[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3230 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3230

To direct the Food and Drug Administration, with respect to devices, to 
  enter into agreements with certain countries regarding methods and 
       approaches to harmonizing certain regulatory requirements.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 14, 2011

   Mrs. McMorris Rodgers (for herself, Mr. Lance, Mr. Guthrie, Mrs. 
 Blackburn, Mr. Paulsen, Mr. Bass of New Hampshire, Mr. Latta, and Mr. 
   Shimkus) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To direct the Food and Drug Administration, with respect to devices, to 
  enter into agreements with certain countries regarding methods and 
       approaches to harmonizing certain regulatory requirements.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Keeping America Competitive Through 
Harmonization Act of 2011''.

SEC. 2. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND 
              LABELING SYMBOLS; REPORT.

    (a) In General.--Paragraph (4) of section 803(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 383(c)) is amended to read as 
follows:
    ``(4) With respect to devices, the Secretary shall, to the maximum 
extent practicable, enter into agreements with those countries 
identified in clauses (i) and (ii) of section 802(b)(1)(A) regarding 
methods and approaches to harmonizing regulatory requirements for 
premarket review, inspections, and common international labeling 
symbols.''.
    (b) Report.--Not later than 3 years after the date of enactment of 
this Act, the Secretary of Health and Human Services shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report listing the agreements entered into under 
section 803(c)(4) of the Federal Food, Drug, and Cosmetic Act (as 
amended by subsection (a)) and itemizing the methods and approaches 
that have been harmonized pursuant to such section.
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