[Federal Register Volume 65, Number 186 (Monday, September 25, 2000)]
[Notices]
[Pages 57617-57618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1328]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Latex Condoms; User Labeling; Expiration 
Dating

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
October 25, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:  In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Latex Condoms; User Labeling; Expiration Dating--21 CFR 801.435 
(OMB Control No. 0910-0352)--Extension

    Sections 502(a), 519, 701, and 704 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 352(a), 360(i), 371, and 374) 
establish the statutory authority to collect information under this 
regulation. Section 519 of the act describes recordkeeping, section 
502(a) describes misbranding, section 704 describes authority for 
inspections, and section 701 describes general administrative 
procedures and regulations and hearings.
    To protect the public health and minimize the risk of device 
failure, latex condoms are required to be labeled with an expiration 
date, which must be supported by data from quality control tests 
demonstrating physical and mechanical integrity of three random lots of 
the same product that were stored under accelerated and real time 
conditions (Sec. 801.435 (21 CFR 801.435)).
    The recording of shelf life testing by condom manufacturers is used 
to support the expiration dating on the labeling of latex condoms. 
Information concerning latex shelf life is necessary to allow lay users 
to use these products safely by avoiding use of products that may have 
degraded. Degradation of latex film products like latex condoms occurs 
when latex is exposed to various types of environmental conditions 
normally experienced in product use, shipment, or storage situations. 
The effectiveness of latex condoms as a barrier to the transmission of 
infectious agents is dependent upon the integrity of the latex 
material. The information and records generated by condom manufacturers 
under this regulation will be used to establish an expiration date that 
will inform consumers when the product should no longer be used.
    Section 510(h) of the act (21 U.S.C. 360(h)) requires that condom 
manufacturers as device manufacturers be inspected at least once in a 
2-year period. During that inspection, FDA inspectors will review the 
test records used to support the expiration date in order to ensure 
that the expiration date is accurate. The respondents to this 
collection of information are domestic and foreign condom 
manufacturers.
    In the Federal Register of June 23, 2000 (65 FR 39150), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                       Number of       Annual frequency     Total annual        Hours per
  21 CFR section      respondents       per  response        responses           response         Total hours
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      801.435             45                  1                 45                 96             4,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of domestic establishments was estimated by reviewing 
the FDA data base of registered medical device manufacturers to arrive 
at 5 domestic and 40 foreign condom manufacturers. Based upon 
conversations with condom manufacturers, FDA field personnel, and 
comments received from the public

[[Page 57618]]

during this collections initial approval, FDA determined the number 
hours to complete labeling and testing of condoms to be 96 hours per 
respondent.

    Dated: September 19, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24480 Filed 9-22-00; 8:45 am]
BILLING CODE 4160-01-F