Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys, 60211-60212 [2023-18832]
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Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
20852, 301–796–3794, 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.
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2023–18806 Filed 8–30–23; 8:45 am]
Rapid Response Surveys
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0940]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Rapid Response
Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by October 2,
2023.
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 0910–0500. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
VerDate Sep<11>2014
18:04 Aug 30, 2023
Jkt 259001
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 (RRS). 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
respondents will be identified for each
unique RRS.
In the Federal Register of April 20,
2023 (88 FR 24423), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment,
which was generally supportive of
FDA’s use of RRS. (Comment) The
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
60211
comment suggested that FDA
‘‘authorize, develop, and implement a
mechanism that provides States and the
most local level of public health
departments immediate notification and
access to RRS results when the FDA
issues a RRS wholly or partially in their
areas of jurisdiction.’’ (Response) FDA
already has in place mechanisms to
share pertinent health information with
State, local, and tribal authorities. We
currently share aggregated data (without
personally identifiable information) of
hospital reporting RRS. However, FDA’s
use of RRS has not recently developed
data about potential safety problems or
risk management solutions that would
require development of a new
mechanism for immediate notification
and access to RRS results. For example,
FDA used a RRS to identify and
maintain a list of drugs essential for the
care and management of hospitalized
patients with COVID–19, particularly
for ventilated patients in the intensive
care units. FDA used the information to
help to identify drugs that may be at risk
of a regional or national shortage, and to
help ensure these drugs remain
available to meet the needs of our
nation. FDA also used a RRS to engage
stakeholders when developing the food
safety surveillance sampling
assignments. FDA shared information
with key external stakeholders on the
hot pepper and cucumber sampling
assignments and garnered industry
feedback through survey questions to
ensure that sample collection is done as
effectively and efficiently as possible.
Neither of these surveys developed
information that would require
development of a new mechanism for
immediate notification and access to
RRS results. The latest update survey
data from FDA can be found here:
https://www.fda.gov/science-research/
fda-science-forum/fda-covid-19-criticalcare-drug-monitoring-survey-portalongoing-surveillance-critical-drugsrelated. Please also note that if you or
your hospital stakeholders are
experiencing a drug shortage and need
assistance on how to obtain supply,
please refer to the information at
Drugshortages@fda.hhs.gov. FDA Drug
Shortage Staff responds to all reports
received on a daily basis.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\31AUN1.SGM
31AUN1
60212
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
FDA Rapid Response Surveys ................................
10,000
1
10,000
0.5 (30 minutes) ........
5,000
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: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2023–18832 Filed 8–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3136]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dispute Resolution
Procedures for Science-Based
Decisions on Products Regulated by
the Center for Veterinary Medicine
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
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of the dispute
resolution procedures for science-based
decisions on products regulated by the
Center for Veterinary Medicine (CVM).
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 30, 2023.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:37 Aug 30, 2023
Jkt 259001
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
October 30, 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.
ADDRESSES:
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–3136 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Dispute
Resolution Procedures for ScienceBased Decisions on Products Regulated
by the Center for Veterinary Medicine.’’
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-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://
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60211-60212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0940]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Rapid Response Surveys
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 2, 2023.
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 0910-0500. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10
a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [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.
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 (RRS). 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 respondents will be
identified for each unique RRS.
In the Federal Register of April 20, 2023 (88 FR 24423), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment, which was generally
supportive of FDA's use of RRS. (Comment) The comment suggested that
FDA ``authorize, develop, and implement a mechanism that provides
States and the most local level of public health departments immediate
notification and access to RRS results when the FDA issues a RRS wholly
or partially in their areas of jurisdiction.'' (Response) FDA already
has in place mechanisms to share pertinent health information with
State, local, and tribal authorities. We currently share aggregated
data (without personally identifiable information) of hospital
reporting RRS. However, FDA's use of RRS has not recently developed
data about potential safety problems or risk management solutions that
would require development of a new mechanism for immediate notification
and access to RRS results. For example, FDA used a RRS to identify and
maintain a list of drugs essential for the care and management of
hospitalized patients with COVID-19, particularly for ventilated
patients in the intensive care units. FDA used the information to help
to identify drugs that may be at risk of a regional or national
shortage, and to help ensure these drugs remain available to meet the
needs of our nation. FDA also used a RRS to engage stakeholders when
developing the food safety surveillance sampling assignments. FDA
shared information with key external stakeholders on the hot pepper and
cucumber sampling assignments and garnered industry feedback through
survey questions to ensure that sample collection is done as
effectively and efficiently as possible. Neither of these surveys
developed information that would require development of a new mechanism
for immediate notification and access to RRS results. The latest update
survey data from FDA can be found here: https://www.fda.gov/science-research/fda-science-forum/fda-covid-19-critical-care-drug-monitoring-survey-portal-ongoing-surveillance-critical-drugs-related. Please also
note that if you or your hospital stakeholders are experiencing a drug
shortage and need assistance on how to obtain supply, please refer to
the information at [email protected]. FDA Drug Shortage Staff
responds to all reports received on a daily basis.
FDA estimates the burden of this collection of information as
follows:
[[Page 60212]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Rapid Response Surveys................ 10,000 1 10,000 0.5 (30 minutes)........................ 5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18832 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P