§ 379f. Recovery and retention of fees for freedom of information requests

Coronavirus Aid, Relief, and Economic Security Act

FDA Reauthorization Act of 2017

Drug Quality and Security Act

Automation of Food and Drug Administration

Transferred

To amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes

To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply

To make corrections with respect to Food and Drug Administration user fees

To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to animal drugs

To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes

Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2010, and for other purposes

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes

Making omnibus appropriations for the fiscal year ending September 30, 2009, and for other purposes

Notice

Notice

Notwithstanding section 1101, the level for “Related Agencies and Food and Drug Administration, Food and Drug Administration, Salaries and Expenses” shall be $3,655,687,000: *Provided*, That of the amount provided under this heading, $667,057,000 shall be derived from prescription drug user fees authorized by section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), shall be credited to this account and remain available until expended, and shall not include any fees pursuant to paragraphs (2) and (3) of section 736(a) of such Act (21 U.S.C. 379h(a)(2) and (a)(3)) assessed for fiscal year 2012 but collected in fiscal year 2011; $61,860,000 shall be derived from medical device user fees authorized by section 738 of such Act (21 U.S.C. 379j), and shall be credited to this account and remain available until expended; $19,448,000 shall be derived from animal drug user fees authorized by section 740 of such Act (21 U.S.C. 379j-12), and shall be credited to this account and remain available until expended; $5,397,000 shall be derived from animal generic drug user fees authorized by section 741 of such Act (21 U.S.C. 379f), and shall be credited to this account and shall remain available until expended; and $450,000,000 shall be derived from tobacco product user fees authorized by section 919 of such Act (21 U.S.C. 387s) and shall be credited to this account and remain available until expended: *Provided** further*, That in addition and notwithstanding any other provision under this heading, amounts collected for prescription drug user fees that exceed the fiscal year 2011 limitation are appropriated and shall be credited to this account and remain available until expended: *Provided further*, That fees derived from prescription drug, medical device, animal drug, animal generic drug, and tobacco product assessments for fiscal year 2011 received during fiscal year 2011, including any such fees assessed prior to fiscal year 2011 but credited for fiscal year 2011, shall be subject to the fiscal year 2011 limitations: *Provided further,* That none of these funds shall be used to develop, establish, or operate any program of user fees authorized by 31 U.S.C. 9701: *Provided further*, That of the total amount appropriated under this heading: (1) $837,358,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $957,116,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $325,647,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $161,730,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $359,781,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $60,664,000 shall be for the National Center for Toxicological Research; (7) $421,463,000 shall be for the Center for Tobacco Products and for related field activities in the Office of Regulatory Affairs; (8) not to exceed $136,239,000 shall be for Rent and Related activities, of which $41,951,000 is for White Oak Consolidation, other than the amounts paid to the General Services Administration for rent; (9) not to exceed $183,048,000 shall be for payments to the General Services Administration for rent; and (10) $212,642,000 shall be for other activities, including the Office of the Commissioner of Food and Drugs; the Office of Foods; the Office of the Chief Scientist; the Office of Policy, Planning and Budget; the Office of International Programs; the Office of Administration; and central services for these offices: *Provided further,* That none of the funds made available under this heading shall be used to transfer funds under section 770(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd): *Provided further*, That not to exceed $25,000 of the amount provided under this heading shall be for official reception and representation expenses, not otherwise provided for, as determined by the Commissioner: *Provided further,* That funds may be transferred from one specified activity to another with the prior approval of the Committees on Appropriations of both Houses of Congress.

FACILITIES MANAGEMENT

CORRECTIONS TO FDA USER FEES

FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES

STRATEGIC INTEGRATED MANAGEMENT PLAN

VOLUNTARY OUTSOURCING FACILITIES

FEES RELATING TO OVER-THE-COUNTER DRUGS

Reporting by wholesale distributors of prescription drugs

Outsourcing facilities

Voluntary outsourcing facilities

Voluntary outsourcing facilities

Voluntary outsourcing facilities

Voluntary outsourcing facilities

Authority to assess and use cosmetic safety fees

Definitions

Transparency

Facilities management

Facilities management

Facilities management

Authority to assess and use cosmetic safety fees

Definitions

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Authority to access and use fees

Authority to access and use fees

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Authority to assess and use cosmetic product fees

Definitions

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Fees relating to over-the-counter drugs

Authority to assess and use cosmetic safety fees

Public information; agency rules, opinions, orders, records, and proceedings

Transferred