United States Government Printing Office printer prt distributor dst United States Congress House of Representatives Office of the Law Revision Counsel author aut Government Organization text government publication eng USCODE Bills and Statutes 2006_uscode_suppl_4 legislative 2011-09-06 Sec. 355 D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec355.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec355.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355 21USC355 http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec355.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec355.htm 21 U.S.C. 355 21 USC 355 21 U.S.C. 355 21 USC 355; FOOD AND DRUGS; New drugs 186 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec355 Sec. 355 section standard June 25, 1938, ch. 675, §505, 52 Stat. 1052; Pub. L. 86-507, §1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I, §§102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76 Stat. 781-783, 784, 785; Pub. L. 92-387, §4(d), Aug. 16, 1972, 86 Stat. 562; Pub. L. 98-417, title I, §§101, 102(a)-(b)(5), 103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L. 102-282, §5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, §3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, §§115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315, 2316, 2318, 2324; Pub. L. 106-113, div. B, §1000(a)(9) [title IV, §4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 107-109, §15(c)(1), Jan. 4, 2002, 115 Stat. 1420; Pub. L. 108-155, §2(b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-173, title XI, §§1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003, 117 Stat. 2448, 2452, 2457, 2460; Pub. L. 110-85, title VII, §701(b), title VIII, §801(b)(3)(A), (B), title IX, §§901(a), 903, 905(a), 914(a), 915, 916, 918, 920, 921, title XI, §1113, Sept. 27, 2007, 121 Stat. 903, 921, 922, 943, 944, 953, 957, 958, 960-962, 976; Pub. L. 110-316, title III, §301, Aug. 14, 2008, 122 Stat. 3524; Pub. L. 110-379, §4(a), Oct. 8, 2008, 122 Stat. 4076; Pub. L. 111-31, div. A, title I, §103(e), June 22, 2009, 123 Stat. 1837; Pub. L. 111-148, title VII, §7002(d)(1), title X, §10609, Mar. 23, 2010, 124 Stat. 816, 1014. referencesInText Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (k)(3)(C)(i)(I), (4)(G)(i)(I), is section 264(c) of Pub. L. 104-191, which is set out as a note under section 1320d-2 of Title 42, The Public Health and Welfare.The General Schedule, referred to in subsec. (n)(5), is set out under section 5332 of Title 5, Government Organization and Employees.Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (<em>o</em>)(3)(E)(i), is section 101(c) of Pub. L. 110-85, which is set out as a note under section 379g of this title.The Food and Drug Administration Modernization Act of 1997, referred to in subsec. (v)(1)(A), (2)(A), (4), is Pub. L. 105-115, Nov. 21, 1997, 111 Stat. 2296. Section 125 of the Act amended sections 321, 331, 335a, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35, Patents, and section 8126 of Title 38, Veterans’ Benefits, repealed sections 356 and 357 of this title, and enacted provisions set out as a note under this section. For complete classification of this Act to the Code, see Short Title of 1997 Amendment note set out under section 301 of this title and Tables.The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (v)(4), is Pub. L. 98-417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables. codification In subsec. (k)(4)(H), “section 132 of title 41” substituted for “section 4(5) of the Federal Procurement Policy Act” on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts. amendments <b>2010</b>-Subsec. (b)(5)(B). Pub. L. 111-148, §7002(d)(1), inserted “or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies” before period at end of first sentence.Subsec. (j)(10). Pub. L. 111-148, §10609, added par. (10).<b>2009</b>-Subsec. (n)(2). Pub. L. 111-31 made technical amendment to reference in original act which appears in text as reference to section 394 of this title.<b>2008</b>-Subsec. (q)(1)(A). Pub. L. 110-316, §301, inserted concluding provisions.Subsec. (v). Pub. L. 110-379 added subsec. (v).<b>2007</b>-Subsec. (b)(6). Pub. L. 110-85, §801(b)(3)(B), added par. (6).Subsec. (e). Pub. L. 110-85, §903, inserted at end “The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 355-1(g)(2)(D) of this title.”Subsec. (i)(4). Pub. L. 110-85, §801(b)(3)(A), inserted at end “The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 282 of title 42.”Subsec. (k)(3), (4). Pub. L. 110-85, §905(a), added pars. (3) and (4).Subsec. (k)(5). Pub. L. 110-85, §921, added par. (5).Subsec. (<em>l</em>). Pub. L. 110-85, §916, designated existing provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), and added par. (2).Subsec. (n)(4) to (8). Pub. L. 110-85, §701(b), redesignated pars. (5) to (8) as (4) to (7), respectively, and struck out former par. (4) which read as follows: “Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary may not grant a waiver for a member of a panel when the member's own scientific work is involved.”Subsecs. (<em>o</em>), (p). Pub. L. 110-85, §901(a), added subsecs. (<em>o</em>) and (p).Subsec. (q). Pub. L. 110-85, §914(a), added subsec. (q).Subsec. (r). Pub. L. 110-85, §915, added subsec. (r).Subsec. (s). Pub. L. 110-85, §918, added subsec. (s).Subsec. (t). Pub. L. 110-85, §920, added subsec. (t).Subsec. (u). Pub. L. 110-85, §1113, added subsec. (u).<b>2003</b>-Subsec. (b)(1). Pub. L. 108-155, in second sentence, substituted “(F)” for “and (F)” and inserted “,and (G) any assessments required under section 355c of this title” before period at end.Subsec. (b)(3). Pub. L. 108-173, §1101(b)(1)(A), added par. (3) and struck out former par. (3) which, in subpar. (A), required an applicant making a certification under par. (2)(A)(iv) to include statement that applicant will give notice to each owner of the patent which is the subject of the certification and to the holder of the approved application, in subpar. (B), directed that notice state that an application has been submitted and include a detailed statement of the applicant's opinion that the patent is not valid or will not be infringed, and, in subpar. (C), provided that if an application is amended, notice shall be given when the amended application is submitted.Subsec. (b)(4), (5). Pub. L. 108-173, §1101(b)(1)(B), added par. (4) and redesignated former par. (4) as (5).Subsec. (c)(3). Pub. L. 108-173, §1101(b)(2)(A), substituted “by applying the following to each certification made under subsection (b)(2)(A) of this section” for “under the following” in introductory provisions.Subsec. (c)(3)(C). Pub. L. 108-173, §1101(b)(2)(B)(iii), which directed the substitution of “subsection (b)(3) of this section” for “paragraph (3)(B)” in third sentence, could not be executed because such words do not appear. See note below.Pub. L. 108-173, §1101(b)(2)(B)(ii)(VI), in concluding provisions, struck out “Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is received, no action may be brought under section 2201 of title 28 for a declaratory judgment with respect to the patent. Any action brought under such section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.” after “expediting the action.”Pub. L. 108-173, §1101(b)(2)(B)(i), (ii)(I), in first sentence of introductory provisions, substituted “unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) of this section is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) of this section before the date on which the application (excluding an amendment or supplement to the application) was submitted” for “unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (3)(B) is received” and, in second sentence of introductory provisions, substituted “subsection (b)(3) of this section” for “paragraph (3)(B)”.Subsec. (c)(3)(C)(i). Pub. L. 108-173, §1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i) which read as follows: “if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court decision,”.Subsec. (c)(3)(C)(ii). Pub. L. 108-173, §1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl. (ii) which read as follows: “if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or”.Subsec. (c)(3)(C)(iii). Pub. L. 108-173, §1101(b)(2)(B)(ii)(IV), substituted “as provided in clause (i); or” for “on the date of such court decision.”Subsec. (c)(3)(C)(iv). Pub. L. 108-173, §1101(b)(2)(B)(ii)(V), added cl. (iv).Subsec. (c)(3)(D), (E). Pub. L. 108-173, §1101(b)(2)(C), (D), added subpar. (D) and redesignated former subpar. (D) as (E).Subsec. (j)(2)(B). Pub. L. 108-173, §1101(a)(1)(A), added subpar. (B) and struck out former subpar. (B) which, in cl. (i), required that an applicant making a certification under subpar. (A)(vii)(IV) include in the application a statement that notice would be given to each owner of the patent and the holder of the approved application, in cl. (ii), required that notice would state that an application had been submitted and that it would include a detailed statement of the basis of the applicant's opinion, and, in cl. (iii), directed that notice <!-- PDFPage:185 -->of an amended application be given when the amended application had been submitted.Subsec. (j)(2)(D). Pub. L. 108-173, §1101(a)(1)(B), added subpar. (D).Subsec. (j)(5)(B). Pub. L. 108-173, §1101(a)(2)(A)(i), substituted “by applying the following to each certification made under paragraph (2)(A)(vii)” for “under the following” in introductory provisions.Subsec. (j)(5)(B)(iii). Pub. L. 108-173, §1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second sentence of subsec. (j)(5)(B)(iii) by striking “Until the expiration” and all that follows in the matter after and below subclause (IV), was executed by striking “Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of title 28, for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.” after “expediting the action.” in concluding provisions, to reflect the probable intent of Congress.Pub. L. 108-173, §1101(a)(2)(A)(ii)(I), in introductory provisions, substituted “unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) of this section before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted” for “unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received”.Subsec. (j)(5)(B)(iii)(I). Pub. L. 108-173, §1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former subcl. (I) which read as follows: “if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision,”.Subsec. (j)(5)(B)(iii)(II). Pub. L. 108-173, §1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former subcl. (II) which read as follows: “if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or”.Subsec. (j)(5)(B)(iii)(III). Pub. L. 108-173, §1101(a)(2)(A)(ii)(II)(cc), substituted “as provided in subclause (I); or” for “on the date of such court decision.”Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108-173, §1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).Subsec. (j)(5)(B)(iv). Pub. L. 108-173, §1102(a)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: “If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after-Subsec. (j)(5)(C). Pub. L. 108-173, §1101(a)(2)(B), (C), added subpar. (C). Former subpar. (C) redesignated (E).Subsec. (j)(5)(D). Pub. L. 108-173, §1102(a)(2), added subpar. (D).Pub. L. 108-173, §1101(a)(2)(B), redesignated subpar. (D) as (F).Subsec. (j)(5)(E), (F). Pub. L. 108-173, §1101(a)(2)(B), redesignated subpars. (C) and (D) as (E) and (F), respectively.Subsec. (j)(8)(A). Pub. L. 108-173, §1103(a)(1), added subpar. (A) and struck out former subpar. (A) which read as follows: “The term ‘bioavailability’ means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.”Subsec. (j)(8)(C). Pub. L. 108-173, §1103(a)(2), added subpar. (C).<b>2002</b>-Subsec. (i)(1)(D). Pub. L. 107-109 added subpar. (D).<b>1999</b>-Subsec. (m). Pub. L. 106-113 substituted “United States Patent and Trademark Office” for “Patent and Trademark Office of the Department of Commerce”.<b>1997</b>-Subsec. (b)(1). Pub. L. 105-115, §115(b), inserted at end “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).”Subsec. (b)(4). Pub. L. 105-115, §119(a), added par. (4).Subsec. (c)(4). Pub. L. 105-115, §124(a), added par. (4).Subsec. (d). Pub. L. 105-115, §115(a), inserted at end “If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence.”Subsec. (i). Pub. L. 105-115, §117, inserted “(1)” after “(i)”, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1), added pars. (2) to (4), and struck out closing provisions which read as follows: “Such regulations shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs.”Subsec. (j)(2)(A)(i). Pub. L. 105-115, §119(b)(2)(A), substituted “paragraph (7)” for “paragraph (6)”.Subsec. (j)(3). Pub. L. 105-115, §119(b)(1)(B), added par. (3). Former par. (3) redesignated (4).Subsec. (j)(4). Pub. L. 105-115, §119(b)(1)(A), (2)(B), redesignated par. (3) as (4) and in introductory provisions substituted “paragraph (5)” for “paragraph (4)”. Former par. (4) redesignated (5).Subsec. (j)(4)(I). Pub. L. 105-115, §119(b)(2)(C), substituted “paragraph (6)” for “paragraph (5)”.Subsec. (j)(5), (6). Pub. L. 105-115, §119(b)(1)(A), redesignated pars. (4) and (5) as (5) and (6), respectively. Former par. (6) redesignated (7).Subsec. (j)(7). Pub. L. 105-115, §119(b)(1)(A), (2)(D), redesignated par. (6) as (7) and in subpar. (C) substituted “paragraph (6)” for “paragraph (5)” in two places. Former par. (7) redesignated (8).Subsec. (j)(8), (9). Pub. L. 105-115, §119(b)(1)(A), redesignated pars. (7) and (8) as (8) and (9), respectively.Subsec. (n). Pub. L. 105-115, §120, added subsec. (n).<b>1993</b>-Subsec. (j)(6)(A)(ii). Pub. L. 103-80, §3(n)(1)(A), substituted “Secretary” for “Secretry”.Subsec. (j)(6)(A)(iii). Pub. L. 103-80, §3(n)(1)(B), inserted comma after “published by the Secretary”.Subsec. (k)(1). Pub. L. 103-80, §3(n)(2), substituted “section. Regulations” for “section: <em>Provided, however</em>, That regulations”.<b>1992</b>-Subsec. (j)(8). Pub. L. 102-282 added par. (8).<b>1984</b>-Subsec. (a). Pub. L. 98-417, §102(b)(1), inserted “or (j)” after “subsection (b)”.Subsec. (b). Pub. L. 98-417, §§102(a)(1), 103(a), designated existing provisions of subsec. (b) as par. (1) thereof and redesignated existing cls. (1) through (6) of such par. (1) as cls. (A) through (F) thereof, respectively, inserted requirement that the applicant file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably by asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, that the applicant amend the application to include such information if an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, and that upon approval of the application, the Secretary publish the information submitted, and added pars. (2) and (3).Subsec. (c). Pub. L. 98-417, §§102(a)(2), (b)(2), 103(b), designated existing provisions of subsec. (c) as par. (1) thereof and in par. (1) as so designated substituted “subsection (b) of this section” for “this subsection” and redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, and added pars. (2) and (3).Subsec. (d)(6), (7). Pub. L. 98-417, §102(a)(3)(A), added cl. (6) relating to the failure of the application to contain the patent information prescribed by subsec. (b) of this section, and redesignated former cl. (6) as (7).Subsec. (e). Pub. L. 98-417, §102(a)(3)(B), in first sentence, added a new cl. (4) relating to the failure to file the patent information prescribed by subsec. (c) of this section within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information, and redesignated former cl. (4) as (5).Pub. L. 98-417, §102(b)(3), (4), in second sentence, inserted in provisions preceding cl. (1) “submitted under subsection (b) or (j) of this section” and in cl. (1) substituted “under subsection (k) of this section or to comply with the notice requirements of section 360(k)(2) of this title” for “under subsection (j) of this section or to comply with the notice requirements of section 360(j)(2) of this title”.Subsecs. (j), (k). Pub. L. 98-417, §101, added subsec. (j) and redesignated former subsec. (j) as (k).Subsec. (k)(1). Pub. L. 98-417, §102(b)(5), substituted “under subsection (b) or (j) of this section” for “pursuant to this section”.Subsecs. (<em>l</em>), (m). Pub. L. 98-417, §104, added subsecs. (<em>l</em>) and (m).<b>1972</b>-Subsec. (e). Pub. L. 92-387 inserted “or to comply with the notice requirements of section 360(j)(2) of this title” in cl. (1) of second sentence relating to the maintenance of records.<b>1962</b>-Subsec. (a). Pub. L. 87-781, §104(a), inserted “an approval of” before “an application”.Subsec. (b). Pub. L. 87-781, §102(b), inserted “and whether such drug is effective in use” after “is safe for use”.Subsec. (c). Pub. L. 87-781, §104(b), substituted provisions requiring the Secretary, within 180 days after filing an application, or such additional period as the Secretary and the applicant agree upon, to either approve the application, if meeting the requirements of subsec. (d) of this section, or give notice of opportunity for hearing on question of whether such application is approvable, and providing that if applicant requests hearing in writing within 30 days, the hearing shall begin within 90 days after expiration of said 30 days, unless the Secretary and applicant agree otherwise, that such hearing shall be expedited, and that the Secretary's order shall be issued within 90 days after date for filing final briefs, for provisions which had an application become effective on the sixtieth day after filing thereof unless prior thereto the Secretary postponed the date by written notice to such time, but not more than 180 days after filing, as the Secretary deemed necessary to study and investigate the application.Subsec. (d). Pub. L. 87-781, §102(c), inserted references to subsec. (c), added cls. (5) and (6), provided that if after notice and opportunity for hearing, the Secretary finds that cls. (1) to (6) do not apply, he shall approve the application, and defined “substantial evidence” as used in this subsection and subsec. (e) of this section.Subsec. (e). Pub. L. 87-781, §102(d), amended subsec. (e) generally, and among other changes, directed the Secretary to withdraw approval of an application if by tests, other scientific data or experience, or new evidence of clinical experience not contained in the application or available at the time of its approval, the drug is shown to be unsafe, or on the basis of new information, there is shown a lack of substantial evidence that the drug has the effect it is represented to have, and provided that if the Secretary, or acting Secretary, finds there is an imminent hazard to the public health, he may suspend approval immediately, notify the applicant, and give him opportunity for an expedited hearing, that the Secretary may withdraw approval if the applicant fails to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain records and make reports, or has refused access to, or copying or verification of such records, or if the Secretary finds on new evidence that the methods, facilities and controls in the manufacturing, processing, and packing are inadequate to assure and preserve the drugs’ identity, strength, quality and purity, and were not made adequate within a reasonable time after receipt of written notice thereof, or finds on new evidence, that the labeling is false or misleading and was not corrected within a reasonable time after receipt of written notice thereof.Subsec. (f). Pub. L. 87-781, §104(c), substituted provisions requiring the Secretary to revoke any previous order under subsecs. (d) or (e) of this section refusing, withdrawing, or suspending approval of an application and to approve such application or reinstate such approval, for provisions which required him to revoke an order refusing effectiveness to an application.Subsec. (h). Pub. L. 87-781, §104(d)(1), (2), inserted “as provided in section 2112 of title 28”, and “except that until the filing of the record the Secretary may modify or set aside his order”, substituted “or withdrawing approval of an application under this section” for “to permit the application to become effective, or suspending the effectiveness of the application”, “United States court of appeals for the circuit” for “district court of the United States within any district”, “Court of Appeals for the District of Columbia Circuit” for “District Court for the District of Columbia”, “transmitted by the clerk of the court to” for “served upon”, and “by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28” for “as provided in sections 225, 346, and 347 of title 28, as amended, and in section 7, as amended, of the Act entitled ‘An Act to establish a Court of Appeals for the District of Columbia’, approved February 9, 1893”, and eliminated “upon” before “any officer designated”, “a transcript of” before “the record” and “and decree” before “of the court affirming”.Subsec. (i). Pub. L. 87-781, §103(b), inserted “the foregoing subsections of” after “operation of”, and “and effectiveness” after “safety”, and provided that the regulations may condition exemptions upon the submission of reports of preclinical tests to justify the proposed clinical testing, upon the obtaining by the manufacturer or sponsor of the investigation of a new drug of a signed agreement from each of the investigators that patients to whom the drug is administered will be under his supervision or under investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings, or upon the establishment and maintenance of records and reports of data obtained by the investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug, and provided that the regulations shall condition an exemption upon the manufacturer or sponsor of the investigation requiring that experts <!-- PDFPage:187 -->using such drugs certify that they will inform humans to whom such drugs or any controls connected therewith are administered, or their representatives, and will obtain the consent of such people where feasible and not contrary to the best interests of such people, and that reports on the investigational use of drugs are not required to be submitted directly to the Secretary.Subsec. (j). Pub. L. 87-781, §103(a), added subsec. (j).<b>1960</b>-Subsec. (g). Pub. L. 86-507 inserted “or by certified mail” after “registered mail”. effectiveDate amendments Pub. L. 110-85, title VII, §701(c), Sept. 27, 2007, 121 Stat. 904, provided that: “The amendments made by this section [enacting section 379d-1 of this title and amending this section] shall take effect on October 1, 2007.”Amendment by sections 901(a), 903, and 905(a) of Pub. L. 110-85 effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110-85, set out as a note under section 331 of this title.Pub. L. 108-173, title XI, §1101(c), Dec. 8, 2003, 117 Stat. 2456, provided that:“(1) <cap-smallcap>In general</cap-smallcap>.-Except as provided in paragraphs (2) and (3), the amendments made by subsections (a) and (b) [amending this section] apply to any proceeding under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or after the date of the enactment of this Act [Dec. 8, 2003] regardless of the date on which the proceeding was commenced or is commenced.“(2) <cap-smallcap>Notice of opinion that patent is invalid or will not be infringed</cap-smallcap>.-The amendments made by subsections (a)(1) and (b)(1) apply with respect to any certification under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after August 18, 2003, in an application filed under subsection (b) or (j) of that section or in an amendment or supplement to an application filed under subsection (b) or (j) of that section.“(3) <cap-smallcap>Effective date of approval</cap-smallcap>.-The amendments made by subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to any patent information submitted under subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) on or after August 18, 2003.”Pub. L. 108-173, title XI, §1102(b), Dec. 8, 2003, 117 Stat. 2460, provided that:“(1) <cap-smallcap>In general</cap-smallcap>.-Except as provided in paragraph (2), the amendment made by subsection (a) [amending this section] shall be effective only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date of the enactment of this Act [Dec. 8, 2003] for a listed drug for which no certification under section 505(j)(2)(A)(vii)(IV) of that Act was made before the date of the enactment of this Act.“(2) <cap-smallcap>Collusive agreements</cap-smallcap>.-If a forfeiture event described in section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an applicant, the applicant shall forfeit the 180-day period under section 505(j)(5)(B)(iv) of that Act without regard to when the first certification under section 505(j)(2)(A)(vii)(IV) of that Act for the listed drug was made.“(3) <cap-smallcap>Decision of a court when the 180-day exclusivity period has not been triggered</cap-smallcap>.-With respect to an application filed before, on, or after the date of the enactment of this Act [Dec. 8, 2003] for a listed drug for which a certification under section 505(j)(2)(A)(vii)(IV) of that Act was made before the date of the enactment of this Act and for which neither of the events described in subclause (I) or (II) of section 505(j)(5)(B)(iv) of that Act (as in effect on the day before the date of the enactment of this Act) has occurred on or before the date of the enactment of this Act, the term ‘decision of a court’ as used in clause (iv) of section 505(j)(5)(B) of that Act means a final decision of a court from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken.”Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108-155, set out as an Effective Date note under section 355c of this title.Amendment by Pub. L. 106-113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106-113, set out as a note under section 1 of Title 35, Patents.Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115, set out as a note under section 321 of this title.Section 105 of Pub. L. 98-417 provided that:“(a) The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 505 of the Federal Food, Drug, and Cosmetic Act [this section], as amended by sections 101, 102, and 103 of this Act, within one year of the date of enactment of this Act [Sept. 24, 1984].“(b) During the period beginning sixty days after the date of the enactment of this Act [Sept. 24, 1984], and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new drug applications may be submitted in accordance with the provisions of section 314.2 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 505(c) of the Federal Food, Drug, and Cosmetic Act [subsec. (c) of this section] before the date of the enactment of this Act. If any such provision is inconsistent with the requirements of section 505(j) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall consider the application under the applicable requirements of such section. The Secretary of Health and Human Services may not approve such an abbreviated new drug application which is filed for a drug which is described in sections 505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act, except in accordance with such section.”Amendment by Pub. L. 92-387 effective on first day of sixth month beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set out as a note under section 360 of this title.Amendment by Pub. L. 87-781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87-781, set out as a note under section 321 of this title. construction amendments Pub. L. 110-85, title IX, §905(b), Sept. 27, 2007, 121 Stat. 949, provided that: “Nothing in this section [amending this section] or the amendment made by this section shall be construed to prohibit the lawful disclosure or use of data or information by an entity other than as described in paragraph (4)(B) or (4)(G) of section 505(k) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(k)], as added by subsection (a).”Amendment by Pub. L. 102-282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private <!-- PDFPage:188 -->right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-282, set out as a note under section 335a of this title. transferOfFunctions For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. amendments Pub. L. 110-85, title IX, §907, Sept. 27, 2007, 121 Stat. 950, provided that: “This subtitle [subtitle A (§§901-909) of title IX of Pub. L. 110-85, enacting sections 353b and 355-1 of this title, amending this section and sections 331, 333, and 352 of this title and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under this section and sections 331, 352, and 355a of this title], and the amendments made by this subtitle, shall have no effect on the use of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] by, or on the lawful written or oral order of, a licensed veterinarian within the context of a veterinarian-client-patient relationship, as provided for under section 512(a)(5) of such Act [21 U.S.C. 360b(a)(5)].”Pub. L. 108-173, title XI, §1103(b), Dec. 8, 2003, 117 Stat. 2461, provided that: “The amendment made by subsection (a) [amending this section] does not alter the standards for approval of drugs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).” false false false

Part A Drugs and Devices Title 5 Section 552 Title 5 Section 553 5 U.S.C. 552 5 U.S.C. 553 Title 15 Section 56(a) Title 15 Section 56(a)(1) 15 U.S.C. 56(a) 15 U.S.C. 56(a)(1) Title 21 Section 321 Title 21 Section 321(aa) Title 21 Section 351(a)(2)(C) Title 21 Section 355 Title 21 Section 355(b) Title 21 Section 355(b)(1) Title 21 Section 355(b)(2) Title 21 Section 355(c) Title 21 Section 355(i) Title 21 Section 355(j) Title 21 Section 355(j)(2)(A)(vii)(IV) Title 21 Section 355(j)(5)(B)(iv) Title 21 Section 355(j)(7) Title 21 Section 355(k) Title 21 Section 357 Title 21 Section 360b(a)(5) 21 U.S.C. 321 21 U.S.C. 321(aa) 21 U.S.C. 351(a)(2)(C) 21 U.S.C. 355 21 U.S.C. 355(b) 21 U.S.C. 355(b)(1) 21 U.S.C. 355(b)(2) 21 U.S.C. 355(c) 21 U.S.C. 355(i) 21 U.S.C. 355(j) 21 U.S.C. 355(j)(2)(A)(vii)(IV) 21 U.S.C. 355(j)(5)(B)(iv) 21 U.S.C. 355(j)(7) 21 U.S.C. 355(k) 21 U.S.C. 357 21 U.S.C. 360b(a)(5) Title 42 Section 262 42 U.S.C. 262 Volume 52 Page 1052 52 Stat. 1052 Volume 74 Page 201 74 Stat. 201 Volume 76 Page 781-783 76 Stat. 781-783 Volume 86 Page 562 86 Stat. 562 Volume 86 Page 770 86 Stat. 770 Volume 98 Page 1585 98 Stat. 1585 Volume 98 Page 1585 98 Stat. 1585 Volume 106 Page 161 106 Stat. 161 Volume 107 Page 777 107 Stat. 777 Volume 111 Page 2313 111 Stat. 2313 Volume 111 Page 2296 111 Stat. 2296 Volume 113 Page 1536 113 Stat. 1536 Volume 115 Page 1420 115 Stat. 1420 Volume 115 Page 1421 115 Stat. 1421 Volume 117 Page 1941 Volume 117 Page 2448 117 Stat. 1941 117 Stat. 2448 Volume 117 Page 2456 Volume 117 Page 2460 Volume 117 Page 2461 117 Stat. 2456 117 Stat. 2460 117 Stat. 2461 Volume 121 Page 903 121 Stat. 903 Volume 121 Page 904 Volume 121 Page 949 Volume 121 Page 950 121 Stat. 904 121 Stat. 949 121 Stat. 950 Volume 122 Page 3524 Volume 122 Page 4076 122 Stat. 3524 122 Stat. 4076 Volume 122 Page 4077 122 Stat. 4077 Volume 123 Page 1837 123 Stat. 1837 Volume 124 Page 816 124 Stat. 816 Volume 124 Page 3854 124 Stat. 3854 Public Law 86-507 Public Law 86-507 Public Law 87-781 Public Law 87-781 Public Law 92-387 Public Law 92-387 Public Law 92-463 Public Law 98-417 Public Law 98-417 Public Law 102-282 Public Law 102-282 Public Law 103-80 Public Law 103-80 Public Law 104-191 Public Law 105-115 Public Law 105-115 Public Law 106-113 Public Law 106-113 Public Law 107-109 Public Law 107-109 Public Law 108-155 Public Law 108-155 Public Law 108-173 Public Law 108-173 Public Law 110-85 Public Law 110-85 Public Law 110-316 Public Law 110-316 Public Law 110-379 Public Law 110-379 Public Law 111-31 Public Law 111-31 Public Law 111-148 Public Law 111-148 Public Law 111-350 U.S. Government Printing Office 2010-12-31 monographic 2010 annual deposited born digital 711 p. Y 1.2/5: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21 P0b002ee180df746e 000645501 21USC DGPO 2011-09-06 2011-09-06 USCODE-2010-title21 machine generated eng fdlp USCODE USCODE-2010-title21 21 true 4 2006 false false 2011-01-07 false false USCODE-title21 Title 21 http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21.htm http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21.pdf U.S.C. Title 21, 2010