[Federal Register Volume 65, Number 122 (Friday, June 23, 2000)]
[Notices]
[Pages 39150-39151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1328]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Extension; 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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in 
theFederal Register concerning each proposed collection of information, 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for an expiration date on latex condom labeling based on 
physical and mechanical testing performed after exposing the product to 
varying conditions that age latex.

DATES: Submit written comments on the collection of information by 
August 22, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520) Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in theFederal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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) misbranding, section 704 authority for inspections, and section 
701 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

[[Page 39151]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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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 during this collections initial 
approval, FDA determined the number hours to complete labeling and 
testing of condoms to be 96 hours per respondent.

    Dated: June 15, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-15865 Filed 6-22-00; 8:45 am]
BILLING CODE 4160-01-F