[Federal Register Volume 61, Number 99 (Tuesday, May 21, 1996)]
[Rules and Regulations]
[Pages 25390-25392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12758]



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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) has granted 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 amends FDA's regulations governing use of 
CFC's to include sterile aerosol talc as an essential use.

EFFECTIVE DATE:  June 4, 1996.


[[Page 25391]]


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

    In the Federal Register of March 1, 1996 (61 FR 8002), FDA 
published, in response to a citizen petition submitted by Bryan, a 
proposed rule to amend Sec. 2.125 (21 CFR 2.125) to add sterile aerosol 
talc administered intrapleurally by thoracoscopy for human use to the 
list of products containing a CFC propellant for an essential use.
    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, or misbranded, or both, 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 (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. 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.
    Based on the evidence before it in the petition and in Bryan's new 
drug application for the drug product, the agency has determined that 
for many patients suffering from pleural effusions, the use of sterile 
aerosol talc provides a special benefit that would be unavailable 
without the use of CFC's. 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 amending 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 the proposed rule was provided to the Administrator. 
Interested persons were given 30 days to comment on the proposed rule. 
FDA received no comments on the proposed rule.

Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 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 final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
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 this final rule will have on any small entities, the agency 
certifies that the final 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.

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

[[Page 25392]]

authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
2 is 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: May 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12758 Filed 5-21-96; 8:45 am]
BILLING CODE 4160-01-F