Meeting of the Advisory Committee on Minority Health, 22729-22730 [2024-06855]
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Federal Register / Vol. 89, No. 64 / Tuesday, April 2, 2024 / Notices
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Susan Levine, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1674,
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Silver Spring, MD 20993–0002, 240–
402–7936, Susan.Levine@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Electronic Submission of Expedited
Safety Reports from IND-Exempt BA/BE
Studies.’’ This guidance provides
instructions for the electronic
submission of expedited ICSRs from
IND-exempt BA/BE studies to FAERS.
An ICSR captures information necessary
to support the reporting of an adverse
event related to an individual subject
that is associated with the use of an
FDA-regulated product.1 The electronic
submission of the ICSRs from INDexempt BA/BE studies is a voluntary
option for submitting these required
reports.
In the Federal Register of September
29, 2010 (75 FR 59935), FDA published
a final rule that revised the IND safety
reporting requirements for human drug
and biological products under 21 CFR
312 and added safety reporting
requirements for persons conducting
IND-exempt BA/BE studies under
§ 320.31 (21 CFR 320.31).2 A serious
adverse event experienced by a study
subject during the conduct of an INDexempt BA/BE study must be submitted
on Form FDA 3500A or in an electronic
format that FDA can process, review,
and archive.3
Previously, to meet the requirements
under § 320.31(d)(3) applicable to INDexempt BA/BE studies, submitters sent
expedited premarket safety reports
directly to the Office of Generic Drugs
(OGD) by email, telephone, or facsimile.
This guidance provides
recommendations on how to
electronically submit ICSRs to FAERS as
an alternate avenue for submitting
reports to OGD.
This guidance finalizes the draft
guidance entitled ‘‘Electronic
Submission of Expedited Safety Reports
from IND-Exempt BA/BE Studies’’
issued on August 3, 2022 (87 FR 47431).
FDA did not receive any comments to
the docket. Editorial changes were made
to improve clarity and incorporate the
FAERS enhancements to enable
1 See
additional information on Individual Case
Safety Reports available at https://www.fda.gov/
industry/fda-resources-data-standards/individualcase-safety-reports.
2 BA and BE studies that meet the conditions for
exemption under 21 CFR 320.31 are not conducted
under an IND and are not subject to the IND safety
reporting requirements. The safety reporting
requirements under § 320.31(d)(3) apply to persons
conducting BA or BE studies that are exempt from
the IND requirements.
3 § 320.31(d)(3).
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22729
electronic submissions of ICSRs from
IND-exempt BA/BE studies.
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 ‘‘Electronic
Submission of Expedited Safety Reports
from IND-Exempt BA/BE Studies.’’ 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 in 21 CFR part 312 for IND
applications and 21 CFR 320.31 for INDexempt BA/BE safety reporting
requirements for human drug and
biological products have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR 314 for safety report submissions
for applications for FDA approval new
drug application have been approved
under OMB control number 0910–0001.
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/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: March 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06726 Filed 4–1–24; 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, 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
SUMMARY:
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khammond on DSKJM1Z7X2PROD with NOTICES
22730
Federal Register / Vol. 89, No. 64 / Tuesday, April 2, 2024 / Notices
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting conducted as a webcast on
April 18, 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 ACMH
members. Any individual who wishes to
participate in the virtual meeting should
register using the Zoom registration link
provided below by 5:00 p.m. EDT on
April 12, 2024. Instructions regarding
participating in the call and providing
written or verbal public comments will
be provided after meeting registration
occurs. 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.
DATES: The ACMH meeting will be held
on April 18, 2024 from 9:00 a.m. to
10:30 a.m. EDT. If the Committee
completes its work before 10:30 a.m.,
the meeting will adjourn early.
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.
The topics to be discussed during the
virtual meeting include finalizing: (1)
meeting notes of the February 13–14,
2024 ACMH meeting; and (2)
recommendations on how OMH and
HHS can support community
awareness, education and engagement
on HHS efforts to implement 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
VerDate Sep<11>2014
17:06 Apr 01, 2024
Jkt 262001
on Race and Ethnicity Standards can be
found on this website:
spd15revision.gov.
Any individual who wishes to attend
the meeting must register via the Zoom
registration link, https://
www.zoomgov.com/meeting/register/
vJItce2spj0jHw9b9h15hNrFezljtnit0_g,
by 5:00 p.m. EDT on April 12, 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.
Dated: March 25, 2024.
Violet Woo,
Designated Federal Officer, Advisory
Committee on Minority Health.
[FR Doc. 2024–06855 Filed 4–1–24; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Purchased/Referred Care
Delivery Area Redesignation for the
Mashantucket Pequot Tribal Nation in
the State of Connecticut
Indian Health Service,
Department of Health and Human
Services.
ACTION: Final notice.
AGENCY:
Notice is hereby given that
the Indian Health Service (IHS) has
decided to expand the geographic
boundaries of the Purchased/Referred
Care Delivery Area (PRCDA) for the
Mashantucket Pequot Tribal Nation to
include the counties of Fairfield,
SUMMARY:
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Hartford, Litchfield, Middlesex, New
Haven, Tolland, and Windham in the
State of Connecticut. The final PRCDA
for the Mashantucket Pequot Tribal
Nation now includes the Connecticut
counties of Fairfield, Hartford,
Litchfield, Middlesex, New Haven, New
London, Tolland, and Windham. The
sole purpose of this expansion is to
authorize additional Mashantucket
Pequot Tribal Nation members and
eligible IHS beneficiaries to receive
purchased/referred care (PRC) services.
DATES: This expansion is effective as of
the publication date of this notice.
ADDRESSES: This notice can be found at
https://www.federalregister.gov. Written
requests for information should be
delivered to: CAPT John Rael, Director,
Office of Resource Access and
Partnerships, Indian Health Service,
5600 Fishers Lane, Mail Stop 10E85C,
Rockville, MD 20857, or by phone at
(301) 443–0969 (this is not a toll-free
number).
The IHS
provides services under regulations in
effect as of September 15, 1987, and
republished at 42 CFR part 136,
subparts A–C. Subpart C defines a
Contract Health Service Delivery Area
(CHSDA), now referred to as a PRCDA,
as the geographic area within which
PRC will be made available by the IHS
to members of an identified Indian
community who reside in the PRCDA.
Residence within a PRCDA by a person
who is within the scope of the Indian
health program, as set forth in 42 CFR
136.12, creates no legal entitlement to
PRC but only potential eligibility for
services. Services needed, but not
available at an IHS/Tribal facility, are
provided under the PRC program
depending on the availability of funds,
the relative medical priority of the
services to be provided, and the actual
availability and accessibility of alternate
resources in accordance with the
regulations.
The regulations at 42 CFR part 136,
subpart C provide that, unless otherwise
designated, a PRCDA shall consist of a
county which includes all or part of a
reservation and any county or counties
which have a common boundary with
the reservation. 42 CFR 136.22(a)(6).
The regulations also provide that after
consultation with the Tribal governing
body or bodies on those reservations
included within the PRCDA, the
Secretary may from time to time,
redesignate areas within the United
States for inclusion in or exclusion from
a PRCDA. 42 CFR 136.22(b). The
regulations require that certain criteria
must be considered before any
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 89, Number 64 (Tuesday, April 2, 2024)]
[Notices]
[Pages 22729-22730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Minority Health
AGENCY: Office of Minority Health, Office of the Secretary, 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
[[Page 22730]]
that the Advisory Committee on Minority Health (ACMH) will hold a
meeting conducted as a webcast on April 18, 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
ACMH members. Any individual who wishes to participate in the virtual
meeting should register using the Zoom registration link provided below
by 5:00 p.m. EDT on April 12, 2024. Instructions regarding
participating in the call and providing written or verbal public
comments will be provided after meeting registration occurs.
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.
DATES: The ACMH meeting will be held on April 18, 2024 from 9:00 a.m.
to 10:30 a.m. EDT. If the Committee completes its work before 10:30
a.m., the meeting will adjourn early.
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 include
finalizing: (1) meeting notes of the February 13-14, 2024 ACMH meeting;
and (2) recommendations on how OMH and HHS can support community
awareness, education and engagement on HHS efforts to implement 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.
Any individual who wishes to attend the meeting must register via
the Zoom registration link, https://www.zoomgov.com/meeting/register/vJItce2spj0jHw9b9h15hNrFezljtnit0_g, by 5:00 p.m. EDT on April 12,
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.
Dated: March 25, 2024.
Violet Woo,
Designated Federal Officer, Advisory Committee on Minority Health.
[FR Doc. 2024-06855 Filed 4-1-24; 8:45 am]
BILLING CODE 4150-29-P
