30 Day FRN

30-Day FRN 0990-0263 2024-13944 Wed 26Jun24.pdf

Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption

30 Day FRN

OMB: 0990-0263

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Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices
TAP Pilot participants will make up the
potential group of respondents for the
interviews, however, FDA intends to
interview only a stratified sample of all
potential participants.
TAP Pilot Passive Observations
FDA would like to obtain interactionrelated data by passively observing
meetings between FDA staff, applicants,
and external stakeholders. Passive
observations impose no burden on
respondents, as they are solely
conducted by FDA staff without
requiring any input or action from the
respondents. We plan to use a
structured observational meeting form
or checklist to standardize data
collection. The purpose of these
observations is to evaluate meeting
attendance, level of collaboration, and
the degree to which key processes and
activities are being adhered. Data
collected may also support
identification of improvement
opportunities to the TAP Pilot. We do
not intend to actively collect
information from meeting participants
directly (e.g., by asking questions or
collecting documents).
TAP Pilot Participant Pulse Surveys
FDA seeks to obtain quantitative
satisfaction ratings and free-response
data from TAP Pilot participants using
a 2-question survey deployed closely
following TAP Pilot interactions (e.g.,
teleconferences, written feedback). The
same pulse survey will be administered
after each interaction. The purpose of
these surveys is to measure level of
satisfaction with the interaction and
allow for an opportunity for participants
to provide feedback regarding the
interaction.
Dated: June 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13961 Filed 6–25–24; 8:45 am]
BILLING CODE 4164–01–P

technology to minimize the information
collection burden.
Title of the Collection: Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form.
Type of Collection: Renewal, 3-year
extension with non-substantive changes
for the Protection of Human Subjects:
Assurance Identification/IRB
Certification/Declaration of Exemption
Form OMB No. 0990–0263 Office of the
Assistant Secretary for Health, Office for
Human Research Protections
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting is
requesting a three-year extension with
non-substantive changes of the
Protection of Human Subjects:
Assurance Identification/IRB
Certification/Declaration of Exemption
Form, OMB No. 0990–0263.
The information collected on the form
is to provide a simplified method for
institutions engaged in research
conducted or supported by the
Department of Health and Human
Services (HHS) to satisfy the
requirements of HHS regulations for the
protection of human subjects at 45 CFR
46.103 for assurance identification and
institutional review board (IRB)
certification and declare exemption
status. Non-substantive changes include
adding instructions that, if additional
assurances apply, those details can be
indicated in the ‘‘Comments’’ section
and clarifying that the form element for
IRB expiration date does not apply to all
projects.
Likely Respondents: Institutions
engaged in research involving human
subjects where the research is supported
by HHS. Institutional use of the form is
also relied upon by other federal
departments and agencies that have
codified or follow the Federal Policy for
the Protection of Human Subjects
(Common Rule), which is codified for
HHS at 45 CFR part 46, subpart A.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0263]

Agency Information Collection
Request (ICR). 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

53431

In compliance with the
requirements of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 26, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990–0263–30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
SUMMARY:

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ESTIMATED ANNUALIZED BURDEN TABLE
Form name

Number of
respondents

Number of
responses per
respondent

Hours per
response

Response
burden
hours

Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................

13,000

2

0.5

13,000

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53432

Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–13944 Filed 6–25–24; 8:45 am]

Anticipated Number of Awards

BILLING CODE 4150–36–P

The IHS anticipates issuing
approximately one award under this
program announcement.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Funding Opportunity for Increasing the
Representation of American Indians
and Alaska Natives in Sanitation and
Engineering Management
Announcement Type: New.
Funding Announcement Number:
HHS–2024–IHS–SEM–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.445.
Key Dates
Application Deadline Date: July 10,
2024.
Earliest Anticipated Start Date: August
1, 2024.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for a Single
(Sole) Source Cooperative Agreement
from the American Indian Science and
Engineering Society (AISES) for
Increasing the Representation of
American Indian and Alaska Native (AI/
AN) people in science, technology,
engineering, and mathematic (STEM)
fields. This program is authorized under
the Snyder Act, 25 U.S.C. 13; and the
Transfer Act, 42 U.S.C. 2001(a). The
Assistance Listings section of SAM.gov
(https://sam.gov/content/home)
describes this program under 93.445.

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Purpose
The purpose of this program is to
increase representation of AI/AN people
in STEM fields by increasing visibility
and awareness of lesser-known STEM
applied public health occupational and
student opportunities as well as the
benefits of these opportunities.
The full Notice of Funding
Opportunity and all application
materials can be found on Grants.gov at
https://grants.gov/search-results-detail/
354775.
II. Award Information
Funding Instrument—Cooperative
Agreement
Estimated Funds Available
The total funding identified for fiscal
year (FY) 2024 is approximately

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$30,000. We estimate $215,000 in FY
2025, $175,000 in FY 2026, $175,000 in
FY 2027 and $150,000 for FY 2028.

protect and advance the physical and
mental health of the American people.
Roselyn Tso,
Director, Indian Health Service.
[FR Doc. 2024–13949 Filed 6–25–24; 8:45 am]
BILLING CODE 4166–14–P

Period of Performance

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

The period of performance is for 5
years.

National Institutes of Health

III. Eligibility Information

Office of the Director; Notice of Charter
Renewal

1. Eligibility
This award is offered as a single
source cooperative agreement to the
AISES.
Note: Please refer to Section IV.2
(Application and Submission Information/
Subsection 2, Content and Form of
Application Submission) for additional proof
of applicant status documents required, such
as proof of nonprofit status, etc.

IV. Agency Contacts
1. Questions on the program matters
may be directed to: Ms. Melissa de Vera,
Assistant Director, Indian Health
Service Headquarters, Division of
Sanitation Facilities Construction, 5600
Fishers Lane, Mail Stop: 10N13,
Rockville, MD 20897, Phone: (240) 462–
4126, Email: Melissa.Devera@ihs.gov.
2. Questions on awards management
and fiscal matters may be directed to:
Indian Health Service, Division of
Grants Management, 5600 Fishers Lane,
Mail Stop: 09E70, Rockville, MD 20857,
Email: DGM@ihs.gov.
3. For technical assistance with
Grants.gov, please contact the
Grants.gov help desk at (800) 518–4726,
or by email at support@grants.gov.
4. For technical assistance with
GrantSolutions, please contact the
GrantSolutions help desk at (866) 577–
0771, or by email at help@
grantsolutions.gov.

The Public Health Service strongly
encourages all grant, cooperative
agreement, and contract recipients to
provide a smoke-free workplace and
promote the non-use of all tobacco
products. In addition, Public Law 103–
227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities
(or in some cases, any portion of the
facility) in which regular or routine
education, library, day care, health care,
or early childhood development
services are provided to children. This
is consistent with the HHS mission to

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Dated: June 21, 2024.
Patricia B. Hansberger,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–14028 Filed 6–25–24; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

V. Other Information

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In accordance with title 41 of the U.S.
Code of Federal Regulations, section
102–3.65(a), notice is hereby given that
the Charter for the National Institutes of
Health Clinical Center Research
Hospital Board was renewed for an
additional two-year period on June 15,
2024.
It is determined that the National
Institutes of Health Clinical Center
Research Hospital Board is in the public
interest in connection with the
performance of duties imposed on the
National Institutes of Health by law, and
that these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or harriscl@mail.nih.gov.

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National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial

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