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Code · STATUTE-COMPILATIONS · Department of Defense and Full-Year Continuing Appropriations Act, 2011 · Sec. 1269

Sec. 1269. 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.

797 words·~4 min read·/statute-compilations/comps-9551/sec-1269

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

## SEC. 1269 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. In addition, mammography user fees authorized by 42 U.S.C. 263b, export certification user fees authorized by 21 U.S.C. 381, and priority review user fees authorized by 21 U.S.C. 360n may be credited to this account, to remain available until expended. In addition, food and feed recall user fees, food reinspection user fees, and voluntary qualified importer program user fees authorized by section 743 of the Federal Food, Drug, and Cosmetic Act, as amended by Public Law 111-353, may be credited to this account in an amount not to exceed the amount determined under subsection
(b)of such section 743, to remain available until expended.
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  • Pub. L. 111-353
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Sec. 1269
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.
Pub. L.Pub. L. 111-353
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