Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability, 41407-41408 [2023-13428]
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Federal Register / Vol. 88, No. 121 / Monday, June 26, 2023 / Notices
conventional platelets are not available,
or their use is not practical. 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. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR 211.100 and
211.160(b) have been approved under
OMB control number 0910–0139; the
collections of information in 21 CFR
601.12 and Form FDA 356h have been
approved under OMB control number
0910–0338; and the collections of
information in 21 CFR 606.121 and 21
CFR 606.122 have been approved under
OMB control number 0910–0116.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13513 Filed 6–23–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–1987]
Psychedelic Drugs: Considerations for
Clinical Investigations; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
ddrumheller on DSK120RN23PROD with NOTICES1
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Psychedelic Drugs: Considerations for
Clinical Investigations.’’ Because
interest in the therapeutic potential of
SUMMARY:
VerDate Sep<11>2014
19:33 Jun 23, 2023
Jkt 259001
psychedelic drugs has been increasing
and designing clinical trials to evaluate
these compounds presents unique
challenges, FDA has developed this
draft guidance to present foundational
aspects for sponsors to consider. This
draft guidance provides general
considerations for sponsors developing
psychedelic drugs for treatment of
medical conditions (e.g., psychiatric
disorders, substance use disorders) and
discusses considerations for clinical
investigations using psychedelic drugs.
DATES: Submit either electronic or
written comments on the draft guidance
by August 25, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
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.’’
PO 00000
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Fmt 4703
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41407
Instructions: All submissions received
must include the Docket No. FDA–
2023–D–1987 for ‘‘Psychedelic Drugs:
Considerations for Clinical
Investigations.’’ Received comments
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft 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–
E:\FR\FM\26JNN1.SGM
26JNN1
41408
Federal Register / Vol. 88, No. 121 / Monday, June 26, 2023 / Notices
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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Kofi
Ansah, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4380, Silver Spring,
MD 20993–0002, 301–796–4158.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Psychedelic Drugs: Considerations for
Clinical Investigations.’’ This draft
guidance outlines general
considerations for drug development
programs considering the therapeutic
potential of psychedelic drugs for
treatment of medical conditions (e.g.,
psychiatric disorders, substance use
disorders).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Psychedelic Drugs: Considerations
for Clinical Investigations.’’ 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. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 relating
to the submission of investigational new
drug applications have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR part 314 relating to the submission
of new drug applications have been
approved under OMB control number
0910–0001. The collections of
information in 21 CFR parts 210 and
211 relating to current good
manufacturing practice requirements
have been approved under OMB control
number 0910–0139. The collections of
information relating to the protection of
human subjects and institutional review
boards in 21 CFR parts 50 and 56 have
been approved under OMB control
number 0910–0130.
VerDate Sep<11>2014
19:33 Jun 23, 2023
Jkt 259001
III. Electronic Access
Persons with access to the internet
may obtain the draft 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: June 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13428 Filed 6–23–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Eunice Kennedy
Shriver National Institute of Child Health
and Human Development Special Emphasis
Panel; Chemical Screening and Optimization
Facility.
Date: July 20, 2023.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2131D, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Anita Szajek, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver, National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Room 2131D,
Bethesda, MD 20892, (301) 943–5604,
anita.szajek@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Dated: June 20, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–13475 Filed 6–23–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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,
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: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Maximizing Investigators’
Research Award—E Study Section.
Date: July 6–7, 2023.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency, Bethesda, One Metro
Center, 7400 W Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Vandana Kumari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 496–3290,
vandana.kumari@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Small Business Innovation
Research/Small Business Technology
Transfer.
Date: July 6–7, 2023.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Hybrid Meeting).
Contact Person: Jennifer Di Noia, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000E,
Bethesda, MD 20892, (301) 594–0288,
dinoiaj2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics: Cellular, Molecular, Bioanalytical
and Imaging Technologies.
Date: July 6, 2023.
Time: 9:30 a.m. to 8:00 p.m.
E:\FR\FM\26JNN1.SGM
26JNN1
Agencies
[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41407-41408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13428]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1987]
Psychedelic Drugs: Considerations for Clinical Investigations;
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Psychedelic Drugs: Considerations for Clinical Investigations.''
Because interest in the therapeutic potential of psychedelic drugs has
been increasing and designing clinical trials to evaluate these
compounds presents unique challenges, FDA has developed this draft
guidance to present foundational aspects for sponsors to consider. This
draft guidance provides general considerations for sponsors developing
psychedelic drugs for treatment of medical conditions (e.g.,
psychiatric disorders, substance use disorders) and discusses
considerations for clinical investigations using psychedelic drugs.
DATES: Submit either electronic or written comments on the draft
guidance by August 25, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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 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-D-1987 for ``Psychedelic Drugs: Considerations for Clinical
Investigations.'' Received comments 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-2015-09-18/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft 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-
[[Page 41408]]
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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Kofi Ansah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4380, Silver Spring, MD 20993-0002, 301-796-4158.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Psychedelic Drugs: Considerations for Clinical
Investigations.'' This draft guidance outlines general considerations
for drug development programs considering the therapeutic potential of
psychedelic drugs for treatment of medical conditions (e.g.,
psychiatric disorders, substance use disorders).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Psychedelic
Drugs: Considerations for Clinical Investigations.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 relating to the submission of
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 relating to the submission of new drug applications have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR parts 210 and 211 relating to current good
manufacturing practice requirements have been approved under OMB
control number 0910-0139. The collections of information relating to
the protection of human subjects and institutional review boards in 21
CFR parts 50 and 56 have been approved under OMB control number 0910-
0130.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13428 Filed 6-23-23; 8:45 am]
BILLING CODE 4164-01-P