To amend the Federal Food, Drug, and Cosmetic Act with respect to the requirements for the small business waiver from device fees related to annual establishment registration, and for other purposes.

To amend the Federal Food, Drug, and Cosmetic Act with respect to the requirements for the small business waiver from device fees related to annual establishment registration, 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.

SEC. 2. Small business fee waiver.

(a) Small businesses fee waiver.—

(1) DEFINITION OF SMALL BUSINESS.—Section 738(a)(3)(B)(ii)(I) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)(3)(B)(ii)(I)) is amended to read as follows:

“(I) DEFINITION OF SMALL BUSINESS.—For purposes of this clause, the term ‘small business’ means an entity that employs less than 20 full-time equivalent employees, including such employees of all of its affiliates.”.

(2) WAIVER.—Section 738(a)(3)(B)(ii)(II) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)(3)(B)(ii)(II)) is amended to read as follows:

“(II) WAIVER.—

“(aa) IN GENERAL.—Subject to subclause (V), the Secretary shall grant a waiver of the fee required under subparagraph (A) for the annual registration of an establishment for a year if the Secretary finds that such establishment is a small business.

“(bb) PROHIBITION ON SECRETARY CONSIDERING PAYMENT HISTORY.—In determining whether to grant a waiver under this clause, the Secretary may not consider whether an establishment paid the fee required under subparagraph (A) for any year prior to the year for which the establishment requests such waiver.

“(cc) SIZE AND AFFILIATION STANDARDS.—For purposes of determining whether an establishment is a small business under this clause, the Secretary shall apply the standards of the Small Business Administration related to size eligibility and affiliation, as described in sections 121.103 and 121.106 of title 13, Code of Federal Regulations (or successor regulations).

“(dd) INFORMATION DEMONSTRATING ESTABLISHMENT SIZE.—For purposes of demonstrating that an establishment requesting a waiver is a small business under this clause, such establishment shall submit to the Secretary, at least 60 days before the fee is due pursuant to subparagraph (C), a copy of its most recent Federal income tax return for a taxable year or its most recent payroll register.”.

(3) EXCLUSION OF FOREIGN COMPANIES.—Section 738(a)(3)(B)(ii)(III) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)(3)(B)(ii)(III)) is amended to read as follows:

“(III) EXCLUSION OF FOREIGN COMPANIES.—An entity that is organized under the laws of a foreign government may not—

“(aa) apply for a waiver under this clause; or

“(bb) form an entity under the laws of the United States for purposes of applying for a waiver under this clause.”.

(4) WAIVER AMOUNT; EXPIRATION OF ELIGIBILITY.—Section 738(a)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)(3)(B)(ii)) is amended by striking subclause (IV) and inserting the following:

“(IV) WAIVER AMOUNT.—A waiver granted by the Secretary to an establishment under this clause shall cover—

“(aa) with respect to the 3-year period beginning on the date on which the Secretary first determines that such establishment qualifies for such waiver, 100 percent of the amount of the fee required under subparagraph (A); and

“(bb) with respect to the subsequent 2-year period, 50 percent of such amount.

“(V) EXPIRATION OF ELIGIBILITY.—The Secretary may not grant a waiver to an establishment under this clause following—

“(aa) the date of a determination by the Secretary, if any, that such establishment is not a small business; or

“(bb) the expiration of the 5-year period of coverage applicable to such establishment under subclause (IV).”.

(5) NON-REVIEWABILITY.—Section 738(a)(3)(B)(ii)(V) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)(3)(B)(ii)(V)) is amended by striking “Request for waiver.—” and all that follows through “subparagraph (C).” and inserting “Non-reviewability.—”.

SEC. 3. Annual registration fee for foreign companies.

“(D) ANNUAL REGISTRATION FEE FOR FOREIGN COMPANIES.—With respect to an establishment owned or operated by an entity organized under the laws of a foreign government, the fee for an initial or annual registration under section 510 shall be equal to the fee required under subparagraph (A) multiplied by 8.”.

SEC. 4. Effective date.