Teacher:In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Teacher: Now, understand the problem? Solve this instance: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Asthma Inhaler Protection Act''.

SEC. 2. ASSESSMENTS RELATED TO TRANSITION FROM USE OF
CHLOROFLUOROCARBONS IN METERED-DOSE INHALERS.

(a) Assessments.--Before beginning rulemaking to issue a regulation
described in section 3(a), the Commissioner of Food and Drugs (referred
to in this Act as the ''Commissioner'') shall conduct the following
assessments concerning the transition from use of chlorofluorocarbons
in metered-dose inhalers:
(1) An assessment of the health risks and benefits of the
regulatory approach set forth in the advance notice of proposed
rulemaking entitled ''Chlorofluorocarbon Propellants in Self-
Pressurized Containers; Determinations That Uses Are No Longer
Essential; Request for Comments'', published in the Federal
Register on March 6, 1997, 62 Fed. Reg. 10242, and the health
risks and benefits of alternative policies for facilitating the
transition to non-chlorofluorocarbon treatments for asthma and
other respiratory diseases.
(2) An assessment of the environmental risks and benefits
of the regulatory approach set forth in the notice described in
paragraph (1), and the environmental risks and benefits of
alternative policies for facilitating the transition to non-
chlorofluorocarbon treatments for asthma and other respiratory
diseases.
(3) An assessment of whether measures and recommendations
adopted by the Tenth Meeting of the Parties to the Montreal
Protocol on Substances That Deplete the Ozone Layer will, when
implemented in the United States, facilitate the transition in
the United States to non-chlorofluorocarbon treatments for
asthma and other respiratory diseases by 2005 without
increasing the health risks to patients of such diseases.
(b) Basis for Assessments.--
(1) Health risks and benefits.--The Commissioner shall base
the assessment described in subsection (a)(1) on factors
including extensive consultations with patients, physicians,
other health care providers, manufacturers of metered-dose
inhalers, and other interested parties.
(2) Environmental risks and benefits.--The Commissioner
shall conduct the assessment described in subsection (a)(2) in
a manner consistent with section 102(2) of the National
Environmental Policy Act of 1969 (42 U.S.C. 4332(2)), and parts
10, 20, 25, 71 , 101, 170, 171, 312, 314, 511, 514, 570, 571,
601, 812, and 814 of title 21, Code of Federal Regulations. In
conducting such assessment, the Commissioner shall consult with the
Administrator of the Environmental Protection Agency, the Administrator
of the National Oceanic and Atmospheric Administration, and the
Administrator of the National Aeronautics and Space Administration, as
appropriate.
(c) Reports.--The Commissioner shall prepare and submit to Congress
a report for each assessment and shall publish the reports in the
Federal Register.

SEC. 3. RULEMAKING ON CHLOROFLUOROCARBONS IN METERED-DOSE INHALERS.

(a) Regulation.--After completing the duties described in section
2, the Commissioner shall issue a regulation setting forth criteria for
determining whether and in what cases particular chlorofluorocarbon
metered-dose inhalers are necessary for purposes of eligibility for
class I allowances under section 604(d) of the Clean Air Act (42 U.S.C.
7671c(d)) and, as a result, represent essential uses of class I
substances under title VI of the Clean Air Act (42 U.S.C. 7671 et
seq.).
(b) Alternatives.--The criteria described in section 3(a) shall
ensure that a range of non-chlorofluorocarbon inhaler alternatives are
available for each active moiety, to the extent consistent with title
35, United States Code, and section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), and that such alternatives are, for all
populations of users, comparable to existing treatments (in existence
on the date of issuance of the regulation) in terms of safety and
effectiveness, use for therapeutic indications, dosage strength,
delivery system, and sufficient availability to meet consumer needs.
(c) Limitations.--The criteria described in section 3(a) shall not
utilize a therapeutic class approach. If a determination described in
subsection (a) results in the withdrawal of a class I allowance for use
of a chlorofluorocarbon in a type of inhaler, inhalers of the type
involved that were introduced into interstate commerce prior to the
date of the determination shall not be considered to be adulterated or
misbranded under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321 et seq.) solely on the basis of the withdrawal.

SEC. 4. APPROVALS OF NEW MEDICAL PRODUCTS CONTAINING
CHLOROFLUOROCARBONS.

Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 505A (21 U.S.C. 355a) the following:

''SEC. 505B. APPROVALS OF NEW DRUGS CONTAINING CHLOROFLUOROCARBONS.

''(a) Preliminary Assessments and Terminations of Review.--
Notwithstanding any other provision of this Act, with respect to any
application submitted to the Secretary under subsection (b) or (j) of
section 505 (21 U.S.C. 355) after December 31, 1998, for any drug
containing chlorofluorocarbons, the Secretary shall conduct a
preliminary assessment of such application to determine if the drug
represents a significant therapeutic advance over products previously
approved under this chapter. If the Secretary determines that the drug
does not represent a significant therapeutic advance over such approved
products, the Secretary shall terminate review of such application and
not approve the application for the drug.
''(b) Limitations.--Subsection (a) shall not apply to a supplement
to an application if the application was approved under subsection (c)
or (j)(4) of section 505.
''(c) Construction.--Notwithstanding any other provision of this
chapter, use of a drug containing chlorofluorocarbons in a
chlorofluorocarbon metered-dose inhaler shall be subject to the
regulation referred to in section 3(a) of the Asthma Inhaler Protection
Act, regardless of whether an application or supplement for the drug is
approved under section 505 in accordance with this section.''.
Student:
Asthma Inhaler Protection Act - Requires the Commissioner of Food and Drugs, before beginning the rulemaking mandated below, to conduct specified assessments regarding: (1) health and environmental risks and benefits; and (2) whether measures and recommendations adopted by the Tenth Meeting of the Parties to the Montreal Protocol on Substances That Deplete the Ozone Layer will facilitate the U.S. transition to non-chlorofluorocarbon (non-CFC) respiratory disease treatments without increasing health risks.
Mandates, after the assessments above, a regulation regarding whether and in what cases particular CFC metered-dose inhalers are necessary for purposes of eligibility for class I allowances and represent essential uses of class I substances under specified provisions of the Clean Air Act.
Amends the Federal Food, Drug, and Cosmetic Act to require, regarding any new drug or abbreviated new drug application for any drug containing CFCs, a preliminary assessment of whether the drug represents a significant therapeutic advance over previously-approved products and, if not, requires application disapproval.