Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 71876-71877 [2023-23002]
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71876
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices
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.
Improving the Quality and
Representativeness of the Treatment
Center Program Data—Data
Modifications to the Current Survey
Instrument Format To Minimize
Misclassification
OMB Control Number 0910–NEW
FDA has a need for valid, high-quality
surveillance data on misuse of
pharmaceutical products and use of
other substances in the United States.
FDA is funding the evaluation and
improvement of the data validity and
reliability of the Researched Abuse,
Diversion and Addiction-Related
Surveillance (RADARS®) Substance
Abuse Treatment Center Programs
Combined (TCPC) survey. The RADARS
TCPC is comprised of two unique
programs, the Opioid Treatment
Program and the Survey of Key
Informants’ Patients Program. These two
programs use the same core paper data
collection form and complement each
other by providing information from
patients entering both private and
public opioid addiction treatment
programs. Patients enrolling in the
study complete a self-administered
anonymous questionnaire, within the
first week of admission. The objective of
these programs is to provide timely
prevalence estimates of abuse of legal
and illegal opioids and other
substances, within the past month,
among patients enrolling in treatment
primarily for opioid use disorders.
Surveillance data collected by these
programs are used by FDA as well as
researchers, industry, and other public
health stakeholders to inform policy and
regulatory decisions. FDA will be
providing public health expertise on the
survey validity and reliability questions
before implementation to ensure that
they generate quality data. FDA will
also be providing its expert input on the
results, analysis, and interpretation, as
well as how the survey may be
improved in light of the results.
This FDA-funded information
collection will include three survey
arms, two arms focused on survey
validity (is the survey measuring what
it is intended to measure) and the third
arm focused on survey reliability (do the
questions consistently produce the same
results when asked at different time
points and in a different format). For
both survey validity arms—a digital
survey only and digital survey plus
interview arm—volunteer participants
will be asked to pause after answering
each survey question to answer a series
of content validation questions
concerning comprehension and quality
of survey items. Items assessed will
include survey instructions, active
pharmaceutical ingredient and product
content, reason for use, and route of
administration. For the survey
reliability arm, TCPC paper survey
participants at selected sites will be
invited to voluntarily participate in a
second, digital survey, and the results of
the two survey formats will be
compared. The data collected through
the three arms of this information
collection will be analyzed to validate
the content of a modified TCPC survey
and to then determine the reliability
among a proxy population for the target
population. Results from the three arms
will inform the format, structure, and
wording of the modified digital TCPC
survey, prior to its launch.
The annual participant burden hours
requested are based on the number of
collections FDA expects the contractor
to conduct over the requested time
frame for this clearance. FDA estimates
the burden of this collection of
information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent/interview
Average
burden per
response
Total annual
responses
Total hours
Content Validity—Digital Survey Arm ..................
Content Validity—Digital Survey and Cognitive
Interview Arm.
Reliability Survey Arm—Digital Survey ................
175
25
1
1
175
25
0.25 (15 minutes) ..........
1.5 (90 minutes) ............
44
38
250
1
250
0.33 (20 minutes) ..........
83
Total ..............................................................
450
........................
450
.......................................
165
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22966 Filed 10–17–23; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0465; FDA–2023–
N–1529; FDA–2010–N–0583; FDA–2020–N–
0145; FDA–2023–N–0918; FDA–2014–N–
1721]
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Number of
responses per
respondent
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
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Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
SUPPLEMENTARY INFORMATION:
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
71877
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control
No.
Title of collection
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 ...........................................................................................................................................................
Voluntary Qualified Importer Program .....................................................................................................................
Radioactive Drug Research Committees ................................................................................................................
Animal Drug and Animal Generic Drug User Fee Submissions .............................................................................
Food Labeling Requirements ..................................................................................................................................
Investigational New Drug Application Requirements ..............................................................................................
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23002 Filed 10–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Strategic
Preparedness and Response
Request for Information (RFI): HHS
Initiative To Enhance National All
Hazards Hospital Situational
Awareness
Administration for Strategic
Preparedness and Response (ASPR),
HHS.
ACTION: Notice of request for
information.
AGENCY:
The Administration for
Strategic Preparedness and Response
(ASPR), Centers for Disease Control and
Prevention (CDC), Centers for Medicare
& Medicaid Services (CMS), and the
Office of the National Coordinator for
Health Information Technology (ONC)
are seeking broad public input from
entities across the health care readiness
community on a national, all-hazards
standardized set of essential elements of
information (EEIs) and vendor-neutral
data collection mechanisms for hospital
data that drive action for emergency
preparedness and response. This input
will inform efforts to provide
recommendations for a standardized
lens into the readiness of, stress on, and
resources available in hospitals before,
during, and after emergencies
DATES: To be assured consideration,
comments on the RFI must be received
on or before December 18, 2023. HHS
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SUMMARY:
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will not reply individually to
responders but will consider all
comments submitted by the deadline.
ADDRESSES: Please submit all responses
via email to AllHazards@hhs.gov within
60 days of publication of this notice as
a Word document attachment or in the
body of an email. Include ‘‘All Hazards
Hospital Situational Awareness RFI’’ in
the subject line of the email.
FOR FURTHER INFORMATION CONTACT: For
additional information, direct questions
to Sayeedha Uddin at (202) 699–1874 or
Sayeedha.Uddin@hhs.gov.
When submitting comments or
requesting information, please include
‘‘All Hazards Hospital Situational
Awareness RFI’’ in the subject line of
the email.
When submitting comments or
requesting information, please include
‘‘All Hazards Hospital Situational
Awareness RFI’’ in the subject line of
the email.
SUPPLEMENTARY INFORMATION:
Respondents may provide information
for one or more of the questions or topic
areas listed below, as desired.
Outside of the federal COVID–19
hospital data collection, what essential
elements of information does your
entity report or collect (or plan to
report/collect in the future) related to
health care capacity, facility status,
stress, supplies, staffing, infrastructure,
and/or other information that is needed
to inform hospital emergency
preparedness and response?
What information do you collect
internally, including key areas your
leadership monitors for preparedness
and response purposes?
What information do you report to
other entities, and to whom?
Specifically, consider regular reporting
that is required by regulatory agencies,
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0910–0520
0910–0840
0910–0053
0910–0540
0910–0381
0910–0014
Date
approval
expires
9/30/2026
9/30/2026
9/30/2026
9/30/2026
9/30/2026
9/30/2026
notifiable disease reporting, payors, as
well as time-limited or voluntary
reporting efforts to trade groups and
professional associations.
On what cadence does your entity
collect and report these essential
elements of information?
How is information used for driving
action in areas such as patient
placement, patient movement, load
balancing, equipment/supply
procurement, or other preparedness and
response areas? If you are a reporting
entity (ex. hospital), do you know how
your data is being used to create value
for your community?
What electronic systems are used to
collect the essential elements of
information (e.g., electronic health
record systems (EHRs), hospital
operations systems, etc.)? Who are the
primary vendors/developers?
What is your expectation for federal
government situational awareness of
hospital status, capacity, stress, etc.
before, during, and after a crisis?
Please share any potentially relevant
clinical and/or situational awareness
measures, efforts, and/or definitions that
might be helpful to inform this effort
(ex. National Emergency Department
Overcrowding Scale (NEDOCS) scores,
International Organization for Standards
(ISO) Health informatics—
Interoperability of public health
emergency preparedness and response
information systems, the Situational
Awareness Network for Emergencies
(SANER) Project, etc.).
We are interested in promising
practices in specific areas:
Decreasing burden is a core goal of
this initiative. Please share any
promising practices related to data
automation and/or other ways to reduce
burden of data collection and reporting.
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]]>Agencies
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71876-71877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23002]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0465; FDA-2023-N-1529; FDA-2010-N-0583; FDA-
2020-N-0145; FDA-2023-N-0918; FDA-2014-N-1721]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD
[[Page 71877]]
20852, 301-796-8867, [email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Prior Notice of Imported Food Under the 0910-0520 9/30/2026
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002..
Voluntary Qualified Importer Program.... 0910-0840 9/30/2026
Radioactive Drug Research Committees.... 0910-0053 9/30/2026
Animal Drug and Animal Generic Drug User 0910-0540 9/30/2026
Fee Submissions........................
Food Labeling Requirements.............. 0910-0381 9/30/2026
Investigational New Drug Application 0910-0014 9/30/2026
Requirements...........................
------------------------------------------------------------------------
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23002 Filed 10-17-23; 8:45 am]
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