Agency Information Collection Activities; Proposed Collection; Comment Request; Exports Notification and Recordkeeping Requirements, 3811-3812 [2022-01372]
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0801]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exports
Notification and Recordkeeping
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 information
collection associated with notifications
and records required for human drug,
biological product, device, animal drug,
food, cosmetic, and tobacco product
exports.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by March 28, 2022.
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 28,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 28, 2022. 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.
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• 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
VerDate Sep<11>2014
17:19 Jan 24, 2022
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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–0801 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Exports
Notification and Recordkeeping
Requirements.’’ 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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
3811
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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
E:\FR\FM\25JAN1.SGM
25JAN1
3812
Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
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.
Exports Notification and
Recordkeeping Requirements—21 CFR
1.101
OMB Control Number 0910–0482—
Extension
Sections 801 and 802 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381 and 21 U.S.C. 382)
charge the Secretary of Health and
Human Services, through FDA, with the
responsibility of helping to ensure that
exports of unapproved new drugs,
biologics, devices, animal drugs, food,
cosmetics, and tobacco products that are
not to be sold in the United States meet
the requirements of the country to
which the product is to be exported.
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or offered for sale in domestic
commerce in the United States as
allowed under section 801(e) of the
FD&C Act. In general, the notification
identifies the product being exported
(e.g., name, description, and in some
cases, country of destination) and
specifies where the notifications were
sent. These notifications are sent only
for an initial export. Subsequent exports
of the same product to the same
destination or to certain countries
identified in section 802(b) of the FD&C
Act would not result in a notification to
FDA.
Respondents to the information
collection are exporters of products that
may not be sold in the United States and
are regulated by FDA’s Center for Drug
Evaluation and Research (CDER); Center
for Biologics Evaluation and Research
(CBER); Center for Devices and
Radiological Health (CDRH); Center for
Veterinary Medicine (CVM); Center for
Food Safety and Applied Nutrition
(CFSAN); and Center for Tobacco
Products. Respondents to this collection
of information maintain records
demonstrating their compliance with
the requirements in 21 CFR 1.101.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR
section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
1.101(d) (CBER) ..................................................................
1.101(d) (CDER) ..................................................................
1.101(d) (CDRH) ..................................................................
5
5
160
92
180
1
460
900
160
15
15
15
6,900
13,500
2,400
Total ..............................................................................
........................
........................
........................
........................
22,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR
section
Number of
recordkeepers
Total
annual
records
Average
burden per
recordkeeping
Total hours
1.101(b), (c), and (e) (CBER, CDER, CDRH, CFSAN, and
CVM) ................................................................................
1.101(b) Office of International Programs only ...................
1.101(b) (currently regulated Tobacco Products) ................
320
1
322
3
189
3
960
189
966
22
22
22
21,120
4,158
21,252
Total ..............................................................................
........................
........................
........................
........................
46,530
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency data, we
are retaining the currently approved
burden estimates associated with the
individual reporting and recordkeeping
elements.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01372 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
records per
recordkeeper
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3662]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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17:19 Jan 24, 2022
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PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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 information
collection associated with the guidance
on reagents for detection of specific
novel influenza A viruses.
DATES: Submit either electronic or
written comments on the collection of
information by March 28, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
E:\FR\FM\25JAN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3811-3812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01372]
[[Page 3811]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports Notification and Recordkeeping Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 information collection
associated with notifications and records required for human drug,
biological product, device, animal drug, food, cosmetic, and tobacco
product exports.
DATES: Submit either electronic or written comments on the collection
of information by March 28, 2022.
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 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 28, 2022. 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:
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-0801 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Exports Notification and
Recordkeeping Requirements.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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
[[Page 3812]]
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.
Exports Notification and Recordkeeping Requirements--21 CFR 1.101
OMB Control Number 0910-0482--Extension
Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381 and 21 U.S.C. 382) charge the Secretary of
Health and Human Services, through FDA, with the responsibility of
helping to ensure that exports of unapproved new drugs, biologics,
devices, animal drugs, food, cosmetics, and tobacco products that are
not to be sold in the United States meet the requirements of the
country to which the product is to be exported. The respondents to this
information collection are exporters who have notified FDA of their
intent to export unapproved products that may not be sold or offered
for sale in domestic commerce in the United States as allowed under
section 801(e) of the FD&C Act. In general, the notification identifies
the product being exported (e.g., name, description, and in some cases,
country of destination) and specifies where the notifications were
sent. These notifications are sent only for an initial export.
Subsequent exports of the same product to the same destination or to
certain countries identified in section 802(b) of the FD&C Act would
not result in a notification to FDA.
Respondents to the information collection are exporters of products
that may not be sold in the United States and are regulated by FDA's
Center for Drug Evaluation and Research (CDER); Center for Biologics
Evaluation and Research (CBER); Center for Devices and Radiological
Health (CDRH); Center for Veterinary Medicine (CVM); Center for Food
Safety and Applied Nutrition (CFSAN); and Center for Tobacco Products.
Respondents to this collection of information maintain records
demonstrating their compliance with the requirements in 21 CFR 1.101.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
1.101(d) (CBER)................. 5 92 460 15 6,900
1.101(d) (CDER)................. 5 180 900 15 13,500
1.101(d) (CDRH)................. 160 1 160 15 2,400
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 22,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1.101(b), (c), and (e) (CBER, 320 3 960 22 21,120
CDER, CDRH, CFSAN, and CVM)....
1.101(b) Office of International 1 189 189 22 4,158
Programs only..................
1.101(b) (currently regulated 322 3 966 22 21,252
Tobacco Products)..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 46,530
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of Agency data, we are retaining the currently
approved burden estimates associated with the individual reporting and
recordkeeping elements.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01372 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P
