Section 1 Short title
This Act may be cited as the “Small Business FDA User Fee Adjustment Act of 2021”.
Small Business FDA User Fee Adjustment Act of 2021
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.
Sec. 2 Waiver and reduction of OTC monograph fees for small businesses
In general— Section 744M of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72) is amended—
by redesignating subsections (d) through (h) as subsections (e) through (i), respectively; and
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”
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”.