[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 964 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 964

  To authorize the marketing of breast self-examination pads without 
                              restriction.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 6, 1997

  Mr. Burr of North Carolina introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
  To authorize the marketing of breast self-examination pads without 
                              restriction.

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

SECTION 1. FINDINGS.

    The Congress finds the following:
            (1) Breast cancer is the second leading cause of death by 
        cancer in women.
            (2) An estimated 180,000 new invasive cases of breast 
        cancer in the United States are expected in 1997.
            (3) An estimated 44,000 women are expected to die of breast 
        cancer during 1997.
            (4) While there is no cure for breast cancer, early 
        detection is the key to survival of this devastating disease.
            (5) In 1995 the Food and Drug Administration made available 
        a plastic pad to aid in self-examination of the breasts and to 
        be used in addition to a bare hand self-examination.
            (6) The Congress believes that such a pad should be 
        directly available to women.

SEC. 2. AIDS FOR SELF-EXAMINATION OF BREASTS.

    In the administration of approvals under chapter V of the Federal 
Food, Drug, and Cosmetic Act of devices to aid in the self-examination 
of breasts, the Secretary of Health and Human Services shall approve 
the marketing of such devices without the requirement under section 
520(e) of such Act that such devices be restricted to sale, 
distribution, or use only upon a prescription of a licensed 
practitioner or otherwise be restricted in their availability to women.
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