Document ID: FDA-2014-N-1414-0009
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 Natural Rubber Latex Condoms
Posted Date: 2021-05-07T04:00Z

[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24633-24634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09620]

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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 Natural Rubber Latex Condoms

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the 
collection of information by June 7, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0633. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three

[[Page 24634]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-8867, 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--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. Accordingly, FDA has established 
the above captioned special controls guidance document regarding the 
labeling of natural rubber latex condoms.
    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 
permits 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. Our assumption of the burden 
per disclosure is based on our history with the information collection. 
Because the packaging requirements for condoms are similar to those of 
many over-the-counter (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 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)).
    In the Federal Register of January 4, 2021 (86 FR 109), 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
                              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 Natural               5                1                5               12               60
 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: May 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09620 Filed 5-6-21; 8:45 am]
BILLING CODE 4164-01-P