Document ID: FDA-2011-N-0492-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Class II Special Controls Guidance Document, Labeling for Natural Rubber Latex Condoms
Posted Date: 2011-07-08T04:00Z

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40377-40378]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17156]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0492]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Class II Special Controls Guidance Document: Labeling 
for Natural Rubber Latex Condoms

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 the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for the labeling of natural rubber latex condoms.

DATES: Submit either electronic or written comments on the collection 
of information by September 6, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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:  Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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 the Federal 
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 these topics: (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.

Class II Special Controls Guidance Document: Labeling for Natural 
Rubber Latex Condoms Classified Under 21 CFR 884.5300--(OMB Control 
Number 0910-0633)--Extension

    Under the Medical Device Amendments of 1976 (Pub. L. 94-295), class 
II devices were defined as those devices for which there was 
insufficient information to show that general controls themselves would 
provide a reasonable assurance of safety and effectiveness, but for 
which there was sufficient information to establish performance 
standards to provide such assurance.
    Condoms without spermicidal lubricant containing nonoxynol-9 are 
classified in class II. They were originally classified before the 
enactment of provisions of the Safe Medical Devices Act of 1990 (Pub. 
L. 101-629) that broadened the definition of class II devices and now 
permit FDA to establish special controls beyond performance standards, 
including guidance documents, to help provide

[[Page 40378]]

reasonable assurance of the safety and effectiveness of such devices. 
In December 2000, Congress enacted Public Law 106-554, which among 
other provisions, directed FDA to ``reexamine existing condom labels'' 
and ``determine whether the labels are medically accurate regarding the 
overall effectiveness or lack of effectiveness in preventing sexually 
transmitted diseases * * *.'' In response, FDA recommended labeling 
intended to provide important information for condom users, including 
the extent of protection provided by condoms against various types of 
sexually transmitted diseases.
    Respondents to this collection of information are manufacturers and 
repackagers of male condoms made of natural rubber latex without 
spermicidal lubricant.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of       disclosures      Total annual   Average  burden    Total hours
                                                                       respondents     per respondent    disclosures     per disclosure
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884.5300...........................................................               3               34              102               12            1,224
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA expects approximately three new manufacturers or repackagers to 
enter the market yearly, and collectively have a third party disclosure 
burden of 1,224 hours. The number of respondents and prospective new 
manufacturers cited in table 1 of this document are based on FDA's 
database of premarket submissions. The remaining figures were derived 
from a study performed for FDA by Eastern Research Group, Inc., an 
economic consulting firm, to estimate the impact of the 1999 over-the-
counter (OTC) human drug labeling requirements final rule (64 FR 13254, 
March 17, 1999). Because the packaging requirements for condoms are 
similar to those of many OTC drugs, we believe the burden to design the 
labeling for OTC drugs is an appropriate proxy for the estimated burden 
to design condom labeling.
    The special controls guidance document also refers to currently 
approved collections of information found in FDA regulations. The 
collections of information under 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information under 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in part 801 (21 
CFR part 801) have been approved under OMB control number 0910-0485.
    The collection of information under Sec.  801.437 does not 
constitute a ``collection of information'' under the PRA. Rather, it is 
a ``public disclosure of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the 
public'' (5 CFR 1320.3(c)(2)).

    Dated: July 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17156 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P