[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1477 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1477

 To establish a user fee for follow-up reinspections under the Federal 
                     Food, Drug, and Cosmetic Act.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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.
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