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, 24633-24634 [2021-09620]
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
24633
Bulk drug substance
Uses evaluated
Melatonin .........................................
Treatment of sleep disorders in patients with autism spectrum disorder (specifically children and adolescents).
Amyotrophic lateral sclerosis (also known as ALS).
Pain management.
Peripheral neuropathy (including diabetic neuropathy).
Inborn errors of metabolism (also known as genetic metabolic disorders) (including
methylenetetrahydrofolate reductase deficiency (also known as MTHFR)).
Hyperhomocysteinemia (including conjunctive therapy in hemodialysis patients).
Vitamin B12 deficiency.
Autism spectrum disorder.
Treatment for patients with tetrahydrobiopterin (BH4) deficiency.
Methylcobalamin .............................
Oxitriptan (5–HTP) ..........................
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19:55 May 06, 2021
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Dated: May 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09621 Filed 5–6–21; 8:45 am]
BILLING CODE 4164–01–P
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 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
SUMMARY:
E:\FR\FM\07MYN1.SGM
07MYN1
24634
Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
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 60day 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
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
‘‘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.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
[FR Doc. 2021–09620 Filed 5–6–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:55 May 06, 2021
Jkt 253001
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
PO 00000
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Fmt 4703
Sfmt 4703
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Small Business Innovation
Research (SBIR) Phase II Program Contract
Solicitation (PHS 2018–1) QrumPharma
Topic 051: Inhaled Delivery of Clofazimine
(CFZ).
Date: May 28, 2021.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia L. De La Fuente,
Ph.D., Scientific Review Officer, Scientific
E:\FR\FM\07MYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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, [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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
``Class II Special Controls Guidance Document: Labeling for Natural 5 1 5 12 60
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.
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
