II 

117TH CONGRESS 

2D SESSION S. 4385 

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 SENATE OF THE UNITED STATES 

JUNE 13, 2022 

Mr. BRAUN introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Small Business Estab5 lishment Registration Waiver Act’’. 

6 SEC. 2. WAIVER OF ANNUAL ESTABLISHMENT REGISTRA7 TION FEES FOR SMALL BUSINESSES. 

8 Section 738 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 379j) is amended— 


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1 (1) in subsection (a)(3)(B)— 

2 (A) by striking ‘‘No fee’’ and inserting the 

3 following: 

4 ‘‘(i) IN GENERAL.—No fee’’; and 

5 (B) by adding at the end the following: 

6 ‘‘(ii) SMALL BUSINESSES FEE WAIV7 ER.— 

8 ‘‘(I) DEFINITION OF SMALL

9 BUSINESS.—For the purposes of this 

10 clause, the term ‘small business’ 

11 means an entity that reported 

12 $1,000,000 or less of gross receipts or 

13 sales in its most recent Federal in14 come tax return for a taxable year, in15 cluding such returns of all of its affili16 ates. 

17 ‘‘(II) WAIVER.—The Secretary 

18 may grant a waiver of the fee required 

19 under subparagraph (A) for the an20 nual registration (excluding the initial 

21 registration) of an establishment for a 

22 year, if the Secretary finds that the 

23 establishment is a small business and 

24 paying the fee for such year rep25 resents a financial hardship to the esVerDate Sep 11 2014 02:11 Jun 17, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4385.IS S4385

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1 tablishment as determined on the 

2 basis of criteria established by the 

3 Secretary. 

4 ‘‘(III) FIRMS SUBMITTING TAX

5 RETURNS TO THE UNITED STATES IN6 TERNAL REVENUE SERVICE.—The es7 tablishment shall support its claim 

8 that it meets the definition under sub9 clause (I) by submission of a copy of 

10 its most recent Federal income tax re11 turn for a taxable year, and a copy of 

12 such returns of its affiliates, which 

13 show an amount of gross sales or re14 ceipts that is less than the maximum 

15 established in subclause (I). The es16 tablishment, and each of such affili17 ates, shall certify that the information 

18 provided is a true and accurate copy 

19 of the actual tax forms they submitted 

20 to the Internal Revenue Service. If no 

21 tax forms are submitted for any affil22 iate, the establishment shall certify 

23 that the establishment has no affili24 ates. 


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1 ‘‘(IV) FIRMS NOT SUBMITTING

2 TAX RETURNS TO THE UNITED

3 STATES INTERNAL REVENUE SERV4 ICE.—In the case of an establishment 

5 that has not previously submitted a 

6 Federal income tax return, the estab7 lishment and each of its affiliates 

8 shall demonstrate that it meets the 

9 definition under subclause (I) by sub10 mission of a signed certification, in 

11 such form as the Secretary may direct 

12 through a notice published in the Fed13 eral Register, that the establishment 

14 or affiliate meets the criteria for a 

15 small business and a certification, in 

16 English, from the national taxing au17 thority, if extant, of the country in 

18 which the establishment or, if applica19 ble, affiliate is headquartered. The 

20 certification from such taxing author21 ity shall bear the official seal of such 

22 taxing authority and shall provide the 

23 establishment’s or affiliate’s gross re24 ceipts or sales for the most recent 

25 year in both the local currency of such 


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1 country and in United States dollars, 

2 the exchange rate used in converting 

3 such local currency to dollars, and the 

4 dates during which these receipts or 

5 sales were collected. The establish6 ment shall also submit a statement 

7 signed by the head of the establish8 ment’s firm or by its chief financial 

9 officer that the establishment has sub10 mitted certifications for all of its af11 filiates, or that the establishment has 

12 no affiliates. 

13 ‘‘(V) REQUEST FOR WAIVER.— 

14 An establishment seeking a fee waiver 

15 for a year under this clause shall sub16 mit supporting information to the 

17 Secretary at least 60 days before the 

18 fee is required pursuant to subpara19 graph (C). The decision of the Sec20 retary regarding whether an entity 

21 may receive the waiver for such year 

22 is not reviewable.’’; 

23 (2) in subsection (d)(2)(B)(iii), by inserting ‘‘, 

24 if extant,’’ after ‘‘national taxing authority’’; and 


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1 (3) in subsection (e)(2)(B)(iii), by inserting ‘‘, 

2 if extant,’’ after ‘‘national taxing authority’’. 

Æ 


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