H. R. 6833—25 
SEC. 205. EXTENSION OF SPECIALLY ADAPTED HOUSING ASSISTIVE 
TECHNOLOGY GRANT PROGRAM. 
Section 2108(g) of title 38, United States Code, is amended 
by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 
2024’’. 
TITLE III—EXTENSIONS OF AUTHORI-
TIES RELATING TO HOMELESS VET-
ERANS 
SEC. 301. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 
HOMELESS VETERANS REINTEGRATION PROGRAMS. 
Section 2021(e)(1)(F) of title 38, United States Code, is amended 
by striking ‘‘2022’’ and inserting ‘‘2024’’. 
SEC. 302. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 
HOMELESS WOMEN VETERANS AND HOMELESS VETERANS 
WITH CHILDREN REINTEGRATION GRANT PROGRAM. 
Section 2021A(f)(1) of title 38, United States Code, is amended 
by striking ‘‘2022’’ and inserting ‘‘2024’’. 
SEC. 
303. 
EXTENSION 
OF 
AUTHORITY 
FOR 
TREATMENT 
AND 
REHABILITATION FOR SERIOUSLY MENTALLY ILL AND 
HOMELESS VETERANS. 
(a) GENERAL TREATMENT.—Section 2031(b) of title 38, United 
States Code, is amended by striking ‘‘September 30, 2022’’ and 
inserting ‘‘September 30, 2024’’. 
(b) ADDITIONAL SERVICES
AT CERTAIN LOCATIONS.—Section 
2033(d) of such title is amended by striking ‘‘September 30, 2022’’ 
and inserting ‘‘September 30, 2024’’. 
SEC. 304. EXTENSION OF FUNDING FOR FINANCIAL ASSISTANCE FOR 
SUPPORTIVE SERVICES FOR VERY LOW-INCOME VETERAN 
FAMILIES IN PERMANENT HOUSING. 
Section 2044(e)(1)(H) of title 38, United States Code, is amended 
by striking ‘‘and 2022’’ and inserting ‘‘through 2024’’. 
SEC. 305. EXTENSION OF FUNDING FOR GRANT PROGRAM FOR HOME-
LESS VETERANS WITH SPECIAL NEEDS. 
Section 2061(d)(1) of title 38, United States Code, is amended 
by striking ‘‘2022’’ and inserting ‘‘2024’’. 
SEC. 306. EXTENSION OF AUTHORITY FOR THE ADVISORY COMMITTEE 
ON HOMELESS VETERANS. 
Section 2066(d) of title 38, United States Code, is amended 
by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 
2026’’.
H. R. 6833—26 
TITLE IV—EXTENSIONS OF OTHER 
AUTHORITIES 
SEC. 401. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 
MONTHLY ASSISTANCE ALLOWANCE UNDER THE OFFICE 
OF NATIONAL VETERANS SPORTS PROGRAMS AND SPE-
CIAL EVENTS. 
Section 322(d)(4) of title 38, United States Code, is amended 
by striking ‘‘2022’’ and inserting ‘‘2026’’. 
SEC. 402. EXTENSION AND AUTHORIZATION OF APPROPRIATIONS FOR 
ADAPTIVE SPORTS PROGRAMS FOR DISABLED VETERANS 
AND MEMBERS OF THE ARMED FORCES. 
(a) AUTHORIZATION OF APPROPRIATIONS.—Subsection (g)(1)(B) 
of section 521A of title 38, United States Code, is amended by 
striking ‘‘and 2022’’ and inserting ‘‘through 2026’’. 
(b) EXTENSION.—Subsection (l) of such section is amended by 
striking ‘‘2022’’ and inserting ‘‘2026’’. 
(c) TECHNICAL CORRECTION.—Subsection (g)(1)(A) of such sec-
tion is amended by striking ‘‘. for each of fiscal years 2010 through 
2020’’. 
SEC. 403. EXTENSION OF ADVISORY COMMITTEE ON MINORITY VET-
ERANS. 
Section 544(e) of title 38, United States Code, is amended 
by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 
2026’’. 
SEC. 404. EXTENSION OF VETERANS’ ADVISORY COMMITTEE ON EDU-
CATION. 
Section 3692(c) of title 38, United States Code, is amended 
by striking ‘‘December 31, 2022’’ and inserting ‘‘December 31, 2026’’. 
SEC. 405. EXTENSION OF AUTHORITY FOR TRANSFER OF REAL PROP-
ERTY. 
Section 8118(a)(5) of title 38, United States Code, is amended 
by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 
2024’’. 
DIVISION F—FDA USER FEE 
REAUTHORIZATION ACT OF 2022 
SEC. 1. SHORT TITLE. 
This division may be cited as the ‘‘FDA User Fee Reauthoriza-
tion Act of 2022’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this division is as follows: 
DIVISION F—FDA USER FEE REAUTHORIZATION ACT OF 2022 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—FEES RELATING TO DRUGS 
Sec. 1001. Short title; finding. 
Sec. 1002. Definitions.
H. R. 6833—27 
Sec. 1003. Authority to assess and use drug fees. 
Sec. 1004. Reauthorization; reporting requirements. 
Sec. 1005. Sunset dates. 
Sec. 1006. Effective date. 
Sec. 1007. Savings clause. 
TITLE II—FEES RELATING TO DEVICES 
Sec. 2001. Short title; finding. 
Sec. 2002. Definitions. 
Sec. 2003. Authority to assess and use device fees. 
Sec. 2004. Reauthorization; reporting requirements. 
Sec. 2005. Conformity assessment pilot program. 
Sec. 2006. Reauthorization of third-party review program. 
Sec. 2007. Sunset dates. 
Sec. 2008. Effective date. 
Sec. 2009. Savings clause. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 3001. Short title; finding. 
Sec. 3002. Authority to assess and use human generic drug fees. 
Sec. 3003. Reauthorization; reporting requirements. 
Sec. 3004. Sunset dates. 
Sec. 3005. Effective date. 
Sec. 3006. Savings clause. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 
Sec. 4001. Short title; finding. 
Sec. 4002. Definitions. 
Sec. 4003. Authority to assess and use biosimilar biological product fees. 
Sec. 4004. Reauthorization; reporting requirements. 
Sec. 4005. Sunset dates. 
Sec. 4006. Effective date. 
Sec. 4007. Savings clause. 
TITLE V—REAUTHORIZATION OF OTHER PROVISIONS 
Sec. 5001. Reauthorization of the best pharmaceuticals for children program. 
Sec. 5002. Reauthorization of the humanitarian device exemption incentive. 
Sec. 5003. Reauthorization of the pediatric device consortia program. 
Sec. 5004. Reauthorization of provision pertaining to drugs containing single 
enantiomers. 
Sec. 5005. Reauthorization of the critical path public-private partnership. 
Sec. 5006. Reauthorization of orphan drug grants. 
Sec. 5007. Reauthorization of certain device inspections. 
Sec. 5008. Reauthorization of reporting requirements related to pending generic 
drug applications and priority review applications. 
TITLE I—FEES RELATING TO DRUGS 
SEC. 1001. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 
Drug User Fee Amendments of 2022’’. 
(b) FINDING.—Congress finds that the fees authorized by the 
amendments made by this title will be dedicated toward expediting 
the drug development process and the process for the review of 
human drug applications, including postmarket drug safety activi-
ties, as set forth in the goals identified for purposes of part 2 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the 
Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the Senate 
and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Congressional 
Record. 
SEC. 1002. DEFINITIONS. 
(a) HUMAN DRUG APPLICATION.—Section 735(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended,
H. R. 6833—28 
in the matter following subparagraph (B), by striking ‘‘an allergenic 
extract product, or’’ and inserting ‘‘does not include an application 
with respect to an allergenic extract product licensed before October 
1, 2022, does not include an application with respect to a standard-
ized allergenic extract product submitted pursuant to a notification 
to the applicant from the Secretary regarding the existence of 
a potency test that measures the allergenic activity of an allergenic 
extract product licensed by the applicant before October 1, 2022, 
does not include an application with respect to’’. 
(b) PRESCRIPTION DRUG PRODUCT.—Section 735(3) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended— 
(1) by redesignating subparagraphs (A), (B), and (C) as 
clauses (i), (ii), and (iii), respectively; 
(2) by striking ‘‘(3) The term’’ and inserting ‘‘(3)(A) The 
term’’; 
(3) by striking ‘‘Such term does not include whole blood’’ 
and inserting the following: 
‘‘(B) Such term does not include whole blood’’; 
(4) by striking ‘‘an allergenic extract product,’’ and inserting 
‘‘an allergenic extract product licensed before October 1, 2022, 
a standardized allergenic extract product submitted pursuant 
to a notification to the applicant from the Secretary regarding 
the existence of a potency test that measures the allergenic 
activity of an allergenic extract product licensed by the 
applicant before October 1, 2022,’’ ; and 
(5) by adding at the end the following: 
‘‘(C)(i) If a written request to place a product in the 
discontinued section of either of the lists referenced in 
subparagraph (A)(iii) is submitted to the Secretary on 
behalf of an applicant, and the request identifies the date 
the product is, or will be, withdrawn from sale, then for 
purposes of assessing the prescription drug program fee 
under section 736(a)(2), the Secretary shall consider such 
product to have been included in the discontinued section 
on the later of— 
‘‘(I) the date such request was received; or 
‘‘(II) if the product will be withdrawn from sale 
on a future date, such future date when the product 
is withdrawn from sale. 
‘‘(ii) For purposes of this subparagraph, a product shall 
be considered withdrawn from sale once the applicant has 
ceased its own distribution of the product, whether or not 
the applicant has ordered recall of all previously distributed 
lots of the product, except that a routine, temporary 
interruption in supply shall not render a product with-
drawn from sale.’’. 
(c) SKIN-TEST DIAGNOSTIC PRODUCT.—Section 735 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended 
by adding at the end the following: 
‘‘(12) The term ‘skin-test diagnostic product’— 
‘‘(A) means a product— 
‘‘(i) for prick, scratch, intradermal, or subcutaneous 
administration; 
‘‘(ii) expected to produce a limited, local reaction 
at the site of administration (if positive), rather than 
a systemic effect;