[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2968 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 2968

   To require the Secretary of Health and Human Services to take no 
     further action on proposed regulation relating to the use of 
             chlorofluorocarbons in metered-dose inhalers.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 8, 1997

   Mr. Smith of New Jersey (for himself and Mr. Stearns of Florida) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To require the Secretary of Health and Human Services to take no 
     further action on proposed regulation relating to the use of 
             chlorofluorocarbons in metered-dose inhalers.

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

SECTION 1. CHLOROFLUOROCARBONS IN METERED-DOSE INHALERS.

    In complying with Title VI of the Clean Air Act, 42 U.S.C. 7671, 
and the Montreal Protocol on Substances that Deplete the Ozone Layer 
(Montreal Protocol), September 16, 1987, S. Treaty Doc. No. 10, 100th 
Cong., 1st session, regarding chlorofluorocarbons (CFCs), any 
regulations under which the Secretary of Health and Human Services may 
remove essential use designations for the purpose of phasing out 
essential use allowances for drug products shall require the Secretary 
of Health and Human Services to certify to the Congress that 
alternatives to such inhalers are available that, for all populations 
of users of such inhalers, are comparable in terms of safety and 
effectiveness, therapeutic indications, dosage strength, cost, and 
retail availability.

SEC. 2. PROCESS FOR FURTHER RULEMAKING.

    The Commissioner of the Food and Drug Administration shall withdraw 
the March 6, 1997 advance notice of proposed rulemaking concerning CFCs 
in metered-dose inhalers (MDIs) and shall issue another proposal only 
after the 10th Meeting of the Parties to the Montreal Protocol on 
Substances That Deplete the Ozone Layer. In carrying out the goals of 
the Montreal Protocol to phase out essential use exemptions of CFC MDI 
products, the Food and Drug Administration shall not prohibit the 
manufacture, sale, or distribution of any CFC MDI product on the basis 
that it is ``adulterated'' or ``misbranded.'' Any subsequent proposal 
shall be in the form of an advance notice of proposed rulemaking and 
shall be initiated only after extensive consultations with patients, 
physicians, other health care providers, manufacturers of metered-dose 
inhalers, and other stakeholders.
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