[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6190 Reported in House (RH)]

                                                 Union Calendar No. 485
112th CONGRESS
  2d Session
                                H. R. 6190

                          [Report No. 112-673]

 To direct the Administrator of the Environmental Protection Agency to 
allow for the distribution, sale, and consumption in the United States 
 of remaining inventories of over-the-counter CFC epinephrine inhalers.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 25, 2012

 Mr. Burgess (for himself, Mr. Ross of Arkansas, Mr. Barton of Texas, 
Mr. Pitts, Mr. Carter, and Mr. Matheson) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

                           September 14, 2012

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed


_______________________________________________________________________

                                 A BILL


 
 To direct the Administrator of the Environmental Protection Agency to 
allow for the distribution, sale, and consumption in the United States 
 of remaining inventories of over-the-counter CFC epinephrine inhalers.


 


    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 ``Asthma Inhalers Relief Act of 
2012''.

SEC. 2. DISTRIBUTION, SALE, AND CONSUMPTION OF REMAINING INVENTORIES OF 
              OVER-THE-COUNTER CFC EPINEPHRINE INHALERS.

    (a) In General.--The Administrator of the Environmental Protection 
Agency--
            (1) shall allow for the distribution, sale, and consumption 
        in the United States of remaining inventories of CFC 
        epinephrine inhalers manufactured pursuant to the exception for 
        medical devices under section 604(d)(2) of the Clean Air Act 
        (42 U.S.C. 7671c(d)(2));
            (2) shall not take any enforcement action or otherwise seek 
        to restrict the distribution, sale, or consumption of such 
        inhalers on the basis of any Federal law implementing the 
        Montreal Protocol; and
            (3) shall, in response to any request of any distributor or 
        seller of such inhalers, including any such request pending on 
        the date of the enactment of this Act, issue a No Action 
        Assurance Letter to the requesting party stating that the 
        Environmental Protection Agency will not initiate an 
        enforcement action relating to the distribution or sale of any 
        such inhaler occurring prior to August 1, 2013.
    (b) Rule of Construction.--Nothing in this Act shall be construed 
to limit or otherwise affect the authority of the Food and Drug 
Administration under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) to ensure the safety and effectiveness of CFC 
epinephrine inhalers to be distributed, sold, or consumed pursuant to 
this Act.
    (c) Definitions.--In this Act:
            (1) The term ``CFC epinephrine inhaler'' means any 
        epinephrine inhaler containing chlorofluorocarbons that was 
        manufactured and classified as over-the-counter before January 
        1, 2012.
            (2) The phrase ``Federal law implementing the Montreal 
        Protocol''--
                    (A) means any provision of title VI of the Clean 
                Air Act (42 U.S.C. 7671 et seq.) or other Federal law 
                implementing the Montreal Protocol; and
                    (B) includes the final rule published by the Food 
                and Drug Administration entitled ``Use of Ozone-
                Depleting Substances; Removal of Essential-Use 
                Designation (Epinephrine)'' published in the Federal 
                Register at 73 Federal Register 69532 (November 19, 
                2008).
            (3) The term ``Montreal Protocol'' has the meaning given 
        such term in section 601 of the Clean Air Act (42 U.S.C. 7671).
            (4) The term ``over-the-counter'' means not subject to 
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 353(b)(1)) or otherwise required pursuant to Federal 
        law to be dispensed only upon issuance of a prescription.
    (d) Sunset.--This section ceases to be effective August 1, 2013.
                                                 Union Calendar No. 485

112th CONGRESS

  2d Session

                               H. R. 6190

                          [Report No. 112-673]

_______________________________________________________________________

                                 A BILL

 To direct the Administrator of the Environmental Protection Agency to 
allow for the distribution, sale, and consumption in the United States 
 of remaining inventories of over-the-counter CFC epinephrine inhalers.

_______________________________________________________________________

                           September 14, 2012

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed