[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2433 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2433

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                 enhancing combination products review.


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                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

Mr. Bilirakis introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

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                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                 enhancing combination products review.

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

SECTION 1. ENHANCING COMBINATION PRODUCTS REVIEW.

    Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 353(g)(4)(C)) is amended by adding at the end the following 
new clause:
            ``(iii) Not later than 18 months after the date of the 
        enactment of the 21st Century Cures Act, the Secretary shall 
        issue final guidance that describes the responsibilities of 
        each agency center regarding its review of combination 
        products. The Secretary shall, after soliciting public comment, 
        review and update the guidance periodically.''.
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