I 112th CONGRESS 1st Session H. R. 3230 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.

1.

Short title

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

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.