Meeting of the Secretary's Advisory Committee on Human Research Protections, 65398-65399 [2023-20577]
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65398
Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
reopening the comment period for the
notice entitled ‘‘In-Home Disposal
Systems for Opioid Analgesics; Request
for Information’’ published in the
Federal Register of April 4, 2023. FDA
is reopening the comment period to
allow interested persons additional time
to develop and submit comments.
DATES: FDA is reopening the comment
period on the notice published April 4,
2023 (88 FR 19959). Either electronic or
written comments must be submitted by
November 6, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 6, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
VerDate Sep<11>2014
16:40 Sep 21, 2023
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Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–0917 for ‘‘In-Home Disposal
Systems for Opioid Analgesics; Request
for Information.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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,
Rockville, MD 20852, 240–402–7500.
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FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of April 4, 2023 (88 FR
19959), FDA published a notice
requesting information and comments
that will assist the Agency in assessing
whether in-home disposal products can
be expected to meet the public health
goal of mitigating the risk of nonmedical
use or overdose if the Agency were to
require drug manufacturers to make inhome disposal products available to
patients under a risk evaluation and
mitigation strategy. The Agency
requested information and comments on
the issues that were discussed at the
public workshop convened by the
National Academies of Sciences,
Engineering, and Medicine’s Forum on
Drug Discovery, Development, and
Translation entitled ‘‘Defining and
Evaluating In-Home Disposal Systems
for Opioid Analgesics’’ on June 26 and
27, 2023. Interested persons were
originally given until August 28, 2023,
to submit comments on in-home
disposal systems for opioid analgesics.
FDA is reopening the public docket to
allow interested persons additional time
to submit comments. We note that there
is a listening session on October 5, 2023,
with federally recognized American
Indian and Alaska Native tribes on the
safe disposal of opioid analgesics. The
Agency believes that reopening the
comment period for an additional 45
days will allow adequate time for
interested persons to submit comments
without significantly delaying Agency
decision-making on these important
issues. FDA is reopening the comment
period for 45 days, until November 6,
2023.
SUPPLEMENTARY INFORMATION:
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20516 Filed 9–21–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
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Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices
ACTION:
Notice.
Pursuant to the Federal
Advisory Committee Act, 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.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Wednesday, October 18, 2023, from 9:00
a.m. until 5:00 p.m., and Thursday,
October 19, 2023, from 9:00 a.m. until
4:00 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 in
person and webcast. Members of the
public may 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:
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 Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:40 Sep 21, 2023
Jkt 259001
The SACHRP meeting will open to the
public at 9:00 a.m., on Wednesday,
October 18, 2023, followed by opening
remarks from Julie Kaneshiro, Acting
Director of OHRP and Dr. Douglas
Diekema, SACHRP Chair. The meeting
will begin with an expert panel
discussion on the ethical and regulatory
considerations for the inclusion of
LGBTQI+ populations in HHS research.
This will be followed by discussion of
IRB effectiveness, topic #4 of the
recently published GAO report #GAO–
23–104721, Institutional Review Boards:
Actions Needed to Improve Federal
Oversight and Examine Effectiveness.
The meeting then will turn to a
discussion of the best interests standard
for permitting continued participation
of subjects in a suspended or terminated
research study. Following this the
committee will discuss IRB review of
research that may be considered
uninformative.
On Thursday, October 19th, the
committee will welcome ADM Rachel
Levine for commentary and remarks;
this will be followed by continued
discussion of the previous day’s topics.
The meeting will adjourn by 4:00 p.m.
October 19, 2023.
Time will be allotted for public
comment on both days of the meeting.
The public may submit written public
comment in advance to SACHRP@
hhs.gov no later than midnight October
13, 2023, ET. Written comments will be
shared with SACHRP members and may
read aloud during the meeting. Public
comment must be relevant to topics
being addressed by the SACHRP.
Dated: September 13, 2023.
Julia G. Gorey,
Executive Director, SACHRP. Office for
Human Research Protections.
[FR Doc. 2023–20577 Filed 9–21–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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,
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65399
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
Mental Health Special Emphasis Panel;
Individually Measured Phenotypes to
Advance Computational Translation in
Mental Health (IMPACT–MH) (U01 & U24).
Date: October 19–20, 2023.
Time: 9:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Rebecca Steiner Garcia,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20892–9608, 301–443–4525,
steinerr@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
ALACRITY: Advanced Laboratories for
Accelerating the Reach and Impact of
Treatments for Youth and Adults with
Mental Illness Centers.
Date: October 19, 2023.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Regina Dolan-Sewell,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20852, (240) 796–6785,
regina.dolan-sewell@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BRAIN Initiative: Brain Behavior
Quantification and Synchronization—Data
Coordination and Artificial Intelligence
Center.
Date: October 20, 2023.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Evon Abisaid, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Blvd., Bethesda, MD 20852,
301–827–0399, ereifejes@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
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]]>Agencies
[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65398-65399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20577]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
[[Page 65399]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to the Federal Advisory Committee Act, 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.dhhs.gov/ohrp/sachrp-committee/meetings/.
DATES: The meeting will be held on Wednesday, October 18, 2023, from
9:00 a.m. until 5:00 p.m., and Thursday, October 19, 2023, from 9:00
a.m. until 4:00 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 in person and webcast. Members of
the public may 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 Subpart A Subcommittee (SAS) was established by SACHRP in
October 2006 and is charged with developing recommendations for
consideration by SACHRP regarding the application of subpart A of 45
CFR part 46 in the current research environment.
The Subcommittee on Harmonization (SOH) was established by SACHRP
at its July 2009 meeting and charged with identifying and prioritizing
areas in which regulations and/or guidelines for human subjects
research adopted by various agencies or offices within HHS would
benefit from harmonization, consistency, clarity, simplification and/or
coordination.
The SACHRP meeting will open to the public at 9:00 a.m., on
Wednesday, October 18, 2023, followed by opening remarks from Julie
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP
Chair. The meeting will begin with an expert panel discussion on the
ethical and regulatory considerations for the inclusion of LGBTQI+
populations in HHS research. This will be followed by discussion of IRB
effectiveness, topic #4 of the recently published GAO report #GAO-23-
104721, Institutional Review Boards: Actions Needed to Improve Federal
Oversight and Examine Effectiveness. The meeting then will turn to a
discussion of the best interests standard for permitting continued
participation of subjects in a suspended or terminated research study.
Following this the committee will discuss IRB review of research that
may be considered uninformative.
On Thursday, October 19th, the committee will welcome ADM Rachel
Levine for commentary and remarks; this will be followed by continued
discussion of the previous day's topics. The meeting will adjourn by
4:00 p.m. October 19, 2023.
Time will be allotted for public comment on both days of the
meeting. The public may submit written public comment in advance to
[email protected] no later than midnight October 13, 2023, ET. Written
comments will be shared with SACHRP members and may read aloud during
the meeting. Public comment must be relevant to topics being addressed
by the SACHRP.
Dated: September 13, 2023.
Julia G. Gorey,
Executive Director, SACHRP. Office for Human Research Protections.
[FR Doc. 2023-20577 Filed 9-21-23; 8:45 am]
BILLING CODE 4150-36-P
