[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]



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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.

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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