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, 15158-15159 [2018-07153]
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
Development of Systemic Drugs; Draft
Guidance for Industry; Availability.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
Outreach, and Development, Center for
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Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Dawn Williams, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5168,
Silver Spring, MD 20993–0002, 301–
796–5376; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Atopic Dermatitis: Timing of Pediatric
Studies During Development of
Systemic Drugs.’’ This draft guidance
addresses FDA’s current thinking about
the relevant age groups to study and
how early in the drug development
pediatric patients should be
incorporated during development of
systemic drugs for AD.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the timing of pediatric studies during
development of systemic drugs for
atopic dermatitis. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: April 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07150 Filed 4–6–18; 8:45 am]
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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.
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 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:
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, 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.
SUMMARY:
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
E:\FR\FM\09APN1.SGM
09APN1
15159
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
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
Class II Special Controls Guidance Document: Labeling
for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300 ..................................................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
Activity
5
1
5
12
Total hours
60
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1011]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Petition To
Request an Exemption From 100
Percent Identity Testing of Dietary
Ingredients: Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
disclosure
Total annual
disclosures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 reporting
requirements contained in existing FDA
regulations governing petitions to
request an exemption from 100 percent
identity testing of dietary ingredients.
DATES: Submit either electronic or
written comments on the collection of
information by June 8, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 8, 2018.
The https://www.regulations.gov
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[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]
-----------------------------------------------------------------------
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
