Source: https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title21-chapter9-subchapter7-partC-subpart5&saved=%7CKHRpdGxlOjIxIHNlY3Rpb246Mzc5ai0yMSBlZGl0aW9uOnByZWxpbSk%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim
Timestamp: 2020-07-11 15:01:17
Document Index: 376885142

Matched Legal Cases: ['art 5', 'art 5', 'art 5', 'art 5', '§741', '§202', '§202', '§202', '§202', '§205', 'art 5', '§205', 'art 5', '§206', '§206', '§206', '§204', '§206', '§204', 'art 5', '§204', 'art 5', '§201', 'art 5', '§201', '§201', '§379', '§742', '§203', '§203', '§203', '§203', '§203', '§203', 'art 5', '§206', '§206', '§206', '§204', '§206']

[USC02] 21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 5: fees relating to generic new animal drugs
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21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 5: fees relating to generic new animal drugs
From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER VII—GENERAL AUTHORITYPart C—Fees
subpart 5—fees relating to generic new animal drugs
Termination of Subpart
For termination of subpart by section 206(a), (b) of Pub. L. 113–14, see Termination Date notes set out under sections 379j–21 and 379j–22 of this title.
Each person—
Such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the generic new animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of—
Such fee shall be due each fiscal year upon the later of—
Of the total revenue amount established for a fiscal year under paragraph (1)—
For fiscal year 2020 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
For fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—
Fees under this section shall not apply with respect to any person who—
The fees authorized by this section—
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of abbreviated applications for generic new animal drugs—
The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by—
The term "costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs" means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for—
The terms "investigational submission for a generic new animal drug" and "investigational submission" mean—
(June 25, 1938, ch. 675, §741, as added Pub. L. 110–316, title II, §202(b), Aug. 14, 2008, 122 Stat. 3515; amended Pub. L. 113–14, title II, §202, June 13, 2013, 127 Stat. 465; Pub. L. 115–234, title II, §202, Aug. 14, 2018, 132 Stat. 2432.)
2018—Subsec. (b). Pub. L. 115–234, §202(a), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts for fiscal years 2014 to 2018.
2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to authority to assess and use generic new animal drug fees.
Pub. L. 115–234, title II, §205, Aug. 14, 2018, 132 Stat. 2435, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title] shall take effect on October 1, 2018, or the date of the enactment of this Act [Aug. 14, 2018], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act."
Pub. L. 113–14, title II, §205, June 13, 2013, 127 Stat. 474, provided that: "The amendments made by this title [amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] shall take effect on October 1, 2013, or the date of enactment of this Act [June 13, 2013], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as amended by this title, shall be assessed for all abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2013, regardless of the date of enactment of this Act."
Pub. L. 115–234, title II, §206(a), Aug. 14, 2018, 132 Stat. 2435, provided that: "Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2023."
Pub. L. 113–14, title II, §206(a), June 13, 2013, 127 Stat. 474, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115–234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.
Pub. L. 110–316, title II, §204(a), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendments made by section 202 of Pub. L. 110–316 (enacting this section and amending sections 379k, 379l, and 379o of this title) would cease to be effective Oct. 1, 2013, was repealed by Pub. L. 113–14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.
Pub. L. 115–234, title II, §204, Aug. 14, 2018, 132 Stat. 2435, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this title [Aug. 14, 2018], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019."
Pub. L. 113–14, title II, §204, June 13, 2013, 127 Stat. 474, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as in effect on the day before the date of enactment of this title [June 13, 2013], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2014."
Pub. L. 115–234, title II, §201(b), Aug. 14, 2018, 132 Stat. 2432, provided that: "Congress finds that the fees authorized by the amendments made in this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title] will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor and Pensions of the Senate as set forth in the Congressional Record."
Pub. L. 113–14, title II, §201(b), June 13, 2013, 127 Stat. 464, provided that: "The fees authorized by this title [see Short Title of 2013 Amendment note set out under section 301 of this title] will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record."
Pub. L. 110–316, title II, §201(b), Aug. 14, 2008, 122 Stat. 3515, provided that: "Congress finds as follows:
§379j–22. Reauthorization; reporting requirements
(a) Performance reports
Beginning with fiscal year 2019, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Animal Generic Drug User Fee Amendments of 2018 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.
(b) Fiscal report
Beginning with fiscal year 2019, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(d) Reauthorization
In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2023, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—
(A) publish a notice in the Federal Register requesting public input on the reauthorization;
(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and
(D) publish the comments on the Food and Drug Administration's Internet Web site.
(3) Periodic consultation
Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After negotiations with the regulated industry, the Secretary shall—
(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(D) hold a meeting at which the public may present its views on such recommendations; and
(E) after consideration of such public views and comments, revise such recommendations as necessary.
(5) Transmittal of recommendations
Not later than January 15, 2023, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §742, as added Pub. L. 110–316, title II, §203, Aug. 14, 2008, 122 Stat. 3522; amended Pub. L. 113–14, title II, §203, June 13, 2013, 127 Stat. 472; Pub. L. 115–234, title II, §203, Aug. 14, 2018, 132 Stat. 2435.)
For termination of section by section 206(b) of Pub. L. 115–234, see Termination Date note below.
Section 201(b) of the Animal Generic Drug User Fee Amendments of 2018, referred to in subsec. (a), is section 201(b) of Pub. L. 115–234, which is set out as a note under section 379j–21 of this title.
2018—Subsec. (a). Pub. L. 115–234, §203(1), (3), substituted "2019" for "2014" and "2018" for "2013".
Subsec. (b). Pub. L. 115–234, §203(2), (3), substituted "2019" for "2014" and "to the Committee on Health, Education, Labor and Pensions" for "to Committee on Health, Education, Labor, and Pensions".
Subsec. (d)(1), (5). Pub. L. 115–234, §203(4), substituted "2023" for "2018".
2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to reauthorization of this subpart and reporting requirements.
Amendment by Pub. L. 115–234 effective on Oct. 1, 2018, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2018, see section 205 of Pub. L. 115–234, set out as a note under section 379j–21 of this title.
Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 205 of Pub. L. 113–14, set out as a note under section 379j–21 of this title.
Pub. L. 115–234, title II, §206(b), Aug. 14, 2018, 132 Stat. 2435, provided that: "Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2024."
Pub. L. 113–14, title II, §206(b), June 13, 2013, 127 Stat. 474, which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2019, was repealed by Pub. L. 115–234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.
Pub. L. 110–316, title II, §204(b), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendment made by section 203 of Pub. L. 110–316 (enacting this section) would cease to be effective Jan. 31, 2014, was repealed by Pub. L. 113–14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.