Meeting of the Secretary's Advisory Committee on Human Research Protections, 83894-83895 [2024-24147]
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Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
guidance-documents, or https://
www.regulations.gov.
present government-issued
identification prior to entry.’’
Dated: October 10, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Advisory
Committee on Blood and Tissue Safety
and Availability
Health Resources and Services
Administration
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Meeting of the National Advisory
Council on Migrant Health; Amended
Notice of Meeting
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
Notice; amended notice of
meeting.
ACTION:
HRSA published a notice in
the Federal Register of July 23, 2024,
concerning a meeting of the National
Advisory Council on Migrant Health on
October 22, 2024, and October 23, 2024.
The notice states the meeting will be
held in-person and via webinar.
However, due to the impact of recent
hurricanes on council members, this
meeting now will be held via webinar
only on Zoom.
SUMMARY:
Liz
Rhee, National Advisory Council on
Migrant Health Designated Federal
Official, Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, 5600 Fishers Lane,
Rockville, MD 20857; 301–443–1082 or
hrsabphcoppdnacmh@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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Amended Notice of Meeting
In the Federal Register Notice of July
23, 2024, FR Doc. 2024–16119, page
59744, column 1, section 2, paragraph 3,
amend the sentences ‘‘This meeting will
be held in-person and via webinar. The
address of the meeting is 5600 Fishers
Lane, Rockville, MD 20857’’ to read:
‘‘This meeting will be held via webinar
only.’’ In paragraph 8, delete the
following sentences: ‘‘Since this
meeting occurs in a federal government
building, attendees must go through a
security check to enter the building.
Non-U.S. citizen attendees must notify
HRSA of their planned attendance at
least 20 business days prior to the
meeting to facilitate their entry into the
building. All attendees are required to
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The Department of Health and
Human Services is hereby giving notice
that the charter for the Advisory
Committee on Blood and Tissue Safety
and Availability (ACBTSA) has been
renewed.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the ACBTSA; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Tower Building, 1101 Wootton
Parkway, Rockville, MD 20852. Phone:
(202) 795–7608. Email: ACBTSA@
hhs.gov.
SUPPLEMENTARY INFORMATION: The
ACBTSA is a non-discretionary federal
advisory committee. The ACBTSA is
authorized under 42 U.S.C. 217a,
section 222 of the Public Health Service
(PHS) Act, as amended. The Committee
is governed by the provisions of the
Federal Advisory Committee Act
(FACA), Public Law 92–463, as
amended (5 U.S.C. App), which sets
forth standards for the formation and
use of advisory committees. The
ACBTSA advises, assists, consults with,
and makes policy recommendations to
the Secretary, through the Assistant
Secretary for Health, regarding broad
responsibilities related to the safety of
blood, blood products, tissues, and
organs. For solid organs and blood stem
cells, the Committee’s work is limited to
policy issues related to donor derived
infectious disease complications of
transplantation.
To carry out its mission, the ACBTSA
provides advice to the Secretary through
the Assistant Secretary for Health on a
range of policy issues which includes:
(1) identification of public health issues
through surveillance of blood and tissue
safety issues with national biovigilance
data tools; (2) identification of public
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health issues that affect availability of
blood, blood products, and tissues; (3)
broad public health, ethical, and legal
issues related to the safety of blood,
blood products, and tissues; (4) the
impact of various economic factors (e.g.,
product cost and supply) on safety and
availability of blood, blood products,
and tissues; (5) risk communications
related to blood transfusion and tissue
transplantation; and (6) identification of
infectious disease transmission issues
for blood, organs, blood stem cells and
tissues.
On September 25, 2024, the Secretary
approved for the ACBTSA charter to be
renewed. Renewal of the Committee’s
charter gives authorization for the
Committee to continue to operate until
October 9, 2026.
A copy of the ACBTSA charter is
available on the Committee’s website at
https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/charter/.
Dated: October 3, 2024.
James J. Berger,
DFO, Advisory Committee on Blood and
Tissue Safety and Availability, Office of
Infectious Disease and HIV/AIDS Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
Pursuant to section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP, the full
meeting agenda, and instructions for
linking to public access will be posted
on the SACHRP website at https://
www.hhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Tuesday, October 22, 2024, from 11:00
a.m. until 4:30 p.m. (times are tentative
and subject to change). The confirmed
times and agenda will be posted on the
SACHRP website as this information
becomes available.
ADDRESSES: This meeting will be held
via webcast. Members of the public may
SUMMARY:
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Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
also attend the meeting via webcast.
Instructions for attending via webcast
will be posted at least one week prior
to the meeting at https://www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html.
Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The SACHRP Advisory Subcommittee
was established by in August 2024 and
is charged with assessing and drafting
recommendations for consideration by
SACHRP pertaining to the language and
interpretation of 45 CFR part 46,
existing relevant HHS guidance
documents and the development of new
HHS guidance documents, and cultural,
ethical, or international issues of
concern which may impact HHS funded
human subjects protections.
The SACHRP meeting will open to the
public at 11:00 a.m., on Tuesday,
October 22, 2024, followed by opening
remarks from Julie Kaneshiro, currently
Acting Director of OHRP. Ms Kaneshiro
will introduce Dr. Molly Klote, newly
appointed Director of OHRP. Dr.
Douglas Diekema, SACHRP Chair, will
make opening remarks. The meeting
will begin with a discussion of the draft
recommendation, Considerations for
Uninformative Research. This will be
followed by panel presentations and
discussion of a new SACHRP topic on
Equivalent Protections and Procedural
Requirements in International Research.
The day will adjourn at approximately
4:30 p.m.
Time will be allotted for public
comment. SACHRP materials will be
publicly posted at HHS–OASH–2024–
0013. The public may submit written
public comment in advance to
SACHRP@hhs.gov no later than
midnight October 18th, 2024, ET.
Written comments will be shared with
SACHRP members and may read aloud
during the meeting. Comments which
are read aloud are limited to three
minutes each. Public comment must be
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FOR FURTHER INFORMATION CONTACT:
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relevant to topics currently being
addressed by the SACHRP.
Dated: September 26, 2024.
Julia G. Gorey.
Executive Director, SACHRP, Office for
Human Research Protections.
[FR Doc. 2024–24147 Filed 10–17–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
This will be a hybrid meeting held inperson and virtually and will be open to
the public as indicated below. Given the
capacity constraints of the venue, the
public is strongly encouraged to attend
virtually via NIH videocast. Interested
individuals should pre-register at
https://cvent.me/vxOKqy to attend this
meeting. Individuals who need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting. The meeting can be
accessed from the NIH Videocasting
website (https://videocast.nih.gov/).
Name of Committee: Scientific
Management Review Board.
Date: November 12, 2024.
Time: 11:15 a.m. to 5:30 p.m.
Agenda: Overview of NIH’s mission,
structure, and budget and summary of
SMRB’s history and future directions.
Address: National Institutes of Health,
Building 31, 6C Room F & G, 31 Center Drive,
Bethesda, MD 20894.
Meeting Format: Hybrid Meeting.
Contact Person: Tyrone Spady, Ph.D.,
Acting Senior Advisor to the NIH Deputy
Director, Office of the Director, One Center
Drive, Building 1, Room 108, Bethesda, MD
20892, (301) 496–2433, smrb@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a government-
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issued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
The draft meeting agenda and other
information about the SMRB, including
information about access to the webcast, will
be available prior to the meeting at https://
smrb.od.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Numbers: 93.14, Intramural
Research Training Award; 93.22, Clinical
Research Loan Repayment Program for
Individuals from Disadvantaged
Backgrounds; 93.232, Loan Repayment
Program for Research Generally; 93.39,
Academic Research Enhancement Award;
93.936, NIH Acquired Immunodeficiency
Syndrome Research Loan Repayment
Program; 93.187, Undergraduate Scholarship
Program for Individuals from Disadvantaged
Backgrounds, National Institutes of Health,
HHS.)
Dated: October 15, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–24125 Filed 10–17–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Bat Immunology Network
Research Projects (R01 Clinical Trial Not
Allowed) and Bat Immunology Network
Research Resource Program (U24 Clinical
Trial Not Allowed).
Date: November 25–26, 2024.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Rockville, MD
20892.
Meeting Format: Video Assisted Meeting.
Contact Person: Sandip Bhattacharyya,
Ph.D., Scientific Review Officer, Scientific
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Agencies
[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83894-83895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold a
meeting that will be open to the public. Information about SACHRP, the
full meeting agenda, and instructions for linking to public access will
be posted on the SACHRP website at https://www.hhs.gov/ohrp/sachrp-committee/meetings/.
DATES: The meeting will be held on Tuesday, October 22, 2024, from
11:00 a.m. until 4:30 p.m. (times are tentative and subject to change).
The confirmed times and agenda will be posted on the SACHRP website as
this information becomes available.
ADDRESSES: This meeting will be held via webcast. Members of the public
may
[[Page 83895]]
also attend the meeting via webcast. Instructions for attending via
webcast will be posted at least one week prior to the meeting at
https://www.hhs.gov/ohrp/sachrp-committee/meetings/.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-453-8141;
fax: 240-453-6909; email address: [email protected].
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services, through the Assistant Secretary
for Health, on issues and topics pertaining to or associated with the
protection of human research subjects.
The SACHRP Advisory Subcommittee was established by in August 2024
and is charged with assessing and drafting recommendations for
consideration by SACHRP pertaining to the language and interpretation
of 45 CFR part 46, existing relevant HHS guidance documents and the
development of new HHS guidance documents, and cultural, ethical, or
international issues of concern which may impact HHS funded human
subjects protections.
The SACHRP meeting will open to the public at 11:00 a.m., on
Tuesday, October 22, 2024, followed by opening remarks from Julie
Kaneshiro, currently Acting Director of OHRP. Ms Kaneshiro will
introduce Dr. Molly Klote, newly appointed Director of OHRP. Dr.
Douglas Diekema, SACHRP Chair, will make opening remarks. The meeting
will begin with a discussion of the draft recommendation,
Considerations for Uninformative Research. This will be followed by
panel presentations and discussion of a new SACHRP topic on Equivalent
Protections and Procedural Requirements in International Research. The
day will adjourn at approximately 4:30 p.m.
Time will be allotted for public comment. SACHRP materials will be
publicly posted at HHS-OASH-2024-0013. The public may submit written
public comment in advance to [email protected] no later than midnight
October 18th, 2024, ET. Written comments will be shared with SACHRP
members and may read aloud during the meeting. Comments which are read
aloud are limited to three minutes each. Public comment must be
relevant to topics currently being addressed by the SACHRP.
Dated: September 26, 2024.
Julia G. Gorey.
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2024-24147 Filed 10-17-24; 8:45 am]
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