I 
117TH CONGRESS 
2D SESSION 
H. R. 9329 
To amend the Federal Food, Drug, and Cosmetic Act to allow waivers 
of annual establishment registration fees for small businesses, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 17, 2022 
Mr. BUCSHON (for himself and Mr. YARMUTH) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
allow waivers of annual establishment registration fees 
for small businesses, 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 ‘‘Small Business Estab-
lishment Registration Waiver Act’’. 
SEC. 2. WAIVER OF ANNUAL ESTABLISHMENT REGISTRA-
TION FEES FOR SMALL BUSINESSES. 
Section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended— 
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(1) in subsection (a)(3)(B)— 
(A) by striking ‘‘No fee’’ and inserting the 
following: 
‘‘(i) IN GENERAL.—No fee’’; and 
(B) by adding at the end the following: 
‘‘(ii) SMALL BUSINESSES FEE WAIV-
ER.— 
‘‘(I) 
DEFINITION
OF
SMALL 
BUSINESS.—For the purposes of this 
clause, the term ‘small business’ 
means 
an 
entity 
that 
reported 
$1,000,000 or less of gross receipts or 
sales in its most recent Federal in-
come tax return for a taxable year, in-
cluding such returns of all of its affili-
ates. 
‘‘(II) WAIVER.—The Secretary 
may grant a waiver of the fee required 
under subparagraph (A) for the an-
nual registration (excluding the initial 
registration) of an establishment for a 
year, if the Secretary finds that the 
establishment is a small business and 
paying the fee for such year rep-
resents a financial hardship to the es-
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tablishment as determined on the 
basis of criteria established by the 
Secretary. 
‘‘(III) FIRMS
SUBMITTING
TAX 
RETURNS TO THE UNITED STATES IN-
TERNAL REVENUE SERVICE.—The es-
tablishment shall support its claim 
that it meets the definition under sub-
clause (I) by submission of a copy of 
its most recent Federal income tax re-
turn for a taxable year, and a copy of 
such returns of its affiliates, which 
show an amount of gross sales or re-
ceipts that is less than the maximum 
established in subclause (I). The es-
tablishment, and each of such affili-
ates, shall certify that the information 
provided is a true and accurate copy 
of the actual tax forms they submitted 
to the Internal Revenue Service. If no 
tax forms are submitted for any affil-
iate, the establishment shall certify 
that the establishment has no affili-
ates. 
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‘‘(IV) FIRMS
NOT
SUBMITTING 
TAX
RETURNS
TO
THE
UNITED 
STATES
INTERNAL
REVENUE
SERV-
ICE.—In the case of an establishment 
that has not previously submitted a 
Federal income tax return, the estab-
lishment and each of its affiliates 
shall demonstrate that it meets the 
definition under subclause (I) by sub-
mission of a signed certification, in 
such form as the Secretary may direct 
through a notice published in the Fed-
eral Register, that the establishment 
or affiliate meets the criteria for a 
small business and a certification, in 
English, from the national taxing au-
thority, if extant, of the country in 
which the establishment or, if applica-
ble, affiliate is headquartered. The 
certification from such taxing author-
ity shall bear the official seal of such 
taxing authority and shall provide the 
establishment’s or affiliate’s gross re-
ceipts or sales for the most recent 
year in both the local currency of such 
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