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device or investigational use, and the initial mar-
keting of such drug or device. 
SEC. 811. BANS OF DEVICES FOR ONE OR MORE INTENDED 
USES. 
(a) IN GENERAL.—Section 516(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360f(a)) is 
amended— 
(1) in paragraph (1), by inserting ‘‘for one or 
more intended use’’ before the semicolon at the end; 
and 
(2) in the matter following paragraph (2), by 
inserting ‘‘for any such intended use or uses. A de-
vice that is banned for one or more intended uses is 
not a legally marketed device under section 1006 
when intended for such use or uses’’ after ‘‘banned 
device’’. 
(b) SPECIFIC DEVICES DEEMED BANNED.—Section 
516 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360f) is further amended by adding at the end the 
following: 
‘‘(c) SPECIFIC DEVICE BANNED.—Electrical stimula-
tion devices that apply a noxious electrical stimulus to a 
person’s skin intended to reduce or cease self-injurious be-
havior or aggressive behavior are deemed to be banned de-
vices, as described in subsection (a).
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‘‘(d) REVERSAL BY REGULATION.—Devices banned 
under this section are banned devices unless or until the 
Secretary promulgates a regulation to make such devices 
or use of such devices no longer banned based on a finding 
that such devices or use of such devices does not present 
substantial deception or an unreasonable and substantial 
risk of illness or injury, or that such risk can be corrected 
or eliminated by labeling.’’. 
SEC. 812. CLARIFYING APPLICATION OF EXCLUSIVE AP-
PROVAL, 
CERTIFICATION, 
OR 
LICENSURE 
FOR DRUGS DESIGNATED FOR RARE DIS-
EASES OR CONDITIONS. 
(a) APPLICATION OF EXCLUSIVE APPROVAL, CER-
TIFICATION, OR LICENSURE
FOR DRUGS DESIGNATED 
FOR RARE DISEASES OR CONDITIONS.—Section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same approved indication or 
use within such rare disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ 
and inserting ‘‘same indication or use for which
202 
the Secretary has approved or licensed such 
drug’’; and 
(B) in paragraph (1), by striking ‘‘with the 
disease or condition for which the drug was des-
ignated’’ and inserting ‘‘for whom the drug is 
indicated’’; and 
(3) in subsection (c), by striking ‘‘same rare 
disease or condition’’ and inserting ‘‘same indication 
or use’’. 
(b) APPLICATION OF AMENDMENTS.—The amend-
ments made by subsection (a) shall apply with respect to 
any drug designated under section 526 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-
less of the date on which the drug was so designated, and 
regardless of the date on which the drug was approved 
under section 505 of such Act (21 U.S.C. 355) or licensed 
under section 351 of the Public Health Service Act (42 
U.S.C. 262). 
SEC. 813. GAO REPORT ON THIRD-PARTY REVIEW. 
Not later than September 30, 2026, the Comptroller 
General of the United States shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the third- 
party review program described in section 523 of the Fed-
203 
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360m). 
Such report shall include— 
(1) a description of the financial and staffing 
resources used to carry out such program; 
(2) a description of actions taken by the Sec-
retary pursuant section 523(b)(2)(C) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360m(b)(2)(C)); and 
(3) the results of an audit of the performance 
of select persons accredited under such program. 
SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLI-
CATIONS AND PRIORITY REVIEW APPLICA-
TIONS. 
Section 807 of the FDA Reauthorization Act of 2017 
(Public Law 115–52) is amended, in the matter preceding 
paragraph (1), by striking ‘‘2022’’ and inserting ‘‘2027’’. 
SEC. 815. FDA WORKFORCE IMPROVEMENTS. 
Section 714A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379d–3a) is amended— 
(1) in subsection (a), by striking ‘‘medical prod-
ucts’’ and inserting ‘‘products regulated by the Food 
and Drug Administration’’; and 
(2) by striking subsection (d) and inserting the 
following:
204 
‘‘(d) 
AGENCY-WIDE
STRATEGIC
WORKFORCE 
PLAN.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the Food and Drug 
Amendments of 2022, the Commissioner of Food 
and Drugs shall develop and begin implementation 
of an agency-wide strategic workforce plan at the 
Food and Drug Administration, which shall in-
clude— 
‘‘(A) agency-wide human capital goals and 
strategies; 
‘‘(B) performance measures, benchmarks, 
or other elements to facilitate the monitoring 
and evaluation of the progress made toward 
such goals and the effectiveness of such strate-
gies; and 
‘‘(C) a process for updating such plan 
based on timely and relevant information on an 
ongoing basis. 
‘‘(2) REPORT TO CONGRESS.—Not later than 
18 months after the date of enactment of the Food 
and Drug Amendments of 2022, the Secretary shall 
submit to the Committee on Energy and Commerce 
of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the
205 
Senate a report describing the plan under paragraph 
(1) and the status of its implementation.’’. 
TITLE IX—MISCELLANEOUS 
SEC. 901. DETERMINATION OF BUDGETARY EFFECTS. 
The budgetary effects of this Act, for the purpose of 
complying with the Statutory Pay-As-You-Go Act of 2010, 
shall be determined by reference to the latest statement 
titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 
Act, submitted for printing in the Congressional Record 
by the Chairman of the House Budget Committee, pro-
vided that such statement has been submitted prior to the 
vote on passage. 
SEC. 902. MEDICAID IMPROVEMENT FUND. 
Section 1941(b)(3)(A) of the Social Security Act (42 
U.S.C. 1396w–1(b)(3)(A)) is amended by striking ‘‘$0’’ 
and inserting ‘‘$450,000,000’’. 
Passed the House of Representatives June 8, 2022. 
Attest: 
Clerk.
117TH CONGRESS 
2D SESSION 
H. R. 7667 
AN ACT 
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.