costs pursuant to Public Law 92–313 for programs and 
activities of the Food and Drug Administration which are 
included in this Act; for rental of special purpose space 
in the District of Columbia or elsewhere; in addition to 
amounts appropriated to the FDA Innovation Account, for 
carrying out the activities described in section 1002(b)(4) 
of the 21st Century Cures Act (Public Law 114–255); for 
miscellaneous and emergency expenses of enforcement ac-
tivities, authorized and approved by the Secretary and to 
be accounted for solely on the Secretary’s certificate, not 
to exceed $25,000; and notwithstanding section 521 of 
Public Law 107–188; $5,891,241,000: Provided, That of 
the amount provided under this heading, $1,119,188,000 
shall be derived from prescription drug user fees author-
ized by 21 U.S.C. 379h, and shall be credited to this ac-
count and remain available until expended; $238,595,000 
shall be derived from medical device user fees authorized 
by 21 U.S.C. 379j, and shall be credited to this account 
and remain available until expended; $526,039,000 shall 
be derived from human generic drug user fees authorized 
by 21 U.S.C. 379j–42, and shall be credited to this ac-
count and remain available until expended; $42,998,000 
shall be derived from biosimilar biological product user 
fees authorized by 21 U.S.C. 379j–52, and shall be cred-
ited to this account and remain available until expended; 
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$31,306,000 shall be derived from animal drug user fees 
authorized by 21 U.S.C. 379j–12, and shall be credited 
to this account and remain available until expended; 
$20,609,000 shall be derived from generic new animal 
drug user fees authorized by 21 U.S.C. 379j–21, and shall 
be credited to this account and remain available until ex-
pended; $712,000,000 shall be derived from tobacco prod-
uct user fees authorized by 21 U.S.C. 387s, and shall be 
credited to this account and remain available until ex-
pended: Provided further, That in addition to and notwith-
standing any other provision under this heading, amounts 
collected for prescription drug user fees, medical device 
user fees, human generic drug user fees, biosimilar biologi-
cal product user fees, animal drug user fees, and generic 
new animal drug user fees that exceed the respective fiscal 
year 2021 limitations are appropriated and shall be cred-
ited to this account and remain available until expended: 
Provided further, That fees derived from prescription drug, 
medical device, human generic drug, biosimilar biological 
product, animal drug, and generic new animal drug as-
sessments for fiscal year 2021, including any such fees 
collected prior to fiscal year 2021 but credited for fiscal 
year 2021, shall be subject to the fiscal year 2021 limita-
tions: Provided further, That the Secretary may accept 
payment during fiscal year 2021 of user fees specified 
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pamtmann on DSKBC07HB2PROD with BILLS
under this heading and authorized for fiscal year 2022, 
prior to the due date for such fees, and that amounts of 
such fees assessed for fiscal year 2022 for which the Sec-
retary accepts payment in fiscal year 2021 shall not be 
included in amounts under this heading: Provided further, 
That none of these funds shall be used to develop, estab-
lish, or operate any program of user fees authorized by 
31 U.S.C. 9701: Provided further, That of the total 
amount appropriated: (1) $1,098,459,000 shall be for the 
Center for Food Safety and Applied Nutrition and related 
field activities in the Office of Regulatory Affairs; (2) 
$2,031,084,000 shall be for the Center for Drug Evalua-
tion and Research and related field activities in the Office 
of Regulatory Affairs; (3) $427,243,000 shall be for the 
Center for Biologics Evaluation and Research and for re-
lated field activities in the Office of Regulatory Affairs; 
(4) $240,257,000 shall be for the Center for Veterinary 
Medicine and for related field activities in the Office of 
Regulatory Affairs; (5) $611,327,000 shall be for the Cen-
ter for Devices and Radiological Health and for related 
field activities in the Office of Regulatory Affairs; (6) 
$66,712,000 shall be for the National Center for Toxi-
cological Research; (7) $662,612,000 shall be for the Cen-
ter for Tobacco Products and for related field activities 
in the Office of Regulatory Affairs; (8) $190,217,000 shall 
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pamtmann on DSKBC07HB2PROD with BILLS
be for Rent and Related activities, of which $53,608,000 
is for White Oak Consolidation, other than the amounts 
paid to the General Services Administration for rent; (9) 
$236,121,000 shall be for payments to the General Serv-
ices Administration for rent; and (10) $327,209,000 shall 
be for other activities, including the Office of the Commis-
sioner of Food and Drugs, the Office of Foods and Veteri-
nary Medicine, the Office of Medical and Tobacco Prod-
ucts, the Office of Global and Regulatory Policy, the Office 
of Operations, the Office of the Chief Scientist, and cen-
tral services for these offices: Provided further, That not 
to exceed $25,000 of this amount shall be for official re-
ception and representation expenses, not otherwise pro-
vided for, as determined by the Commissioner: Provided 
further, That any transfer of funds pursuant to section 
770(n) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379dd(n)) shall only be from amounts made avail-
able under this heading for other activities: Provided fur-
ther, That of the amounts that are made available under 
this heading for ‘‘other activities’’, and that are not de-
rived from user fees, $1,500,000 shall be transferred to 
and merged with the appropriation for ‘‘Department of 
Health and Human Services—Office of Inspector Gen-
eral’’ for oversight of the programs and operations of the 
Food and Drug Administration and shall be in addition 
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pamtmann on DSKBC07HB2PROD with BILLS
to funds otherwise made available for oversight of the 
Food and Drug Administration: Provided further, That 
funds may be transferred from one specified activity to 
another with the prior approval of the Committees on Ap-
propriations 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, priority review user fees authorized by 
21 U.S.C. 360n and 360ff, food and feed recall fees, food 
reinspection fees, and voluntary qualified importer pro-
gram fees authorized by 21 U.S.C. 379j–31, outsourcing 
facility fees authorized by 21 U.S.C. 379j–62, prescription 
drug wholesale distributor licensing and inspection fees 
authorized by 21 U.S.C. 353(e)(3), third-party logistics 
provider licensing and inspection fees authorized by 21 
U.S.C. 360eee–3(c)(1), third-party auditor fees authorized 
by 21 U.S.C. 384d(c)(8), medical countermeasure priority 
review voucher user fees authorized by 21 U.S.C. 360bbb– 
4a, and fees relating to over-the-counter monograph drugs 
authorized by 21 U.S.C. 379j–72 shall be credited to this 
account, to remain available until expended. 
BUILDINGS AND FACILITIES 
For plans, construction, repair, improvement, exten-
sion, alteration, demolition, and purchase of fixed equip-
ment or facilities of or used by the Food and Drug Admin-
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istration, where not otherwise provided, $11,788,000, to 
remain available until expended. 
FDA INNOVATION ACCOUNT, CURES ACT 
(INCLUDING TRANSFER OF FUNDS) 
For necessary expenses to carry out the purposes de-
scribed under section 1002(b)(4) of the 21st Century 
Cures Act, in addition to amounts available for such pur-
poses under the heading ‘‘Salaries and Expenses’’, 
$70,000,000, to remain available until expended: Pro-
vided, That amounts appropriated in this paragraph are 
appropriated pursuant to section 1002(b)(3) of the 21st 
Century Cures Act, are to be derived from amounts trans-
ferred under section 1002(b)(2)(A) of such Act, and may 
be transferred by the Commissioner of Food and Drugs 
to the appropriation for ‘‘Department of Health and 
Human Services Food and Drug Administration Salaries 
and Expenses’’ solely for the purposes provided in such 
Act: Provided further, That upon a determination by the 
Commissioner that funds transferred pursuant to the pre-
vious proviso are not necessary for the purposes provided, 
such amounts may be transferred back to the account: 
Provided further, That such transfer authority is in addi-
tion to any other transfer authority provided by law. 
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