Announcement of Revision to the Department of Health and Human Services Guidance on Procedures for the Provision of Marijuana for Medical Research as Published on May 21, 1999., 35960-35961 [2015-15479]
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35960
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
Purpose: This Committee is charged
with advising the Director, CDC, and the
Acting Administrator, HRSA, regarding
activities related to prevention and
control of HIV/AIDS, Viral Hepatitis and
other STDs, the support of health care
services to persons living with HIV/
AIDS, and the education of health
professionals and the public about HIV/
AIDS, Viral Hepatitis, and other STDs.
Agenda: Agenda items include: (1)
Discuss and vote on the ‘‘Resolution to
express CHACHSPT’s recognition on the
25th Anniversary of the Ryan White
CARE Act’’; and (2) hear the orientation
session and discuss the purpose and
role of the CHACHSPT. Agenda items
are subject to change as priorities
dictate.
FOR FURTHER INFORMATION CONTACT:
Shelley B. Gordon, Senior Public Health
Analyst, Health Resources and Services
Administration, HIV/AIDS Bureau,
Division of Policy and Data, 5600
Fishers Lane, Room 7C–26, Rockville,
Maryland 20857, telephone (301) 443–
9684, fax (301) 443–3343, or email
sgordon@hrsa.gov.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–15283 Filed 6–22–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Revision to the
Department of Health and Human
Services Guidance on Procedures for
the Provision of Marijuana for Medical
Research as Published on May 21,
1999.
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
Announcement of the
elimination of the Public Health Service
(PHS) review of non-federally funded
research protocols involving marijuana
and the utilization of the existing Food
and Drug Administration (FDA)
Investigational New Drug (IND) process
for drug development.
DATES: Effective June 2015.
ADDRESSES: Not applicable.
FOR FURTHER INFORMATION CONTACT:
Christine Cichetti, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human
Services; telephone (202) 619–0242;
email: Christine.Cichetti@
samhsa.hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:39 Jun 22, 2015
Jkt 235001
On May
21, 1999, the PHS review process was
established in response to enhanced
interest by the biomedical research
community in determining the potential
therapeutic benefits of marijuana. The
original notice of policy change can be
found at https://grants.nih.gov/grants/
guide/notice-files/not99-091.html. The
PHS review process, which includes a
committee review of study protocols,
helped create a pathway for nonfederally funded researchers to conduct
these studies. In order to further
facilitate research, HHS recently reevaluated the PHS review procedures to
identify opportunities for increased
efficiency. The Office of the Assistant
Secretary for Health (OASH), in
consultation with the National Institutes
of Health (NIH) and FDA, determined
that the PHS review overlaps in several
important ways with FDA’s IND process
and is no longer necessary to support
the conduct of scientifically-sound
studies into the potential therapeutic
uses of marijuana. The PHS review
committee considers the following:
Research quality; incorporation of
elements of good clinical and laboratory
research practices; emphasis on
adequate and well-controlled clinical
studies; and development of dosage
forms of marijuana that would be an
alternative to smoked marijuana. The
FDA’s IND review process considers
similar research characteristics:
Adherence to good clinical and
laboratory practices; whether pivotal
clinical trials to support the marketing
of proposed drug products are adequate
and well-controlled; and the therapeutic
benefits and risks to study subjects,
favoring dosage forms that would
provide measured and consistent dosing
to patients as well as reduced exposure
to potentially harmful constituents.
Therefore, while not identical, the two
processes have similar goals (e.g.,
guiding research on drug development
and assuring appropriate treatment of
human subjects), share similar criteria
for protocol reviews, and possess
similar capacity to engage with federal
experts for consultation. Based on these
considerations, and in order to
streamline the application and approval
processes for cannabis research, the
committee that conducts the PHS
review shall be eliminated. Below are
instructions for researchers interested in
the acquisition of cannabis for medical
research. Complete guidance can be
found on the NIH/National Institute on
Drug Abuse (NIDA) Web site: (https://
www.drugabuse.gov/researchers/
research-resources/nida-drug-supplyprogram).
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Background
Under the 1961 international Single
Convention on Narcotic Drugs
(amended in 1972), cannabis is
designated a Schedule I substance, and
participating countries are required to
restrict production, manufacture,
possession, and distribution of
marijuana except for medical and
scientific purposes. The Drug
Enforcement Administration (DEA)
regulates the cultivation of marijuana
for research purposes through licensing
requirements and establishment of
annual aggregate production quotas
under the authority of the 1970
Controlled Substances Act (CSA), which
implements the Single Convention.
Marijuana for use in research can be
obtained through the NIDA Drug Supply
Program. All applicants must fulfill the
following criteria:
For non-NIH funded human research
projects:
1. Demonstrate scientific validity and
ethical soundness through review by the
FDA’s IND process. Research protocols
will undergo a scientific review which
assures the safety and rights of subjects
and the scientific quality of the clinical
investigations, and assesses the
likelihood that investigations will yield
data capable of meeting the statutory
standards for drug marketing approval;
and
2. Possess a DEA registration for
marijuana, a Schedule I controlled
substance under the CSA.
For NIH-funded projects:
1. Demonstrate scientific validity and
ethical soundness through the NIH grant
review process which consists of three
steps: (1) The NIH peer review system,
which assesses the scientific and
technical merit of all grant applications;
(2) the National Advisory Council of the
funding institute, comprising eminent
scientists as well as public members;
and (3) the funding institute’s Director,
who makes the final funding decision
on the merit of an application, based on
peer review, public health significance,
and institute priorities. To find studies
approved through the NIH review
process go to: https://projectreporter.
nih.gov/reporter.cfm;
2. Have an active-status IND
application on file with the FDA (for
human research only), which has been
evaluated by FDA and found safe to
proceed. For additional information go
to: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/How
DrugsareDevelopedandApproved/
ApprovalApplications/Investigational
NewDrugINDApplication/default.htm;
and
E:\FR\FM\23JNN1.SGM
23JNN1
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
3. Possess a DEA registration for
marijuana, a Schedule I controlled
substance under the CSA.
Once the above steps have been
completed, investigators should contact
the NIDA Drug Supply Program to place
an order for marijuana with specific
characteristics with regard to
concentrations of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD),
and other cannabinoids. The program
official will verify that the application is
complete (with all the above-mentioned
steps fulfilled), and forward the order
on to the contractor responsible for
shipping the marijuana. While not
required in all cases, it is recommended
that researchers contact the NIDA Drug
Supply Program early in the planning of
a study to obtain information on specific
strains of marijuana available so that
this information can be included in the
protocol and IND (https://
www.drugabuse.gov/researchers/
research-resources/nida-drug-supplyprogram).
Dated: June 17, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health.
BILLING CODE 4150–28–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
mstockstill on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section 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
Child Health and Human Development
Special Emphasis Panel; CHRCDA/K12.
Date: July 21, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
18:39 Jun 22, 2015
Jkt 235001
Dated: June 17, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–15301 Filed 6–22–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center For Complementary &
Integrative Health; Notice of Closed
Meeting
[FR Doc. 2015–15479 Filed 6–22–15; 8:45 am]
VerDate Sep<11>2014
Contact Person: Rita Anand, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health And Human
Development, NIH, 6100 Executive
Boulevard, Room 5B01, Bethesda, MD
20892–9304, (301) 496–1487, anandr@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel Clinical Research.
Date: July 16, 2015.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Democracy Two, Suite 401, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Hungyi Shau, Ph.D.,
Scientific Review Officer, National Center for
Complementary and Integrative Health,
National Institutes of Health, 6707
Democracy Boulevard, Suite 401, Bethesda,
MD 20892, Phone: 301–402–1030,
Hungyi.Shau@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
35961
Dated: June 17, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–15303 Filed 6–22–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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: National Institute of
Environmental Health Sciences Special
Emphasis Panel—NIEHS Outstanding New
Environmental Scientist Review Meeting.
Date: July 16, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Durham
Southpoint, 7007 Fayetteville Road, Durham,
NC 27713.
Contact Person: Janice B. Allen, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Science, P.O. Box 12233, MD EC–30/
Room 3170 B, Research Triangle Park, NC
27709, 919/541–7556.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel—Review of Conferences in
Environmental Health.
Date: July 16, 2015.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIEHS/National Institutes of Health,
Keystone Building, 530 Davis Drive, Research
Triangle Park, NC 27709, (Telephone
Conference Call).
Contact Person: Sally Eckert-Tilotta, Ph.D.,
Scientific Review Officer, Nat. Institute of
Environmental Health Sciences, Office of
Program Operations, Scientific Review
Branch, P.O. Box 12233, Research Triangle
Park, NC 27709, (919) 541–1446, eckertt1@
niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35960-35961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15479]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Announcement of Revision to the Department of Health and Human
Services Guidance on Procedures for the Provision of Marijuana for
Medical Research as Published on May 21, 1999.
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Announcement of the elimination of the Public Health Service
(PHS) review of non-federally funded research protocols involving
marijuana and the utilization of the existing Food and Drug
Administration (FDA) Investigational New Drug (IND) process for drug
development.
DATES: Effective June 2015.
ADDRESSES: Not applicable.
FOR FURTHER INFORMATION CONTACT: Christine Cichetti, Office of the
Assistant Secretary for Health, U.S. Department of Health and Human
Services; telephone (202) 619-0242; email:
Christine.Cichetti@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: On May 21, 1999, the PHS review process was
established in response to enhanced interest by the biomedical research
community in determining the potential therapeutic benefits of
marijuana. The original notice of policy change can be found at https://grants.nih.gov/grants/guide/notice-files/not99-091.html. The PHS review
process, which includes a committee review of study protocols, helped
create a pathway for non-federally funded researchers to conduct these
studies. In order to further facilitate research, HHS recently re-
evaluated the PHS review procedures to identify opportunities for
increased efficiency. The Office of the Assistant Secretary for Health
(OASH), in consultation with the National Institutes of Health (NIH)
and FDA, determined that the PHS review overlaps in several important
ways with FDA's IND process and is no longer necessary to support the
conduct of scientifically-sound studies into the potential therapeutic
uses of marijuana. The PHS review committee considers the following:
Research quality; incorporation of elements of good clinical and
laboratory research practices; emphasis on adequate and well-controlled
clinical studies; and development of dosage forms of marijuana that
would be an alternative to smoked marijuana. The FDA's IND review
process considers similar research characteristics: Adherence to good
clinical and laboratory practices; whether pivotal clinical trials to
support the marketing of proposed drug products are adequate and well-
controlled; and the therapeutic benefits and risks to study subjects,
favoring dosage forms that would provide measured and consistent dosing
to patients as well as reduced exposure to potentially harmful
constituents. Therefore, while not identical, the two processes have
similar goals (e.g., guiding research on drug development and assuring
appropriate treatment of human subjects), share similar criteria for
protocol reviews, and possess similar capacity to engage with federal
experts for consultation. Based on these considerations, and in order
to streamline the application and approval processes for cannabis
research, the committee that conducts the PHS review shall be
eliminated. Below are instructions for researchers interested in the
acquisition of cannabis for medical research. Complete guidance can be
found on the NIH/National Institute on Drug Abuse (NIDA) Web site:
(https://www.drugabuse.gov/researchers/research-resources/nida-drug-supply-program).
Background
Under the 1961 international Single Convention on Narcotic Drugs
(amended in 1972), cannabis is designated a Schedule I substance, and
participating countries are required to restrict production,
manufacture, possession, and distribution of marijuana except for
medical and scientific purposes. The Drug Enforcement Administration
(DEA) regulates the cultivation of marijuana for research purposes
through licensing requirements and establishment of annual aggregate
production quotas under the authority of the 1970 Controlled Substances
Act (CSA), which implements the Single Convention.
Marijuana for use in research can be obtained through the NIDA Drug
Supply Program. All applicants must fulfill the following criteria:
For non-NIH funded human research projects:
1. Demonstrate scientific validity and ethical soundness through
review by the FDA's IND process. Research protocols will undergo a
scientific review which assures the safety and rights of subjects and
the scientific quality of the clinical investigations, and assesses the
likelihood that investigations will yield data capable of meeting the
statutory standards for drug marketing approval; and
2. Possess a DEA registration for marijuana, a Schedule I
controlled substance under the CSA.
For NIH-funded projects:
1. Demonstrate scientific validity and ethical soundness through
the NIH grant review process which consists of three steps: (1) The NIH
peer review system, which assesses the scientific and technical merit
of all grant applications; (2) the National Advisory Council of the
funding institute, comprising eminent scientists as well as public
members; and (3) the funding institute's Director, who makes the final
funding decision on the merit of an application, based on peer review,
public health significance, and institute priorities. To find studies
approved through the NIH review process go to: https://projectreporter.nih.gov/reporter.cfm;
2. Have an active-status IND application on file with the FDA (for
human research only), which has been evaluated by FDA and found safe to
proceed. For additional information go to: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm;
and
[[Page 35961]]
3. Possess a DEA registration for marijuana, a Schedule I
controlled substance under the CSA.
Once the above steps have been completed, investigators should
contact the NIDA Drug Supply Program to place an order for marijuana
with specific characteristics with regard to concentrations of delta-9-
tetrahydro-cannabinol (THC), cannabidiol (CBD), and other cannabinoids.
The program official will verify that the application is complete (with
all the above-mentioned steps fulfilled), and forward the order on to
the contractor responsible for shipping the marijuana. While not
required in all cases, it is recommended that researchers contact the
NIDA Drug Supply Program early in the planning of a study to obtain
information on specific strains of marijuana available so that this
information can be included in the protocol and IND (https://www.drugabuse.gov/researchers/research-resources/nida-drug-supply-program).
Dated: June 17, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health.
[FR Doc. 2015-15479 Filed 6-22-15; 8:45 am]
BILLING CODE 4150-28-P
