Small Business FDA User Fee Adjustment Act of 2021
Bill: H.R.4405 | Sponsor: Rep. Steube, W. Gregory (R-FL)
Policy area: Health

Summary:
Small Business FDA User Fee Adjustment Act of 2021
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.
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.)
The fee for each subsequent OTC monograph order request for such a business shall be 25% of the amount otherwise owed.
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.)

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.

    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 FDA User Fee 
Adjustment Act of 2021''.

SEC. 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''.
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