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of a device that is life-supporting, life-sustaining, or in-
tended for use in emergency medical care or during surgery, 
or any other device the Secretary determines to be critical 
to the public health, pertaining to a permanent discontinu-
ance in the manufacture of the device (except for any dis-
continuance as a result of an approved modification of the 
device) or an interruption of the manufacture of the device 
that is likely to lead to a meaningful disruption in the sup-
ply of that device in the United States, and the reasons 
for such discontinuance or interruption.’’. 
(b) GUIDANCE ON VOLUNTARY NOTIFICATIONS OF DIS-
CONTINUANCE OR INTERRUPTION OF DEVICE MANUFAC-
TURE.—Not later than 1 year after the date of enactment 
of this Act, the Secretary shall issue draft guidance to facili-
tate voluntary notifications under subsection (h) of section 
506J of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356j), as added by subsection (a). Such guidance 
shall include a description of circumstances in which a vol-
untary notification under such subsection (h) may be ap-
propriate, recommended timeframes for such a notification, 
the process for receiving such a notification, and actions 
the Secretary may take to mitigate or prevent a shortage 
resulting from a discontinuance or interruption in the 
manufacture of a device for which such notification is re-
ceived. The Secretary shall issue final guidance not later
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than 1 year after the close of the comment period for the 
draft guidance. 
(c) GUIDANCE ON DEVICE SHORTAGE NOTIFICATION 
REQUIREMENT.—Not later than 1 year after the date of en-
actment of this Act, the Secretary shall issue or revise draft 
guidance regarding requirements under section 506J of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j). 
Such guidance shall include a list of each device product 
code for which a manufacturer of such device is required 
to notify the Secretary in accordance with section 506J. 
SEC. 2515. TECHNICAL CORRECTIONS. 
(a) TECHNICAL CORRECTIONS TO THE CARES ACT.— 
Division A of the CARES Act (Public Law 116–136) is 
amended— 
(1) in section 3111(1), by striking ‘‘in para-
graph (1)’’ and inserting ‘‘in the matter preceding 
paragraph (1)’’; 
(2) in section 3112(d)(1), by striking ‘‘and sub-
paragraphs (A) and (B)’’ and inserting ‘‘as subpara-
graphs (A) and (B)’’; and 
(3) in section 3112(e), by striking ‘‘Federal 
Food, Drug, Cosmetic Act’’ and inserting ‘‘Federal 
Food, Drug, and Cosmetic Act’’.
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(b) TECHNICAL
CORRECTIONS
TO
THE
FEDERAL 
FOOD, DRUG, AND COSMETIC ACT RELATED
TO
THE 
CARES ACT.— 
(1) SECTION 506C.—Section 506C(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
356c(a)) is amended, in the flush text at the end, by 
striking the second comma after ‘‘in the United 
States’’. 
(2) EFFECTIVE DATE.—The amendment made by 
paragraph (1) shall take effect as if included in sec-
tion 3112 of division A of the CARES Act (Public 
Law 116–136). 
(c) OTHER TECHNICAL CORRECTION TO THE FEDERAL 
FOOD, DRUG, AND COSMETIC ACT.—Section 505B(f)(6)(I) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(f)(6)(I)) 
is 
amended 
by 
striking 
‘‘subsection 
(a)(3)(B)’’ and inserting ‘‘subsection (a)(4)(C)’’. 
TITLE III—FOOD AND DRUG 
ADMINISTRATION 
SEC. 3001. SHORT TITLE. 
This title may be cited as the ‘‘Food and Drug Omni-
bus Reform Act of 2022’’.
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SEC. 3002. DEFINITION. 
In this title, except as otherwise specified, the term 
‘‘Secretary’’ means the Secretary of Health and Human 
Services. 
Subtitle A—Reauthorizations 
SEC. 3101. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIP. 
Section 566(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 
‘‘$1,265,753 for the period beginning on October 1, 2022 
and ending on December 23, 2022’’ and inserting 
‘‘$6,000,000 for each of fiscal years 2023 through 2027’’. 
SEC. 3102. REAUTHORIZATION OF THE BEST PHARMA-
CEUTICALS FOR CHILDREN PROGRAM. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘$5,273,973 
for the period beginning on October 1, 2022 and ending 
on December 23, 2022’’ and inserting ‘‘$25,000,000 for each 
of fiscal years 2023 through 2027’’. 
SEC. 3103. REAUTHORIZATION OF THE HUMANITARIAN DE-
VICE EXEMPTION INCENTIVE. 
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended 
by striking ‘‘December 24, 2022’’ and inserting ‘‘October 
1, 2027’’.
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SEC. 3104. REAUTHORIZATION OF THE PEDIATRIC DEVICE 
CONSORTIA PROGRAM. 
Section 305(e) of the Food and Drug Administration 
Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 
282 note) is amended by striking ‘‘$1,107,534 for the period 
beginning on October 1, 2022, and ending on December 23, 
2022’’ and inserting ‘‘$7,000,000 for each of fiscal years 
2023 through 2027’’. 
SEC. 3105. REAUTHORIZATION OF PROVISION PERTAINING 
TO 
DRUGS 
CONTAINING 
SINGLE 
ENANTIOMERS. 
Section 505(u) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(u)) is amended— 
(1) in paragraph (1)(A)(ii)(II), by adding 
‘‘(other than bioavailability studies)’’ after ‘‘any clin-
ical investigations’’; and 
(2) in paragraph (4), by striking ‘‘December 24, 
2022’’ and inserting ‘‘October 1, 2027’’. 
SEC. 3106. REAUTHORIZATION OF CERTAIN DEVICE INSPEC-
TIONS. 
Section 704(g)(11) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374(g)(11)) is amended by striking 
‘‘December 24, 2022’’ and inserting ‘‘October 1, 2027’’. 
SEC. 3107. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) 
is amended—
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(1) in subsection (a)— 
(A) by striking ‘‘and (3)’’ and inserting 
‘‘(3)’’; and 
(B) by inserting before the period at the end 
the following: ‘‘, and (4) developing regulatory 
science pertaining to the chemistry, manufac-
turing, and controls of individualized medical 
products to treat individuals with rare diseases 
or conditions’’; and 
(2) in subsection (c), by striking ‘‘$6,328,767 for 
the period beginning on October 1, 2022, and ending 
on December 23, 2022’’ and inserting ‘‘$30,000,000 
for each of fiscal years 2023 through 2027’’. 
SEC. 3108. REAUTHORIZATION OF REPORTING REQUIRE-
MENTS 
RELATED 
TO 
PENDING 
GENERIC 
DRUG APPLICATIONS AND PRIORITY REVIEW 
APPLICATIONS. 
Section 807 of the FDA Reauthorization Act of 2017 
(Public Law 115–52) is amended, in the matter preceding 
paragraph (1), by striking ‘‘December 23, 2022’’ and insert-
ing ‘‘October 1, 2027’’.
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SEC. 3109. REAUTHORIZATION OF THIRD-PARTY REVIEW 
PROGRAM. 
Section 523(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360m(c)) is amended by striking ‘‘De-
cember 24, 2022’’ and inserting ‘‘on October 1, 2027’’ . 
Subtitle B—Drugs and Biologics 
CHAPTER 1—RESEARCH, DEVELOPMENT, 
AND COMPETITION IMPROVEMENTS 
SEC. 3201. PROMPT REPORTS OF MARKETING STATUS BY 
HOLDERS OF APPROVED APPLICATIONS FOR 
BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 506I of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘The holder of an application ap-
proved under subsection (c) or (j) of section 505’’ 
and inserting ‘‘The holder of an application ap-
proved under subsection (c) or (j) of section 505 
of this Act or subsection (a) or (k) of section 351 
of the Public Health Service Act’’; 
(B) in paragraph (2), by striking ‘‘estab-
lished name’’ and inserting ‘‘established name 
(or, in the case of a biological product, the prop-
er name)’’; and