Sec. 903. User fee program transparency and accountability
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Section 736B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2(a) ) is amended— in paragraph (1)— in subparagraph (B)— in clause (vii), by striking ; and and inserting a semicolon; in clause (viii), by striking the period and inserting ; and ; and by adding at the end the following: the number of investigational new drug applications submitted per fiscal year, including for each review division. ; and by adding at the end the following flush text: Nothing in subparagraph
(B)shall be construed to authorize the disclosure of confidential commercial information or other information considered proprietary or trade secret, as prohibited under section 301(j) of this Act of section 1905 of title 18, United States Code. ; and in paragraph (4)— by amending subparagraph
(A)to read as follows: data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 736, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; by amending subparagraph
(B)to read as follows: data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying— drivers of such changes; and changes in the average total cost per full-time equivalent in the prescription drug review program; ; in subparagraph (C), by striking the period and inserting ; and ; and by adding at the end the following: data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application. . Section 736B(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2(f) ) is amended— by redesignating paragraphs
(4)through
(6)as paragraphs
(5)through (7), respectively; by inserting after paragraph
(3)the following: The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and in paragraph (7), as so redesignated— in subparagraph (A)— by striking Before presenting the recommendations developed under paragraphs
(1)through
(5)to the Congress, the and inserting The ; and by inserting , not later than 30 days after each such negotiation meeting before the period at the end; and in subparagraph (B), by inserting , in sufficient detail, after shall summarize . Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(a)(1)(A) ) is amended— in clause (ii)— in subclause (II), by striking ; and and inserting a semicolon; in subclause (III), by striking the period and inserting a semicolon; by adding at the end the following: the number of investigational device exemption applications submitted under section 520(g) per fiscal year, including for each review division; and the number of expedited development and priority review requests and designations under section 515B per fiscal year, including for each review division. ; and by adding at the end the following flush text: Nothing in this clause shall be construed to authorize the disclosure of confidential commercial information or other information considered proprietary or trade secret, as prohibited under section 301(j) of this Act or section 1905 of title 18, United States Code. ; in the first clause
(iv)(relating to rationale for MDUFA program changes)— by amending subclause
(I)to read as follows: data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 738, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; by amending subclause
(II)to read as follows: data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying— drivers of such changes; and changes in the average total cost per full-time equivalent in the medical device review program; ; in subclause (III), by striking the period and inserting ; and ; and by adding at the end the following: data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types. ; and by redesignating the second clause
(iv)(relating to analysis) as clause (v). Section 738A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(b) ) is amended— by redesignating paragraphs
(4)through
(6)as paragraphs
(5)through (7), respectively; by inserting after paragraph
(3)the following: The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and in paragraph (7), as so redesignated— in subparagraph (A)— by striking Before presenting the recommendations developed under paragraphs
(1)through
(5)to the Congress, the and inserting The ; and by inserting , not later than 30 days after each such negotiation meeting before the period at the end; and in subparagraph (B), by inserting , in sufficient detail, after shall summarize . Section 744C(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43(a)(3) ) is amended— by amending subparagraph
(A)to read as follows: data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 744B, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; by amending subparagraph
(B)to read as follows: data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including— identifying drivers of such changes; and changes in the total average cost per full-time equivalent in the generic drug review program; ; in subparagraph (C), by striking the period at the end and inserting ; and ; and by adding at the end the following: data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application. . Section 744C(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43(f) ) is amended— by redesignating paragraphs
(4)through
(6)as paragraphs
(5)through (7), respectively; by inserting after paragraph
(3)the following: The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and in paragraph (7), as so redesignated— in subparagraph (A)— by striking Before presenting the recommendations developed under paragraphs
(1)through
(5)to the Congress, the and inserting The ; and by inserting , not later than 30 days after each such negotiation meeting before the period at the end; and in subparagraph (B), by inserting , in sufficient detail, after shall summarize . Section 744I(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53(a)(4) ) is amended— by amending subparagraph
(A)to read as follows: data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 744H, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; by amending subparagraph
(B)to read as follows: data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying— drivers of such changes; and changes in the average total cost per full-time equivalent in the biosimilar biological product review program; ; in subparagraph (C), by striking the period at the end and inserting ; and ; and by adding at the end the following: data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application. . Section 744I(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53(f) ) is amended— by redesignating paragraphs
(2)and
(3)as paragraphs
(5)and (6), respectively; by inserting after paragraph
(1)the following: Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall— publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization; provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and publish the comments on the Food and Drug Administration’s website. Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2). The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and by adding at the end the following: The Secretary shall make publicly available, on the public website 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, not later than 30 days after each such negotiation meeting. The minutes described under subparagraph
(A)shall summarize, in sufficient detail, 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. .
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- 21 USC 379h–2(a)
- 21 USC 379h–2(f)
- 21 USC 379j–1(a)(1)(A)
- 21 USC 379j–1(b)
- 21 USC 379j–43(a)(3)
- 21 USC 379j–43(f)
- 21 USC 379j–53(a)(4)
- 21 USC 379j–53(f)
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Sec. 903
User fee program transparency and accountability
Cite21 USC 379h–2(a)
Cite21 USC 379h–2(f)
Cite21 USC 379j–1(a)(1)(A)
Cite21 USC 379j–1(b)
Cite21 USC 379j–43(a)(3)
Cites 8 · showing 5Cited by 0 across 0 sources