[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
