```

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4385 Introduced in Senate (IS)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Small Business Establishment 
Registration Waiver Act''.

SEC. 2. WAIVER OF ANNUAL ESTABLISHMENT REGISTRATION FEES FOR SMALL 
              BUSINESSES.

    Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j) is amended--
            (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 waiver.--
                                    ``(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 income tax return 
                                for a taxable year, including such 
                                returns of all of its affiliates.
                                    ``(II) Waiver.--The Secretary may 
                                grant a waiver of the fee required 
                                under subparagraph (A) for the annual 
                                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 represents 
                                a financial hardship to the 
                                establishment as determined on the 
                                basis of criteria established by the 
                                Secretary.
                                    ``(III) Firms submitting tax 
                                returns to the united states internal 
                                revenue service.--The establishment 
                                shall support its claim that it meets 
                                the definition under subclause (I) by 
                                submission of a copy of its most recent 
                                Federal income tax return for a taxable 
                                year, and a copy of such returns of its 
                                affiliates, which show an amount of 
                                gross sales or receipts that is less 
                                than the maximum established in 
                                subclause (I). The establishment, and 
                                each of such affiliates, 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 affiliate, the 
                                establishment shall certify that the 
                                establishment has no affiliates.
                                    ``(IV) Firms not submitting tax 
                                returns to the united states internal 
                                revenue service.--In the case of an 
                                establishment that has not previously 
                                submitted a Federal income tax return, 
                                the establishment and each of its 
                                affiliates shall demonstrate that it 
                                meets the definition under subclause 
                                (I) by submission of a signed 
                                certification, in such form as the 
                                Secretary may direct through a notice 
                                published in the Federal Register, that 
                                the establishment or affiliate meets 
                                the criteria for a small business and a 
                                certification, in English, from the 
                                national taxing authority, if extant, 
                                of the country in which the 
                                establishment or, if applicable, 
                                affiliate is headquartered. The 
                                certification from such taxing 
                                authority shall bear the official seal 
                                of such taxing authority and shall 
                                provide the establishment's or 
                                affiliate's gross receipts or sales for 
                                the most recent year in both the local 
                                currency of such country and in United 
                                States dollars, the exchange rate used 
                                in converting such local currency to 
                                dollars, and the dates during which 
                                these receipts or sales were collected. 
                                The establishment shall also submit a 
                                statement signed by the head of the 
                                establishment's firm or by its chief 
                                financial officer that the 
                                establishment has submitted 
                                certifications for all of its 
                                affiliates, or that the establishment 
                                has no affiliates.
                                    ``(V) Request for waiver.--An 
                                establishment seeking a fee waiver for 
                                a year under this clause shall submit 
                                supporting information to the Secretary 
                                at least 60 days before the fee is 
                                required pursuant to subparagraph (C). 
                                The decision of the Secretary regarding 
                                whether an entity may receive the 
                                waiver for such year is not 
                                reviewable.'';
            (2) in subsection (d)(2)(B)(iii), by inserting ``, if 
        extant,'' after ``national taxing authority''; and
            (3) in subsection (e)(2)(B)(iii), by inserting ``, if 
        extant,'' after ``national taxing authority''.
                                 <all>
```