Document ID: FDA-2014-N-1414-0005
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: 2018-04-09T04:00Z

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15158-15159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07153]

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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) 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 (PRA).

DATES: Fax written comments on the collection of information by May 9, 
2018.

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 [email protected]. 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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

[[Page 15159]]

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. The number of respondents 
cited in table 1 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 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 November 9, 2017 (82 FR 52056) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    We therefore retain the currently approved burden estimate for the 
information collection, which is as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of                        Average
            Activity                 Number of      disclosures    Total annual     burden per      Total hours
                                    respondents   per respondent    disclosures     disclosure
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Class II Special Controls                      5               1               5              12              60
 Guidance 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: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07153 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P