II 111th CONGRESS 1st Session S. 1477 IN THE SENATE OF THE UNITED STATES July 21, 2009 Mr. Feingold introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish a user fee for follow-up reinspections under the Federal Food, Drug, and Cosmetic Act.

1.

Establishment of user fee for follow-up reinspections

(a)

In general

The Secretary shall assess and collect a user fee from each facility registered under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), establishment registered under section 510 of such Act (21 U.S.C. 360), and facility described in section 351(a)(1)(C) of the Public Health Service Act (42 U.S.C. 262(1)(C)) for which a follow-up reinspection is required to ensure correction of a violation found by the Secretary during initial inspection of the facility or establishment of a good manufacturing practices requirement under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (b)

Payment of fee

The user fee required under subsection (a) shall be due from a facility or establishment described in such subsection upon the reinspection of such facility or establishment, as described in subsection (a). (c)

Amount of user fee

The amount of the user fee required under subsection (a) shall be established by the Secretary. (d)

Definitions

For purposes of this section— (1)the terms animal drug, device, drug, and food have the meanings given those terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); (2)the term biological product has the meaning given the term in section 351 of the Public Health Service Act (42 U.S.C. 262); and (3)the term Secretary means the Secretary of Health and Human Services.