United States Government Printing Office printer prt distributor dst United States National Archives and Records Administration Federal Register Office author aut Government Organization text government publication eng CFR Regulatory Information 2007_cfr_21v1 executive Office of the Federal Register, National Archives and Records Administration 2007-04-01 monographic annual deposited born digital 504 p. AE 2.106/3:21/ http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1 21CFR DGPO 2010-02-05 2010-02-05 CFR-2007-title21-vol1 machine generated eng fdlp CFR CFR-2007-title21-vol1 21 1 9 parts 1 to 99 false CFR-title21-vol1 false false 2007-04-01 Food and Drugs Title 21 Volume 1 Code of Federal Regulations http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/html/CFR-2007-title21-vol1.htm http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1.xml Code of Federal Regulations Title 21, Volume 1, April 1, 2007 Food and Drugs http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1/content-detail.html 21 CFR Title 21 21 21CFR Title 21; Food and Drugs NODE CFR-2007-title21-vol1 1 Title 21 title 21 false Code of Federal Regulations Title 21 Part I 21 CFR Part I Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-toc-id2 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-toc-id2/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-toc-id2.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-toc-id2.xml 21 CFR 21CFR Table Of Contents TOC CFR-2007-title21-vol1-toc-id2 2 toc FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-chapI http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-chapI/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-chapI.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-chapI.xml 21 CFR Chapter I I 21CFR Chapter I; FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-chapI 3 Chapter I chapter I Nomenclature changes to chapter I appear at 66 FR 56035, Nov. 6, 2001, 69 FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004. Federal Register Volume 66 Page 56035 66 FR. 56035 Federal Register Volume 69 Page 13717 69 FR. 13717 Federal Register Volume 69 Page 18803 69 FR. 18803 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-chapI-toc-id4 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-chapI-toc-id4/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-chapI-toc-id4.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-chapI-toc-id4.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES TOC CFR-2007-title21-vol1-chapI-toc-id4 4 toc GENERAL http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-chapI-subchapA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-chapI-subchapA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-chapI-subchapA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-chapI-subchapA.xml 21 CFR Subchapter A A 21CFR Subchapter A; GENERAL Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-chapI-subchapA 5 Subchapter A subchap A false GENERAL ENFORCEMENT REGULATIONS http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1.xml 21 CFR 1 21CFR1 Part 1; GENERAL ENFORCEMENT REGULATIONS Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part1 6 Part 1 part 1 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264. 42 FR 15553, Mar. 22, 1977, unless otherwise noted. false
United States Code Title 15 Section 1453 Title 15 Section 1453 Title 15 Section 1454 Title 15 Section 1454 Title 15 Section 1455 Title 15 Section 1455 15 U.S.C. 1453 15 U.S.C. 1453 15 U.S.C. 1454 15 U.S.C. 1454 15 U.S.C. 1455 15 U.S.C. 1455 United States Code Title 19 Section 1490 Title 19 Section 1490 Title 19 Section 1491 Title 19 Section 1491 19 U.S.C. 1490 19 U.S.C. 1490 19 U.S.C. 1491 19 U.S.C. 1491 United States Code Title 21 Section 321 Title 21 Section 321 Title 21 Section 331 Title 21 Section 331 Title 21 Section 332 Title 21 Section 332 Title 21 Section 333 Title 21 Section 333 Title 21 Section 334 Title 21 Section 334 Title 21 Section 335a Title 21 Section 335a Title 21 Section 343 Title 21 Section 343 Title 21 Section 350c Title 21 Section 350c Title 21 Section 350d Title 21 Section 350d Title 21 Section 352 Title 21 Section 352 Title 21 Section 355 Title 21 Section 355 Title 21 Section 360b Title 21 Section 360b Title 21 Section 362 Title 21 Section 362 Title 21 Section 371 Title 21 Section 371 Title 21 Section 374 Title 21 Section 374 Title 21 Section 381 Title 21 Section 381 Title 21 Section 382 Title 21 Section 382 Title 21 Section 393 Title 21 Section 393 21 U.S.C. 321 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 331 21 U.S.C. 332 21 U.S.C. 332 21 U.S.C. 333 21 U.S.C. 333 21 U.S.C. 334 21 U.S.C. 334 21 U.S.C. 335a 21 U.S.C. 335a 21 U.S.C. 343 21 U.S.C. 343 21 U.S.C. 350c 21 U.S.C. 350c 21 U.S.C. 350d 21 U.S.C. 350d 21 U.S.C. 352 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 355 21 U.S.C. 360b 21 U.S.C. 360b 21 U.S.C. 362 21 U.S.C. 362 21 U.S.C. 371 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 374 21 U.S.C. 381 21 U.S.C. 381 21 U.S.C. 382 21 U.S.C. 382 21 U.S.C. 393 21 U.S.C. 393 United States Code Title 42 Section 216 Title 42 Section 216 Title 42 Section 241 Title 42 Section 241 Title 42 Section 243 Title 42 Section 243 Title 42 Section 262 Title 42 Section 262 Title 42 Section 264 Title 42 Section 264 42 U.S.C. 216 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 241 42 U.S.C. 243 42 U.S.C. 243 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 264 42 U.S.C. 264 Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Federal Register Volume 42 Page 15553 42 FR. 15553 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-toc-id7 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-toc-id7/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-toc-id7.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-toc-id7.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS TOC CFR-2007-title21-vol1-part1-toc-id7 7 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartA 8 Subpart A subpart A false General. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-1.xml 21 CFR 1.1 21CFR1.1 Section 1.1; General. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-1 9 Section 1.1 section 1.1 42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993 false Federal Register Volume 42 Page 15553 42 FR. 15553 Federal Register Volume 58 Page 17085 58 FR. 17085 Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-3.xml 21 CFR 1.3 21CFR1.3 Section 1.3; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-3 10 Section 1.3 section 1.3 false Authority citations. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-4 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-4/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-4.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-4.xml 21 CFR 1.4 21CFR1.4 Section 1.4; Authority citations. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-4 11 Section 1.4 section 1.4 54 FR 39630, Sept. 27, 1989 false
United States Code Title 5 Section 552 5 U.S.C. 552 United States Code Title 21 Section 371 21 U.S.C. 371 Federal Register Volume 54 Page 39630 54 FR. 39630 General Labeling Requirements http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartB.xml 21 CFR B 21CFR Subpart B; General Labeling Requirements Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartB 12 Subpart B subpart B false Presence of mandatory label information. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-20.xml 21 CFR 1.20 21CFR1.20 Section 1.20; Presence of mandatory label information. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Labeling Requirements Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-20 13 Section 1.20 section 1.20 false
United States Code Title 15 Section 231-233 Title 15 Section 234-236 Title 15 Section 251-256 Title 15 Section 257-257i 15 U.S.C. 231-233 15 U.S.C. 234-236 15 U.S.C. 251-256 15 U.S.C. 257-257i United States Statutes At large Volume 37 Page 250 37 Stat. 250 United States Statutes At large Volume 38 Page 1186 38 Stat. 1186 United States Statutes At large Volume 39 Page 673 39 Stat. 673 United States Statutes At large Volume 45 Page 635 45 Stat. 635 Failure to reveal material facts. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-21 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-21/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-21.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-21.xml 21 CFR 1.21 21CFR1.21 Section 1.21; Failure to reveal material facts. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Labeling Requirements Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-21 14 Section 1.21 section 1.21 false Procedures for requesting variations and exemptions from required label statements. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-23 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-23/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-23.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-23.xml 21 CFR 1.23 21CFR1.23 Section 1.23; Procedures for requesting variations and exemptions from required label statements. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Labeling Requirements Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-23 15 Section 1.23 section 1.23 false Exemptions from required label statements. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-24 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-24/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-24.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-24.xml 21 CFR 1.24 21CFR1.24 Section 1.24; Exemptions from required label statements. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Labeling Requirements Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-24 16 Section 1.24 section 1.24 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, 2001 false United States Statutes At large Volume 42 Page 1500 42 Stat. 1500 Federal Register Volume 42 Page 15553 42 FR. 15553 Federal Register Volume 47 Page 32421 47 FR. 32421 Federal Register Volume 47 Page 946 47 FR. 946 Federal Register Volume 49 Page 13339 49 FR. 13339 Federal Register Volume 54 Page 9033 54 FR. 9033 Federal Register Volume 58 Page 2174 58 FR. 2174 Federal Register Volume 61 Page 14478 61 FR. 14478 Federal Register Volume 66 Page 56035 66 FR. 56035 Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartC.xml 21 CFR C 21CFR Subparts C-D; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartC 17 Subparts C-D subpart C false Imports and Exports http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartE http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartE/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartE.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartE.xml 21 CFR E 21CFR Subpart E; Imports and Exports Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartE 18 Subpart E subpart E false Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-83 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-83/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-83.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-83.xml 21 CFR 1.83 21CFR1.83 Section 1.83; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-83 19 Section 1.83 section 1.83 false
United States Code Title 19 Section 1483 Title 19 Section 1484 Title 19 Section 1485 19 U.S.C. 1483 19 U.S.C. 1484 19 U.S.C. 1485 Notice of sampling. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-90 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-90/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-90.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-90.xml 21 CFR 1.90 21CFR1.90 Section 1.90; Notice of sampling. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-90 20 Section 1.90 section 1.90 false Payment for samples. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-91 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-91/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-91.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-91.xml 21 CFR 1.91 21CFR1.91 Section 1.91; Payment for samples. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-91 21 Section 1.91 section 1.91 false Hearing on refusal of admission. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-94 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-94/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-94.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-94.xml 21 CFR 1.94 21CFR1.94 Section 1.94; Hearing on refusal of admission. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-94 22 Section 1.94 section 1.94 false Application for authorization to relabel and recondition. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-95 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-95/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-95.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-95.xml 21 CFR 1.95 21CFR1.95 Section 1.95; Application for authorization to relabel and recondition. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-95 23 Section 1.95 section 1.95 false Granting of authorization to relabel and recondition. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-96 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-96/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-96.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-96.xml 21 CFR 1.96 21CFR1.96 Section 1.96; Granting of authorization to relabel and recondition. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-96 24 Section 1.96 section 1.96 42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989 false Federal Register Volume 42 Page 15553 42 FR. 15553 Federal Register Volume 54 Page 9033 54 FR. 9033 Bonds. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-97 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-97/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-97.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-97.xml 21 CFR 1.97 21CFR1.97 Section 1.97; Bonds. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-97 25 Section 1.97 section 1.97 false Costs chargeable in connection with relabeling and reconditioning inadmissible imports. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-99 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-99/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-99.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-99.xml 21 CFR 1.99 21CFR1.99 Section 1.99; Costs chargeable in connection with relabeling and reconditioning inadmissible imports. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-99 26 Section 1.99 section 1.99 false
United States Code Title 19 Section 267 19 U.S.C. 267 United States Statutes At large Volume 36 Page 901 36 Stat. 901 Notification and recordkeeping. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-101 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-101/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-101.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-101.xml 21 CFR 1.101 21CFR1.101 Section 1.101; Notification and recordkeeping. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Imports and Exports Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-101 27 Section 1.101 section 1.101 66 FR 65447, Dec. 19, 2001, as amended at 69 FR 48774, Aug. 11, 2004; 70 FR 14980, Mar. 24, 2005 false
United States Code Title 18 Section 1001 18 U.S.C. 1001 United States Code Title 21 Section 381 Title 21 Section 382 21 U.S.C. 381 21 U.S.C. 382 United States Code Title 42 Section 262 42 U.S.C. 262 Federal Register Volume 66 Page 65447 66 FR. 65447 Federal Register Volume 69 Page 48774 69 FR. 48774 Federal Register Volume 70 Page 14980 70 FR. 14980 Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartF http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartF/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartF.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartF.xml 21 CFR F 21CFR Subparts F-G; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartF 28 Subparts F-G subpart F false Registration of Food Facilities http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartH.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartH.xml 21 CFR H 21CFR Subpart H; Registration of Food Facilities Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartH 29 Subpart H subpart H 68 FR 58960, Oct. 10, 2003, unless otherwise noted. General Provisions false Federal Register Volume 68 Page 58960 68 FR. 58960 General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id30.pdf 21 CFR 21CFR General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id30 30 subjgrp Who must register under this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-225 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-225/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-225.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-225.xml 21 CFR 1.225 21CFR1.225 Section 1.225; Who must register under this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-225 31 Section 1.225 section 1.225 General Provisions false Who does not have to register under this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-226 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-226/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-226.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-226.xml 21 CFR 1.226 21CFR1.226 Section 1.226; Who does not have to register under this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-226 32 Section 1.226 section 1.226 General Provisions false
United States Code Title 21 Section 451et seq. Title 21 Section 601et seq. Title 21 Section 1031et seq. 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. 21 U.S.C. 1031et seq. What definitions apply to this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-227 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-227/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-227.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-227.xml 21 CFR 1.227 21CFR1.227 Section 1.227; What definitions apply to this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-227 33 Section 1.227 section 1.227 Procedures for Registration of Food Facilities false
United States Code Title 7 Section 136(u) 7 U.S.C. 136(u) United States Code Title 21 Section 321(e) Title 21 Section 321(f) Title 21 Section 348(h)(6) 21 U.S.C. 321(e) 21 U.S.C. 321(f) 21 U.S.C. 348(h)(6) United States Code Title 26 Section 501(c)(3) 26 U.S.C. 501(c)(3) Procedures for Registration of Food Facilities http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id34 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id34/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id34.pdf 21 CFR 21CFR Procedures for Registration of Food Facilities Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id34 34 subjgrp When must you register? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-230 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-230/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-230.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-230.xml 21 CFR 1.230 21CFR1.230 Section 1.230; When must you register? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-230 35 Section 1.230 section 1.230 Procedures for Registration of Food Facilities false How and where do you register? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-231 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-231/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-231.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-231.xml 21 CFR 1.231 21CFR1.231 Section 1.231; How and where do you register? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-231 36 Section 1.231 section 1.231 68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004 Procedures for Registration of Food Facilities false Federal Register Volume 68 Page 58960 68 FR. 58960 Federal Register Volume 69 Page 29428 69 FR. 29428 What information is required in the registration? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-232 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-232/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-232.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-232.xml 21 CFR 1.232 21CFR1.232 Section 1.232; What information is required in the registration? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-232 37 Section 1.232 section 1.232 68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004 Procedures for Registration of Food Facilities false Federal Register Volume 68 Page 58960 68 FR. 58960 Federal Register Volume 69 Page 29428 69 FR. 29428 What optional items are included in the registration form? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-233 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-233/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-233.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-233.xml 21 CFR 1.233 21CFR1.233 Section 1.233; What optional items are included in the registration form? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-233 38 Section 1.233 section 1.233 Procedures for Registration of Food Facilities false How and when do you update your facility's registration information? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-234 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-234/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-234.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-234.xml 21 CFR 1.234 21CFR1.234 Section 1.234; How and when do you update your facility's registration information? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-234 39 Section 1.234 section 1.234 Procedures for Registration of Food Facilities false How and when do you cancel your facility's registration information? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-235 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-235/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-235.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-235.xml 21 CFR 1.235 21CFR1.235 Section 1.235; How and when do you cancel your facility's registration information? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-235 40 Section 1.235 section 1.235 Additional Provisions false Additional Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id41 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id41/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id41.pdf 21 CFR 21CFR Additional Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartH-subjectgroup-id41 41 subjgrp What other registration requirements apply? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-240 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-240/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-240.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-240.xml 21 CFR 1.240 21CFR1.240 Section 1.240; What other registration requirements apply? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-240 42 Section 1.240 section 1.240 Additional Provisions false What are the consequences of failing to register, update, or cancel your registration? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-241 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-241/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-241.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-241.xml 21 CFR 1.241 21CFR1.241 Section 1.241; What are the consequences of failing to register, update, or cancel your registration? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-241 43 Section 1.241 section 1.241 Additional Provisions false
United States Code Title 21 Section 331 Title 21 Section 332 Title 21 Section 333 Title 21 Section 335a 21 U.S.C. 331 21 U.S.C. 332 21 U.S.C. 333 21 U.S.C. 335a What does assignment of a registration number mean? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-242 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-242/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-242.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-242.xml 21 CFR 1.242 21CFR1.242 Section 1.242; What does assignment of a registration number mean? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-242 44 Section 1.242 section 1.242 Additional Provisions false Is food registration information available to the public? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-243 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-243/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-243.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-243.xml 21 CFR 1.243 21CFR1.243 Section 1.243; Is food registration information available to the public? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Registration of Food Facilities Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-243 45 Section 1.243 section 1.243 Additional Provisions false
United States Code Title 5 Section 552 5 U.S.C. 552 Prior Notice of Imported Food http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartI.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartI.xml 21 CFR I 21CFR Subpart I; Prior Notice of Imported Food Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartI 46 Subpart I subpart I 68 FR 59070, Oct. 10, 2003, unless otherwise noted. General Provisions false Federal Register Volume 68 Page 59070 68 FR. 59070 General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id47 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id47/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id47.pdf 21 CFR 21CFR General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id47 47 subjgrp What definitions apply to this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-276 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-276/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-276.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-276.xml 21 CFR 1.276 21CFR1.276 Section 1.276; What definitions apply to this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-276 48 Section 1.276 section 1.276 68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004 General Provisions false
United States Code Title 7 Section 136(u) 7 U.S.C. 136(u) United States Code Title 21 Section 321 Title 21 Section 348(h)(6) Title 21 Section 350d 21 U.S.C. 321 21 U.S.C. 348(h)(6) 21 U.S.C. 350d Code of Federal Regulations Title 19 Part 101.1 19 CFR Part 101.1 Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4851 69 FR. 4851 What is the scope of this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-277 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-277/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-277.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-277.xml 21 CFR 1.277 21CFR1.277 Section 1.277; What is the scope of this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-277 49 Section 1.277 section 1.277 Requirements To Submit Prior Notice of Imported Food false
United States Code Title 21 Section 451et seq. Title 21 Section 601et seq. Title 21 Section 1031et seq. 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. 21 U.S.C. 1031et seq. Requirements to Submit Prior Notice of Imported Food http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id50 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id50/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id50.pdf 21 CFR 21CFR Requirements to Submit Prior Notice of Imported Food Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id50 50 subjgrp Who is authorized to submit prior notice? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-278 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-278/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-278.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-278.xml 21 CFR 1.278 21CFR1.278 Section 1.278; Who is authorized to submit prior notice? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-278 51 Section 1.278 section 1.278 Requirements to Submit Prior Notice of Imported Food false When must prior notice be submitted to FDA? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-279 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-279/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-279.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-279.xml 21 CFR 1.279 21CFR1.279 Section 1.279; When must prior notice be submitted to FDA? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-279 52 Section 1.279 section 1.279 68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004 Requirements to Submit Prior Notice of Imported Food false Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4851 69 FR. 4851 How must you submit prior notice? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-280 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-280/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-280.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-280.xml 21 CFR 1.280 21CFR1.280 Section 1.280; How must you submit prior notice? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-280 53 Section 1.280 section 1.280 68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2003; 69 FR 8330, Feb. 24, 2004 Requirements to Submit Prior Notice of Imported Food false Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4851 69 FR. 4851 Federal Register Volume 69 Page 8330 69 FR. 8330 What information must be in a prior notice? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-281 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-281/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-281.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-281.xml 21 CFR 1.281 21CFR1.281 Section 1.281; What information must be in a prior notice? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-281 54 Section 1.281 section 1.281 68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004 Requirements to Submit Prior Notice of Imported Food false Code of Federal Regulations Title 21 Part 113.60 21 CFR Part 113.60 Code of Federal Regulations Title 21 Part 114.80 21 CFR Part 114.80 Code of Federal Regulations Title 21 Part 106.90 21 CFR Part 106.90 Code of Federal Regulations Title 21 Part 101.5 21 CFR Part 101.5 Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Code of Federal Regulations Title 21 Part 113.60 21 CFR Part 113.60 Code of Federal Regulations Title 21 Part 114.80 21 CFR Part 114.80 Code of Federal Regulations Title 21 Part 106.90 21 CFR Part 106.90 Code of Federal Regulations Title 21 Part 101.5 21 CFR Part 101.5 Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Code of Federal Regulations Title 21 Part 113.60 21 CFR Part 113.60 Code of Federal Regulations Title 21 Part 114.80 21 CFR Part 114.80 Code of Federal Regulations Title 21 Part 106.90 21 CFR Part 106.90 Code of Federal Regulations Title 21 Part 101.5 21 CFR Part 101.5 Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4851 69 FR. 4851 What must you do if information changes after you have received confirmation of a prior notice from FDA? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-282 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-282/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-282.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-282.xml 21 CFR 1.282 21CFR1.282 Section 1.282; What must you do if information changes after you have received confirmation of a prior notice from FDA? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-282 55 Section 1.282 section 1.282 Consequences false Consequences http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id56 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id56/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id56.pdf 21 CFR 21CFR Consequences Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartI-subjectgroup-id56 56 subjgrp What happens to food that is imported or offered for import without adequate prior notice? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-283 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-283/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-283.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-283.xml 21 CFR 1.283 21CFR1.283 Section 1.283; What happens to food that is imported or offered for import without adequate prior notice? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-283 57 Section 1.283 section 1.283 68 FR 59070, Oct. 10, 2003; 69 FR 4851, 4852, Feb. 2, 2004 Consequences false
United States Code Title 19 Section 1490 19 U.S.C. 1490 United States Code Title 21 Section 381(m)(1) 21 U.S.C. 381(m)(1) Code of Federal Regulations Title 19 Part 127 19 CFR Part 127 Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4851 69 FR. 4851 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-284 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-284/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-284.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-284.xml 21 CFR 1.284 21CFR1.284 Section 1.284; What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-284 58 Section 1.284 section 1.284 68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004 Consequences false
United States Code Title 21 Section 331(ee) Title 21 Section 331 Title 21 Section 332 Title 21 Section 333 Title 21 Section 335a 21 U.S.C. 331(ee) 21 U.S.C. 331 21 U.S.C. 332 21 U.S.C. 333 21 U.S.C. 335a Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4852 69 FR. 4852 What happens to food that is imported or offered for import from unregistered facilities that are required to register under 21 CFR part 1, subpart H? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-285 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-285/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-285.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-285.xml 21 CFR 1.285 21CFR1.285 Section 1.285; What happens to food that is imported or offered for import from unregistered facilities that are required to register under 21 CFR part 1, subpart H? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Prior Notice of Imported Food Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-285 59 Section 1.285 section 1.285 68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004 Consequences false
United States Code Title 19 Section 1490 19 U.S.C. 1490 United States Code Title 21 Section 350d Title 21 Section 381(b) 21 U.S.C. 350d 21 U.S.C. 381(b) Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Code of Federal Regulations Title 21 Part 1 21 CFR Part 1 Federal Register Volume 68 Page 59070 68 FR. 59070 Federal Register Volume 69 Page 4852 69 FR. 4852 Establishment, Maintenance, and Availability of Records http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartJ.xml 21 CFR J 21CFR Subpart J; Establishment, Maintenance, and Availability of Records Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ 60 Subpart J subpart J 69 FR 71651, Dec. 9, 2004, unless otherwise noted. General Provisions false Federal Register Volume 69 Page 71651 69 FR. 71651 General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id61 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id61/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id61.pdf 21 CFR 21CFR General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id61 61 subjgrp Who is subject to this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-326 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-326/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-326.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-326.xml 21 CFR 1.326 21CFR1.326 Section 1.326; Who is subject to this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-326 62 Section 1.326 section 1.326 General Provisions false Who is excluded from all or part of the regulations in this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-327 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-327/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-327.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-327.xml 21 CFR 1.327 21CFR1.327 Section 1.327; Who is excluded from all or part of the regulations in this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-327 63 Section 1.327 section 1.327 General Provisions false
United States Code Title 21 Section 451et seq. Title 21 Section 601et seq. Title 21 Section 1031et seq. 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. 21 U.S.C. 1031et seq. What definitions apply to this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-328 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-328/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-328.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-328.xml 21 CFR 1.328 21CFR1.328 Section 1.328; What definitions apply to this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-328 64 Section 1.328 section 1.328 General Provisions false
United States Code Title 21 Section 321 Title 21 Section 348(h)(6) 21 U.S.C. 321 21 U.S.C. 348(h)(6) United States Code Title 26 Section 501(c)(3) 26 U.S.C. 501(c)(3) Do other statutory provisions and regulations apply? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-329 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-329/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-329.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-329.xml 21 CFR 1.329 21CFR1.329 Section 1.329; Do other statutory provisions and regulations apply? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-329 65 Section 1.329 section 1.329 General Provisions false Code of Federal Regulations Title 21 Part 11.3 21 CFR Part 11.3 Can existing records satisfy the requirements of this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-330 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-330/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-330.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-330.xml 21 CFR 1.330 21CFR1.330 Section 1.330; Can existing records satisfy the requirements of this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-330 66 Section 1.330 section 1.330 Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Previous Sources of Food false Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Previous Sources of Food http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id67 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id67/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id67.pdf 21 CFR 21CFR Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Previous Sources of Food Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id67 67 subjgrp What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-337 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-337/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-337.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-337.xml 21 CFR 1.337 21CFR1.337 Section 1.337; What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-337 68 Section 1.337 section 1.337 Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food false Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id69 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id69/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id69.pdf 21 CFR 21CFR Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id69 69 subjgrp What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-345 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-345/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-345.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-345.xml 21 CFR 1.345 21CFR1.345 Section 1.345; What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-345 70 Section 1.345 section 1.345 Requirements for Transporters To Establish and Maintain Records false Requirements for Transporters to Establish and Maintain Records http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id71 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id71/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id71.pdf 21 CFR 21CFR Requirements for Transporters to Establish and Maintain Records Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id71 71 subjgrp What information must transporters establish and maintain? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-352 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-352/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-352.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-352.xml 21 CFR 1.352 21CFR1.352 Section 1.352; What information must transporters establish and maintain? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-352 72 Section 1.352 section 1.352 General Requirements false Code of Federal Regulations Title 49 Part 373.103 49 CFR Part 373.103 Code of Federal Regulations Title 49 Part 1035.2 49 CFR Part 1035.2 General Requirements http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id73 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id73/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id73.pdf 21 CFR 21CFR General Requirements Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id73 73 subjgrp What are the record retention requirements? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-360 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-360/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-360.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-360.xml 21 CFR 1.360 21CFR1.360 Section 1.360; What are the record retention requirements? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-360 74 Section 1.360 section 1.360 General Requirements false What are the record availability requirements? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-361 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-361/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-361.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-361.xml 21 CFR 1.361 21CFR1.361 Section 1.361; What are the record availability requirements? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-361 75 Section 1.361 section 1.361 General Requirements false
United States Code Title 21 Section 350c Title 21 Section 374(a) 21 U.S.C. 350c 21 U.S.C. 374(a) What records are excluded from this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-362 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-362/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-362.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-362.xml 21 CFR 1.362 21CFR1.362 Section 1.362; What records are excluded from this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-362 76 Section 1.362 section 1.362 General Requirements false What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-363 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-363/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-363.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-363.xml 21 CFR 1.363 21CFR1.363 Section 1.363; What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-363 77 Section 1.363 section 1.363 69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8726, Feb. 23, 2005 Compliance Dates false Federal Register Volume 69 Page 71651 69 FR. 71651 Federal Register Volume 70 Page 8726 70 FR. 8726 Compliance Dates http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id78 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id78/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id78.pdf 21 CFR 21CFR Compliance Dates Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartJ-subjectgroup-id78 78 subjgrp What are the compliance dates for this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-368 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-368/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-368.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-368.xml 21 CFR 1.368 21CFR1.368 Section 1.368; What are the compliance dates for this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart J Establishment, Maintenance, and Availability of Records Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-368 79 Section 1.368 section 1.368 69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8727, Feb. 23, 2005 Compliance Dates false Federal Register Volume 69 Page 71651 69 FR. 71651 Federal Register Volume 70 Page 8727 70 FR. 8727 Administrative Detention of Food for Human or Animal Consumption http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartK.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part1-subpartK.xml 21 CFR K 21CFR Subpart K; Administrative Detention of Food for Human or Animal Consumption Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartK 80 Subpart K subpart K 69 FR 31701, June 4, 2004, unless otherwise noted. General Provisions false Federal Register Volume 69 Page 31701 69 FR. 31701 General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id81 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id81/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id81.pdf 21 CFR 21CFR General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id81 81 subjgrp What definitions apply to this subpart? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-377 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-377/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-377.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-377.xml 21 CFR 1.377 21CFR1.377 Section 1.377; What definitions apply to this subpart? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-377 82 Section 1.377 section 1.377 General Provisions false
United States Code Title 21 Section 321(f) Title 21 Section 321 21 U.S.C. 321(f) 21 U.S.C. 321 What criteria does FDA use to order a detention? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-378 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-378/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-378.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-378.xml 21 CFR 1.378 21CFR1.378 Section 1.378; What criteria does FDA use to order a detention? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-378 83 Section 1.378 section 1.378 General Provisions false How long may FDA detain an article of food? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-379 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-379/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-379.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-379.xml 21 CFR 1.379 21CFR1.379 Section 1.379; How long may FDA detain an article of food? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-379 84 Section 1.379 section 1.379 General Provisions false Where and under what conditions must the detained article of food be held? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-380 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-380/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-380.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-380.xml 21 CFR 1.380 21CFR1.380 Section 1.380; Where and under what conditions must the detained article of food be held? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-380 85 Section 1.380 section 1.380 General Provisions false
United States Code Title 21 Section 331 21 U.S.C. 331 May a detained article of food be delivered to another entity or transferred to another location? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-381 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-381/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-381.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-381.xml 21 CFR 1.381 21CFR1.381 Section 1.381; May a detained article of food be delivered to another entity or transferred to another location? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-381 86 Section 1.381 section 1.381 General Provisions false
United States Code Title 21 Section 334(h) Title 21 Section 381(b) 21 U.S.C. 334(h) 21 U.S.C. 381(b) What labeling or marking requirements apply to a detained article of food? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-382 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-382/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-382.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-382.xml 21 CFR 1.382 21CFR1.382 Section 1.382; What labeling or marking requirements apply to a detained article of food? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-382 87 Section 1.382 section 1.382 General Provisions false What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-383 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-383/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-383.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-383.xml 21 CFR 1.383 21CFR1.383 Section 1.383; What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-383 88 Section 1.383 section 1.383 General Provisions false When does a detention order terminate? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-384 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-384/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-384.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-384.xml 21 CFR 1.384 21CFR1.384 Section 1.384; When does a detention order terminate? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-384 89 Section 1.384 section 1.384 How Does FDA Order a Detention? false How Does Fda Order A Detention? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id90 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id90/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id90.pdf 21 CFR 21CFR How Does Fda Order A Detention? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id90 90 subjgrp Who approves a detention order? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-391 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-391/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-391.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-391.xml 21 CFR 1.391 21CFR1.391 Section 1.391; Who approves a detention order? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-391 91 Section 1.391 section 1.391 How Does Fda Order A Detention? false Who receives a copy of the detention order? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-392 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-392/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-392.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-392.xml 21 CFR 1.392 21CFR1.392 Section 1.392; Who receives a copy of the detention order? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-392 92 Section 1.392 section 1.392 How Does Fda Order A Detention? false What information must FDA include in the detention order? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-393 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-393/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-393.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-393.xml 21 CFR 1.393 21CFR1.393 Section 1.393; What information must FDA include in the detention order? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-393 93 Section 1.393 section 1.393 What Is the Appeal Process for a Detention Order? false What Is the Appeal Process for A Detention Order? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id94 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id94/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id94.pdf 21 CFR 21CFR What Is the Appeal Process for A Detention Order? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS NODE CFR-2007-title21-vol1-part1-subpartK-subjectgroup-id94 94 subjgrp Who is entitled to appeal? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-401 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-401/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-401.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-401.xml 21 CFR 1.401 21CFR1.401 Section 1.401; Who is entitled to appeal? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-401 95 Section 1.401 section 1.401 What Is the Appeal Process for A Detention Order? false What are the requirements for submitting an appeal? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-402 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-402/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-402.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-402.xml 21 CFR 1.402 21CFR1.402 Section 1.402; What are the requirements for submitting an appeal? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-402 96 Section 1.402 section 1.402 What Is the Appeal Process for A Detention Order? false
United States Code Title 21 Section 276 21 U.S.C. 276 What requirements apply to an informal hearing? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-403 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-403/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-403.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-403.xml 21 CFR 1.403 21CFR1.403 Section 1.403; What requirements apply to an informal hearing? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-403 97 Section 1.403 section 1.403 What Is the Appeal Process for A Detention Order? false Who serves as the presiding officer for an appeal, and for an informal hearing? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-404 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-404/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-404.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-404.xml 21 CFR 1.404 21CFR1.404 Section 1.404; Who serves as the presiding officer for an appeal, and for an informal hearing? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-404 98 Section 1.404 section 1.404 What Is the Appeal Process for A Detention Order? false When does FDA have to issue a decision on an appeal? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-405 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-405/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-405.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-405.xml 21 CFR 1.405 21CFR1.405 Section 1.405; When does FDA have to issue a decision on an appeal? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-405 99 Section 1.405 section 1.405 What Is the Appeal Process for A Detention Order? false
United States Code Title 5 Section 702 5 U.S.C. 702 How will FDA handle classified information in an informal hearing? http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-406 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec1-406/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec1-406.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec1-406.xml 21 CFR 1.406 21CFR1.406 Section 1.406; How will FDA handle classified information in an informal hearing? Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart K Administrative Detention of Food for Human or Animal Consumption Part 1 GENERAL ENFORCEMENT REGULATIONS CONTENT CFR-2007-title21-vol1-sec1-406 100 Section 1.406 section 1.406 What Is the Appeal Process for A Detention Order? false GENERAL ADMINISTRATIVE RULINGS AND DECISIONS http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2.xml 21 CFR 2 21CFR2 Part 2; GENERAL ADMINISTRATIVE RULINGS AND DECISIONS Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part2 101 Part 2 part 2 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. 42 FR 15559, Mar. 22, 1977, unless otherwise noted. false
United States Code Title 15 Section 402 Title 15 Section 402 Title 15 Section 409 Title 15 Section 409 15 U.S.C. 402 15 U.S.C. 402 15 U.S.C. 409 15 U.S.C. 409 United States Code Title 21 Section 321 Title 21 Section 321 Title 21 Section 331 Title 21 Section 331 Title 21 Section 335 Title 21 Section 335 Title 21 Section 342 Title 21 Section 342 Title 21 Section 343 Title 21 Section 343 Title 21 Section 346a Title 21 Section 346a Title 21 Section 348 Title 21 Section 348 Title 21 Section 351 Title 21 Section 351 Title 21 Section 352 Title 21 Section 352 Title 21 Section 355 Title 21 Section 355 Title 21 Section 360b Title 21 Section 360b Title 21 Section 361 Title 21 Section 361 Title 21 Section 362 Title 21 Section 362 Title 21 Section 371 Title 21 Section 371 Title 21 Section 372 Title 21 Section 372 Title 21 Section 374 Title 21 Section 374 21 U.S.C. 321 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 331 21 U.S.C. 335 21 U.S.C. 335 21 U.S.C. 342 21 U.S.C. 342 21 U.S.C. 343 21 U.S.C. 343 21 U.S.C. 346a 21 U.S.C. 346a 21 U.S.C. 348 21 U.S.C. 348 21 U.S.C. 351 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 355 21 U.S.C. 360b 21 U.S.C. 360b 21 U.S.C. 361 21 U.S.C. 361 21 U.S.C. 362 21 U.S.C. 362 21 U.S.C. 371 21 U.S.C. 371 21 U.S.C. 372 21 U.S.C. 372 21 U.S.C. 374 21 U.S.C. 374 United States Code Title 42 Section 7671et seq. Title 42 Section 7671et seq. 42 U.S.C. 7671et seq. 42 U.S.C. 7671et seq. Federal Register Volume 42 Page 15559 42 FR. 15559 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-toc-id102 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-toc-id102/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2-toc-id102.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2-toc-id102.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS TOC CFR-2007-title21-vol1-part2-toc-id102 102 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS NODE CFR-2007-title21-vol1-part2-subpartA 103 Subpart A subpart A false Imminent hazard to the public health. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-5.xml 21 CFR 2.5 21CFR2.5 Section 2.5; Imminent hazard to the public health. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-5 104 Section 2.5 section 2.5 false Examination and investigation samples. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-10.xml 21 CFR 2.10 21CFR2.10 Section 2.10; Examination and investigation samples. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-10 105 Section 2.10 section 2.10 42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998 false Federal Register Volume 42 Page 15559 42 FR. 15559 Federal Register Volume 63 Page 51299 63 FR. 51299 Methods of analysis. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-19 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-19/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-19.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-19.xml 21 CFR 2.19 21CFR2.19 Section 2.19; Methods of analysis. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-19 106 Section 2.19 section 2.19 42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54 FR 9034, Mar. 3, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005 false Federal Register Volume 42 Page 15559 42 FR. 15559 Federal Register Volume 47 Page 946 47 FR. 946 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 70 Page 40880 70 FR. 40880 Federal Register Volume 70 Page 67651 70 FR. 67651 Human and Animal Foods http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2-subpartB.xml 21 CFR B 21CFR Subpart B; Human and Animal Foods Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS NODE CFR-2007-title21-vol1-part2-subpartB 107 Subpart B subpart B false Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-25 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-25/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-25.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-25.xml 21 CFR 2.25 21CFR2.25 Section 2.25; Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Human and Animal Foods Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-25 108 Section 2.25 section 2.25 false
United States Code Title 7 Section 1551et seq. 7 U.S.C. 1551et seq. United States Statutes At large Volume 53 Page 1275 53 Stat. 1275 United States Statutes At large Volume 72 Page 476 72 Stat. 476 Use of secondhand containers for the shipment or storage of food and animal feed. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-35 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-35/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-35.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-35.xml 21 CFR 2.35 21CFR2.35 Section 2.35; Use of secondhand containers for the shipment or storage of food and animal feed. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Human and Animal Foods Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-35 109 Section 2.35 section 2.35 false Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2-subpartC.xml 21 CFR C 21CFR Subparts C-E; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS NODE CFR-2007-title21-vol1-part2-subpartC 110 Subparts C-E subpart C false Caustic Poisons http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartF http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartF/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2-subpartF.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2-subpartF.xml 21 CFR F 21CFR Subpart F; Caustic Poisons Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS NODE CFR-2007-title21-vol1-part2-subpartF 111 Subpart F subpart F false Definition of ammonia under Federal Caustic Poison Act. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-110 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-110/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-110.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-110.xml 21 CFR 2.110 21CFR2.110 Section 2.110; Definition of ammonia under Federal Caustic Poison Act. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart F Caustic Poisons Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-110 112 Section 2.110 section 2.110 false Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartG http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part2-subpartG/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part2-subpartG.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part2-subpartG.xml 21 CFR G 21CFR Subpart G; Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS NODE CFR-2007-title21-vol1-part2-subpartG 113 Subpart G subpart G false Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-125 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec2-125/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec2-125.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec2-125.xml 21 CFR 2.125 21CFR2.125 Section 2.125; Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act Part 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS CONTENT CFR-2007-title21-vol1-sec2-125 114 Section 2.125 section 2.125 67 FR 48384, July 24, 2002 false Code of Federal Regulations Title 40 Part 82 40 CFR Part 82 Code of Federal Regulations Title 40 Part 82 40 CFR Part 82 Federal Register Volume 67 Page 48384 67 FR. 48384 Federal Register Volume 70 Page 17192 70 FR. 17192 Federal Register Volume 71 Page 70873 71 FR. 70873 PRODUCT JURISDICTION http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part3.xml 21 CFR 3 21CFR3 Part 3; PRODUCT JURISDICTION Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part3 115 Part 3 part 3 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264. 56 FR 58756, Nov. 21, 1991, unless otherwise noted. false
United States Code Title 21 Section 321 Title 21 Section 321 Title 21 Section 351 Title 21 Section 351 Title 21 Section 353 Title 21 Section 353 Title 21 Section 355 Title 21 Section 355 Title 21 Section 360bbb-2 Title 21 Section 360bbb-2 Title 21 Section 360c-360f Title 21 Section 360c-360f Title 21 Section 360 Title 21 Section 360 Title 21 Section 360gg-360ss Title 21 Section 360gg-360ss Title 21 Section 360h-360j Title 21 Section 360h-360j Title 21 Section 371(a) Title 21 Section 371(a) Title 21 Section 379e Title 21 Section 379e Title 21 Section 381 Title 21 Section 381 Title 21 Section 394 Title 21 Section 394 21 U.S.C. 321 21 U.S.C. 321 21 U.S.C. 351 21 U.S.C. 351 21 U.S.C. 353 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 355 21 U.S.C. 360bbb-2 21 U.S.C. 360bbb-2 21 U.S.C. 360c-360f 21 U.S.C. 360c-360f 21 U.S.C. 360 21 U.S.C. 360 21 U.S.C. 360gg-360ss 21 U.S.C. 360gg-360ss 21 U.S.C. 360h-360j 21 U.S.C. 360h-360j 21 U.S.C. 371(a) 21 U.S.C. 371(a) 21 U.S.C. 379e 21 U.S.C. 379e 21 U.S.C. 381 21 U.S.C. 381 21 U.S.C. 394 21 U.S.C. 394 United States Code Title 42 Section 216 Title 42 Section 216 Title 42 Section 262 Title 42 Section 262 Title 42 Section 264 Title 42 Section 264 42 U.S.C. 216 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 264 42 U.S.C. 264 Federal Register Volume 56 Page 58756 56 FR. 58756 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3-toc-id116 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3-toc-id116/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part3-toc-id116.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part3-toc-id116.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 3 PRODUCT JURISDICTION TOC CFR-2007-title21-vol1-part3-toc-id116 116 toc Assignment of Agency Component for Review of Premarket Applications http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part3-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part3-subpartA.xml 21 CFR A 21CFR Subpart A; Assignment of Agency Component for Review of Premarket Applications Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 3 PRODUCT JURISDICTION NODE CFR-2007-title21-vol1-part3-subpartA 117 Subpart A subpart A false Purpose. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-1.xml 21 CFR 3.1 21CFR3.1 Section 3.1; Purpose. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-1 118 Section 3.1 section 3.1 56 FR 58756, Nov. 21, 1991, as amended by 68 FR 37077, June 23, 2003 false United States Public Law 101-629 Public Law 101-629 United States Public Law 107-250 Public Law 107-250 Federal Register Volume 56 Page 58756 56 FR. 58756 Federal Register Volume 68 Page 37077 68 FR. 37077 Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-2 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-2/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-2.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-2.xml 21 CFR 3.2 21CFR3.2 Section 3.2; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-2 119 Section 3.2 section 3.2 56 FR 58756, Nov. 21, 1991 as amended at 64 FR 398, Jan. 5, 1999; 64 FR 56447, Oct. 20, 1999; 68 FR 37077, June 23, 2003; 70 FR 49861, Aug. 25, 2005 false
United States Code Title 42 Section 262(a) 42 U.S.C. 262(a) Federal Register Volume 56 Page 58756 56 FR. 58756 Federal Register Volume 64 Page 398 64 FR. 398 Federal Register Volume 64 Page 56447 64 FR. 56447 Federal Register Volume 68 Page 37077 68 FR. 37077 Federal Register Volume 70 Page 49861 70 FR. 49861 Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-3.xml 21 CFR 3.3 21CFR3.3 Section 3.3; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-3 120 Section 3.3 section 3.3 false Designated agency component. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-4 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-4/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-4.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-4.xml 21 CFR 3.4 21CFR3.4 Section 3.4; Designated agency component. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-4 121 Section 3.4 section 3.4 56 FR 58756, Nov. 21, 1991, as amended at 70 FR 49861, Aug. 25, 2005 false Federal Register Volume 56 Page 58756 56 FR. 58756 Federal Register Volume 70 Page 49861 70 FR. 49861 Procedures for identifying the designated agency component. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-5.xml 21 CFR 3.5 21CFR3.5 Section 3.5; Procedures for identifying the designated agency component. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-5 122 Section 3.5 section 3.5 56 FR 58756, Nov. 21, 1991, as amended at 68 FR 24879, May 9, 2003 false Federal Register Volume 56 Page 58756 56 FR. 58756 Federal Register Volume 68 Page 24879 68 FR. 24879 Product jurisdiction officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-6 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-6/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-6.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-6.xml 21 CFR 3.6 21CFR3.6 Section 3.6; Product jurisdiction officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-6 123 Section 3.6 section 3.6 68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006 false Federal Register Volume 68 Page 37077 68 FR. 37077 Federal Register Volume 71 Page 16033 71 FR. 16033 Request for designation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-7 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-7/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-7.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-7.xml 21 CFR 3.7 21CFR3.7 Section 3.7; Request for designation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-7 124 Section 3.7 section 3.7 56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003; 70 FR 49861, Aug. 25, 2005 false Federal Register Volume 56 Page 58756 56 FR. 58756 Federal Register Volume 68 Page 37077 68 FR. 37077 Federal Register Volume 70 Page 49861 70 FR. 49861 Letter of designation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-8 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-8/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-8.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-8.xml 21 CFR 3.8 21CFR3.8 Section 3.8; Letter of designation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-8 125 Section 3.8 section 3.8 false Effect of letter of designation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-9 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-9/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-9.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-9.xml 21 CFR 3.9 21CFR3.9 Section 3.9; Effect of letter of designation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-9 126 Section 3.9 section 3.9 56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003 false Federal Register Volume 56 Page 58756 56 FR. 58756 Federal Register Volume 68 Page 37077 68 FR. 37077 Stay of review time. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec3-10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec3-10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec3-10.xml 21 CFR 3.10 21CFR3.10 Section 3.10; Stay of review time. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A Assignment of Agency Component for Review of Premarket Applications Part 3 PRODUCT JURISDICTION CONTENT CFR-2007-title21-vol1-sec3-10 127 Section 3.10 section 3.10 false Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part3-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part3-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part3-subpartB.xml 21 CFR B 21CFR Subpart B; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 3 PRODUCT JURISDICTION NODE CFR-2007-title21-vol1-part3-subpartB 128 Subpart B subpart B false ORGANIZATION http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part5.xml 21 CFR 5 21CFR5 Part 5; ORGANIZATION Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part5 129 Part 5 part 5 5 U.S.C. 552; 21 U.S.C. 301-397. 69 FR 17286, Apr. 2, 2004, unless otherwise noted. false
United States Code Title 5 Section 552 Title 5 Section 552 5 U.S.C. 552 5 U.S.C. 552 United States Code Title 21 Section 301-397 Title 21 Section 301-397 21 U.S.C. 301-397 21 U.S.C. 301-397 Federal Register Volume 69 Page 17286 69 FR. 17286 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5-toc-id130 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5-toc-id130/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part5-toc-id130.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part5-toc-id130.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 5 ORGANIZATION TOC CFR-2007-title21-vol1-part5-toc-id130 130 toc Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part5-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part5-subpartA.xml 21 CFR A 21CFR Subparts A-L; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 5 ORGANIZATION NODE CFR-2007-title21-vol1-part5-subpartA 131 Subparts A-L subpart A false Organization http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5-subpartM http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part5-subpartM/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part5-subpartM.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part5-subpartM.xml 21 CFR M 21CFR Subpart M; Organization Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 5 ORGANIZATION NODE CFR-2007-title21-vol1-part5-subpartM 132 Subpart M subpart M false Headquarters. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1100 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1100/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec5-1100.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec5-1100.xml 21 CFR 5.1100 21CFR5.1100 Section 5.1100; Headquarters. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart M Organization Part 5 ORGANIZATION CONTENT CFR-2007-title21-vol1-sec5-1100 133 Section 5.1100 section 5.1100 69 FR 17286, Apr. 2, 2004, as amended at 69 FR 52600, Aug. 27, 2004 false Federal Register Volume 69 Page 17286 69 FR. 17286 Federal Register Volume 69 Page 52600 69 FR. 52600 Chief Counsel, Food and Drug Administration. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1105 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1105/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec5-1105.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec5-1105.xml 21 CFR 5.1105 21CFR5.1105 Section 5.1105; Chief Counsel, Food and Drug Administration. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart M Organization Part 5 ORGANIZATION CONTENT CFR-2007-title21-vol1-sec5-1105 134 Section 5.1105 section 5.1105 false FDA public information offices. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1110 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1110/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec5-1110.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec5-1110.xml 21 CFR 5.1110 21CFR5.1110 Section 5.1110; FDA public information offices. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart M Organization Part 5 ORGANIZATION CONTENT CFR-2007-title21-vol1-sec5-1110 135 Section 5.1110 section 5.1110 false Field structure. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1115 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec5-1115/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec5-1115.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec5-1115.xml 21 CFR 5.1115 21CFR5.1115 Section 5.1115; Field structure. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart M Organization Part 5 ORGANIZATION CONTENT CFR-2007-title21-vol1-sec5-1115 136 Section 5.1115 section 5.1115 false United States Private Law 00901-3223 Private Law 00901-3223 ENFORCEMENT POLICY http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7.xml 21 CFR 7 21CFR7 Part 7; ENFORCEMENT POLICY Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part7 137 Part 7 part 7 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264. 42 FR 15567, Mar. 22, 1977, unless otherwise noted. false
United States Code Title 21 Section 321-393 Title 21 Section 321-393 21 U.S.C. 321-393 21 U.S.C. 321-393 United States Code Title 42 Section 241 Title 42 Section 241 Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b-263n Title 42 Section 263b-263n Title 42 Section 264 Title 42 Section 264 42 U.S.C. 241 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b-263n 42 U.S.C. 263b-263n 42 U.S.C. 264 42 U.S.C. 264 Federal Register Volume 42 Page 15567 42 FR. 15567 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-toc-id138 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-toc-id138/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7-toc-id138.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7-toc-id138.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 7 ENFORCEMENT POLICY TOC CFR-2007-title21-vol1-part7-toc-id138 138 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 7 ENFORCEMENT POLICY NODE CFR-2007-title21-vol1-part7-subpartA 139 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-1.xml 21 CFR 7.1 21CFR7.1 Section 7.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-1 140 Section 7.1 section 7.1 43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000 false
United States Code Title 21 Section 301et seq. 21 U.S.C. 301et seq. Federal Register Volume 43 Page 26218 43 FR. 26218 Federal Register Volume 65 Page 56476 65 FR. 56476 Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-3.xml 21 CFR 7.3 21CFR7.3 Section 7.3; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-3 141 Section 7.3 section 7.3 42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, 1979 false Federal Register Volume 42 Page 15567 42 FR. 15567 Federal Register Volume 43 Page 26218 43 FR. 26218 Federal Register Volume 44 Page 12167 44 FR. 12167 Guaranty. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-12 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-12/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-12.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-12.xml 21 CFR 7.12 21CFR7.12 Section 7.12; Guaranty. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-12 142 Section 7.12 section 7.12 false Suggested forms of guaranty. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-13 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-13/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-13.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-13.xml 21 CFR 7.13 21CFR7.13 Section 7.13; Suggested forms of guaranty. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-13 143 Section 7.13 section 7.13 false Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7-subpartB.xml 21 CFR B 21CFR Subpart B; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 7 ENFORCEMENT POLICY NODE CFR-2007-title21-vol1-part7-subpartB 144 Subpart B subpart B false Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7-subpartC.xml 21 CFR C 21CFR Subpart C; Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 7 ENFORCEMENT POLICY NODE CFR-2007-title21-vol1-part7-subpartC 145 Subpart C subpart C 43 FR 26218, June 16, 1978, unless otherwise noted. false Federal Register Volume 43 Page 26218 43 FR. 26218 Recall policy. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-40.xml 21 CFR 7.40 21CFR7.40 Section 7.40; Recall policy. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-40 146 Section 7.40 section 7.40 43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000 false Federal Register Volume 43 Page 26218 43 FR. 26218 Federal Register Volume 65 Page 56476 65 FR. 56476 Health hazard evaluation and recall classification. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-41 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-41/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-41.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-41.xml 21 CFR 7.41 21CFR7.41 Section 7.41; Health hazard evaluation and recall classification. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-41 147 Section 7.41 section 7.41 false Recall strategy. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-42 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-42/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-42.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-42.xml 21 CFR 7.42 21CFR7.42 Section 7.42; Recall strategy. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-42 148 Section 7.42 section 7.42 43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, 1994; 68 FR 24879, May 9, 2003 false Federal Register Volume 43 Page 26218 43 FR. 26218 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 59 Page 14363 59 FR. 14363 Federal Register Volume 68 Page 24879 68 FR. 24879 Food and Drug Administration-requested recall. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-45 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-45/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-45.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-45.xml 21 CFR 7.45 21CFR7.45 Section 7.45; Food and Drug Administration-requested recall. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-45 149 Section 7.45 section 7.45 43 FR 26218, June 16, 1978, as amended at 69 FR 17290, Apr. 2, 2004 false Federal Register Volume 43 Page 26218 43 FR. 26218 Federal Register Volume 69 Page 17290 69 FR. 17290 Firm-initiated recall. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-46 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-46/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-46.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-46.xml 21 CFR 7.46 21CFR7.46 Section 7.46; Firm-initiated recall. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-46 150 Section 7.46 section 7.46 false Recall communications. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-49 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-49/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-49.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-49.xml 21 CFR 7.49 21CFR7.49 Section 7.49; Recall communications. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-49 151 Section 7.49 section 7.49 false Public notification of recall. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-50 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-50/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-50.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-50.xml 21 CFR 7.50 21CFR7.50 Section 7.50; Public notification of recall. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-50 152 Section 7.50 section 7.50 false Recall status reports. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-53 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-53/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-53.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-53.xml 21 CFR 7.53 21CFR7.53 Section 7.53; Recall status reports. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-53 153 Section 7.53 section 7.53 false Termination of a recall. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-55 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-55/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-55.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-55.xml 21 CFR 7.55 21CFR7.55 Section 7.55; Termination of a recall. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-55 154 Section 7.55 section 7.55 false General industry guidance. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-59 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-59/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-59.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-59.xml 21 CFR 7.59 21CFR7.59 Section 7.59; General industry guidance. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-59 155 Section 7.59 section 7.59 false Reserved http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartD http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartD/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7-subpartD.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7-subpartD.xml 21 CFR D 21CFR Subpart D; Reserved Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 7 ENFORCEMENT POLICY NODE CFR-2007-title21-vol1-part7-subpartD 156 Subpart D subpart D false Criminal Violations http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartE http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part7-subpartE/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part7-subpartE.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part7-subpartE.xml 21 CFR E 21CFR Subpart E; Criminal Violations Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 7 ENFORCEMENT POLICY NODE CFR-2007-title21-vol1-part7-subpartE 157 Subpart E subpart E false Opportunity for presentation of views before report of criminal violation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-84 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-84/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-84.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-84.xml 21 CFR 7.84 21CFR7.84 Section 7.84; Opportunity for presentation of views before report of criminal violation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Criminal Violations Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-84 158 Section 7.84 section 7.84 44 FR 12167, Mar. 6, 1979 false Federal Register Volume 44 Page 12167 44 FR. 12167 Conduct of a presentation of views before report of criminal violation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-85 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-85/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-85.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-85.xml 21 CFR 7.85 21CFR7.85 Section 7.85; Conduct of a presentation of views before report of criminal violation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Criminal Violations Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-85 159 Section 7.85 section 7.85 44 FR 12168, Mar. 6, 1979 false
United States Code Title 21 Section 333(c) 21 U.S.C. 333(c) Federal Register Volume 44 Page 12168 44 FR. 12168 Records related to opportunities for presentation of views conducted before report of criminal violation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-87 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec7-87/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec7-87.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec7-87.xml 21 CFR 7.87 21CFR7.87 Section 7.87; Records related to opportunities for presentation of views conducted before report of criminal violation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Criminal Violations Part 7 ENFORCEMENT POLICY CONTENT CFR-2007-title21-vol1-sec7-87 160 Section 7.87 section 7.87 44 FR 12168, Mar. 6, 1979 false Federal Register Volume 44 Page 12168 44 FR. 12168 ADMINISTRATIVE PRACTICES AND PROCEDURES http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part10.xml 21 CFR 10 21CFR10 Part 10; ADMINISTRATIVE PRACTICES AND PROCEDURES Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part10 161 Part 10 part 10 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. 44 FR 22323, Apr. 13, 1979, unless otherwise noted. Nomenclature changes to part 10 appear at 68 FR 24879, May 9, 2003. false
United States Code Title 5 Section 551-558 Title 5 Section 551-558 Title 5 Section 701-706 Title 5 Section 701-706 5 U.S.C. 551-558 5 U.S.C. 551-558 5 U.S.C. 701-706 5 U.S.C. 701-706 United States Code Title 15 Section 1451-1461 Title 15 Section 1451-1461 15 U.S.C. 1451-1461 15 U.S.C. 1451-1461 United States Code Title 21 Section 141-149 Title 21 Section 141-149 Title 21 Section 321-397 Title 21 Section 321-397 Title 21 Section 467f Title 21 Section 467f Title 21 Section 679 Title 21 Section 679 Title 21 Section 821 Title 21 Section 821 Title 21 Section 1034 Title 21 Section 1034 21 U.S.C. 141-149 21 U.S.C. 141-149 21 U.S.C. 321-397 21 U.S.C. 321-397 21 U.S.C. 467f 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 821 21 U.S.C. 1034 21 U.S.C. 1034 United States Code Title 28 Section 2112 Title 28 Section 2112 28 U.S.C. 2112 28 U.S.C. 2112 United States Code Title 42 Section 201 Title 42 Section 201 Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b Title 42 Section 263b Title 42 Section 264 Title 42 Section 264 42 U.S.C. 201 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b 42 U.S.C. 263b 42 U.S.C. 264 42 U.S.C. 264 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 68 Page 24879 68 FR. 24879 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-toc-id162 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-toc-id162/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part10-toc-id162.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part10-toc-id162.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES TOC CFR-2007-title21-vol1-part10-toc-id162 162 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part10-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part10-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES NODE CFR-2007-title21-vol1-part10-subpartA 163 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-1.xml 21 CFR 10.1 21CFR10.1 Section 10.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-1 164 Section 10.1 section 10.1 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 69 FR 17290, Apr. 2, 2004 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 69 Page 17290 69 FR. 17290 Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-3.xml 21 CFR 10.3 21CFR10.3 Section 10.3; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-3 165 Section 10.3 section 10.3 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, 1994; 69 FR 17290, Apr. 2, 2004 false
United States Code Title 5 Section 3105 5 U.S.C. 3105 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 50 Page 8994 50 FR. 8994 Federal Register Volume 54 Page 6886 54 FR. 6886 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 59 Page 14363 59 FR. 14363 Federal Register Volume 69 Page 17290 69 FR. 17290 Summaries of administrative practices and procedures. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-10.xml 21 CFR 10.10 21CFR10.10 Section 10.10; Summaries of administrative practices and procedures. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-10 166 Section 10.10 section 10.10 false Waiver, suspension, or modification of procedural requirements. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-19 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-19/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-19.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-19.xml 21 CFR 10.19 21CFR10.19 Section 10.19; Waiver, suspension, or modification of procedural requirements. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-19 167 Section 10.19 section 10.19 false General Administrative Procedures http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part10-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part10-subpartB.xml 21 CFR B 21CFR Subpart B; General Administrative Procedures Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES NODE CFR-2007-title21-vol1-part10-subpartB 168 Subpart B subpart B false Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-20.xml 21 CFR 10.20 21CFR10.20 Section 10.20; Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-20 169 Section 10.20 section 10.20 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, 2001; 68 FR 25285, May 12, 2003 false
United States Code Title 18 Section 1001 18 U.S.C. 1001 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 49 Page 7363 49 FR. 7363 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 59 Page 14363 59 FR. 14363 Federal Register Volume 64 Page 69190 64 FR. 69190 Federal Register Volume 65 Page 56477 65 FR. 56477 Federal Register Volume 66 Page 56035 66 FR. 56035 Federal Register Volume 66 Page 66742 66 FR. 66742 Federal Register Volume 68 Page 25285 68 FR. 25285 Initiation of administrative proceedings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-25 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-25/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-25.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-25.xml 21 CFR 10.25 21CFR10.25 Section 10.25; Initiation of administrative proceedings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-25 170 Section 10.25 section 10.25 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 54 Page 9034 54 FR. 9034 Citizen petition. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-30.xml 21 CFR 10.30 21CFR10.30 Section 10.30; Citizen petition. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-30 171 Section 10.30 section 10.30 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, 2001 false Code of Federal Regulations Title 21 Part 5.10 21 CFR Part 5.10 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 57 Page 17980 57 FR. 17980 Federal Register Volume 59 Page 14364 59 FR. 14364 Federal Register Volume 62 Page 40592 62 FR. 40592 Federal Register Volume 66 Page 12848 66 FR. 12848 Federal Register Volume 66 Page 6467 66 FR. 6467 Administrative reconsideration of action. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-33 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-33/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-33.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-33.xml 21 CFR 10.33 21CFR10.33 Section 10.33; Administrative reconsideration of action. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-33 172 Section 10.33 section 10.33 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, 2001 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 59 Page 14364 59 FR. 14364 Federal Register Volume 66 Page 12848 66 FR. 12848 Federal Register Volume 66 Page 6467 66 FR. 6467 Administrative stay of action. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-35 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-35/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-35.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-35.xml 21 CFR 10.35 21CFR10.35 Section 10.35; Administrative stay of action. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-35 173 Section 10.35 section 10.35 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, 2001 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 59 Page 14364 59 FR. 14364 Federal Register Volume 66 Page 12848 66 FR. 12848 Federal Register Volume 66 Page 6468 66 FR. 6468 Promulgation of regulations for the efficient enforcement of the law. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-40.xml 21 CFR 10.40 21CFR10.40 Section 10.40; Promulgation of regulations for the efficient enforcement of the law. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-40 174 Section 10.40 section 10.40 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, 2001 false
United States Code Title 5 Section 551 Title 5 Section 552 Title 5 Section 553 5 U.S.C. 551 5 U.S.C. 552 5 U.S.C. 553 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 52 Page 36401 52 FR. 36401 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 56 Page 13758 56 FR. 13758 Federal Register Volume 62 Page 40592 62 FR. 40592 Federal Register Volume 66 Page 12848 66 FR. 12848 Federal Register Volume 66 Page 6468 66 FR. 6468 Court review of final administrative action; exhaustion of administrative remedies. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-45 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-45/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-45.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-45.xml 21 CFR 10.45 21CFR10.45 Section 10.45; Court review of final administrative action; exhaustion of administrative remedies. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-45 175 Section 10.45 section 10.45 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, 2000; 69 FR 31705, June 4, 2004 false
United States Code Title 5 Section 701et seq. 5 U.S.C. 701et seq. United States Code Title 21 Section 355(j)(2)(C) 21 U.S.C. 355(j)(2)(C) United States Code Title 28 Section 1404(a) Title 28 Section 2112(a) Title 28 Section 2201 28 U.S.C. 1404(a) 28 U.S.C. 2112(a) 28 U.S.C. 2201 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 54 Page 6886 54 FR. 6886 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 57 Page 17980 57 FR. 17980 Federal Register Volume 65 Page 56477 65 FR. 56477 Federal Register Volume 69 Page 31705 69 FR. 31705 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-50 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-50/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-50.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-50.xml 21 CFR 10.50 21CFR10.50 Section 10.50; Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-50 176 Section 10.50 section 10.50 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, 2002 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 54 Page 9034 54 FR. 9034 Federal Register Volume 58 Page 49190 58 FR. 49190 Federal Register Volume 60 Page 38626 60 FR. 38626 Federal Register Volume 63 Page 26697 63 FR. 26697 Federal Register Volume 64 Page 398 64 FR. 398 Federal Register Volume 64 Page 56448 64 FR. 56448 Federal Register Volume 67 Page 4906 67 FR. 4906 Separation of functions; ex parte communications. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-55 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-55/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-55.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-55.xml 21 CFR 10.55 21CFR10.55 Section 10.55; Separation of functions; ex parte communications. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-55 177 Section 10.55 section 10.55 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, 1999 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 50 Page 8994 50 FR. 8994 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 64 Page 398 64 FR. 398 Referral by court. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-60 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-60/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-60.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-60.xml 21 CFR 10.60 21CFR10.60 Section 10.60; Referral by court. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-60 178 Section 10.60 section 10.60 false Meetings and correspondence. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-65 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-65/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-65.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-65.xml 21 CFR 10.65 21CFR10.65 Section 10.65; Meetings and correspondence. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-65 179 Section 10.65 section 10.65 66 FR 6468, Jan. 22, 2001 false Federal Register Volume 66 Page 6468 66 FR. 6468 Documentation of significant decisions in administrative file. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-70 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-70/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-70.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-70.xml 21 CFR 10.70 21CFR10.70 Section 10.70; Documentation of significant decisions in administrative file. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-70 180 Section 10.70 section 10.70 false Internal agency review of decisions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-75 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-75/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-75.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-75.xml 21 CFR 10.75 21CFR10.75 Section 10.75; Internal agency review of decisions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-75 181 Section 10.75 section 10.75 44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63 FR 63982, Nov. 18, 1998 false
United States Code Title 42 Section 262 42 U.S.C. 262 Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 50 Page 8994 50 FR. 8994 Federal Register Volume 63 Page 63982 63 FR. 63982 Dissemination of draft Federal Register notices and regulations. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-80 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-80/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-80.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-80.xml 21 CFR 10.80 21CFR10.80 Section 10.80; Dissemination of draft Federal Register notices and regulations. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-80 182 Section 10.80 section 10.80 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999 false
United States Code Title 42 Section 263f 42 U.S.C. 263f Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 64 Page 398 64 FR. 398 Advisory opinions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-85 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-85/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-85.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-85.xml 21 CFR 10.85 21CFR10.85 Section 10.85; Advisory opinions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-85 183 Section 10.85 section 10.85 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, 2000 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 59 Page 14364 59 FR. 14364 Federal Register Volume 65 Page 56477 65 FR. 56477 Food and Drug Administration regulations, recommendations, and agreements. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-90 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-90/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-90.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-90.xml 21 CFR 10.90 21CFR10.90 Section 10.90; Food and Drug Administration regulations, recommendations, and agreements. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-90 184 Section 10.90 section 10.90 44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 FR 56477, Sept. 19, 2000 false
United States Code Title 42 Section 243 Title 42 Section 263d(b) 42 U.S.C. 243 42 U.S.C. 263d(b) Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 65 Page 56477 65 FR. 56477 Participation in outside standard-setting activities. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-95 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-95/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-95.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-95.xml 21 CFR 10.95 21CFR10.95 Section 10.95; Participation in outside standard-setting activities. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-95 185 Section 10.95 section 10.95 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, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005 false Federal Register Volume 44 Page 22323 44 FR. 22323 Federal Register Volume 46 Page 8455 46 FR. 8455 Federal Register Volume 52 Page 35064 52 FR. 35064 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 70 Page 40880 70 FR. 40880 Federal Register Volume 70 Page 67651 70 FR. 67651 Public calendar. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-100 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-100/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-100.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-100.xml 21 CFR 10.100 21CFR10.100 Section 10.100; Public calendar. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-100 186 Section 10.100 section 10.100 66 FR 6468, Jan. 22, 2001 false Federal Register Volume 66 Page 6468 66 FR. 6468 Representation by an organization. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-105 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-105/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-105.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-105.xml 21 CFR 10.105 21CFR10.105 Section 10.105; Representation by an organization. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-105 187 Section 10.105 section 10.105 false Settlement proposals. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-110 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-110/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-110.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-110.xml 21 CFR 10.110 21CFR10.110 Section 10.110; Settlement proposals. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-110 188 Section 10.110 section 10.110 false Good guidance practices. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-115 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-115/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-115.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-115.xml 21 CFR 10.115 21CFR10.115 Section 10.115; Good guidance practices. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B General Administrative Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-115 189 Section 10.115 section 10.115 65 FR 56477, Sept. 19, 2000 false Federal Register Volume 65 Page 56477 65 FR. 56477 Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part10-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part10-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part10-subpartC.xml 21 CFR C 21CFR Subpart C; Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES NODE CFR-2007-title21-vol1-part10-subpartC 190 Subpart C subpart C 49 FR 14726, Apr. 13, 1984, unless otherwise noted. false Federal Register Volume 49 Page 14726 49 FR. 14726 Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-200 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-200/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-200.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-200.xml 21 CFR 10.200 21CFR10.200 Section 10.200; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-200 191 Section 10.200 section 10.200 false Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-203 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-203/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-203.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-203.xml 21 CFR 10.203 21CFR10.203 Section 10.203; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-203 192 Section 10.203 section 10.203 49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 49 Page 14726 49 FR. 14726 Federal Register Volume 54 Page 9035 54 FR. 9035 General. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-204 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-204/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-204.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-204.xml 21 CFR 10.204 21CFR10.204 Section 10.204; General. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-204 193 Section 10.204 section 10.204 false Electronic media coverage of public administrative proceedings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-205 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-205/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-205.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-205.xml 21 CFR 10.205 21CFR10.205 Section 10.205; Electronic media coverage of public administrative proceedings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-205 194 Section 10.205 section 10.205 false Procedures for electronic media coverage of agency public administrative proceedings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-206 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec10-206/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec10-206.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec10-206.xml 21 CFR 10.206 21CFR10.206 Section 10.206; Procedures for electronic media coverage of agency public administrative proceedings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures Part 10 ADMINISTRATIVE PRACTICES AND PROCEDURES CONTENT CFR-2007-title21-vol1-sec10-206 195 Section 10.206 section 10.206 49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 49 Page 14726 49 FR. 14726 Federal Register Volume 54 Page 9035 54 FR. 9035 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part11.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part11.xml 21 CFR 11 21CFR11 Part 11; ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part11 196 Part 11 part 11 21 U.S.C. 321-393; 42 U.S.C. 262. 62 FR 13464, Mar. 20, 1997, unless otherwise noted. false
United States Code Title 21 Section 321-393 Title 21 Section 321-393 21 U.S.C. 321-393 21 U.S.C. 321-393 United States Code Title 42 Section 262 Title 42 Section 262 42 U.S.C. 262 42 U.S.C. 262 Federal Register Volume 62 Page 13464 62 FR. 13464 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-toc-id197 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-toc-id197/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part11-toc-id197.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part11-toc-id197.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES TOC CFR-2007-title21-vol1-part11-toc-id197 197 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part11-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part11-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES NODE CFR-2007-title21-vol1-part11-subpartA 198 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-1.xml 21 CFR 11.1 21CFR11.1 Section 11.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-1 199 Section 11.1 section 11.1 62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004 false Federal Register Volume 62 Page 13464 62 FR. 13464 Federal Register Volume 69 Page 71655 69 FR. 71655 Implementation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-2 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-2/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-2.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-2.xml 21 CFR 11.2 21CFR11.2 Section 11.2; Implementation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-2 200 Section 11.2 section 11.2 false Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-3.xml 21 CFR 11.3 21CFR11.3 Section 11.3; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-3 201 Section 11.3 section 11.3 false
United States Code Title 21 Section 321-393 21 U.S.C. 321-393 Electronic Records http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part11-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part11-subpartB.xml 21 CFR B 21CFR Subpart B; Electronic Records Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES NODE CFR-2007-title21-vol1-part11-subpartB 202 Subpart B subpart B false Controls for closed systems. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-10.xml 21 CFR 11.10 21CFR11.10 Section 11.10; Controls for closed systems. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Electronic Records Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-10 203 Section 11.10 section 11.10 false Controls for open systems. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-30.xml 21 CFR 11.30 21CFR11.30 Section 11.30; Controls for open systems. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Electronic Records Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-30 204 Section 11.30 section 11.30 false Signature manifestations. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-50 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-50/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-50.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-50.xml 21 CFR 11.50 21CFR11.50 Section 11.50; Signature manifestations. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Electronic Records Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-50 205 Section 11.50 section 11.50 false Signature/record linking. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-70 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-70/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-70.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-70.xml 21 CFR 11.70 21CFR11.70 Section 11.70; Signature/record linking. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Electronic Records Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-70 206 Section 11.70 section 11.70 false Electronic Signatures http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part11-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part11-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part11-subpartC.xml 21 CFR C 21CFR Subpart C; Electronic Signatures Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES NODE CFR-2007-title21-vol1-part11-subpartC 207 Subpart C subpart C false General requirements. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-100 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-100/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-100.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-100.xml 21 CFR 11.100 21CFR11.100 Section 11.100; General requirements. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Signatures Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-100 208 Section 11.100 section 11.100 false Electronic signature components and controls. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-200 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-200/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-200.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-200.xml 21 CFR 11.200 21CFR11.200 Section 11.200; Electronic signature components and controls. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Signatures Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-200 209 Section 11.200 section 11.200 false Controls for identification codes/passwords. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-300 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec11-300/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec11-300.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec11-300.xml 21 CFR 11.300 21CFR11.300 Section 11.300; Controls for identification codes/passwords. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Electronic Signatures Part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES CONTENT CFR-2007-title21-vol1-sec11-300 210 Section 11.300 section 11.300 false FORMAL EVIDENTIARY PUBLIC HEARING http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12.xml 21 CFR 12 21CFR12 Part 12; FORMAL EVIDENTIARY PUBLIC HEARING Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part12 211 Part 12 part 12 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. 44 FR 22339, Apr. 13, 1979, unless otherwise noted. false
United States Code Title 5 Section 551-558 Title 5 Section 551-558 Title 5 Section 701-721 Title 5 Section 701-721 5 U.S.C. 551-558 5 U.S.C. 551-558 5 U.S.C. 701-721 5 U.S.C. 701-721 United States Code Title 15 Section 1451-1461 Title 15 Section 1451-1461 15 U.S.C. 1451-1461 15 U.S.C. 1451-1461 United States Code Title 21 Section 141-149 Title 21 Section 141-149 Title 21 Section 321-393 Title 21 Section 321-393 Title 21 Section 467f Title 21 Section 467f Title 21 Section 679 Title 21 Section 679 Title 21 Section 821 Title 21 Section 821 Title 21 Section 1034 Title 21 Section 1034 21 U.S.C. 141-149 21 U.S.C. 141-149 21 U.S.C. 321-393 21 U.S.C. 321-393 21 U.S.C. 467f 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 821 21 U.S.C. 1034 21 U.S.C. 1034 United States Code Title 28 Section 2112 Title 28 Section 2112 28 U.S.C. 2112 28 U.S.C. 2112 United States Code Title 42 Section 201 Title 42 Section 201 Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b-263n Title 42 Section 263b-263n Title 42 Section 264 Title 42 Section 264 42 U.S.C. 201 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b-263n 42 U.S.C. 263b-263n 42 U.S.C. 264 42 U.S.C. 264 Federal Register Volume 44 Page 22339 44 FR. 22339 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-toc-id212 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-toc-id212/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-toc-id212.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-toc-id212.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING TOC CFR-2007-title21-vol1-part12-toc-id212 212 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartA 213 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-1.xml 21 CFR 12.1 21CFR12.1 Section 12.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-1 214 Section 12.1 section 12.1 false Initiation of Proceedings http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartB.xml 21 CFR B 21CFR Subpart B; Initiation of Proceedings Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartB 215 Subpart B subpart B false Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-20.xml 21 CFR 12.20 21CFR12.20 Section 12.20; Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-20 216 Section 12.20 section 12.20 44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 64 Page 399 64 FR. 399 Initiation of a hearing involving the issuance, amendment, or revocation of an order. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-21 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-21/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-21.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-21.xml 21 CFR 12.21 21CFR12.21 Section 12.21; Initiation of a hearing involving the issuance, amendment, or revocation of an order. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-21 217 Section 12.21 section 12.21 44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982; 54 FR 9035, Mar. 3, 1989 false
United States Code Title 5 Section 504 Title 5 Section 504note 5 U.S.C. 504 5 U.S.C. 504note Code of Federal Regulations Title 45 Part 13 45 CFR Part 13 Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 47 Page 25734 47 FR. 25734 Federal Register Volume 54 Page 9035 54 FR. 9035 Filing objections and requests for a hearing on a regulation or order. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-22 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-22/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-22.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-22.xml 21 CFR 12.22 21CFR12.22 Section 12.22; Filing objections and requests for a hearing on a regulation or order. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-22 218 Section 12.22 section 12.22 44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10, 1999 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 64 Page 69190 64 FR. 69190 Notice of filing of objections. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-23 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-23/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-23.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-23.xml 21 CFR 12.23 21CFR12.23 Section 12.23; Notice of filing of objections. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-23 219 Section 12.23 section 12.23 false Ruling on objections and requests for hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-24 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-24/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-24.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-24.xml 21 CFR 12.24 21CFR12.24 Section 12.24; Ruling on objections and requests for hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-24 220 Section 12.24 section 12.24 44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 64 Page 399 64 FR. 399 Modification or revocation of regulation or order. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-26 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-26/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-26.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-26.xml 21 CFR 12.26 21CFR12.26 Section 12.26; Modification or revocation of regulation or order. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-26 221 Section 12.26 section 12.26 false Denial of hearing in whole or in part. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-28 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-28/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-28.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-28.xml 21 CFR 12.28 21CFR12.28 Section 12.28; Denial of hearing in whole or in part. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-28 222 Section 12.28 section 12.28 false
United States Code Title 28 Section 2112(a) 28 U.S.C. 2112(a) Judicial review after waiver of hearing on a regulation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-30.xml 21 CFR 12.30 21CFR12.30 Section 12.30; Judicial review after waiver of hearing on a regulation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-30 223 Section 12.30 section 12.30 false Request for alternative form of hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-32 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-32/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-32.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-32.xml 21 CFR 12.32 21CFR12.32 Section 12.32; Request for alternative form of hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-32 224 Section 12.32 section 12.32 false Notice of hearing; stay of action. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-35 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-35/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-35.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-35.xml 21 CFR 12.35 21CFR12.35 Section 12.35; Notice of hearing; stay of action. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-35 225 Section 12.35 section 12.35 44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 47 Page 26375 47 FR. 26375 Effective date of a regulation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-37 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-37/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-37.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-37.xml 21 CFR 12.37 21CFR12.37 Section 12.37; Effective date of a regulation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-37 226 Section 12.37 section 12.37 false Effective date of an order. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-38 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-38/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-38.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-38.xml 21 CFR 12.38 21CFR12.38 Section 12.38; Effective date of an order. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-38 227 Section 12.38 section 12.38 false Appearance and Participation http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartC.xml 21 CFR C 21CFR Subpart C; Appearance and Participation Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartC 228 Subpart C subpart C false Appearance. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-40.xml 21 CFR 12.40 21CFR12.40 Section 12.40; Appearance. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Appearance and Participation Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-40 229 Section 12.40 section 12.40 false Notice of participation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-45 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-45/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-45.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-45.xml 21 CFR 12.45 21CFR12.45 Section 12.45; Notice of participation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Appearance and Participation Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-45 230 Section 12.45 section 12.45 44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003 false Code of Federal Regulations Title 21 Part 12 21 CFR Part 12 Code of Federal Regulations Title 21 Part 12.85 21 CFR Part 12.85 Code of Federal Regulations Title 21 Part 13.25 21 CFR Part 13.25 Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 46 Page 8456 46 FR. 8456 Federal Register Volume 59 Page 14364 59 FR. 14364 Federal Register Volume 68 Page 24879 68 FR. 24879 Advice on public participation in hearings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-50 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-50/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-50.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-50.xml 21 CFR 12.50 21CFR12.50 Section 12.50; Advice on public participation in hearings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Appearance and Participation Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-50 231 Section 12.50 section 12.50 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, 1993 false Federal Register Volume 44 Page 22329 44 FR. 22329 Federal Register Volume 50 Page 8994 50 FR. 8994 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 58 Page 17096 58 FR. 17096 Presiding Officer http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartD http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartD/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartD.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartD.xml 21 CFR D 21CFR Subpart D; Presiding Officer Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartD 232 Subpart D subpart D false Presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-60 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-60/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-60.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-60.xml 21 CFR 12.60 21CFR12.60 Section 12.60; Presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Presiding Officer Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-60 233 Section 12.60 section 12.60 false
United States Code Title 5 Section 3105 5 U.S.C. 3105 Commencement of functions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-62 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-62/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-62.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-62.xml 21 CFR 12.62 21CFR12.62 Section 12.62; Commencement of functions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Presiding Officer Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-62 234 Section 12.62 section 12.62 false Authority of presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-70 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-70/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-70.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-70.xml 21 CFR 12.70 21CFR12.70 Section 12.70; Authority of presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Presiding Officer Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-70 235 Section 12.70 section 12.70 false Disqualification of presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-75 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-75/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-75.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-75.xml 21 CFR 12.75 21CFR12.75 Section 12.75; Disqualification of presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Presiding Officer Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-75 236 Section 12.75 section 12.75 false Unavailability of presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-78 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-78/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-78.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-78.xml 21 CFR 12.78 21CFR12.78 Section 12.78; Unavailability of presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Presiding Officer Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-78 237 Section 12.78 section 12.78 false Hearing Procedures http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartE http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartE/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartE.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartE.xml 21 CFR E 21CFR Subpart E; Hearing Procedures Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartE 238 Subpart E subpart E false Filing and service of submissions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-80 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-80/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-80.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-80.xml 21 CFR 12.80 21CFR12.80 Section 12.80; Filing and service of submissions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-80 239 Section 12.80 section 12.80 false Petition to participate in forma pauperis. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-82 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-82/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-82.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-82.xml 21 CFR 12.82 21CFR12.82 Section 12.82; Petition to participate in forma pauperis. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-82 240 Section 12.82 section 12.82 false Advisory opinions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-83 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-83/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-83.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-83.xml 21 CFR 12.83 21CFR12.83 Section 12.83; Advisory opinions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-83 241 Section 12.83 section 12.83 false Disclosure of data and information by the participants. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-85 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-85/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-85.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-85.xml 21 CFR 12.85 21CFR12.85 Section 12.85; Disclosure of data and information by the participants. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-85 242 Section 12.85 section 12.85 44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 54 Page 9035 54 FR. 9035 Purpose; oral and written testimony; burden of proof. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-87 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-87/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-87.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-87.xml 21 CFR 12.87 21CFR12.87 Section 12.87; Purpose; oral and written testimony; burden of proof. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-87 243 Section 12.87 section 12.87 44 FR 22339, Apr. 13, 1979 as amended at 64 FR 399, Jan. 5, 1999 false
United States Code Title 5 Section 556(d) 5 U.S.C. 556(d) Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 64 Page 399 64 FR. 399 Participation of nonparties. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-89 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-89/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-89.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-89.xml 21 CFR 12.89 21CFR12.89 Section 12.89; Participation of nonparties. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-89 244 Section 12.89 section 12.89 44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 48 Page 51770 48 FR. 51770 Conduct at oral hearings or conferences. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-90 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-90/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-90.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-90.xml 21 CFR 12.90 21CFR12.90 Section 12.90; Conduct at oral hearings or conferences. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-90 245 Section 12.90 section 12.90 false Time and place of prehearing conference. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-91 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-91/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-91.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-91.xml 21 CFR 12.91 21CFR12.91 Section 12.91; Time and place of prehearing conference. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-91 246 Section 12.91 section 12.91 false Prehearing conference procedure. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-92 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-92/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-92.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-92.xml 21 CFR 12.92 21CFR12.92 Section 12.92; Prehearing conference procedure. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-92 247 Section 12.92 section 12.92 false Summary decisions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-93 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-93/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-93.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-93.xml 21 CFR 12.93 21CFR12.93 Section 12.93; Summary decisions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-93 248 Section 12.93 section 12.93 false Receipt of evidence. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-94 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-94/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-94.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-94.xml 21 CFR 12.94 21CFR12.94 Section 12.94; Receipt of evidence. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-94 249 Section 12.94 section 12.94 false Official notice. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-95 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-95/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-95.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-95.xml 21 CFR 12.95 21CFR12.95 Section 12.95; Official notice. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-95 250 Section 12.95 section 12.95 false Briefs and arguments. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-96 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-96/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-96.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-96.xml 21 CFR 12.96 21CFR12.96 Section 12.96; Briefs and arguments. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-96 251 Section 12.96 section 12.96 false Interlocutory appeal from ruling of presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-97 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-97/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-97.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-97.xml 21 CFR 12.97 21CFR12.97 Section 12.97; Interlocutory appeal from ruling of presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-97 252 Section 12.97 section 12.97 false Official transcript. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-98 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-98/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-98.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-98.xml 21 CFR 12.98 21CFR12.98 Section 12.98; Official transcript. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-98 253 Section 12.98 section 12.98 false Motions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-99 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-99/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-99.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-99.xml 21 CFR 12.99 21CFR12.99 Section 12.99; Motions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Hearing Procedures Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-99 254 Section 12.99 section 12.99 false Administrative Record http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartF http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartF/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartF.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartF.xml 21 CFR F 21CFR Subpart F; Administrative Record Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartF 255 Subpart F subpart F false Administrative record of a hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-100 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-100/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-100.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-100.xml 21 CFR 12.100 21CFR12.100 Section 12.100; Administrative record of a hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart F Administrative Record Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-100 256 Section 12.100 section 12.100 false Examination of record. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-105 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-105/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-105.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-105.xml 21 CFR 12.105 21CFR12.105 Section 12.105; Examination of record. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart F Administrative Record Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-105 257 Section 12.105 section 12.105 false Initial and Final Decisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartG http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartG/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartG.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartG.xml 21 CFR G 21CFR Subpart G; Initial and Final Decisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartG 258 Subpart G subpart G false Initial decision. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-120 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-120/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-120.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-120.xml 21 CFR 12.120 21CFR12.120 Section 12.120; Initial decision. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Initial and Final Decisions Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-120 259 Section 12.120 section 12.120 false Appeal from or review of initial decision. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-125 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-125/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-125.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-125.xml 21 CFR 12.125 21CFR12.125 Section 12.125; Appeal from or review of initial decision. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Initial and Final Decisions Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-125 260 Section 12.125 section 12.125 44 FR 22339, Apr. 13, 1979, as amended at 53 FR 29453, Aug. 5, 1988 false Federal Register Volume 44 Page 22339 44 FR. 22339 Federal Register Volume 53 Page 29453 53 FR. 29453 Decision by Commissioner on appeal or review of initial decision. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-130 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-130/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-130.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-130.xml 21 CFR 12.130 21CFR12.130 Section 12.130; Decision by Commissioner on appeal or review of initial decision. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Initial and Final Decisions Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-130 261 Section 12.130 section 12.130 false Reconsideration and stay of action. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-139 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-139/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-139.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-139.xml 21 CFR 12.139 21CFR12.139 Section 12.139; Reconsideration and stay of action. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Initial and Final Decisions Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-139 262 Section 12.139 section 12.139 false Judicial Review http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartH http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part12-subpartH/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part12-subpartH.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part12-subpartH.xml 21 CFR H 21CFR Subpart H; Judicial Review Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 12 FORMAL EVIDENTIARY PUBLIC HEARING NODE CFR-2007-title21-vol1-part12-subpartH 263 Subpart H subpart H false Review by the courts. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-140 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-140/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-140.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-140.xml 21 CFR 12.140 21CFR12.140 Section 12.140; Review by the courts. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Judicial Review Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-140 264 Section 12.140 section 12.140 false
United States Code Title 28 Section 2112(a) 28 U.S.C. 2112(a) Copies of petitions for judicial review. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-159 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec12-159/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec12-159.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec12-159.xml 21 CFR 12.159 21CFR12.159 Section 12.159; Copies of petitions for judicial review. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Judicial Review Part 12 FORMAL EVIDENTIARY PUBLIC HEARING CONTENT CFR-2007-title21-vol1-sec12-159 265 Section 12.159 section 12.159 false PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part13.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part13.xml 21 CFR 13 21CFR13 Part 13; PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part13 266 Part 13 part 13 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. 44 FR 22348, Apr. 13, 1979, unless otherwise noted. false
United States Code Title 5 Section 551-558 Title 5 Section 551-558 Title 5 Section 701-721 Title 5 Section 701-721 5 U.S.C. 551-558 5 U.S.C. 551-558 5 U.S.C. 701-721 5 U.S.C. 701-721 United States Code Title 15 Section 1451-1461 Title 15 Section 1451-1461 15 U.S.C. 1451-1461 15 U.S.C. 1451-1461 United States Code Title 21 Section 141-149 Title 21 Section 141-149 Title 21 Section 321-393 Title 21 Section 321-393 Title 21 Section 467f Title 21 Section 467f Title 21 Section 679 Title 21 Section 679 Title 21 Section 821 Title 21 Section 821 Title 21 Section 1034 Title 21 Section 1034 21 U.S.C. 141-149 21 U.S.C. 141-149 21 U.S.C. 321-393 21 U.S.C. 321-393 21 U.S.C. 467f 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 821 21 U.S.C. 1034 21 U.S.C. 1034 United States Code Title 28 Section 2112 Title 28 Section 2112 28 U.S.C. 2112 28 U.S.C. 2112 United States Code Title 42 Section 201 Title 42 Section 201 Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b-263n Title 42 Section 263b-263n Title 42 Section 264 Title 42 Section 264 42 U.S.C. 201 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b-263n 42 U.S.C. 263b-263n 42 U.S.C. 264 42 U.S.C. 264 Federal Register Volume 44 Page 22348 44 FR. 22348 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-toc-id267 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-toc-id267/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part13-toc-id267.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part13-toc-id267.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY TOC CFR-2007-title21-vol1-part13-toc-id267 267 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part13-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part13-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY NODE CFR-2007-title21-vol1-part13-subpartA 268 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-1.xml 21 CFR 13.1 21CFR13.1 Section 13.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-1 269 Section 13.1 section 13.1 false Notice of a hearing before a Board. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-5.xml 21 CFR 13.5 21CFR13.5 Section 13.5; Notice of a hearing before a Board. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-5 270 Section 13.5 section 13.5 44 FR 22348, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982 false Federal Register Volume 44 Page 22348 44 FR. 22348 Federal Register Volume 47 Page 26375 47 FR. 26375 Members of a Board. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-10.xml 21 CFR 13.10 21CFR13.10 Section 13.10; Members of a Board. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-10 271 Section 13.10 section 13.10 44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985 false Federal Register Volume 44 Page 22348 44 FR. 22348 Federal Register Volume 50 Page 8994 50 FR. 8994 Separation of functions; ex parte communications; administrative support. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-15 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-15/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-15.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-15.xml 21 CFR 13.15 21CFR13.15 Section 13.15; Separation of functions; ex parte communications; administrative support. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-15 272 Section 13.15 section 13.15 44 FR 22348, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 44 Page 22348 44 FR. 22348 Federal Register Volume 54 Page 9035 54 FR. 9035 Hearing Procedures http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part13-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part13-subpartB.xml 21 CFR B 21CFR Subpart B; Hearing Procedures Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY NODE CFR-2007-title21-vol1-part13-subpartB 273 Subpart B subpart B false Submissions to a Board. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-20.xml 21 CFR 13.20 21CFR13.20 Section 13.20; Submissions to a Board. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Hearing Procedures Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-20 274 Section 13.20 section 13.20 false Disclosure of data and information by the participants. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-25 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-25/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-25.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-25.xml 21 CFR 13.25 21CFR13.25 Section 13.25; Disclosure of data and information by the participants. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Hearing Procedures Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-25 275 Section 13.25 section 13.25 44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 44 Page 22348 44 FR. 22348 Federal Register Volume 50 Page 8994 50 FR. 8994 Federal Register Volume 54 Page 9035 54 FR. 9035 Proceedings of a Board. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-30.xml 21 CFR 13.30 21CFR13.30 Section 13.30; Proceedings of a Board. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Hearing Procedures Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-30 276 Section 13.30 section 13.30 false Records of a Hearing Before a Board http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part13-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part13-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part13-subpartC.xml 21 CFR C 21CFR Subpart C; Records of a Hearing Before a Board Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY NODE CFR-2007-title21-vol1-part13-subpartC 277 Subpart C subpart C false Administrative record of a Board. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-40.xml 21 CFR 13.40 21CFR13.40 Section 13.40; Administrative record of a Board. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Records of a Hearing Before a Board Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-40 278 Section 13.40 section 13.40 false Examination of administrative record. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-45 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-45/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-45.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-45.xml 21 CFR 13.45 21CFR13.45 Section 13.45; Examination of administrative record. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Records of a Hearing Before a Board Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-45 279 Section 13.45 section 13.45 false Record for administrative decision. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-50 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec13-50/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec13-50.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec13-50.xml 21 CFR 13.50 21CFR13.50 Section 13.50; Record for administrative decision. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Records of a Hearing Before a Board Part 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY CONTENT CFR-2007-title21-vol1-sec13-50 280 Section 13.50 section 13.50 false PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14.xml 21 CFR 14 21CFR14 Part 14; PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part14 281 Part 14 part 14 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; Pub. L. 107-109; Pub. L. 108-155. 44 FR 22351, Apr. 13, 1979, unless otherwise noted. false
United States Code Title 5 Appendix 2 Title 5 Appendix 2 5 U.S.C. App. 2 5 U.S.C. App. 2 United States Code Title 15 Section 1451-1461 Title 15 Section 1451-1461 15 U.S.C. 1451-1461 15 U.S.C. 1451-1461 United States Code Title 21 Section 41-50 Title 21 Section 41-50 Title 21 Section 141-149 Title 21 Section 141-149 Title 21 Section 321-394 Title 21 Section 321-394 Title 21 Section 467f Title 21 Section 467f Title 21 Section 679 Title 21 Section 679 Title 21 Section 821 Title 21 Section 821 Title 21 Section 1034 Title 21 Section 1034 21 U.S.C. 41-50 21 U.S.C. 41-50 21 U.S.C. 141-149 21 U.S.C. 141-149 21 U.S.C. 321-394 21 U.S.C. 321-394 21 U.S.C. 467f 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 821 21 U.S.C. 1034 21 U.S.C. 1034 United States Code Title 28 Section 2112 Title 28 Section 2112 28 U.S.C. 2112 28 U.S.C. 2112 United States Code Title 42 Section 201 Title 42 Section 201 Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b Title 42 Section 263b Title 42 Section 264 Title 42 Section 264 42 U.S.C. 201 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b 42 U.S.C. 263b 42 U.S.C. 264 42 U.S.C. 264 United States Public Law 107-109 Public Law 107-109 United States Public Law 107-109 Public Law 107-109 United States Public Law 108-155 Public Law 108-155 United States Public Law 108-155 Public Law 108-155 Federal Register Volume 44 Page 22351 44 FR. 22351 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-toc-id282 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-toc-id282/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-toc-id282.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-toc-id282.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE TOC CFR-2007-title21-vol1-part14-toc-id282 282 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartA 283 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-1.xml 21 CFR 14.1 21CFR14.1 Section 14.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-1 284 Section 14.1 section 14.1 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 54 Page 9035 54 FR. 9035 Purpose of proceedings before an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-5.xml 21 CFR 14.5 21CFR14.5 Section 14.5; Purpose of proceedings before an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-5 285 Section 14.5 section 14.5 false Administrative remedies. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-7 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-7/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-7.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-7.xml 21 CFR 14.7 21CFR14.7 Section 14.7; Administrative remedies. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-7 286 Section 14.7 section 14.7 44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990 false Code of Federal Regulations Title 45 Part 5.34 45 CFR Part 5.34 Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 55 Page 1404 55 FR. 1404 Applicability to Congress. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-10 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-10/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-10.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-10.xml 21 CFR 14.10 21CFR14.10 Section 14.10; Applicability to Congress. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-10 287 Section 14.10 section 14.10 false Committees working under a contract with FDA. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-15 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-15/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-15.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-15.xml 21 CFR 14.15 21CFR14.15 Section 14.15; Committees working under a contract with FDA. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-15 288 Section 14.15 section 14.15 false Meeting Procedures http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartB.xml 21 CFR B 21CFR Subpart B; Meeting Procedures Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartB 289 Subpart B subpart B false Notice of hearing before an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-20.xml 21 CFR 14.20 21CFR14.20 Section 14.20; Notice of hearing before an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-20 290 Section 14.20 section 14.20 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, 2001 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 47 Page 26375 47 FR. 26375 Federal Register Volume 54 Page 9035 54 FR. 9035 Federal Register Volume 66 Page 12850 66 FR. 12850 Federal Register Volume 66 Page 6469 66 FR. 6469 Meetings of an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-22 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-22/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-22.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-22.xml 21 CFR 14.22 21CFR14.22 Section 14.22; Meetings of an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-22 291 Section 14.22 section 14.22 44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 48 Page 40887 48 FR. 40887 Federal Register Volume 54 Page 9035 54 FR. 9035 Portions of advisory committee meetings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-25 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-25/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-25.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-25.xml 21 CFR 14.25 21CFR14.25 Section 14.25; Portions of advisory committee meetings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-25 292 Section 14.25 section 14.25 false Determination to close portions of advisory committee meetings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-27 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-27/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-27.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-27.xml 21 CFR 14.27 21CFR14.27 Section 14.27; Determination to close portions of advisory committee meetings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-27 293 Section 14.27 section 14.27 44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000 false
United States Code Title 5 Section 552b(c) 5 U.S.C. 552b(c) Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 65 Page 56479 65 FR. 56479 Conduct of a hearing before an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-29 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-29/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-29.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-29.xml 21 CFR 14.29 21CFR14.29 Section 14.29; Conduct of a hearing before an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-29 294 Section 14.29 section 14.29 false Chairman of an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-30.xml 21 CFR 14.30 21CFR14.30 Section 14.30; Chairman of an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-30 295 Section 14.30 section 14.30 false Consultation by an advisory committee with other persons. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-31 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-31/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-31.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-31.xml 21 CFR 14.31 21CFR14.31 Section 14.31; Consultation by an advisory committee with other persons. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-31 296 Section 14.31 section 14.31 44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990 false
United States Code Title 18 Section 208 Title 18 Section 1905 18 U.S.C. 208 18 U.S.C. 1905 United States Code Title 21 Section 331(j) 21 U.S.C. 331(j) Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 55 Page 42703 55 FR. 42703 Compilation of materials for members of an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-33 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-33/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-33.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-33.xml 21 CFR 14.33 21CFR14.33 Section 14.33; Compilation of materials for members of an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-33 297 Section 14.33 section 14.33 44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 65 Page 56479 65 FR. 56479 Written submissions to an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-35 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-35/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-35.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-35.xml 21 CFR 14.35 21CFR14.35 Section 14.35; Written submissions to an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-35 298 Section 14.35 section 14.35 false Additional rules for a particular advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-39 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-39/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-39.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-39.xml 21 CFR 14.39 21CFR14.39 Section 14.39; Additional rules for a particular advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Meeting Procedures Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-39 299 Section 14.39 section 14.39 false Establishment of Advisory Committees http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartC.xml 21 CFR C 21CFR Subpart C; Establishment of Advisory Committees Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartC 300 Subpart C subpart C false Establishment and renewal of advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-40.xml 21 CFR 14.40 21CFR14.40 Section 14.40; Establishment and renewal of advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Establishment of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-40 301 Section 14.40 section 14.40 44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990 false Code of Federal Regulations Title 45 Part 11 45 CFR Part 11 Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 55 Page 42703 55 FR. 42703 Termination of advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-55 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-55/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-55.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-55.xml 21 CFR 14.55 21CFR14.55 Section 14.55; Termination of advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Establishment of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-55 302 Section 14.55 section 14.55 false
United States Code Title 21 Section 42 21 U.S.C. 42 United States Code Title 42 Section 263f(f)(1)(A) 42 U.S.C. 263f(f)(1)(A) Records of Meetings and Hearings Before Advisory Committees http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartD http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartD/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartD.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartD.xml 21 CFR D 21CFR Subpart D; Records of Meetings and Hearings Before Advisory Committees Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartD 303 Subpart D subpart D false Minutes and reports of advisory committee meetings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-60 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-60/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-60.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-60.xml 21 CFR 14.60 21CFR14.60 Section 14.60; Minutes and reports of advisory committee meetings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Records of Meetings and Hearings Before Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-60 304 Section 14.60 section 14.60 44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980 false
United States Code Title 5 Section 552(b) 5 U.S.C. 552(b) Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 45 Page 85725 45 FR. 85725 Transcripts of advisory committee meetings. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-61 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-61/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-61.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-61.xml 21 CFR 14.61 21CFR14.61 Section 14.61; Transcripts of advisory committee meetings. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Records of Meetings and Hearings Before Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-61 305 Section 14.61 section 14.61 44 FR 22351, Apr. 13, 1979, as amended at 68 FR 25285, May 12, 2003 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 68 Page 25285 68 FR. 25285 Public inquiries and requests for advisory committee records. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-65 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-65/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-65.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-65.xml 21 CFR 14.65 21CFR14.65 Section 14.65; Public inquiries and requests for advisory committee records. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Records of Meetings and Hearings Before Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-65 306 Section 14.65 section 14.65 44 FR 22351, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 46 Page 8456 46 FR. 8456 Administrative record of a public hearing before an advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-70 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-70/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-70.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-70.xml 21 CFR 14.70 21CFR14.70 Section 14.70; Administrative record of a public hearing before an advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Records of Meetings and Hearings Before Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-70 307 Section 14.70 section 14.70 false Examination of administrative record and other advisory committee records. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-75 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-75/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-75.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-75.xml 21 CFR 14.75 21CFR14.75 Section 14.75; Examination of administrative record and other advisory committee records. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Records of Meetings and Hearings Before Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-75 308 Section 14.75 section 14.75 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 54 Page 9035 54 FR. 9035 Members of Advisory Committees http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartE http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartE/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartE.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartE.xml 21 CFR E 21CFR Subpart E; Members of Advisory Committees Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartE 309 Subpart E subpart E false Qualifications for members of standing policy and technical advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-80 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-80/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-80.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-80.xml 21 CFR 14.80 21CFR14.80 Section 14.80; Qualifications for members of standing policy and technical advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Members of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-80 310 Section 14.80 section 14.80 44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988; 54 FR 9035, Mar. 3, 1989 false
United States Code Title 18 Section 208(a) Title 18 Section 208(b) 18 U.S.C. 208(a) 18 U.S.C. 208(b) Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 53 Page 50949 53 FR. 50949 Federal Register Volume 54 Page 9035 54 FR. 9035 Nominations of voting members of standing advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-82 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-82/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-82.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-82.xml 21 CFR 14.82 21CFR14.82 Section 14.82; Nominations of voting members of standing advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Members of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-82 311 Section 14.82 section 14.82 false Nominations and selection of nonvoting members of standing technical advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-84 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-84/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-84.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-84.xml 21 CFR 14.84 21CFR14.84 Section 14.84; Nominations and selection of nonvoting members of standing technical advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Members of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-84 312 Section 14.84 section 14.84 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989 false
United States Code Title 18 Section 208(a) Title 18 Section 208(b) 18 U.S.C. 208(a) 18 U.S.C. 208(b) Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 54 Page 9035 54 FR. 9035 Rights and responsibilities of nonvoting members of advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-86 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-86/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-86.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-86.xml 21 CFR 14.86 21CFR14.86 Section 14.86; Rights and responsibilities of nonvoting members of advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Members of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-86 313 Section 14.86 section 14.86 false Ad hoc advisory committee members. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-90 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-90/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-90.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-90.xml 21 CFR 14.90 21CFR14.90 Section 14.90; Ad hoc advisory committee members. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Members of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-90 314 Section 14.90 section 14.90 false Compensation of advisory committee members. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-95 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-95/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-95.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-95.xml 21 CFR 14.95 21CFR14.95 Section 14.95; Compensation of advisory committee members. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Members of Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-95 315 Section 14.95 section 14.95 44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 53 Page 50949 53 FR. 50949 Standing Advisory Committees http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartF http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartF/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartF.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartF.xml 21 CFR F 21CFR Subpart F; Standing Advisory Committees Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartF 316 Subpart F subpart F false List of standing advisory committees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-100 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-100/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-100.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-100.xml 21 CFR 14.100 21CFR14.100 Section 14.100; List of standing advisory committees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart F Standing Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-100 317 Section 14.100 section 14.100 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, 1989 false
United States Code Title 21 Section 42 21 U.S.C. 42 United States Code Title 42 Section 263f(f)(1)(A) 42 U.S.C. 263f(f)(1)(A) Federal Register Volume 54 Page 9036 54 FR. 9036 Technical Electronic Products Radiation Safety Standards Committee http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartG http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartG/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartG.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartG.xml 21 CFR G 21CFR Subpart G; Technical Electronic Products Radiation Safety Standards Committee Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartG 318 Subpart G subpart G false Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-120 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-120/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-120.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-120.xml 21 CFR 14.120 21CFR14.120 Section 14.120; Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Technical Electronic Products Radiation Safety Standards Committee Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-120 319 Section 14.120 section 14.120 false
United States Code Title 42 Section 263f(f)(1)(A) 42 U.S.C. 263f(f)(1)(A) Functions of TEPRSSC. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-122 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-122/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-122.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-122.xml 21 CFR 14.122 21CFR14.122 Section 14.122; Functions of TEPRSSC. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Technical Electronic Products Radiation Safety Standards Committee Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-122 320 Section 14.122 section 14.122 false
United States Code Title 42 Section 263f 42 U.S.C. 263f Procedures of TEPRSSC. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-125 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-125/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-125.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-125.xml 21 CFR 14.125 21CFR14.125 Section 14.125; Procedures of TEPRSSC. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Technical Electronic Products Radiation Safety Standards Committee Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-125 321 Section 14.125 section 14.125 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989 false
United States Code Title 42 Section 263f(f)(1)(A) 42 U.S.C. 263f(f)(1)(A) Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 54 Page 9037 54 FR. 9037 Membership of TEPRSSC. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-127 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-127/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-127.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-127.xml 21 CFR 14.127 21CFR14.127 Section 14.127; Membership of TEPRSSC. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Technical Electronic Products Radiation Safety Standards Committee Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-127 322 Section 14.127 section 14.127 false
United States Code Title 42 Section 210(c) 42 U.S.C. 210(c) Conduct of TEPRSSC meeting; availability of TEPRSSC records. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-130 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-130/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-130.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-130.xml 21 CFR 14.130 21CFR14.130 Section 14.130; Conduct of TEPRSSC meeting; availability of TEPRSSC records. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Technical Electronic Products Radiation Safety Standards Committee Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-130 323 Section 14.130 section 14.130 false
United States Code Title 42 Section 263f(f)(1)(B) 42 U.S.C. 263f(f)(1)(B) Color Additive Advisory Committees http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartH http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartH/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartH.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartH.xml 21 CFR H 21CFR Subpart H; Color Additive Advisory Committees Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartH 324 Subpart H subpart H false Establishment of a color additive advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-140 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-140/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-140.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-140.xml 21 CFR 14.140 21CFR14.140 Section 14.140; Establishment of a color additive advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Color Additive Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-140 325 Section 14.140 section 14.140 false Functions of a color additive advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-142 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-142/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-142.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-142.xml 21 CFR 14.142 21CFR14.142 Section 14.142; Functions of a color additive advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Color Additive Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-142 326 Section 14.142 section 14.142 false Procedures of a color additive advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-145 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-145/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-145.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-145.xml 21 CFR 14.145 21CFR14.145 Section 14.145; Procedures of a color additive advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Color Additive Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-145 327 Section 14.145 section 14.145 false Membership of a color additive advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-147 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-147/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-147.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-147.xml 21 CFR 14.147 21CFR14.147 Section 14.147; Membership of a color additive advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Color Additive Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-147 328 Section 14.147 section 14.147 false Fees and compensation pertaining to a color additive advisory committee. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-155 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-155/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-155.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-155.xml 21 CFR 14.155 21CFR14.155 Section 14.155; Fees and compensation pertaining to a color additive advisory committee. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart H Color Additive Advisory Committees Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-155 329 Section 14.155 section 14.155 false Advisory Committees for Human Prescription Drugs http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartI http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part14-subpartI/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part14-subpartI.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part14-subpartI.xml 21 CFR I 21CFR Subpart I; Advisory Committees for Human Prescription Drugs Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE NODE CFR-2007-title21-vol1-part14-subpartI 330 Subpart I subpart I false Establishment of standing technical advisory committees for human prescription drugs. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-160 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-160/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-160.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-160.xml 21 CFR 14.160 21CFR14.160 Section 14.160; Establishment of standing technical advisory committees for human prescription drugs. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Advisory Committees for Human Prescription Drugs Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-160 331 Section 14.160 section 14.160 false Utilization of an advisory committee on the initiative of FDA. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-171 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-171/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-171.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-171.xml 21 CFR 14.171 21CFR14.171 Section 14.171; Utilization of an advisory committee on the initiative of FDA. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Advisory Committees for Human Prescription Drugs Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-171 332 Section 14.171 section 14.171 44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989 false Federal Register Volume 44 Page 22351 44 FR. 22351 Federal Register Volume 54 Page 9037 54 FR. 9037 Utilization of an advisory committee at the request of an interested person. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-172 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-172/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-172.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-172.xml 21 CFR 14.172 21CFR14.172 Section 14.172; Utilization of an advisory committee at the request of an interested person. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Advisory Committees for Human Prescription Drugs Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-172 333 Section 14.172 section 14.172 false Advice and recommendations in writing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-174 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec14-174/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec14-174.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec14-174.xml 21 CFR 14.174 21CFR14.174 Section 14.174; Advice and recommendations in writing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart I Advisory Committees for Human Prescription Drugs Part 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE CONTENT CFR-2007-title21-vol1-sec14-174 334 Section 14.174 section 14.174 false PUBLIC HEARING BEFORE THE COMMISSIONER http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part15.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part15.xml 21 CFR 15 21CFR15 Part 15; PUBLIC HEARING BEFORE THE COMMISSIONER Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part15 335 Part 15 part 15 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. 44 FR 22366, Apr. 13, 1979, unless otherwise noted. false
United States Code Title 5 Section 553 Title 5 Section 553 5 U.S.C. 553 5 U.S.C. 553 United States Code Title 15 Section 1451-1461 Title 15 Section 1451-1461 15 U.S.C. 1451-1461 15 U.S.C. 1451-1461 United States Code Title 21 Section 141-149 Title 21 Section 141-149 Title 21 Section 321-393 Title 21 Section 321-393 Title 21 Section 467f Title 21 Section 467f Title 21 Section 679 Title 21 Section 679 Title 21 Section 821 Title 21 Section 821 Title 21 Section 1034 Title 21 Section 1034 21 U.S.C. 141-149 21 U.S.C. 141-149 21 U.S.C. 321-393 21 U.S.C. 321-393 21 U.S.C. 467f 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 821 21 U.S.C. 1034 21 U.S.C. 1034 United States Code Title 28 Section 2112 Title 28 Section 2112 28 U.S.C. 2112 28 U.S.C. 2112 United States Code Title 42 Section 201 Title 42 Section 201 Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b-263n Title 42 Section 263b-263n Title 42 Section 264 Title 42 Section 264 42 U.S.C. 201 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b-263n 42 U.S.C. 263b-263n 42 U.S.C. 264 42 U.S.C. 264 Federal Register Volume 44 Page 22366 44 FR. 22366 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-toc-id336 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-toc-id336/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part15-toc-id336.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part15-toc-id336.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER TOC CFR-2007-title21-vol1-part15-toc-id336 336 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part15-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part15-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER NODE CFR-2007-title21-vol1-part15-subpartA 337 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-1.xml 21 CFR 15.1 21CFR15.1 Section 15.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-1 338 Section 15.1 section 15.1 false Procedures for Public Hearing Before the Commissioner http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part15-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part15-subpartB.xml 21 CFR B 21CFR Subpart B; Procedures for Public Hearing Before the Commissioner Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER NODE CFR-2007-title21-vol1-part15-subpartB 339 Subpart B subpart B false Notice of a public hearing before the Commissioner. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-20.xml 21 CFR 15.20 21CFR15.20 Section 15.20; Notice of a public hearing before the Commissioner. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Procedures for Public Hearing Before the Commissioner Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-20 340 Section 15.20 section 15.20 44 FR 22366, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982 false Federal Register Volume 44 Page 22366 44 FR. 22366 Federal Register Volume 47 Page 26375 47 FR. 26375 Notice of participation; schedule for hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-21 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-21/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-21.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-21.xml 21 CFR 15.21 21CFR15.21 Section 15.21; Notice of participation; schedule for hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Procedures for Public Hearing Before the Commissioner Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-21 341 Section 15.21 section 15.21 false Written submissions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-25 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-25/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-25.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-25.xml 21 CFR 15.25 21CFR15.25 Section 15.25; Written submissions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Procedures for Public Hearing Before the Commissioner Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-25 342 Section 15.25 section 15.25 false Conduct of a public hearing before the Commissioner. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-30.xml 21 CFR 15.30 21CFR15.30 Section 15.30; Conduct of a public hearing before the Commissioner. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Procedures for Public Hearing Before the Commissioner Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-30 343 Section 15.30 section 15.30 false Records of a Public Hearing Before the Commissioner http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part15-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part15-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part15-subpartC.xml 21 CFR C 21CFR Subpart C; Records of a Public Hearing Before the Commissioner Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER NODE CFR-2007-title21-vol1-part15-subpartC 344 Subpart C subpart C false Administrative record. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-40.xml 21 CFR 15.40 21CFR15.40 Section 15.40; Administrative record. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Records of a Public Hearing Before the Commissioner Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-40 345 Section 15.40 section 15.40 false Examination of administrative record. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-45 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec15-45/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec15-45.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec15-45.xml 21 CFR 15.45 21CFR15.45 Section 15.45; Examination of administrative record. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Records of a Public Hearing Before the Commissioner Part 15 PUBLIC HEARING BEFORE THE COMMISSIONER CONTENT CFR-2007-title21-vol1-sec15-45 346 Section 15.45 section 15.45 false REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16.xml 21 CFR 16 21CFR16 Part 16; REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part16 347 Part 16 part 16 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. 44 FR 22367, Apr. 13, 1979, unless otherwise noted. false
United States Code Title 15 Section 1451-1461 Title 15 Section 1451-1461 15 U.S.C. 1451-1461 15 U.S.C. 1451-1461 United States Code Title 21 Section 141-149 Title 21 Section 141-149 Title 21 Section 321-394 Title 21 Section 321-394 Title 21 Section 467f Title 21 Section 467f Title 21 Section 679 Title 21 Section 679 Title 21 Section 821 Title 21 Section 821 Title 21 Section 1034 Title 21 Section 1034 21 U.S.C. 141-149 21 U.S.C. 141-149 21 U.S.C. 321-394 21 U.S.C. 321-394 21 U.S.C. 467f 21 U.S.C. 467f 21 U.S.C. 679 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 821 21 U.S.C. 1034 21 U.S.C. 1034 United States Code Title 28 Section 2112 Title 28 Section 2112 28 U.S.C. 2112 28 U.S.C. 2112 United States Code Title 42 Section 201-262 Title 42 Section 201-262 Title 42 Section 263b Title 42 Section 263b Title 42 Section 364 Title 42 Section 364 42 U.S.C. 201-262 42 U.S.C. 201-262 42 U.S.C. 263b 42 U.S.C. 263b 42 U.S.C. 364 42 U.S.C. 364 Federal Register Volume 44 Page 22367 44 FR. 22367 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-toc-id348 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-toc-id348/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-toc-id348.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-toc-id348.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION TOC CFR-2007-title21-vol1-part16-toc-id348 348 toc General Provisions http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartA http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartA/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartA.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartA.xml 21 CFR A 21CFR Subpart A; General Provisions Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartA 349 Subpart A subpart A false Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-1.xml 21 CFR 16.1 21CFR16.1 Section 16.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-1 350 Section 16.1 section 16.1 For Federal Register citations affecting § 16.1 see the List of CFR Sections Affected, which appears in the Finding Aids sections of the printed volume and on GPO Access. 44 FR 22367, Apr. 13, 1979 false Federal Register Volume 44 Page 22367 44 FR. 22367 Inapplicability and limited applicability. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-5.xml 21 CFR 16.5 21CFR16.5 Section 16.5; Inapplicability and limited applicability. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart A General Provisions Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-5 351 Section 16.5 section 16.5 44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5, 2000 false
United States Code Title 42 Section 264 42 U.S.C. 264 Federal Register Volume 44 Page 22367 44 FR. 22367 Federal Register Volume 57 Page 58403 57 FR. 58403 Federal Register Volume 65 Page 76110 65 FR. 76110 Initiation of Proceedings http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartB http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartB/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartB.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartB.xml 21 CFR B 21CFR Subpart B; Initiation of Proceedings Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartB 352 Subpart B subpart B false Initiation of regulatory hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-22 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-22/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-22.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-22.xml 21 CFR 16.22 21CFR16.22 Section 16.22; Initiation of regulatory hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-22 353 Section 16.22 section 16.22 44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984 false Code of Federal Regulations Title 21 Part 10 21 CFR Part 10 Federal Register Volume 44 Page 22367 44 FR. 22367 Federal Register Volume 49 Page 32173 49 FR. 32173 Regulatory hearing required by the act or a regulation. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-24 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-24/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-24.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-24.xml 21 CFR 16.24 21CFR16.24 Section 16.24; Regulatory hearing required by the act or a regulation. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-24 354 Section 16.24 section 16.24 44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982; 54 FR 9037, Mar. 3, 1989 false Federal Register Volume 44 Page 22367 44 FR. 22367 Federal Register Volume 47 Page 26375 47 FR. 26375 Federal Register Volume 54 Page 9037 54 FR. 9037 Denial of hearing and summary decision. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-26 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-26/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-26.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-26.xml 21 CFR 16.26 21CFR16.26 Section 16.26; Denial of hearing and summary decision. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart B Initiation of Proceedings Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-26 355 Section 16.26 section 16.26 53 FR 4615, Feb. 17, 1988, as amended at 69 FR 17290, Apr. 2, 2004 false Federal Register Volume 53 Page 4615 53 FR. 4615 Federal Register Volume 69 Page 17290 69 FR. 17290 Commissioner and Presiding Officer http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartC http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartC/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartC.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartC.xml 21 CFR C 21CFR Subpart C; Commissioner and Presiding Officer Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartC 356 Subpart C subpart C false Commissioner. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-40 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-40/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-40.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-40.xml 21 CFR 16.40 21CFR16.40 Section 16.40; Commissioner. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Commissioner and Presiding Officer Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-40 357 Section 16.40 section 16.40 69 FR 17290, Apr. 2, 2004 false Federal Register Volume 69 Page 17290 69 FR. 17290 Presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-42 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-42/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-42.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-42.xml 21 CFR 16.42 21CFR16.42 Section 16.42; Presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Commissioner and Presiding Officer Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-42 358 Section 16.42 section 16.42 44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 67 FR 53306, Aug. 15, 2002 false Code of Federal Regulations Title 5 Part 930(b) or (c) 5 CFR Part 930(b) or (c) Federal Register Volume 44 Page 22367 44 FR. 22367 Federal Register Volume 54 Page 9037 54 FR. 9037 Federal Register Volume 67 Page 53306 67 FR. 53306 Communication to presiding officer and Commissioner. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-44 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-44/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-44.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-44.xml 21 CFR 16.44 21CFR16.44 Section 16.44; Communication to presiding officer and Commissioner. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart C Commissioner and Presiding Officer Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-44 359 Section 16.44 section 16.44 false Procedures for Regulatory Hearing http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartD http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartD/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartD.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartD.xml 21 CFR D 21CFR Subpart D; Procedures for Regulatory Hearing Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartD 360 Subpart D subpart D false Hearing procedure. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-60 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-60/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-60.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-60.xml 21 CFR 16.60 21CFR16.60 Section 16.60; Hearing procedure. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Procedures for Regulatory Hearing Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-60 361 Section 16.60 section 16.60 44 FR 22367, Apr. 13, 1979, as amended at 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001 false Federal Register Volume 44 Page 22367 44 FR. 22367 Federal Register Volume 66 Page 12850 66 FR. 12850 Federal Register Volume 66 Page 6469 66 FR. 6469 Right to counsel. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-62 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-62/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-62.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-62.xml 21 CFR 16.62 21CFR16.62 Section 16.62; Right to counsel. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart D Procedures for Regulatory Hearing Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-62 362 Section 16.62 section 16.62 false Administrative Record and Decision http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartE http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartE/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartE.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartE.xml 21 CFR E 21CFR Subpart E; Administrative Record and Decision Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartE 363 Subpart E subpart E false Administrative record of a regulatory hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-80 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-80/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-80.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-80.xml 21 CFR 16.80 21CFR16.80 Section 16.80; Administrative record of a regulatory hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Administrative Record and Decision Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-80 364 Section 16.80 section 16.80 false Examination of administrative record. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-85 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-85/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-85.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-85.xml 21 CFR 16.85 21CFR16.85 Section 16.85; Examination of administrative record. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Administrative Record and Decision Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-85 365 Section 16.85 section 16.85 false Administrative decision and record for decision. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-95 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-95/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-95.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-95.xml 21 CFR 16.95 21CFR16.95 Section 16.95; Administrative decision and record for decision. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart E Administrative Record and Decision Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-95 366 Section 16.95 section 16.95 false Reconsideration and Stay http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartF http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartF/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartF.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartF.xml 21 CFR F 21CFR Subpart F; Reconsideration and Stay Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartF 367 Subpart F subpart F false Reconsideration and stay of action. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-119 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-119/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-119.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-119.xml 21 CFR 16.119 21CFR16.119 Section 16.119; Reconsideration and stay of action. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart F Reconsideration and Stay Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-119 368 Section 16.119 section 16.119 44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989 false Federal Register Volume 44 Page 22367 44 FR. 22367 Federal Register Volume 54 Page 9037 54 FR. 9037 Judicial Review http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartG http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part16-subpartG/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part16-subpartG.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part16-subpartG.xml 21 CFR G 21CFR Subpart G; Judicial Review Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION NODE CFR-2007-title21-vol1-part16-subpartG 369 Subpart G subpart G false Judicial review. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-120 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec16-120/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec16-120.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec16-120.xml 21 CFR 16.120 21CFR16.120 Section 16.120; Judicial review. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subpart G Judicial Review Part 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION CONTENT CFR-2007-title21-vol1-sec16-120 370 Section 16.120 section 16.120 false CIVIL MONEY PENALTIES HEARINGS http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part17 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part17/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part17.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part17.xml 21 CFR 17 21CFR17 Part 17; CIVIL MONEY PENALTIES HEARINGS Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES NODE CFR-2007-title21-vol1-part17 371 Part 17 part 17 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. 60 FR 38626, July 27, 1995, unless otherwise noted. Nomenclature changes to part 17 appear at 68 FR 24879, May 9, 2003. false
United States Code Title 5 Section 554 Title 5 Section 554 Title 5 Section 555 Title 5 Section 555 Title 5 Section 556 Title 5 Section 556 Title 5 Section 557 Title 5 Section 557 5 U.S.C. 554 5 U.S.C. 554 5 U.S.C. 555 5 U.S.C. 555 5 U.S.C. 556 5 U.S.C. 556 5 U.S.C. 557 5 U.S.C. 557 United States Code Title 21 Section 331 Title 21 Section 331 Title 21 Section 333 Title 21 Section 333 Title 21 Section 337 Title 21 Section 337 Title 21 Section 351 Title 21 Section 351 Title 21 Section 352 Title 21 Section 352 Title 21 Section 355 Title 21 Section 355 Title 21 Section 360c Title 21 Section 360c Title 21 Section 360 Title 21 Section 360 Title 21 Section 360f Title 21 Section 360f Title 21 Section 360i Title 21 Section 360i Title 21 Section 360j Title 21 Section 360j Title 21 Section 371 Title 21 Section 371 21 U.S.C. 331 21 U.S.C. 331 21 U.S.C. 333 21 U.S.C. 333 21 U.S.C. 337 21 U.S.C. 337 21 U.S.C. 351 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 355 21 U.S.C. 360c 21 U.S.C. 360c 21 U.S.C. 360 21 U.S.C. 360 21 U.S.C. 360f 21 U.S.C. 360f 21 U.S.C. 360i 21 U.S.C. 360i 21 U.S.C. 360j 21 U.S.C. 360j 21 U.S.C. 371 21 U.S.C. 371 United States Code Title 42 Section 262 Title 42 Section 262 Title 42 Section 263b Title 42 Section 263b Title 42 Section 300aa-28 Title 42 Section 300aa-28 42 U.S.C. 262 42 U.S.C. 262 42 U.S.C. 263b 42 U.S.C. 263b 42 U.S.C. 300aa-28 42 U.S.C. 300aa-28 Federal Register Volume 60 Page 38626 60 FR. 38626 Federal Register Volume 68 Page 24879 68 FR. 24879 Table Of Contents http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part17-toc-id372 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-part17-toc-id372/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-part17-toc-id372.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-part17-toc-id372.xml 21 CFR 21CFR Table Of Contents Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS TOC CFR-2007-title21-vol1-part17-toc-id372 372 toc Scope. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-1 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-1/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-1.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-1.xml 21 CFR 17.1 21CFR17.1 Section 17.1; Scope. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-1 373 Section 17.1 section 17.1 60 FR 38626, July 27, 1995, as amended at 69 FR 43301, July 20, 2004 false Federal Register Volume 60 Page 38626 60 FR. 38626 Federal Register Volume 69 Page 43301 69 FR. 43301 Maximum penalty amounts. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-2 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-2/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-2.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-2.xml 21 CFR 17.2 21CFR17.2 Section 17.2; Maximum penalty amounts. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-2 374 Section 17.2 section 17.2 69 FR 43301, July 20, 2004; 69 FR 49807, Aug. 12, 2004 false Federal Register Volume 69 Page 43301 69 FR. 43301 Federal Register Volume 69 Page 49807 69 FR. 49807 Definitions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-3 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-3/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-3.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-3.xml 21 CFR 17.3 21CFR17.3 Section 17.3; Definitions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-3 375 Section 17.3 section 17.3 false
United States Code Title 5 Section 3105 5 U.S.C. 3105 United States Code Title 21 Section 333(g)(1)(B)(i) Title 21 Section 333(g)(1)(B)(ii) Title 21 Section 333(g)(1)(B)(iii) Title 21 Section 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) 21 U.S.C. 333(g)(1) Complaint. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-5 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-5/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-5.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-5.xml 21 CFR 17.5 21CFR17.5 Section 17.5; Complaint. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-5 376 Section 17.5 section 17.5 false Service of complaint. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-7 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-7/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-7.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-7.xml 21 CFR 17.7 21CFR17.7 Section 17.7; Service of complaint. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-7 377 Section 17.7 section 17.7 false Answer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-9 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-9/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-9.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-9.xml 21 CFR 17.9 21CFR17.9 Section 17.9; Answer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-9 378 Section 17.9 section 17.9 false Default upon failure to file an answer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-11 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-11/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-11.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-11.xml 21 CFR 17.11 21CFR17.11 Section 17.11; Default upon failure to file an answer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-11 379 Section 17.11 section 17.11 false Notice of hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-13 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-13/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-13.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-13.xml 21 CFR 17.13 21CFR17.13 Section 17.13; Notice of hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-13 380 Section 17.13 section 17.13 false Parties to the hearing. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-15 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-15/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-15.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-15.xml 21 CFR 17.15 21CFR17.15 Section 17.15; Parties to the hearing. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-15 381 Section 17.15 section 17.15 false Summary decisions. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-17 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-17/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-17.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-17.xml 21 CFR 17.17 21CFR17.17 Section 17.17; Summary decisions. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-17 382 Section 17.17 section 17.17 false Interlocutory appeal from ruling of presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-18 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-18/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-18.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-18.xml 21 CFR 17.18 21CFR17.18 Section 17.18; Interlocutory appeal from ruling of presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-18 383 Section 17.18 section 17.18 false Authority of the presiding officer. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-19 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-19/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-19.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-19.xml 21 CFR 17.19 21CFR17.19 Section 17.19; Authority of the presiding officer. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-19 384 Section 17.19 section 17.19 false Ex parte contacts. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-20 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-20/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-20.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-20.xml 21 CFR 17.20 21CFR17.20 Section 17.20; Ex parte contacts. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-20 385 Section 17.20 section 17.20 false Prehearing conferences. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-21 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-21/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-21.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-21.xml 21 CFR 17.21 21CFR17.21 Section 17.21; Prehearing conferences. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-21 386 Section 17.21 section 17.21 false Discovery. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-23 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-23/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-23.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-23.xml 21 CFR 17.23 21CFR17.23 Section 17.23; Discovery. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-23 387 Section 17.23 section 17.23 false Exchange of witness lists, witness statements, and exhibits. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-25 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-25/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-25.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-25.xml 21 CFR 17.25 21CFR17.25 Section 17.25; Exchange of witness lists, witness statements, and exhibits. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-25 388 Section 17.25 section 17.25 false Hearing subpoenas. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-27 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-27/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-27.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-27.xml 21 CFR 17.27 21CFR17.27 Section 17.27; Hearing subpoenas. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-27 389 Section 17.27 section 17.27 false Protective order. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-28 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-28/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-28.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-28.xml 21 CFR 17.28 21CFR17.28 Section 17.28; Protective order. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-28 390 Section 17.28 section 17.28 false Code of Federal Regulations Title 21 Part 20 21 CFR Part 20 Fees. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-29 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-29/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-29.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-29.xml 21 CFR 17.29 21CFR17.29 Section 17.29; Fees. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-29 391 Section 17.29 section 17.29 false Computation of time. http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-30 http://www.gpo.gov/fdsys/granule/CFR-2007-title21-vol1/CFR-2007-title21-vol1-sec17-30/content-detail.html http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/pdf/CFR-2007-title21-vol1-sec17-30.pdf http://www.gpo.gov/fdsys/pkg/CFR-2007-title21-vol1/xml/CFR-2007-title21-vol1-sec17-30.xml 21 CFR 17.30 21CFR17.30 Section 17.30; Computation of time. Chapter I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Part 17 CIVIL MONEY PENALTIES HEARINGS CONTENT CFR-2007-title21-vol1-sec17-30 392 Section 17.30 section 17.30 false Form, filing, and service of papers. <