Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, 3408-3409 [2024-00886]
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3408
Federal Register / Vol. 89, No. 12 / Thursday, January 18, 2024 / Notices
Dated: January 12, 2024.
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–00897 Filed 1–17–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Runaway and Homeless
Youth—Homeless Management
Information System (RHY–HMIS; Office
of Management and Budget #0970–
0573)
Family and Youth Services
Bureau, Administration for Children
and Families, Department of Health and
Human Services.
AGENCY:
ACTION:
Request for public comments.
SUPPLEMENTARY INFORMATION:
The Family and Youth
Services Bureau’s Runaway and
Homeless Youth (RHY) Program is
requesting a 3-year extension of the
Runaway and Homeless Youth—
Homeless Management Information
System (RHY–HMIS) data collection
efforts (OMB #0970–0573, expiration
07/31/2024). There are no changes
requested to the data elements.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUMMARY:
Description: The RHY Program has a
requirement to collect information from
all youth who receive shelter and
supportive services with RHY funding.
In April 2015, the Administration on
Children, Youth and Families, through
a formal Memorandum of
Understanding, integrated the RHY data
collection with the U.S. Department of
Housing and Urban Development’s
(HUD) HMIS and HUD’s data standards
along with other federal partners. HUD
has OMB approval for HUD’s data
standards and ACF has approval under
a separate OMB number for the RHY
data elements. The data collection effort
includes universal data elements that
are collected by all federal partners and
RHY program specific elements, which
are tailored to the RHY Program using
HUD’s HMIS.
Respondents: Youth who receive
emergency and longer-term shelter and
supportive services under RHY funding.
ANNUAL BURDEN ESTIMATES
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RHY–HMIS: Basic Center Program (Intake) .......................
RHY–HMIS: Basic Center Program (Exit) ...........................
RHY–HMIS: Transitional Living Program (including Maternity Group Home program and TLP Demonstration Programs; Intake) ..................................................................
RHY–HMIS: Transitional Living Program (including Maternity Group Home program and TLP Demonstration Programs; Exit) ......................................................................
RHY–HMIS: Street Outreach Program (Contact) ................
RHY–HMIS: Street Outreach Program (Engagement) ........
RHY Funded Grantees (data entry) ....................................
RHY Funded Grantees (data submission)—FY24 ..............
RHY Funded Grantees (data submission)—FY25 & FY26
Estimated Total Annual Burden Hours .........................
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
VerDate Sep<11>2014
17:32 Jan 17, 2024
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Total number
of responses
per
respondent
Total number
of respondents
Instrument
Average
burden hours
per response
Total burden
hours
Annual burden
hours
123,000
123,000
1
1
0.38
0.33
46,740
40,590
15,580
13,530
24,000
1
0.38
9,120
3,040
24,000
108,000
30,000
308,225
675
675
1
1
1
2
2
8
0.33
0.5
0.28
0.36
0.16
0.16
7,920
54,000
8,400
221,922
216
864
2,640
18,000
2,800
73,974
72
288
........................
........................
........................
........................
129,924
Authority: Reconnecting Homeless
Youth Act of 2008 (Public Law 110–378)
through Fiscal Year (FY) 2013 and
reauthorized by the Juvenile Justice
Reform Act through FY 2019.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Institutional Review Board Waiver or
Alteration of Informed Consent for
Minimal Risk Clinical Investigations
[FR Doc. 2024–00924 Filed 1–17–24; 8:45 am]
BILLING CODE 4184–04–P
PO 00000
Food and Drug Administration
[Docket No. FDA–2018–N–2727]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a collection of
information entitled ‘‘Institutional
SUMMARY:
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Federal Register / Vol. 89, No. 12 / Thursday, January 18, 2024 / Notices
Review Board Waiver or Alteration of
Informed Consent for Minimal Risk
Clinical Investigations’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
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.
On
November 27, 2023, the Agency
submitted a proposed collection of
information entitled ‘‘Institutional
Review Board Waiver or Alteration of
Informed Consent for Minimal Risk
Clinical Investigations’’ to OMB for
review and clearance under 44 U.S.C.
3507. 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. OMB has now
approved the information collection and
has assigned OMB control number
0910–0130. The approval expires on
December 31, 2026. A copy of the
supporting statement for this
information collection is available on
the internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: January 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00886 Filed 1–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: National
Survey of Organ Donation Attitudes
and Practices, OMB No. 0915–0290—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
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AGENCY:
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects of the
Paperwork Reduction Act of 1995,
HRSA announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
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to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 18, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland, 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
National Survey of Organ Donation
Attitudes and Practices (NSODAP) OMB
No. 0915–0290—Revision with changes.
Abstract: The overall purpose of this
study is to conduct an independent
multi-mode (web and telephone) survey
of public opinion regarding various
issues related to organ donation. The
survey will measure public opinion on
issues such as willingness to become an
organ donor, financial incentives for
donation, living donation, impediments
to donation, and level of public
knowledge about donation. Previous
NSODAPs were conducted during 1993,
2005, 2012, and 2019. Similar to the
2019 survey, the goal is to complete
10,000 interviews with adults (18 years
of age or older) nationwide. Specifically,
this will include 1,000 equal-probability
of selection method computer-assisted
telephone interviewing (CATI)
interviews, 1,000 ethnic oversamples
CATI interviews, and a supplemental
web panel of 8,000 respondents. The
final sample will include 1,000
interviews each with Black/African
Americans, Asians, Hispanics, and
Native Americans, and a statistically
sufficient sample for meaningful
comparisons across demographic levels
of age group, education, and income
groups. A total sample of 10,000 is
necessary to achieve sufficiently large
subgroups for statistical analysis across
demographic groups.
Need and Proposed Use of the
Information: The Division of
Transplantation, within the Health
Systems Bureau of HRSA at the
Department of Health and Human
Services, is the primary federal entity
responsible for oversight of the solid
organ and blood stem cell transplant
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3409
systems in the United States and for
initiatives to increase organ donor
registration and donation. Sponsorship
of a national survey on the American
public’s donation attitudes and
practices is one of the services that the
Division of Transplantation provides for
the larger donation community,
consistent with its legal authority to
establish a public education and
awareness program (section 377A of the
Public Health Service Act, 42 U.S.C.
274f–1).
Patients in need of organ
transplantation in the United States face
a longstanding critical shortage of
organs. Approximately 103,000
Americans were on the waiting list for
transplantation by the end of 2022, but
only 42,000 transplants were performed,
only meeting two-fifths of the national
need. While this represents an increase
in the number of transplants performed
in 2021, the organ shortage remains in
the United States. Understanding public
attitudes about organ donation and how
the attitudes change over time is critical
to addressing organ shortage through
public awareness and education efforts.
The information from this survey will
facilitate appropriate tailoring and
targeting of donation outreach messages
and strategies and provide an overall
assessment of the impact of previous
outreach messages and strategies. The
data will also inform the development
of policies related to organ donation and
transplantation.
Likely Respondents: A nationally
representative sample of adults over the
age of 18 with a higher number of
responses from populations of interest
such as racial-ethnic minorities,
including African American, Asian,
Native American, and Hispanic
respondents, as well as respondents of
all age groups and education levels.
Burden Statement: The modes of data
collection are web surveys and CATI
interviews and include both landline
and cell phones. Respondent burden is
minimized by having automatic data
entry either electronically by the
respondent answering the online survey
or by a trained CATI interviewer for a
telephone survey that includes no
additional requirements for
respondents. The survey will capture
only the minimum necessary
information for analysis and will take
only about 22 minutes of the
respondent’s time for the CATI survey
and 16 minutes for the web survey. The
questions are the same in both the CATI
and web surveys, but prior research
experience by the contractor has found
web surveys take 25 percent less time to
complete than the same survey
conducted via phone, because
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]]>Agencies
[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Notices]
[Pages 3408-3409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00886]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2727]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Institutional Review Board Waiver or
Alteration of Informed Consent for Minimal Risk Clinical Investigations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that a collection of information entitled ``Institutional
[[Page 3409]]
Review Board Waiver or Alteration of Informed Consent for Minimal Risk
Clinical Investigations'' has been approved by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995.
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: On November 27, 2023, the Agency submitted a
proposed collection of information entitled ``Institutional Review
Board Waiver or Alteration of Informed Consent for Minimal Risk
Clinical Investigations'' to OMB for review and clearance under 44
U.S.C. 3507. 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. OMB has now approved the
information collection and has assigned OMB control number 0910-0130.
The approval expires on December 31, 2026. A copy of the supporting
statement for this information collection is available on the internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: January 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00886 Filed 1-17-24; 8:45 am]
BILLING CODE 4164-01-P
