Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, 62385-62386 [2023-19542]
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Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices
Although FDA has issued guidance on
expanded access requests, including
expanded access for individual patients,
the Agency is aware that IRBs seek
further clarity on this topic.
Under FDA regulations, there are
three categories of expanded access:
individual (also known as single)
patient, including for emergency use;
intermediate-size for intermediate-size
patient populations; and ‘‘treatment’’ for
larger populations. This guidance only
applies to IRB review of individual
patient expanded access submissions, as
outlined in 21 CFR 312.310. The
recommendations in this guidance are
intended to provide additional clarity to
assist IRBs in conducting efficient
reviews of individual patient expanded
access requests.
In the Federal Register of June 9, 2020
(85 FR 35311), FDA announced the
availability of a guidance for IRBs and
investigators entitled ‘‘Institutional
Review Board (IRB) Review of
Individual Patient Expanded Access
Requests for Investigational Drugs and
Biological Products During the COVID–
19 Public Health Emergency: Guidance
for IRBs and Clinical Investigators’’
(2020 COVID–19 guidance) to support
public health efforts following a
determination, under section 319 of the
Public Health Service (PHS) Act (42
U.S.C. 247d), by the Secretary of Health
and Human Services that a public
health emergency existed related to
Coronavirus Disease 2019 (COVID–19
public health emergency). The 2020
COVID–19 guidance focused on
addressing the COVID–19 public health
emergency and was intended to remain
in effect only for the duration of the
COVID–19 public health emergency.
However, the 2020 COVID–19 guidance
explained we expected the
recommendations would assist the
Agency more broadly in its continued
efforts to facilitate access to drugs
through expanded access for individual
patients beyond the COVID–19 public
health emergency and that FDA would
replace the 2020 COVID–19 guidance
with any appropriate changes based on
comments received and the Agency’s
experience with implementation. FDA
continues to believe that many of the
recommendations set forth in the 2020
COVID–19 guidance are applicable
outside the context of the COVID–19
public health emergency and are
applicable to key factors and procedures
IRBs should consider when reviewing
individual patient expanded access
submissions. In addition, in the Federal
Register of March 13, 2023 (88 FR
15417), FDA listed the 2020 COVID–19
guidance as one of the guidances FDA
was revising to continue in effect for
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180 days after the COVID–19 PHE
declaration issued under the PHS Act
expired on May 11, 2023, during which
time FDA planned to further revise
those guidances. Consistent with what
we said in the Federal Register of
March 13, 2023, FDA is therefore
issuing this revised final guidance,
which supersedes the 2020 COVID–19
guidance. FDA revised the guidance to
remove references to the COVID–19
public health emergency and made
editorial changes to improve clarity.
FDA also clarified recommendations on
IRB procedures and factors to consider
for individual patient expanded access
submissions.
FDA is issuing this guidance for
immediate implementation in
accordance with our good guidance
practices regulation (21 CFR
10.115(g)(3)) without initially seeking
prior comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (see 21 CFR 10.115(g)(2)
and section 701(h)(1)(C)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)(i))). Specifically, we are not
seeking prior comment because public
health emergencies (PHEs) and the need
to address individual patient expanded
access submissions for patient access to
investigational drugs for diagnosing,
monitoring, or treating diseases or
conditions related to PHEs may occur
without notice and, as we have learned
from experience during the COVID–19
PHE, may hinder physicians seeking to
treat their patients in a timely manner.
It is thus important to public health to
provide recommendations regarding the
key factors and procedures IRBs should
consider when reviewing requests.
Interested parties had an opportunity to
comment on the recommendations in
the 2020 COVID–19 guidance, and FDA
considered those comments when
revising the guidance. Although this
guidance document is being
implemented immediately, it remains
subject to comment in accordance with
FDA’s good guidance practices
regulation (§ 10.115(g)(3)(D)).
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the current
thinking of FDA on ‘‘Institutional
Review Board (IRB) Review of
Individual Patient Expanded Access
Submissions for Investigational Drugs
and Biological Products.’’ 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.
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62385
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 and
Form FDA 1571 have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR parts 50 and 56 relating to the
protection of human subjects, informed
consent, and IRBs have been approved
under OMB control number 0910–0130.
The collections of information in 21
CFR 312.300 through 312.320 relating to
expanded access to investigational
drugs for treatment use and Form FDA
3926 have been approved under OMB
control number 0910–0814. The
collections of information in 21 CFR
part 11 relating to electronic records and
signatures have been approved under
OMB control number 0910–0303.
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, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19501 Filed 9–8–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Centers for Disease Control and
Prevention (CDC)/HRSA Advisory
Committee on HIV, Viral Hepatitis and
SUMMARY:
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62386
Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices
STD Prevention and Treatment (CHAC)
has scheduled a public meeting.
Information about CHAC and the
meeting can be found on the CHAC
website at https://www.cdc.gov/faca/
committees/chachspt.html and the
meeting website at https://targethiv.org/
ta-org/chac.
DATES: Tuesday, October 24, 2023, 9
a.m. to 4 p.m. Eastern Time (ET); and
Wednesday, October 25, 2023, 9 a.m. to
3 p.m. ET.
ADDRESSES: This meeting will be hybrid,
held both virtually through Zoom and in
person at 5600 Fishers Lane, Pavilion
Rooms 5A02, 5A03, and 5A04,
Rockville, Maryland 20857. Advance
registration is required to attend. Please
visit the meeting website to register. The
in-person registration deadline is
Monday, October 16, 2023, at 5 p.m. ET;
registration for virtual attendance will
remain open. Prior to the meeting, each
individual registrant will receive a
registration confirmation along with an
access link to the virtual meeting
location.
FOR FURTHER INFORMATION CONTACT:
Shalonda Collins, Public Health
Analyst, HIV/AIDS Bureau, HRSA, (301)
945–0835; CHACAdvisoryComm@
hrsa.gov.
CHAC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
matters of significance concerning the
activities under Section 222 of the
Public Health Service Act, 42 U.S.C.
217a.
The purpose of the CHAC is to advise
the Secretary of HHS, CDC Director, and
HRSA Administrator regarding
objectives, strategies, policies, and
priorities for the prevention and
treatment of HIV, viral hepatitis, and
other STDs, including surveillance,
epidemiologic, behavioral, health
services, and laboratory research,
identification of policy issues related to
professional eduction, patient
healthcare delivery, and prevention
services; agency policies regarding
health care delivery, research and
training; strategic issues influencing the
ability of CDC and HRSA to fulfill their
missions’ programmatic efforts to
prevent and treat HIV, viral hepatitis,
and other STDs; and support to CDC
and HRSA in their development of
responses to emerging health needs
related to these issues.
During the October 24–25, 2023,
meeting, CHAC will discuss issues
related to reducing barriers and
improving outcomes in HIV and
Hepatitis C co-infection, payment
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
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models for addressing social
determinants of health, incorporating
stigma reduction in HIV care and
treatment, as well as other special
presentations. Agenda items are subject
to change as priorities dictate. Refer to
the CHAC meeting information page for
any updated information concerning the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may also submit
written statements as further described
below. Oral comments will be honored
in the order they are requested and may
be limited as time allows. Requests to
submit a written statement or make oral
comments to CHAC should be sent via
the meeting website at https://
targethiv.org/ta-org/chac. Requests for
oral comment must be received by
October 17, 2023, at 5 p.m. ET to be
considered. Written comments may be
submitted to Shalonda Collins at the
email address and/or phone number
listed above prior to and up to 10
business days after the meeting. Visit
the meeting information page for
additional details: https://targethiv.org/
ta-org/chac.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Shalonda Collins at the email
address and/or phone number listed
above at least 10 business days prior to
the meeting.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Societal and
Ethical Issues in Research.
Date: October 6, 2023.
Time: 10:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maria De Jesus Diaz Perez,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000G,
Bethesda, MD 20892, (301) 496–4227,
diazperezm2@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Maria G. Button,
Director, Executive Secretariat.
Extension and Redesignation of South
Sudan for Temporary Protected Status
[FR Doc. 2023–19542 Filed 9–8–23; 8:45 am]
Correction
In Notice document 2023–19312
beginning on page 60971 in the issue of
Wednesday, September 6, 2023, make
the following correction:
On page 60976, in the first column, in
the signature, in the first line
‘‘Alejandro N. Mayorkas,Vienna’’
should read ‘‘Alejandro N. Mayorkas,’’.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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.
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Dated: September 6, 2023.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–19506 Filed 9–8–23; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[CIS No. 2748–23; DHS Docket No. USCIS–
2014–004]
RIN 1615–ZB79
[FR Doc. C1–2023–19312 Filed 9–8–23; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0001]
Agency Information Collection
Activities; Revision of a Currently
Approved Collection: Petition for Alien
Fiance´(e)
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
AGENCY:
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[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62385-62386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and Treatment
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Secretary's Centers for Disease Control and
Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and
[[Page 62386]]
STD Prevention and Treatment (CHAC) has scheduled a public meeting.
Information about CHAC and the meeting can be found on the CHAC website
at https://www.cdc.gov/faca/committees/chachspt.html and the meeting
website at https://targethiv.org/ta-org/chac.
DATES: Tuesday, October 24, 2023, 9 a.m. to 4 p.m. Eastern Time (ET);
and Wednesday, October 25, 2023, 9 a.m. to 3 p.m. ET.
ADDRESSES: This meeting will be hybrid, held both virtually through
Zoom and in person at 5600 Fishers Lane, Pavilion Rooms 5A02, 5A03, and
5A04, Rockville, Maryland 20857. Advance registration is required to
attend. Please visit the meeting website to register. The in-person
registration deadline is Monday, October 16, 2023, at 5 p.m. ET;
registration for virtual attendance will remain open. Prior to the
meeting, each individual registrant will receive a registration
confirmation along with an access link to the virtual meeting location.
FOR FURTHER INFORMATION CONTACT: Shalonda Collins, Public Health
Analyst, HIV/AIDS Bureau, HRSA, (301) 945-0835;
[email protected].
SUPPLEMENTARY INFORMATION: CHAC provides advice and recommendations to
the Secretary of HHS (Secretary) on policy, program development, and
other matters of significance concerning the activities under Section
222 of the Public Health Service Act, 42 U.S.C. 217a.
The purpose of the CHAC is to advise the Secretary of HHS, CDC
Director, and HRSA Administrator regarding objectives, strategies,
policies, and priorities for the prevention and treatment of HIV, viral
hepatitis, and other STDs, including surveillance, epidemiologic,
behavioral, health services, and laboratory research, identification of
policy issues related to professional eduction, patient healthcare
delivery, and prevention services; agency policies regarding health
care delivery, research and training; strategic issues influencing the
ability of CDC and HRSA to fulfill their missions' programmatic efforts
to prevent and treat HIV, viral hepatitis, and other STDs; and support
to CDC and HRSA in their development of responses to emerging health
needs related to these issues.
During the October 24-25, 2023, meeting, CHAC will discuss issues
related to reducing barriers and improving outcomes in HIV and
Hepatitis C co-infection, payment models for addressing social
determinants of health, incorporating stigma reduction in HIV care and
treatment, as well as other special presentations. Agenda items are
subject to change as priorities dictate. Refer to the CHAC meeting
information page for any updated information concerning the meeting.
Members of the public will have the opportunity to provide
comments. Public participants may also submit written statements as
further described below. Oral comments will be honored in the order
they are requested and may be limited as time allows. Requests to
submit a written statement or make oral comments to CHAC should be sent
via the meeting website at https://targethiv.org/ta-org/chac. Requests
for oral comment must be received by October 17, 2023, at 5 p.m. ET to
be considered. Written comments may be submitted to Shalonda Collins at
the email address and/or phone number listed above prior to and up to
10 business days after the meeting. Visit the meeting information page
for additional details: https://targethiv.org/ta-org/chac.
Individuals who plan to attend and need special assistance or
another reasonable accommodation should notify Shalonda Collins at the
email address and/or phone number listed above at least 10 business
days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-19542 Filed 9-8-23; 8:45 am]
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