Notice2023-18832
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 31, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 168 (Thursday, August 31, 2023)</title>
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[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60211-60212]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18832]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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, <a href="/cdn-cgi/l/email-protection#e6b6b4a7b592878080a6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="550507140621343333153331347b3d3d267b323a23">[email protected]</span></a>.
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: <a href="https://www.fda.gov/science-research/fda-science-forum/fda-covid-19-critical-care-drug-monitoring-survey-portal-ongoing-surveillance-critical-drugs-related">https://www.fda.gov/science-research/fda-science-forum/fda-covid-19-critical-care-drug-monitoring-survey-portal-ongoing-surveillance-critical-drugs-related</a>. 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 <a href="/cdn-cgi/l/email-protection#692d1b1c0e1a01061b1d080e0c1a290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="296d5b5c4e5a41465b5d484e4c5a694f4d480741415a074e465f">[email protected]</span></a>. 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\
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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: 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
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