Document ID: FDA-2014-N-1414-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Class II Special Controls Guidance Document:
Labeling of Natural Rubber Latex Condoms
Posted Date: 2014-10-15T04:00Z

[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61874-61875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24445]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1414]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Class II Special Controls Guidance Document: Labeling 
of 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 the information collection for 
the labeling of natural rubber latex condoms.

DATES: Submit either electronic or written comments on the collection 
of information by December 15, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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), which broadened the definition of class II devices and now 
permit FDA to establish special controls beyond performance standards, 
including guidance documents, to help provide 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 expects approximately 5 new manufacturers or 
repackagers to enter the market yearly and to collectively have a 
third-party disclosure burden of 60 hours. The number of respondents 
cited in table 1 of this document is based on FDA's database of 
premarket submissions and the electronic registration and listing 
database. The average burden per disclosure was 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 previously 
approved collections of information found in FDA regulations. The 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485; the collections of information in 21 CFR 
807 subpart E have been approved under OMB control number 0910-0120; 
and the collections of information in 21 CFR part 820 have been 
approved under OMB control number 0910-0073.

[[Page 61875]]

    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)).
    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
                         Activity                              Number of       disclosures per      Total annual      Average burden      Total hours
                                                              respondents         respondent        disclosures       per disclosure
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Class II Special Controls Guidance Document: Labeling for                 5                  1                  5                 12                 60
 Natural Rubber Latex Condoms Classified Under 21 CFR
 884.5300................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24445 Filed 10-14-14; 8:45 am]
BILLING CODE 4164-01-P