II 117th CONGRESS 2d Session S. 4385 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. Short title This Act may be cited as the Small Business Establishment Registration Waiver Act . 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 .