[Federal Register Volume 61, Number 42 (Friday, March 1, 1996)]
[Proposed Rules]
[Pages 8002-8003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4714]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration-
21 CFR Part 2
[Docket No. 95P-0088]
Chlorofluorocarbon Propellants in Self-Pressurized Containers;
Addition to List of Essential Uses
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to grant
the petition of Bryan Corp. (Bryan) to add sterile aerosol talc to the
list of products containing a chlorofluorocarbon (CFC) propellant for
an essential use. Essential use products are exempt from FDA's ban on
the use of CFC propellants in FDA-regulated products and the
Environmental Protection Agency's (EPA's) ban on the use of CFC's in
pressurized dispensers. This document proposes to amend FDA's
regulations governing use of CFC's to include sterile aerosol talc as
an essential use.
DATES: Written comments by April 1, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1049.
SUPPLEMENTARY INFORMATION:
I. Background
Under Sec. 2.125 (21 CFR 2.125), any food, drug, device, or
cosmetic in a self-pressurized container that contains a CFC propellant
for a nonessential use is adulterated and/or misbranded under the
Federal Food, Drug, and Cosmetic Act. This prohibition is based on
scientific research indicating that CFC's may reduce the amount of
ozone in the stratosphere and thereby increase the amount of
ultraviolet radiation reaching the earth. An increase in ultraviolet
radiation may increase the incidence of skin cancer, change the
climate, and produce other adverse effects of unknown magnitude on
humans, animals, and plants. Section 2.125(d) exempts from the
adulteration and misbranding provisions of Sec. 2.125(c) certain
products containing CFC propellants that FDA determines provide unique
health benefits that would not be available without the use of a CFC.
These products are referred to in the regulation as essential uses of
CFC's and are listed in Sec. 2.125(e).
Under Sec. 2.125(f), any person may petition the agency to request
additions to the list of uses considered essential. To demonstrate that
the use of a CFC is essential, the petition must be supported by an
adequate showing that: (1) There are no technically feasible
alternatives to the use of a CFC in the product; (2) the product
provides a substantial health, environmental, or other public benefit
unobtainable without the use of the CFC; and (3) the use does not
involve a significant release of CFC's into the atmosphere or, if it
does, the release is warranted by the consequence if the use were not
permitted.
EPA regulations implementing provisions of the Clean Air Act
contain a general ban on the use of CFC's in pressurized dispensers (40
CFR 82.64(c) and 82.66(d)). These regulations exempt from the general
ban ``medical devices'' that FDA considers essential and that are
listed in Sec. 2.125(e). Section 601(8) of the Clean Air Act (42 U.S.C.
7671(8)) defines ``medical device'' as any device (as defined in the
Federal Food, Drug, and Cosmetic Act), diagnostic product, drug (as
defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery
system, if such device, product, drug, or drug delivery system uses a
class I or class II ozone-depleting substance for which no safe and
effective alternative has been developed (and where necessary, approved
by the Commissioner of Food and Drugs (the Commissioner)); and if such
device, product, drug, or drug delivery system has, after notice and
opportunity for public comment, been approved and determined to be
essential by the Commissioner in consultation with the Administrator of
EPA (the Administrator). Class I substances include CFC's, halons,
carbon tetrachloride, methyl chloroform, methyl bromide, and other
chemicals not relevant to this document (see 40 CFR part 82, appendix A
to subpart A). Class II substances include hydrochlorofluorocarbons
(HCFC's) (see 40 CFR part 82, appendix B to subpart A).
II. Petition Received by FDA
Bryan submitted a petition under Sec. 2.125(f) and 21 CFR part 10
requesting an addition to the list of CFC uses considered essential.
The petition is on file under the docket number appearing in the
heading of this document and may be seen in the Dockets Management
Branch (address above). The petition requested that sterile aerosol
talc be included in Sec. 2.125(e) as an essential use of CFC's. The
petition contained a discussion supporting the position that there are
no technically feasible alternatives to the use of CFC's in the
product. It included information showing that no alternative delivery
systems (e.g., the pneumatic atomizer) can assure consistent sterility.
The petition also stated that Bryan is unaware of any appropriate
substitute propellants (e.g., compressed gases). Also, the petition
stated that the product provides a substantial health benefit that
would not be obtainable without the use of CFC's. In this regard, the
petition contained information to support the use of this product in
the treatment of malignant pleural effusions, a condition in which
fluid accumulates in the space between the outside surface of the lung
and the inside surface of the chest wall (pleural cavity) as a result
of involvement by an underlying cancer. The petition also provided
information indicating that use of the product would involve a limited
release of CFC's into the atmosphere and the release is warranted by
the health benefits of the product.
III. FDA'S Review of the Petition
The agency has tentatively decided that for many patients suffering
from malignant pleural effusions, the use of sterile aerosol talc
provides a special benefit that would be unavailable without the use of
CFC's. Based on the evidence currently before it, FDA also agrees that
the use of CFC's for this product does not involve a significant
release of CFC's into the atmosphere. Therefore, FDA is proposing to
amend Sec. 2.125(e) to include sterile aerosol talc administered
intrapleurally by thoracoscopy for human use in the list of essential
uses of CFC propellants. A copy of this document has been provided to
the Administrator.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order
[[Page 8003]]
12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the agency is not aware of any adverse
impact of this proposed rule will have on any small entities, the
agency certifies that the proposed rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
V. Opportunity for Public Comment
Interested persons may, on or before April 1, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 2
Administrative practice and procedure, Cosmetics, Devices, Drugs,
Foods.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 2 be amended as follows:
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
1. The authority citation for 21 CFR part 2 continues to read as
follows:
Authority: Secs. 201, 301, 305, 402, 408, 409, 501, 502, 505,
507, 512, 601, 701, 702, 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 355, 357,
360b, 361, 371, 372, 374); 15 U.S.C. 402, 409.
2. Section 2.125 is amended by adding new paragraph (e)(15) to read
as follows:
Sec. 2.125 Use of chlorofluorocarbon propellants in self-pressurized
containers.
* * * * *
(e) * * *
(15) Sterile aerosol talc administered intrapleurally by
thoracoscopy for human use.
* * * * *
Dated: February 22, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4714 Filed 2-29-96; 8:45 am]
BILLING CODE 4160-01-F