Document ID: FDA-2014-N-1414-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Class II Special
Controls Guidance Document: Labeling of Natural Rubber Latex
Condoms
Posted Date: 2015-01-27T05:00Z

[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4273-4274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01403]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 26, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0633. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 4274]]

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 
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 five 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 
part 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.
    The collection of information under 21 CFR 801.437 does not 
constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995. 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)).
    In the Federal Register of October 15, 2014 (79 FR 61874), FDA 
published a 60-day notice requesting public comment 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 Third-Party Disclosure Burden \1\
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                                                            Number of
                                              Number of    disclosures      Total        Average
                 Activity                    respondents       per         annual      burden per    Total hours
                                                           respondent    disclosures   disclosure
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Class II Special Controls Guidance                    5             1             5            12            60
 Document: Labeling for 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: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01403 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P