83 FR 15158 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

Page Range		15158-15159
FR Document		2018-07153

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).

Federal Register, Volume 83 Issue 68 (Monday, April 9, 2018)

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15158-15159]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of      disclosures    Total annual     burden per      Total hours
                                    respondents   per respondent    disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Class II Special Controls                      5               1               5              12              60
 Guidance Document: Labeling for
 Natural Rubber Latex Condoms
 Classified Under 21 CFR
 884.5300.......................
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15159

effectiveness but for which there was condom users, including the extent of The special controls guidance
sufficient information to establish protection provided by condoms against document also refers to previously
performance standards to provide such various types of sexually transmitted approved collections of information
assurance. Accordingly, FDA has diseases. found in FDA regulations. The
established the above captioned Special Respondents to this collection of collections of information in 21 CFR
Controls Guidance Document regarding information are manufacturers and part 801 have been approved under
the labeling of natural rubber latex repackagers of male condoms made of OMB control number 0910–0485; the
condoms. natural rubber latex without spermicidal collections of information in 21 CFR
Condoms without spermicidal lubricant. FDA expects approximately part 807, subpart E have been approved
lubricant containing nonoxynol 9 are five new manufacturers or repackagers under OMB control number 0910–0120;
classified in class II. They were to enter the market yearly and to and the collections of information in 21
originally classified before the collectively have a third-party CFR part 820 have been approved under
enactment of provisions of the Safe disclosure burden of 60 hours. The OMB control number 0910–0073.
Medical Devices Act of 1990 (Pub. L. number of respondents cited in table 1 The collection of information under
101–629), which broadened the is based on FDA’s database of premarket 21 CFR 801.437 does not constitute a
definition of class II devices and now submissions and the electronic ‘‘collection of information’’ under the
permits FDA to establish special registration and listing database. The PRA. Rather, it is a ‘‘public disclosure
controls beyond performance standards, average burden per disclosure was of information originally supplied by
including guidance documents, to help derived from a study performed for FDA the Federal Government to the recipient
provide reasonable assurance of the by Eastern Research Group, Inc., an for the purpose of disclosure to the
safety and effectiveness of such devices. economic consulting firm, to estimate public’’ (5 CFR 1320.3(c)(2)).
In December 2000, Congress enacted the impact of the 1999 over-the-counter In the Federal Register of November
Public Law 106–554, which directed (OTC) human drug labeling 9, 2017 (82 FR 52056) FDA published a
FDA to ‘‘reexamine existing condom requirements final rule (64 FR 13254, 60-day notice requesting public
labels’’ and ‘‘determine whether the March 17, 1999). Because the packaging comment on the proposed collection of
labels are medically accurate regarding requirements for condoms are similar to information. No comments were
the overall effectiveness or lack of those of many OTC drugs, we believe received in response to the notice.
effectiveness in preventing sexually the burden to design the labeling for We therefore retain the currently
transmitted diseases. . . .’’ In response, OTC drugs is an appropriate proxy for approved burden estimate for the
FDA recommended labeling intended to the estimated burden to design condom information collection, which is as
provide important information for labeling. follows:

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent

Class II Special Controls Guidance Document: Labeling
for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300 .................................................................. 5 1 5 12 60
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 3, 2018. DEPARTMENT OF HEALTH AND certain information by the Agency.
Leslie Kux, HUMAN SERVICES Under the Paperwork Reduction Act of
Associate Commissioner for Policy. 1995 (PRA), Federal Agencies are
Food and Drug Administration required to publish notice in the
[FR Doc. 2018–07153 Filed 4–6–18; 8:45 am]
[Docket No. FDA–2018–N–1011] Federal Register concerning each
BILLING CODE 4164–01–P
proposed collection of information,
Agency Information Collection including each proposed extension of an
Activities; Proposed Collection; existing collection of information, and
Comment Request; Petition To to allow 60 days for public comment in
Request an Exemption From 100 response to the notice. This notice
Percent Identity Testing of Dietary solicits comments on reporting
Ingredients: Current Good requirements contained in existing FDA
Manufacturing Practice in regulations governing petitions to
Manufacturing, Packaging, Labeling, or request an exemption from 100 percent
Holding Operations for Dietary identity testing of dietary ingredients.
Supplements DATES: Submit either electronic or
written comments on the collection of
sradovich on DSK3GMQ082PROD with NOTICES

AGENCY: Food and Drug Administration,
HHS. information by June 8, 2018.
ACTION: Notice. ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY: The Food and Drug untimely filed comments will not be
Administration (FDA or Agency) is considered. Electronic comments must
announcing an opportunity for public be submitted on or before June 8, 2018.
comment on the proposed collection of The https://www.regulations.gov

VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1

Document Created: 2018-04-07 02:38:54
Document Modified: 2018-04-07 02:38:54

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by May 9, 2018.
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]
FR Citation		83 FR 15158

83 FR 15158 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration