[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3975 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 3975

To amend title V of the Federal Food, Drug, and Cosmetic Act to extend 
 the provisions of the Pediatric Medical Device Safety and Improvement 
                                  Act.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 8, 2012

  Mr. Rogers of Michigan (for himself and Mr. Markey) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To amend title V of the Federal Food, Drug, and Cosmetic Act to extend 
 the provisions of the Pediatric Medical Device Safety and Improvement 
                                  Act.

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

SECTION 1. EXTENSION OF PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT 
              ACT.

    (a) Humanitarian Device Exemption Extension.--Section 
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(6)(A)(iv)) is amended by striking ``2012'' and inserting 
``2017''.
    (b) Demonstration Grants To Improve Pediatric Device 
Availability.--Section 305(e) of Pediatric Medical Device Safety and 
Improvement Act (Public Law 110-85; 42 U.S.C. 282 note)) is amended by 
striking ``2012'' and inserting ``2017''.
    (c) Effective Date for Rule Relating to Tracking of Pediatric Uses 
of Devices.--Notwithstanding subchapter II of chapter 5, and chapter 7, 
of title 5, the United States Code (commonly known as the 
``Administrative Procedures Act'') and any other provision of law, the 
proposed rule issued by the Commissioner of Food and Drugs entitled 
``Medical Devices; Pediatric Uses of Devices; Requirement for 
Submission of Information on Pediatric Subpopulations That Suffer From 
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or 
Cure,'' 75 Fed. Reg. 16365 (April 1, 2010), shall take effect on 
January 1, 2013, unless such Commissioner issues the final rule before 
such date.
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