I 
117TH CONGRESS 
2D SESSION 
H. R. 8828 
To address potential conflicts of interest among entities serving as Food 
and Drug Administration contractors, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 14, 2022 
Ms. KUSTER introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To address potential conflicts of interest among entities serv-
ing as Food and Drug Administration contractors, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Ethics Act of 
2022’’. 
SEC. 2. REQUIREMENTS REGARDING ONGOING REPORTING 
OF CONTRACTOR CONFLICTS OF INTEREST. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall require entities that contract with 
the Food and Drug Administration— 
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(1) to disclose, on an ongoing basis during the 
term of the contract, any information related to po-
tential and actual conflicts of interest, including con-
flicts of interest concerning the contractor’s per-
sonnel, consultants, and subcontractors; and 
(2) during the term of the contract, to refrain 
from entering into consulting or other contractual 
arrangements with any person to perform work that 
may reasonably create a potential or actual conflict 
of interest, without receiving the written approval of 
the contracting officer before the execution of the 
contractual arrangement. 
(b) REGULATIONS.—Not later than 18 months after 
the date of enactment of this Act, the Secretary, in con-
sultation with the Federal Acquisition Regulatory Council, 
shall issue regulations to carry out subsection (a). 
SEC. 3. REQUIREMENTS REGARDING WAIVERS RELATING 
TO ORGANIZATIONAL CONFLICTS OF INTER-
EST. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall, not later than 14 days after awarding a 
contract relating to the Food and Drug Administration, 
publish, on the website of the Food and Drug Administra-
tion, a notification of any waiver of any requirements re-
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garding a potential or actual organizational conflict of in-
terest granted to the contractor. Such notification shall 
be made publicly available in an easily accessible format, 
and shall include the name of the contract, the contractor 
receiving the waiver, the other contracts or clients that 
created the potential or actual organizational conflict of 
interest, and the efforts that the contractor plans to take 
to mitigate the potential or actual organizational conflict 
of interest. 
(b) REGULATIONS.—Not later than 18 months after 
the date of enactment of this Act, the Secretary, in con-
sultation with the Federal Acquisition Regulatory Council, 
shall issue regulations to carry out subsection (a). 
SEC. 4. RESTRICTIONS ON CONSULTING FIRMS SERVING AS 
FDA CONTRACTORS. 
(a) PROHIBITION AGAINST CERTAIN CONTRACTS.— 
(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary of Health and Human Services (re-
ferred to in this section as the ‘‘Secretary’’) shall 
not award a contract relating to the duties of the 
Food and Drug Administration to any person pro-
viding consulting services (referred to in this section 
as a ‘‘consulting firm’’) unless such contract pro-
vides that, during the restricted period described in 
paragraph (3), subject to paragraph (2), no indi-
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vidual employee or subcontractor of such consulting 
firm may provide services to both— 
(A) the Food and Drug and Administra-
tion under the consulting firm’s contract; and 
(B)(i) a person engaged in the develop-
ment or manufacturing of a device, drug, or bi-
ological product; or 
(ii) any other private entity engaged in ac-
tivities regulated by the Food and Drug Admin-
istration. 
(2) EXCEPTION.— 
(A) IN
GENERAL.—The Secretary may 
issue an exception to the requirement under 
paragraph (1) with respect to an employee or 
subcontractor of a consulting firm only if the 
Secretary or designee determines in writing 
that there is a compelling reason to award a 
contract with such consulting firm with such 
exception. The Secretary shall not delegate the 
authority to issue exceptions under this sub-
paragraph below the level of head of a con-
tracting activity. 
(B) REPORTING.—Not later than 14 days 
after issuing an exception under subparagraph 
(A), the Secretary shall publish, on the website 
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of the Food and Drug Administration, a notifi-
cation of the exception. Such notification shall 
be made publicly available in an easily acces-
sible format, and shall include— 
(i) the name of the contract; 
(ii) the consulting firm receiving the 
exception, and the employee or subcon-
tractor to whom the exception applies; 
(iii) the other contracts or clients that 
would, in the absence of the exception, 
cause the consulting firm to be in violation 
of paragraph (1); and 
(iv) the efforts that the consulting 
firm plans to take to mitigate any potential 
or actual conflict of interest arising from 
the other work of its employees or sub-
contractors. 
(3) RESTRICTED PERIOD.— 
(A) IN GENERAL.—For purposes of para-
graph (1), the restricted period is the period 
that— 
(i) begins when the applicable em-
ployee or subcontractor of the consulting 
firm first provides services under the con-
sulting firm’s contract; and 
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(ii) ends not less than the applicable 
period specified in subparagraph (B) after 
the last date on which such employee or 
subcontractor provides services under the 
consulting firm’s contract. 
(B) APPLICABLE PERIOD SPECIFIED.—For 
purposes of subparagraph (A)(ii), the applicable 
period specified in this subparagraph is— 
(i) 30 days; or 
(ii) such longer period of time as the 
Secretary may specify after consultation 
with the Federal Acquisition Regulatory 
Council, which shall apply with respect to 
all exceptions issued under paragraph (2). 
(b) REGULATIONS.—Not later than 18 months after 
the date of enactment of this Act, the Secretary, in con-
sultation with the Federal Acquisition Regulatory Council, 
shall issue regulations to carry out subsection (a). 
(c) DEFINITION.—In this section, the term ‘‘con-
sulting services’’— 
(1) means providing advice or recommendations 
to improve organizational effectiveness; and 
(2) does not include services provided pursuant 
to a contract related to regulatory science research, 
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public health surveillance, or information technology, 
or services provided by a small business concern. 
Æ 
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