Meeting of the Advisory Committee on Minority Health, 22412-22413 [2024-06850]
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Federal Register / Vol. 89, No. 63 / Monday, April 1, 2024 / Notices
drugs/questions-and-answers-fdasadverse-event-reporting-system-faers/
fda-adverse-event-reporting-systemfaers-electronic-submissions-e2br3standards).
The electronic format requirements
specified in this guidance will be
effective 24 months after the publication
of this guidance (April 1, 2026). Before
the effective date of this requirement,
FDA will accept the IND safety reports
described in this guidance to FAERS as
part of a voluntary submission program.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Providing
Regulatory Submissions in Electronic
Format: IND Safety Reports.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information under 21 CFR 312.10 for
submitting waiver requests and in 21
CFR 312.32 for submitting IND safety
reports and reporting serious and
unexpected suspected adverse events
have been approved under OMB control
number 0910–0014. The collections of
information for submitting Forms FDA
3500 and 3500A, and for FDA adverse
event reporting and electronic
submissions using the Electronic
Submission Gateway and the Safety
Reporting Portal have been approved
under OMB control number 0910–0291.
The collections of information for
submitting periodic adverse drug
experience reports have been approved
under OMB control number 0910–0230.
The collections of information for
submitting FAERS reports have been
approved under 0910–0308.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
VerDate Sep<11>2014
17:17 Mar 29, 2024
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search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: March 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06736 Filed 3–29–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Office of Minority Health,
Office of the Secretary, U.S. Department
of Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting conducted as a webcast on
April 30, 2024. This virtual meeting will
be open to the public. Registration is
required for the public to attend the
meeting, provide comment, and/or
distribute material(s) to the ACMH
members. Instructions regarding
participating in the call and providing
written or verbal public comments will
be provided after meeting registration
occurs.
SUMMARY:
The ACMH meeting will be held
on April 30, 2024 from 11 a.m. to 12:30
p.m. EDT. If the Committee completes
its work before 12:30 p.m., the meeting
will adjourn early.
Any individual who wishes to
participate in the virtual meeting should
register using the Zoom registration link
provided below by 5 p.m. EDT on April
24, 2024.
ADDRESSES: The meeting will be held
virtually and will be accessible by
webcast. Instructions regarding webcast
access and providing written or verbal
public comments will be given after
meeting registration occurs.
FOR FURTHER INFORMATION CONTACT:
Violet Woo, Designated Federal Officer,
Advisory Committee on Minority
Health, OMH, HHS, Tower Building,
1101 Wootton Parkway, Suite 100,
Rockville, Maryland 20852. Phone: 240–
453–6816; email: OMH-ACMH@hhs.gov.
SUPPLEMENTARY INFORMATION: In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health on the development
of goals and program activities related to
OMH’s duties.
DATES:
PO 00000
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The topics to be discussed during the
virtual meeting will be finalizing the
recommendations on how OMH and
HHS can support community
awareness, education and engagement
on HHS efforts to implement the revised
Office of Management and Budget
(OMB) Statistical Policy Directive No.
15: Standards for Maintaining,
Collecting, and Presenting Federal Data
on Race and Ethnicity (SPD 15). The
final recommendations will be given to
the Deputy Assistant Secretary for
Minority Health to inform efforts related
to implementation of the revised OMB
standards. Information on OMB’s
Interagency Technical Working Group
on Race and Ethnicity Standards can be
found on this website:
spd15revision.gov.
Information about the meeting will be
posted on the HHS Office of Minority
Health (OMH) website:
www.minorityhealth.hhs.gov.
Information about ACMH activities can
be found on the OMH website under the
heading About OMH, Committees and
Working Groups.
Any individual who wishes to attend
the meeting must register via the Zoom
registration link, https://
www.zoomgov.com/meeting/register/
vJIscuuhqzIqHX5wssDFc84ZH6jdn4NgZg, by 5 p.m. EDT on April 24,
2024. Each registrant should provide
their name, affiliation, phone number,
email address, if they plan to provide
either written or verbal comment, and
whether they have requests for special
accommodations, including sign
language interpretation. After
registering, registrants will receive an
automated email response with the
meeting connection link. The meeting
connection link is unique to each
registrant and should not be shared.
Members of the public will have an
opportunity to provide comments at the
meeting. Individuals should indicate
during registration whether they intend
to provide written or verbal comment.
Public comments will be limited to two
minutes per speaker during the time
allotted. Written statements are limited
to two pages. If the two-page limit is
exceeded, the full statement will not be
included. Registered members of the
public who plan to submit and
distribute electronic or printed public
statements or material(s) related to this
meeting’s topic should email the
material to OMH-ACMH@hhs.gov at
least five (5) business days prior to the
meeting.
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22413
Federal Register / Vol. 89, No. 63 / Monday, April 1, 2024 / Notices
Dated: March 25, 2024.
Violet Woo,
Designated Federal Officer, Advisory
Committee on Minority Health.
[FR Doc. 2024–06850 Filed 3–29–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0263]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement 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 May 31, 2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0263–60D
SUMMARY:
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
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
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, threeyear 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.
ANNUALIZED BURDEN HOUR 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
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–06803 Filed 3–29–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ddrumheller on DSK120RN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:17 Mar 29, 2024
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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; NIAID Clinical Trial
Planning Grants (R34); NIAID Clinical Trial
Implementation Cooperative Agreement
(U01); NIAID SBIR Phase II Clinical Trial
Implementation Cooperative Agreement
(U44); Investigator Initiated Extended
Clinical Trial (R01).
Date: April 30–May 1, 2024.
Time: 9:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20852 (Video Assisted
Meeting).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20852, 240–669–5026,
haririmf@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 26, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–06859 Filed 3–29–24; 8:45 am]
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]]>Agencies
[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
[Notices]
[Pages 22412-22413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06850]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Minority Health
AGENCY: Office of Minority Health, Office of the Secretary, U.S.
Department of Health and Human Services.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Services (HHS) is hereby giving notice
that the Advisory Committee on Minority Health (ACMH) will hold a
meeting conducted as a webcast on April 30, 2024. This virtual meeting
will be open to the public. Registration is required for the public to
attend the meeting, provide comment, and/or distribute material(s) to
the ACMH members. Instructions regarding participating in the call and
providing written or verbal public comments will be provided after
meeting registration occurs.
DATES: The ACMH meeting will be held on April 30, 2024 from 11 a.m. to
12:30 p.m. EDT. If the Committee completes its work before 12:30 p.m.,
the meeting will adjourn early.
Any individual who wishes to participate in the virtual meeting
should register using the Zoom registration link provided below by 5
p.m. EDT on April 24, 2024.
ADDRESSES: The meeting will be held virtually and will be accessible by
webcast. Instructions regarding webcast access and providing written or
verbal public comments will be given after meeting registration occurs.
FOR FURTHER INFORMATION CONTACT: Violet Woo, Designated Federal
Officer, Advisory Committee on Minority Health, OMH, HHS, Tower
Building, 1101 Wootton Parkway, Suite 100, Rockville, Maryland 20852.
Phone: 240-453-6816; email: [email protected].
SUPPLEMENTARY INFORMATION: In accordance with Public Law 105-392, the
ACMH was established to provide advice to the Deputy Assistant
Secretary for Minority Health on the development of goals and program
activities related to OMH's duties.
The topics to be discussed during the virtual meeting will be
finalizing the recommendations on how OMH and HHS can support community
awareness, education and engagement on HHS efforts to implement the
revised Office of Management and Budget (OMB) Statistical Policy
Directive No. 15: Standards for Maintaining, Collecting, and Presenting
Federal Data on Race and Ethnicity (SPD 15). The final recommendations
will be given to the Deputy Assistant Secretary for Minority Health to
inform efforts related to implementation of the revised OMB standards.
Information on OMB's Interagency Technical Working Group on Race and
Ethnicity Standards can be found on this website: spd15revision.gov.
Information about the meeting will be posted on the HHS Office of
Minority Health (OMH) website: www.minorityhealth.hhs.gov. Information
about ACMH activities can be found on the OMH website under the heading
About OMH, Committees and Working Groups.
Any individual who wishes to attend the meeting must register via
the Zoom registration link, https://www.zoomgov.com/meeting/register/vJIscuuhqzIqHX5wssDFc84ZH-6jdn4NgZg, by 5 p.m. EDT on April 24, 2024.
Each registrant should provide their name, affiliation, phone number,
email address, if they plan to provide either written or verbal
comment, and whether they have requests for special accommodations,
including sign language interpretation. After registering, registrants
will receive an automated email response with the meeting connection
link. The meeting connection link is unique to each registrant and
should not be shared.
Members of the public will have an opportunity to provide comments
at the meeting. Individuals should indicate during registration whether
they intend to provide written or verbal comment. Public comments will
be limited to two minutes per speaker during the time allotted. Written
statements are limited to two pages. If the two-page limit is exceeded,
the full statement will not be included. Registered members of the
public who plan to submit and distribute electronic or printed public
statements or material(s) related to this meeting's topic should email
the material to [email protected] at least five (5) business days prior
to the meeting.
[[Page 22413]]
Dated: March 25, 2024.
Violet Woo,
Designated Federal Officer, Advisory Committee on Minority Health.
[FR Doc. 2024-06850 Filed 3-29-24; 8:45 am]
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