190 
HR 7667 RDS
‘‘(C) contains any such technological char-
acteristics that could be vulnerable to cyberse-
curity threats. 
‘‘(2) LIFECYCLE OF THE CYBER DEVICE.—The 
term ‘lifecycle of the cyber device’ includes the 
postmarket lifecycle of the cyber device. 
‘‘(3) PREMARKET SUBMISSION.—The term ‘pre-
market submission’ means any submission under 
section 510(k), 513, 515(c), 515(f), or 520(m). 
‘‘(e) EXEMPTION.—The Secretary may identify de-
vices or types of devices that are exempt from meeting 
the cybersecurity requirements established by this section 
and regulations promulgated pursuant to this section. The 
Secretary shall publish in the Federal Register, and up-
date, as appropriate, a list of the devices and types of de-
vices so identified by the Secretary.’’. 
(b) PROHIBITED ACT.—Section 301(q) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)) 
is amended by adding at the end the following: 
‘‘(3) The failure to comply with any requirement 
under section 524C (relating to ensuring device cybersecu-
rity).’’. 
(c) ADULTERATION.—Section 501 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-
ed by inserting after paragraph (j) the following: 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00190
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
191 
HR 7667 RDS
‘‘(k) If it is a device subject to the requirements set 
forth in section 524C (relating to ensuring device cyberse-
curity) and fails to comply with any requirement under 
that section.’’. 
(d) MISBRANDING.—Section 502(t) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is 
amended— 
(1) by striking ‘‘or (3)’’ and inserting ‘‘(3)’’; 
and 
(2) by inserting before the period at the end the 
following: ‘‘, or (4) to furnish a software bill of ma-
terials as required under section 524C (relating to 
ensuring device cybersecurity)’’. 
SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO 
THIRD-PARTY VENDORS. 
(a) IN GENERAL.— 
(1) OPENING PUBLIC DOCKET.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall open 
a single public docket to solicit comments on factors 
that generally should be considered by the Secretary 
when reviewing requests from sponsors of drugs sub-
ject to risk evaluation and mitigation strategies to 
change third-party vendors engaged by sponsors to 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00191
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
192 
HR 7667 RDS
aid in implementation and management of the strat-
egies. 
(2) FACTORS.—Such factors include the poten-
tial effects of changes in third-party vendors on— 
(A) patient access; and 
(B) prescribing and administration of the 
drugs by health care providers. 
(3) CLOSING PUBLIC DOCKET.—The Secretary 
of Health and Human Services may close such pub-
lic docket not earlier than 90 days after such docket 
is opened. 
(4) NO DELAY.—Nothing in this section shall 
delay agency action on any modification to a risk 
evaluation and mitigation strategy. 
(b) GAO REPORT.—Not later than December 31, 
2026, the Comptroller General of the United States 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 Senate a report 
on— 
(1) the number of changes in third-party ven-
dors (engaged by sponsors to aid implementation 
and management of risk evaluation and mitigation 
strategies) for an approved risk evaluation and miti-
gation strategy the Secretary of Health and Human 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00192
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
193 
HR 7667 RDS
Services has approved under section 505–1(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1(h)); 
(2) any issues affecting patient access to the 
drug that is subject to the strategy or considerations 
with respect to the administration or prescribing of 
such drug by health care providers that arose as a 
result of such modifications; and 
(3) how such issues were resolved, as applica-
ble. 
SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFOR-
MATION PRIOR TO APPROVAL. 
(a) IN GENERAL.—Section 502 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352) is amended— 
(1) in paragraph (a)— 
(A) by striking ‘‘drugs for coverage’’ and 
inserting ‘‘drugs or devices for coverage’’; and 
(B) by striking ‘‘drug’’ each place it ap-
pears and inserting ‘‘drug or device’’, respec-
tively; 
(2) in paragraphs (a)(1) and (a)(2)(B), by 
striking ‘‘under section 505 or under section 351 of 
the Public Health Service Act’’ and inserting ‘‘under 
section 505, 510(k), 513(f)(2), or 515 of this Act or 
section 351 of the Public Health Service Act’’; 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00193
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
194 
HR 7667 RDS
(3) in paragraph (a)(1)— 
(A) by striking ‘‘under section 505 or 
under section 351(a) of the Public Health Serv-
ice Act’’ and inserting ‘‘under section 505, 
510(k), 513(f)(2), or 515 of this Act or section 
351 of the Public Health Service Act’’; and 
(B) by striking ‘‘in section 505(a) or in 
subsections (a) and (k) of section 351 of the 
Public Health Service Act’’ and inserting ‘‘in 
section 505, 510(k), 513(f)(2), or 515 of this 
Act or section 351 of the Public Health Service 
Act’’; and 
(4) by adding at the end the following: 
‘‘(gg)(1) Unless its labeling bears adequate directions 
for use in accordance with paragraph (f), except that (in 
addition to drugs or devices that conform with exemptions 
pursuant to such paragraph) no drug or device shall be 
deemed to be misbranded under such paragraph through 
the provision of product information to a payor, formulary 
committee, or other similar entity with knowledge and ex-
pertise in the area of health care economic analysis car-
rying out its responsibilities for the selection of drugs or 
devices for coverage or reimbursement if the product infor-
mation relates to an investigational drug or device or in-
vestigational use of a drug or device that is approved, 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00194
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
195 
HR 7667 RDS
cleared, granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of this Act 
or section 351 of the Public Health Service Act (as appli-
cable), provided— 
‘‘(A) the product information includes— 
‘‘(i) a clear statement that the investiga-
tional drug or device or investigational use of a 
drug or device has not been approved, cleared, 
granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of 
this Act or section 351 of the Public Health 
Service Act (as applicable) and that the safety 
and effectiveness of the drug or device or use 
has not been established; 
‘‘(ii) information related to the stage of de-
velopment of the drug or device involved, such 
as— 
‘‘(I) the status of any study or studies 
in which the investigational drug or device 
or investigational use is being investigated; 
‘‘(II) how the study or studies relate 
to the overall plan for the development of 
the drug or device; and 
‘‘(III) whether an application, pre-
market notification, or request for classi-
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00195
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
196 
HR 7667 RDS
fication for the investigational drug or de-
vice or investigational use has been sub-
mitted to the Secretary and when such a 
submission is planned; 
‘‘(iii) in the case of information that in-
cludes factual presentations of results from 
studies, which shall not be selectively presented, 
a description of— 
‘‘(I) all material aspects of study de-
sign, methodology, and results; and 
‘‘(II) all material limitations related 
to the study design, methodology, and re-
sults; 
‘‘(iv) where applicable, a prominent state-
ment disclosing the indication or indications for 
which the Secretary has approved, granted mar-
keting authorization, cleared, or licensed the 
product pursuant to section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of 
the Public Health Service Act, and a copy of 
the most current required labeling; and 
‘‘(v) updated information, if previously 
communicated information becomes materially 
outdated as a result of significant changes or as 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00196
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
197 
HR 7667 RDS
a result of new information regarding the prod-
uct or its review status; and 
‘‘(B) the product information does not in-
clude— 
‘‘(i) information that represents that an 
unapproved product— 
‘‘(I) has been approved, cleared, 
granted marketing authorization, or li-
censed 
under 
section 
505, 
510(k), 
513(f)(2), or 515 of this Act or section 
351 of the Public Health Service Act (as 
applicable); or 
‘‘(II) has otherwise been determined 
to be safe or effective for the purpose or 
purposes for which the drug or device is 
being studied; or 
‘‘(ii) information that represents that an 
unapproved use of a drug or device that has 
been so approved, granted marketing authoriza-
tion, cleared, or licensed— 
‘‘(I) is so approved, granted mar-
keting authorization, cleared, or licensed; 
or 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00197
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
198 
HR 7667 RDS
‘‘(II) that the product is safe or effec-
tive for the use or uses for which the drug 
or device is being studied. 
‘‘(2) For purposes of this paragraph, the term ‘prod-
uct information’ includes— 
‘‘(A) information describing the drug or device 
(such as drug class, device description, and fea-
tures); 
‘‘(B) information about the indication or indica-
tions being investigated; 
‘‘(C) the anticipated timeline for a possible ap-
proval, clearance, marketing authorization, or licen-
sure pursuant to section 505, 510(k), 513, or 515 
of this Act or section 351 of the Public Health Serv-
ice Act; 
‘‘(D) drug or device pricing information; 
‘‘(E) patient utilization projections; 
‘‘(F) product-related programs or services; and 
‘‘(G) factual presentations of results from stud-
ies that do not characterize or make conclusions re-
garding safety or efficacy.’’. 
(b) GAO STUDY AND REPORT.—Beginning on the 
date that is 5 years and 6 months after the date of enact-
ment of this Act, the Comptroller General of the United 
States shall conduct a study on the provision and use of 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00198
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
199 
HR 7667 RDS
information pursuant to section 502(gg) of the Federal 
Food, Drug, and Cosmetic Act, as added by this sub-
section (a), between manufacturers of drugs and devices 
(as defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)) and entities described in 
such section 502(gg). Such study shall include an analysis 
of the following: 
(1) The types of information communicated be-
tween such manufacturers and payors. 
(2) The manner of communication between 
such manufacturers and payors. 
(3)(A) Whether such manufacturers file an ap-
plication for approval, marketing authorization, 
clearance, or licensing of a new drug or device or the 
new use of a drug or device that is the subject of 
communication between such manufacturers and 
payors under section 502(gg) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a). 
(B) How frequently the Food and Drug Admin-
istration approves, grants marketing authorization, 
clears, or licenses the new drug or device or new use. 
(C) The timeframe between the initial commu-
nications permitted under section 502(gg) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), regarding an investigational drug or 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00199
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
200 
HR 7667 RDS
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). 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00200
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
201 
HR 7667 RDS
‘‘(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 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00201
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
202 
HR 7667 RDS
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-
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00202
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
203 
HR 7667 RDS
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: 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00203
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
204 
HR 7667 RDS
‘‘(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 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00204
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS
205 
HR 7667 RDS
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: 
CHERYL L. JOHNSON, 
Clerk. 
VerDate Sep 11 2014 
04:25 Jan 04, 2023
Jkt 039200
PO 00000
Frm 00205
Fmt 6652
Sfmt 6201
E:\BILLS\H7667.RDS
H7667
kjohnson on DSK79L0C42PROD with BILLS