DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration [Docket No. 93NÄ0485]

Opportunity for Submission of Petitions for Essential Use Exemption for
Certain Ozone-Depleting Substances Pursuant to the Clean Air Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing specific
procedures whereby a manufacturer of a potentially essential medical product
that is regulated by FDA and that is affected by the nonessential use bans
under the Clean Air Act (CAA), as amended in 1990, may apply to FDA, using the
petition process provided in FDA's administrative regulations for an exemption
from the bans if the product meets certain criteria.

DATES: Submit written comments by January 27, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFAÄ305),
Food and Drug Administration, rm. 1Ä23, 12420 Parklawn Dr., Rockville, MD
20857. Submit petitions that do not contain confidential commercial
information, pursuant to this notice, to the Dockets Management Branch
(address above).

FOR FURTHER INFORMATION CONTACT: For specific questions contact the
appropriate center:

For general questions: Ilisa B. Bernstein, Office of Policy, Food and Drug
Administration, 5600 Fishers Lane (HFÄ23), rm. 15Ä74, Rockville, MD 20857,
301Ä443Ä2831.

For questions about medical devices: Kerry G. Rothschild, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2094 Gaither
Rd., Rockville, MD 20850, 301Ä594Ä4765.

For questions about human drugs: Wayne Mitchell, Center for Drug Evaluation
and Research (HFDÄ362), Food and Drug Administration, rm. 116, 7500 Standish
Place, Rockville, MD 20855, 301Ä594Ä1046.

For questions about biological products: Thomas G. Bird, Center for Biological
Products (HFMÄ2), Food and Drug Administration, 1401 Rockville Pike, suite
200S, Rockville, MD 20852, 301Ä496Ä3556.

For questions about animal drug products: John C. Mathison, Center for
Veterinary Medicine (HFVÄ150), Food and Drug Administration, MPNÄ2, 7500
Standish Pl., Rockville, MD 20855, 301Ä594Ä1679.

SUPPLEMENTARY INFORMATION:

I. Background

Title VI of the CAA, as amended in 1990 (42 U.S.C. 7671), directs the U.S.
Environmental Protection Agency (EPA) to promulgate regulations that prohibit,
among other things, the sale or distribution in interstate commerce of certain
nonessential products that release class I ozone-depleting substances into the
environment (section 610(b) of the CAA) and any aerosol or pressurized
dispenser that contains a class II ozone-depleting substance (section 610(d)
of the CAA). Class I and class II substances are defined in sections 601(3)
and (4) of the CAA. (See EPA's listing notice of January 22, 1991 (56 FR
2420)). Class I ozone-depleting products include chlorofluorocarbons (CFC's),
halons, carbon tetrachloride, and methyl chloroform. Class II ozone-depleting
substances include hydrochlorofluorocarbons (HCFC's). Section 610(b) of the
CAA authorizes EPA to determine which products that release class I substances
are nonessential (58 FR 4768, January 15, 1993.) Section 610(d) of the CAA
addresses the nonessential use ban for class II substances and authorizes EPA
to grant exceptions to the class II ban in certain circumstances (proposed
September 27, 1993, 58 FR 50464). Medical products, as defined in section
601(8) (42 U.S.C. 7671(8)), are exempt from the nonessential use ban (42
U.S.C. 7671i(e)). Exempt medical products consist of:

* * * any device (as defined in the Federal Food, Drug, and Cosmetic Act (21
U.S.C.  321)), diagnostic product, drug (as defined in the Federal Food,
Drug, and Cosmetic Act [21 U.S.C.  301 et seq.]), and drug delivery system

(A) if such device, product, drug, or drug delivery system utilizes a class I
or class II substance for which no safe and effective alternative has been
developed, and where necessary, approved by the Commissioner [of FDA]; and

(B) 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].

(42 U.S.C. 7671(8).)

EPA's existing or proposed regulations state that exceptions to the class I
(58 FR 4768, January 15, 1993) and class II (proposed September 27, 1993, 58
FR 50464) bans include medical products that FDA considers essential and
medical products that FDA has listed in  2.125(e) (21 CFR 2.125(e)). Pursuant
to EPA regulations, the class I ban is effective January 17, 1994. The class
II ban is effective January 1, 1994.

      Currently,  2.125 addresses the use of CFC propellants in
self-pressurized containers. This document describes the process by which
manufacturers of products that use other class I substances and class II
substances as propellants in self-pressurized containers, and in aerosols and
other pressurized containers, may petition for an exemption from the ban.
Petitions need not be submitted for products already listed in  2.125(e). The
use of a CFC propellant in a self-pressurized container in those products is
considered an essential use, and such products are exempt under EPA
regulations implementing section 610(b) of the CAA (58 FR 4768, January 15,
1993).

II. Opportunity to Petition

A. Process for Submitting a Petition Requesting Exemption

A manufacturer of an FDA-regulated product seeking an essential use exemption
from the section 610(b) and section 610(d) bans under the CAA may submit a
petition to FDA in accordance with  10.30 (21 CFR 10.30) requesting the
exemption. The petition should include the following information:

1. A request to amend  2.125(e) to specify the use as essential;

2. The name of the class I or class II substance used in the product and a
description of how it is used;

3. A request for an interim exemption pending a decision on the petition;

4. A statement containing an explanation of the basis for the exemption and
certifying that:

(a) There are no technically feasible alternatives to the use of a class I or
class II ozone-depleting substance in the product;

(b) The product provides a substantial health benefit, environmental benefit,
or other public benefit that would not be obtainable without the use of a
class I or class II ozone-depleting substance; and

(c) The use does not involve a significant release of class I or class II
ozone-depleting substances into the atmosphere or the release is warranted in
view of the consequence if the use were not permitted; and

5. Data and information to support the statement described in section II.A.4.
of this document.

The criteria listed in section II.A.4. of this document are the same criteria
currently listed in  2.125(f), but they are expanded to apply to all class I
and class II substances. These criteria are consistent with the nonessential
use criteria that the CAA states EPA shall consider. These include "the
purpose or intended use of the product, the technological availability of
substitutes for such product and for such class I substance, safety, health,
and other relevant factors.'' (42 U.S.C. 7671i). In addition to these
criteria, FDA may also consider the criteria for exemption under the Montreal
Protocol on Substances that Deplete the Ozone Layer for that use, including
the economic feasibility of using an alternative to a CFC, other class I
substance, or class II substance. (See 58 FR 50464 for a summary of the
Montreal Protocol).

Petitions should be submitted to the Dockets Management Branch (address
above). If a petition contains confidential commercial information that the
petitioner does not want to disclose publicly, the petition should be
submitted directly to the appropriate reviewing center within FDA. In such an
event, a copy of the petition, which refers to, but does not include the
confidential data, must also be submitted to the Dockets Management Branch.
The center contact person and their address is listed in the "Summary''
section of this document.

B. Interim Exemption

Because of the impending effective dates for the class I and class II bans,
FDA will consider granting an interim exemption based on the filing of a
petition that includes the statement and summary explanation of the basis for
the requested exemption, specified in section II.A.4. of this document, and a
statement that the supporting data and information specified in section
II.A.5. of this document will be provided to FDA within 90 days of filing the
original petition. The statements must be certified by a responsible company
official.

If an interim exemption has been granted and FDA determines that the certified
statement, or any other element of the petition is not supported by data or
information available to the agency, was not made in good faith, contains
false or misleading information, or the data or information identified in
section II.A.5. of this document was not provided to the agency within 90
days, FDA will rescind the interim exemption.

FDA believes that the interim exemption procedure is necessary to prevent a
possible public health hazard that may result from the removal from the market
of a potentially essential medical product under the CAA. This interim
exemption is provided to ensure continued availability of potentially
essential medical products pending a full review of all available data and
information by the agency.

Pursuant to section 601(8) of the CAA, FDA will consult with EPA prior to
granting an interim exemption for a medical product. Periodically, FDA will
publish in the Federal Register a list of products that have received interim
exemptions. FDA intends to place the petitions in the public docket for public
comment. FDA also intends to undertake notice and comment rulemaking and to
consult with EPA in determining essential use exemptions, which will be
codified in FDA regulations. FDA intends to amend  2.125 and other affected
sections to reflect the essential use exemptions and the expansion of the
regulation to include other class I and class II substances.

At this time, FDA is not proposing any specific medical products for exemption
under  2.125(e) and section 601(8) of the CAA. Products already exempted in 
2.125(e) will continue to be exempted. FDA will only consider a new exemption
or interim exemption upon submission of a petition as described above.

III. Opportunity for Public Comment

Interested persons may, on or before January 27, 1994, submit to the Dockets
Management Branch (address above) written comments regarding this notice. 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.

Dated: December 22, 1993.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 93Ä31705 Filed 12Ä22Ä93; 5:08 pm]

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Social Security Administration

Agency Forms Submitted to the Office of Management and Budget for Clearance

Normally on Fridays, the Social Security Administration publishes a list of
information collection packages that have been submitted to the Office of
Management and Budget (OMB) for clearance in compliance with Public Law
96Ä511, The Paperwork Reduction Act. The following clearance packages have
been submitted to OMB since the last list was published in the Federal
Register on Friday, December 3, 1993.

(Call Reports Clearance Officer on (410) 965Ä4142 for copies of package.)

1. Certificate of Election for Reduced Spouse's Benefits 0960Ä0398. The
information on form SSAÄ25 is used by the Social Security Administration to
entitle eligible spouses to reduced benefits for months in which they do not
have an entitled child in care. The affected public consists of spouses who
file this certificate to elect reduced benefits.

Number of Respondents 30,000

Frequency of Response 1

Average Burden Per Response 2 minutes

Estimated Annual Burden 1,000 hours

2. Appointment of Representative 0960ÄNEW. The information on form SSAÄ1696 is
used by the Social Security Administration (SSA) to verify the applicant's
appointment of a representative. It allows SSA to inform the representative of
items which affect the applicant's claim. The affected public consists of
applicants who notify SSA that they have appointed a person to represent them
and such representatives.

Number of Respondents 360,000

Frequency of Response 1

Average Burden Per Response 10 minutes

Estimated Annual Burden 60,000 hours

3. Marital Relationship Questionnaire 0960Ä0460. The information on form
SSAÄ4178 is used by the Social Security Administration to determine if two
unrelated individuals of the opposite sex who are living together are
considered married for Supplemental Security Income (SSI) purposes. The
respondents are applicants for and recipients of SSI who are living together
in a questionable relationship.

Number of Respondents 5,100

Frequency of Response 1

Average Burden Per Response 5 minutes

Estimated Annual Burden 425 hours

4. Letter to Employer Requesting Wage Information 0960Ä0138. The information
on form SSA-L4201 is used by the Social Security Administration to verify
wages claimed by an applicant for Supplemental Security Income. The affected
public consists of employers who are requested to verify the applicant's claim
by completing this form.

Number of Respondents 133,000

Frequency of Response 1

Average Burden Per Response 30 minutes

Estimated Annual Burden 66,500 hours

5. Request for Correction of Earnings Record 0960Ä0029. Form SSAÄ7008 is used
by individuals to request that the Social Security Administration (SSA)
correct its record of earnings. The respondents are individuals who question
SSA's record of their earnings.

Number of Respondents 375,000

Frequency of Response 1

Average Burden Per Response 10 minutes

Estimated Annual Burden 62,500 hours

6. Report to U.S. Social Security Administration by Person Receiving Benefits
for a Child or for an Adult Unable to handle Funds (SSAÄ7161); Report to U.S.
Social Security Administration (SSAÄ7162) 0960Ä0049. The information on these
forms is used by the Social Security Administration to determine continuing
entitlement and proper benefit amounts for Social Security beneficiaries who
live outside the U.S. The affected public consists of persons living outside
the U.S. who are entitled to benefits or who are representative payees for an
entitled beneficiary.

Number of Respondents 275,000

Frequency of Response 1

Average Burden Per Response (SSAÄ7161) 15 minutes, (SSAÄ7162) 5 minutes

Estimated Annual Burden 31,250 hours

      7. Employer Classification Update 0960Ä0262. The information on form
SSAÄL378 is combined with other data obtained by the Social Security
Administration and used in program planning, revenue estimates, and employment
studies. The affected public consists of employers who have at least 11
employees and who have not provided sufficient information on form SSÄ4 for
geographical and industrial classification.

Number of Respondents 75,000

Frequency of Response 1

Average Burden Per Response 3 minutes

Estimated Annual Burden 3,750 hours

Written comments and recommendations regarding these information collections
should be sent directly to the appropriate OMB Desk Officer designated above
at the following address: OMB Reports Management Branch, New Executive Office
Building, room 3208, Washington, DC 20503.

Dated: January 21, 1993.

Charlotte Whitenight,

Reports Clearance Officer, Social Security Administration.

[FR Doc. 93Ä31598 Filed 12Ä27Ä93; 8:45 am]

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