Small Business FDA User Fee Adjustment Act of 2021

Bill: 117-hr-4405
Sponsor: full_name: Rep. Steube, W. Gregory [R-FL-17]
Introduced: 2021-07-09
Policy area: Health
Latest action: action_date: 2021-07-12
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2021-07-09
action_desc: Introduced in House
text: <p><strong>Small Business FDA User Fee Adjustment Act of 2021</strong></p> <p>This bill reduces and waives certain fees related to marketing certain over-the-counter (OTC) drugs for businesses with fewer than 500 employees, including employees of affiliates.</p> <p>Starting in FY2022, the Food and Drug Administration (FDA) must waive the fee for the first OTC monograph order request from such a business. (Generally, an OTC monograph order request is a request for the FDA to evaluate whether a nonprescription drug meets certain standards.) </p> <p>The fee for each subsequent OTC monograph order request for such a business shall be 25% of the amount otherwise owed. </p> <p>For such a business, the FDA must also reduce the annual OTC monograph drug facility fee to 25% of the amount otherwise owed. (Generally, such a facility is engaged in the manufacturing or processing of an OTC monograph drug.)</p>

tv_txt: I 117th CONGRESS 1st Session H. R. 4405 IN THE HOUSE OF REPRESENTATIVES July 9, 2021 Mr. Steube 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 waive or reduce the amount of over-the-counter monograph fees applicable to small businesses, and for other purposes.

1. Short title This Act may be cited as the Small Business FDA User Fee Adjustment Act of 2021 . 2. Waiver and reduction of OTC monograph fees for small businesses (a) In general Section 744M of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–72 ) is amended— (1) by redesignating subsections (d) through (h) as subsections (e) through (i), respectively; and (2) by inserting after subsection (c) the following: (d) Fee waiver and reduction for small businesses (1) In general Beginning with respect to fiscal year 2022: (A) The Secretary shall waive the fee under subsection (a)(2) with respect to the first OTC monograph order request that a small business submits to the Secretary for review. (B) The Secretary shall reduce the fees that are applicable to a small business under subsections (a)(1) (facility fees) and (a)(2) (OTC monograph order request fees), and not waived under subparagraph (A), to 25 percent of the amount otherwise owed. (2) Certification The Secretary shall require any person who applies for a waiver or reduction of fees under paragraph (1) to certify their qualification for the waiver or reduction. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications. (3) Small business defined In this subsection, the term small business means an entity that has fewer than 500 employees, including employees of affiliates . (b) Conforming change to fee revenue amounts Section 744M(b)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–72(b)(2) ) is amended by striking For each of the fiscal years 2022 through 2025 and inserting Subject to subsection (d), for each of the fiscal years 2022 through 2025 .