(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.—.