Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys, 24423-24425 [2023-08297]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices
‘‘REGISTER FOR NSAC MEETING’’ in
the subject line. The deadline for
members of the public to register to
attend the meeting in-person is
Tuesday, May 9, at 5 p.m. eastern.
Members of the public are encouraged
to submit registration requests via email
in advance of the deadline, as space is
limited and will be available on a firstcome, first-served basis for those who
register in advance. We will note when
the limit of in-person attendees has been
reached. The meeting will also stream
live via a link on the Federal Maritime
Commission’s website, www.fmc.gov. If
technical issues prevent the
Commission from live streaming, the
Commission will post a recording of the
meeting on the FMC’s YouTube
channel.
FOR FURTHER INFORMATION CONTACT: Mr.
Dylan Richmond, Designated Federal
Officer of the National Shipper
Advisory Committee, phone: (202) 523–
5810; email: drichmond@fmc.gov.
SUPPLEMENTARY INFORMATION:
Background: The National Shipper
Advisory Committee is a federal
advisory committee. It operates under
the provisions of the Federal Advisory
Committee Act, 5 U.S.C. app., and 46
U.S.C. chapter 425. The Committee was
established on January 1, 2021, when
the National Defense Authorization Act
for Fiscal Year 2021 became law. Public
Law 116–283, section 8604, 134 Stat.
3388 (2021). The Committee provides
information, insight, and expertise
pertaining to conditions in the ocean
freight delivery system to the
Commission. Specifically, the
Committee advises the Federal Maritime
Commission on policies relating to the
competitiveness, reliability, integrity,
and fairness of the international ocean
freight delivery system. 46 U.S.C.
42502(b).
The Committee will receive an update
from each of its subcommittees. The
Committee may receive proposals for
recommendations to the Federal
Maritime Commission and may vote on
these recommendations. Any proposed
recommendations will be available for
the public to view in advance of the
meeting on the NSAC’s website, https://
www.fmc.gov/industry-oversight/
national-shipper-advisory-committee/.
Public Comments: Members of the
public may submit written comments to
NSAC at any time. Comments should be
addressed to NSAC, c/o Dylan
Richmond, Federal Maritime
Commission, 800 North Capitol St. NW,
Washington, DC 20573 or nsac@
fmc.gov.
The Committee will also take public
comment at its meeting. If attending the
VerDate Sep<11>2014
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Jkt 259001
meeting in person and providing
comments, please note that in the
registration request. Comments are most
helpful if they address the Committee’s
objectives or their proposed
recommendations. Comments at the
meeting will be limited to 3 minutes
each.
A copy of all meeting documentation,
including meeting minutes, will be
available at www.fmc.gov following the
meeting.
24423
Market Street, San Francisco, California
94105. Comments can also be sent
electronically to
sf.fisc.comments.applications@
sf.frb.org.
1. Lexicon Bancorp; to become a bank
holding company by acquiring Lexicon
Bank, both of Las Vegas, Nevada.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
By the Commission.
Dated: April 14, 2023.
William Cody,
Secretary.
[FR Doc. 2023–08388 Filed 4–19–23; 8:45 am]
[FR Doc. 2023–08318 Filed 4–19–23; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE P
BILLING CODE 6730–02–P
Food and Drug Administration
FEDERAL RESERVE SYSTEM
[Docket No. FDA–2023–N–0940]
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Rapid Response
Surveys
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in the BHC Act
(12 U.S.C. 1842(c)).
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than May 22, 2023.
A. Federal Reserve Bank of San
Francisco (Joseph Cuenco, Assistant
Vice President, Formations &
Transactions and Enforcement) 101
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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 the use of rapid
response surveys to obtain data on
safety information that supports quick
turnaround decision making about
potential safety problems or risk
management solutions.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
20, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 20, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
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Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / 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
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’’).
ddrumheller on DSK120RN23PROD with NOTICES1
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–
2023–N–0940 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food and
Drug Administration Rapid Response
Surveys.’’ 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
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20:01 Apr 19, 2023
Jkt 259001
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-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.
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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.
Rapid Response Surveys
OMB Control Number 0910–0500—
Extension
This generic information collection
supports research conducted by FDA, as
authorized under section 1003(d)(2) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)).
FDA is requesting extension of OMB
approval to conduct rapid response
surveys. Through these surveys, FDA
seeks to determine whether a problem
impacts the public health and to quickly
obtain vital information about risks and
interventions. FDA will use the
information gathered from these surveys
to make quick turnaround decisions
about safety problems or risk
management solutions so the Agency
may take appropriate public health
action including dissemination of
information as necessary. Participation
in these surveys is voluntary.
Respondents may include
manufacturers and distributors of
biologics, drugs, food, animal food and
drugs, dietary supplements, food
additives, cosmetics, medical devices,
and tobacco products; distributors;
sponsors and importers; consumers;
healthcare professionals; hospitals;
specialized medical facilities (e.g.,
cardiac surgery, obstetrics/gynecology
services, pediatric services, etc.) and
other user facilities including nursing
homes, ambulatory surgical and
outpatient diagnostic and treatment
facilities when FDA must quickly
determine whether or not a problem
impacts the public health. Once FDA
understands the need for additional
surveillance data to address a potential
public health hazard, the appropriate
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Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices
respondents will be identified for each
unique rapid response survey.
24425
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
FDA Rapid Response Surveys ...................................
1 There
Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08297 Filed 4–19–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1378]
Revocation of Two Authorizations of
Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis
of Ebola; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to BioFire
Defense, LLC, for the FilmArray NGDS
BT-E Assay, and Biocartis NV, for the
Idylla Rapid Ebola Virus Triage Test.
FDA revoked these Authorizations
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as requested
by each Authorization holder. The
revocations, which include an
explanation of the reasons for each
revocation, are reprinted at the end of
this document.
DATES: The revocation of the
Authorization for the BioFire Defense,
LLC’s FilmArray NGDS BT-E Assay is
effective as of March 8, 2023. The
revocation of the Authorization for the
Biocartis NV’s Idylla Rapid Ebola Virus
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
10,000
Total annual
responses
1
10,000
Average burden
per response
0.5 (30 minutes) .....
Total hours
5,000
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that each rapid response
survey will take no more than 30
minutes to complete.
Based on a review of the information
collection since our last request, we
have adjusted our burden estimate
which has resulted in a decrease to the
currently approved burden. We now
estimate one response per respondent
which results in a decrease in overall
burden of 25,000 hours.
AGENCY:
Number of
responses per
respondent
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20:01 Apr 19, 2023
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Triage Test is effective as of March 9,
2023.
Submit written requests for
a single copy of the revocations to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a Fax number to which the
revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. On
October 25, 2014, FDA issued the
Authorization to BioFire Defense, LLC,
for the FilmArray NGDS BT-E Assay,
subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on February 9, 2015
(80 FR 6972), as required by section
564(h)(1) of the FD&C Act. On May 26,
2016, FDA issued the Authorization to
Biocartis NV, for the Idylla Rapid Ebola
Virus Triage Test, subject to the terms
of the Authorization. Notice of the
issuance of this Authorization was
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
published in the Federal Register on
July 8, 2016 (81 FR 44616), as required
by section 564(h)(1) of the FD&C Act.
Subsequent updates to the
Authorizations were made available on
FDA’s website. The authorization of a
device for emergency use under section
564 of the FD&C Act may, pursuant to
section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section
564(c) of the FD&C Act for issuance of
such authorization are no longer met
(section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such
revocation appropriate to protect the
public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorization Revocation Requests
In a request received by FDA on
February 24, 2023, BioFire Defense,
LLC, requested the revocation of, and on
March 8, 2023, FDA revoked, the
Authorization for the BioFire Defense,
LLC’s FilmArray NGDS BT-E Assay.
Because BioFire Defense, LLC, notified
FDA that it is obsolescing the FilmArray
NGDS BT-E Assay and requested FDA
withdraw the BioFire Defense, LLC’s,
FilmArray NGDS BT-E Assay, FDA has
determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
In a request received by FDA on
November 23, 2022, Biocartis US, Inc.,
on behalf of Biocartis NV, requested
rescission of, and on March 9, 2023,
FDA revoked, the Authorization for the
Idylla Rapid Ebola Virus Triage Test.
Because Biocartis US, Inc., on behalf of
Biocartis NV, notified FDA that it has
discontinued the production of Idylla
Rapid Ebola Virus Triage Test and
requested FDA rescind the
Authorization for the Idylla Rapid Ebola
Virus Triage Test, FDA has determined
that it is appropriate to protect the
public health or safety to revoke this
Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
revocations are available on the internet
at https://www.regulations.gov/.
E:\FR\FM\20APN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24423-24425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08297]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0940]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration Rapid Response Surveys
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 the use of rapid response
surveys to obtain data on safety information that supports quick
turnaround decision making about potential safety problems or risk
management solutions.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 20, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 20, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
[[Page 24424]]
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-2023-N-0940 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food and Drug Administration
Rapid Response Surveys.'' 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.
Rapid Response Surveys
OMB Control Number 0910-0500--Extension
This generic information collection supports research conducted by
FDA, as authorized under section 1003(d)(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 393(d)(2)).
FDA is requesting extension of OMB approval to conduct rapid
response surveys. Through these surveys, FDA seeks to determine whether
a problem impacts the public health and to quickly obtain vital
information about risks and interventions. FDA will use the information
gathered from these surveys to make quick turnaround decisions about
safety problems or risk management solutions so the Agency may take
appropriate public health action including dissemination of information
as necessary. Participation in these surveys is voluntary.
Respondents may include manufacturers and distributors of
biologics, drugs, food, animal food and drugs, dietary supplements,
food additives, cosmetics, medical devices, and tobacco products;
distributors; sponsors and importers; consumers; healthcare
professionals; hospitals; specialized medical facilities (e.g., cardiac
surgery, obstetrics/gynecology services, pediatric services, etc.) and
other user facilities including nursing homes, ambulatory surgical and
outpatient diagnostic and treatment facilities when FDA must quickly
determine whether or not a problem impacts the public health. Once FDA
understands the need for additional surveillance data to address a
potential public health hazard, the appropriate
[[Page 24425]]
respondents will be identified for each unique rapid response survey.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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FDA Rapid Response Surveys................... 10,000 1 10,000 0.5 (30 minutes)......................... 5,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that each rapid response survey will take no more than
30 minutes to complete.
Based on a review of the information collection since our last
request, we have adjusted our burden estimate which has resulted in a
decrease to the currently approved burden. We now estimate one response
per respondent which results in a decrease in overall burden of 25,000
hours.
Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08297 Filed 4-19-23; 8:45 am]
BILLING CODE 4164-01-P
