-401https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-401https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-401.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-401.xml21 CFR 99.40121CFR99.401Section 99.401; Corrective actions and cessation of dissemination of information.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ECorrective Actions and Cessation of DisseminationPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-4011108Section 99.401section99.401 falseid-CFR-2003-title21-vol1-part99-subpartETermination of approvals of applications for exemption.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-403.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-403.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-403https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-403https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-403.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-403.xml21 CFR 99.40321CFR99.403Section 99.403; Termination of approvals of applications for exemption.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ECorrective Actions and Cessation of DisseminationPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-4031109Section 99.403section99.403 falseid-CFR-2003-title21-vol1-part99-subpartEApplicability of labeling, adulteration, and misbranding authority.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-405.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-405.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-405https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-405https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-405.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-405.xml21 CFR 99.40521CFR99.405Section 99.405; Applicability of labeling, adulteration, and misbranding authority.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart ECorrective Actions and Cessation of DisseminationPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-4051110Section 99.405section99.405 falseUnited States CodeTitle 21 Section 360aaa21 U.S.C. 360aaaid-CFR-2003-title21-vol1-part99Recordkeeping and ReportsD09002ee18a5cbbf0-CFR-2003-title21-vol1-part99-subpartF.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-part99-subpartF.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartFhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-part99-subpartFhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-part99-subpartF.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-part99-subpartF.xml21 CFR F21CFRSubpart F; Recordkeeping and ReportsChapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESNODECFR-2003-title21-vol1-part99-subpartF1111Subpart FsubpartF falseid-CFR-2003-title21-vol1-part99-subpartFRecordkeeping and reports.D09002ee18a5cbbf0-CFR-2003-title21-vol1-sec99-501.xmlD09002ee18a5cbbef-CFR-2003-title21-vol1-sec99-501.pdfhttps://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-501https://www.govinfo.gov/app/details/CFR-2003-title21-vol1/CFR-2003-title21-vol1-sec99-501https://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/pdf/CFR-2003-title21-vol1-sec99-501.pdfhttps://www.govinfo.gov/content/pkg/CFR-2003-title21-vol1/xml/CFR-2003-title21-vol1-sec99-501.xml21 CFR 99.50121CFR99.501Section 99.501; Recordkeeping and reports.Chapter IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubpart FRecordkeeping and ReportsPart 99DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESCONTENTCFR-2003-title21-vol1-sec99-5011112Section 99.501section99.501 false