Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms, 109-111 [2020-29091]
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<![CDATA[
109
Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices
TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued
Citation
referenced in
COVID–19
guidance
COVID–19 guidance title
Another guidance referenced
in COVID–19 guidance
Emergency Use Authorization
of Medical Products and Related Authorities; Guidance
for Industry and Other
Stakeholders.
OMB control
No(s).
New collection covered by
PHE PRA waiver
0910–0595
Updates to FDA every 6 weeks
after initial notification on the
shortage situation.
Voluntary submission of other
information.
Enforcement Policy for Bioburden Reduction Systems Using
Dry Heat to Support Single-User Reuse of Certain Filtering
Facepiece Respirators During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency (November
2020).
.........................
Emergency Use Authorization
of Medical Products and Related Authorities; Guidance
for Industry and Other
Stakeholders.
0910–0595
Labeling of the bioburden reduction system.
Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act [MQSA] During the COVID–19
Public Health Emergency (December 2020).
21 CFR Part
900.
..................................................
0910–0309
Document the time period that
the facility was temporarily
closed and present information during the facility’s
MQSA inspection.
Document and provide the circumstances re: lack of medical physicist survey within
14 months of the last annual
survey.
Information on inability to meet
the survey timeframes described in the guidance.
Provide documentation of the
dates and events that led to
noncompliance and that facility will ensure compliance
as soon as possible after
COVID–19 restrictions are
lifted.
IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–29058 Filed 12–31–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:28 Dec 31, 2020
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1414]
Agency Information Collection
Activities; Proposed Collection;
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 Agency) is
announcing an opportunity for public
comment on the proposed collection of
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
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection for the labeling of natural
rubber latex condoms.
Submit either electronic or
written comments on the collection of
information by March 5, 2021.
DATES:
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 March 5,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 5, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\04JAN1.SGM
04JAN1
110
Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1414 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Class II
Special Controls Guidance Document:
Labeling Natural Rubber Latex
Condoms.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), 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, 240–402–7500.
• 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
VerDate Sep<11>2014
17:28 Dec 31, 2020
Jkt 253001
‘‘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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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.
E:\FR\FM\04JAN1.SGM
04JAN1
111
Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices
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
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)).
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.
Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–29091 Filed 12–31–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the National Toxicology
Program (NTP) Board of Scientific
Counselors (BSC). The BSC, a federally
chartered, external advisory group
composed of scientists from the public
and private sectors, will review and
provide advice on programmatic
activities. This meeting is a virtual
meeting and is open to the public.
Written comments will be accepted and
registration is required to present oral
comments. Information about the
meeting and registration is available at
https://ntp.niehs.nih.gov/go/165.
DATES:
SUMMARY:
VerDate Sep<11>2014
17:28 Dec 31, 2020
Jkt 253001
Meeting: Scheduled for February 2,
2021, 12:30 p.m.–5:00 p.m. Eastern
Standard Time (EST). Written Public
Comment Submissions: Deadline is
January 26, 2021.
Registration for Oral Comments:
Deadline is January 26, 2021.
ADDRESSES:
Meeting Web page: The preliminary
agenda, registration, and other meeting
materials are available at https://
ntp.niehs.nih.gov/go/165.
Virtual Meeting: The URL for viewing
the virtual meeting will be provided on
the meeting web page.
FOR FURTHER INFORMATION CONTACT: Dr.
Sheena Scruggs, Designated Federal
Official for the BSC, Office of Liaison,
Policy and Review, Division of NTP,
NIEHS, P.O. Box 12233, K2–03,
Research Triangle Park, NC 27709.
Phone: 984–287–3355, Fax: 301–451–
5759, Email: sheena.scruggs@nih.gov.
Hand Deliver/Courier address: 530
Davis Drive, Room K2130, Morrisville,
NC 27560.
SUPPLEMENTARY INFORMATION: The BSC
will provide input to the NTP on
programmatic activities and issues. The
preliminary agenda topics include
presentations from two of the Division
of the National Toxicology Program
(DNTP)’s research program areas. The
preliminary agenda, roster of BSC
members, background materials, public
comments, and any additional
information, when available, will be
posted on the BSC meeting web page
(https://ntp.niehs.nih.gov/go/165) or
may be requested in hardcopy from the
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Designated Federal Official for the BSC.
Following the meeting, summary
minutes will be prepared and made
available on the BSC meeting web page.
Meeting Attendance Registration: The
meeting is open to the public with time
scheduled for oral public comments.
Registration is not required to view the
virtual meeting; the URL for the virtual
meeting is provided on the BSC meeting
web page (https://ntp.niehs.nih.gov/go/
165). TTY users should contact the
Federal TTY Relay Service at 800–877–
8339. Requests should be made at least
five business days in advance of the
event.
Written Public Comments: NTP
invites written public comments.
Guidelines for public comments are
available at https://ntp.niehs.nih.gov/
ntp/about_ntp/guidelines_public_
comments_508.pdf.
The deadline for submission of
written comments is January 26, 2021.
Written public comments should be
submitted through the meeting web
page. Persons submitting written
comments should include name,
affiliation, mailing address, phone,
email, and sponsoring organization (if
any). Written comments received in
response to this notice will be posted on
the NTP web page, and the submitter
will be identified by name, affiliation,
and sponsoring organization (if any).
Oral Public Comment Registration:
The agenda allows for two formal public
comment periods—one comment period
for each program area (up to 3
commenters, up to 5 minutes per
speaker, per topic). Persons wishing to
E:\FR\FM\04JAN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 109-111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29091]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1414]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of 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 the information collection for the labeling
of natural rubber latex condoms.
DATES: Submit either electronic or written comments on the collection
of information by March 5, 2021.
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 March 5, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 5, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
[[Page 110]]
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1414 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Class II Special Controls
Guidance Document: Labeling Natural Rubber Latex Condoms.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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, 240-402-7500.
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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
[[Page 111]]
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 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)).
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: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29091 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P
