Sec. 774.
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Fees derived from amounts assessed and collected for fiscal year 2026, credited under the heading Department of Health and Human Services—Food and Drug Administration—Salaries and Expenses , and made available for expenditure under such heading must comply with each provision contained in current user fee authorizations, appropriations Acts, and commitment letters, as transmitted from the Secretary of Health and Human Services to the chair and ranking member of the Committee on Health, Education, Labor, and Pensions of the Senate and the chair and ranking member of the Committee on Energy and Commerce of the House of Representatives regarding reauthorization of such current user fee authorizations:
That the term current user fee authorizations means those user fees authorized at Provided, 21 U.S.C. 379h , 21 U.S.C. 379j , 21 U.S.C. 379j–42 , 21 U.S.C. 379j–52 , 21 U.S.C. 379j–12 , 21 U.S.C. 379j–21 , 21 U.S.C. 387s , 42 U.S.C. 263b , 21 U.S.C. 381 , 21 U.S.C. 360n and 360ff, 21 U.S.C. 379–j31, 21 U.S.C. 379j–62 , 21 U.S.C. 353(e)(3) , 21 U.S.C. 360eee–3(c)(1) , 21 U.S.C. 384d(c)(8) , 21 U.S.C. 360bbb–4a, and 21 U.S.C. 379j–72 . Not later than 90 days after the date of enactment of this Act, the Food and Drug Administration shall submit to the Committees on Appropriations of the House of Representatives and the Senate a report that includes obligation and outlay estimates and full-time equivalent
(FTE)personnel staffing estimates for fiscal year 2026 for each Food and Drug Administration program that uses both general fund appropriations and funds derived from user fees: That such report shall include a table with separate columns for general fund appropriations and funds derived from user fees for such obligations, outlays and FTE personnel staffing: Provided, That such report shall be certified by the Ombudsman of the Food and Drug Administration. Provided further, The report in paragraph
(1)shall be updated, certified by the Ombudsman of the Food and Drug Administration, and submitted to the Committees on Appropriations of the House of Representatives and the Senate not later than 45 days after each fiscal quarter until all such funds are expended: That a plan for such ongoing quarterly reporting shall be submitted with the report required by subsection (b)(1). Provided, Of the amounts provided in this Act in paragraph
(10)under the heading Department of Health and Human Services—Food and Drug Administration—Salaries and Expenses and made available by the Food and Drug Administration for Office of the Commissioner of Food and Drugs, 50 percent shall be withheld from obligation until the reporting requirements outlined in subsection
(b)are met: That an additional 25 percent of the amounts withheld from obligation shall be available when the report required by subsection (b)(1) is submitted and the remaining 25 percent shall be available when the plan for satisfying the ongoing quarterly reporting requirements outlined in the proviso in subsection (b)(2) is submitted. Provided,
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U.S. Code
- Authority to assess and use drug fees§ 379h
- Authority to assess and use device fees§ 379j
- User fees§ 387s
- Certification of mammography facilities§ 263b
- Imports and exports§ 381
- Priority review to encourage treatments for tropical diseases§ 360n
- Confidential information§ 379
- Exemptions and consideration for certain drugs, devices, and biological products§ 353
- Accreditation of third-party auditors§ 384d
8 references not yet in our index
- 21 USC 379j–42
- 21 USC 379j–52
- 21 USC 379j–12
- 21 USC 379j–21
- 21 USC 379j–62
- 21 USC 360eee–3(c)(1)
- 21 USC 360bbb–4a
- 21 USC 379j–72
Citation graph
cites case law
Sec. 774
Cite21 USC 379j–42
Cite21 USC 379j–52
Cite21 USC 379j–12
Cites 17 · showing 12Cited by 0 across 0 sources