80 FR 35960 - 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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 120 (June 23, 2015)
Federal Register Volume 80, Issue 120 (June 23, 2015)
| Page Range | 35960-35961 | |
| FR Document | 2015-15479 |
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)] [Notices] [Pages 35960-35961] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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 http://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: (http://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: http://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: http://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 (http://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
![35960 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
Purpose: This Committee is charged SUPPLEMENTARY INFORMATION: On May Background
with advising the Director, CDC, and the 21, 1999, the PHS review process was Under the 1961 international Single
Acting Administrator, HRSA, regarding established in response to enhanced Convention on Narcotic Drugs
activities related to prevention and interest by the biomedical research (amended in 1972), cannabis is
control of HIV/AIDS, Viral Hepatitis and community in determining the potential designated a Schedule I substance, and
other STDs, the support of health care therapeutic benefits of marijuana. The participating countries are required to
services to persons living with HIV/ original notice of policy change can be restrict production, manufacture,
AIDS, and the education of health found at http://grants.nih.gov/grants/ possession, and distribution of
professionals and the public about HIV/ guide/notice-files/not99-091.html. The marijuana except for medical and
AIDS, Viral Hepatitis, and other STDs. PHS review process, which includes a scientific purposes. The Drug
Agenda: Agenda items include: (1) committee review of study protocols, Enforcement Administration (DEA)
Discuss and vote on the ‘‘Resolution to helped create a pathway for non- regulates the cultivation of marijuana
express CHACHSPT’s recognition on the federally funded researchers to conduct for research purposes through licensing
25th Anniversary of the Ryan White these studies. In order to further requirements and establishment of
CARE Act’’; and (2) hear the orientation facilitate research, HHS recently re- annual aggregate production quotas
session and discuss the purpose and evaluated the PHS review procedures to under the authority of the 1970
role of the CHACHSPT. Agenda items identify opportunities for increased Controlled Substances Act (CSA), which
are subject to change as priorities efficiency. The Office of the Assistant implements the Single Convention.
dictate. Secretary for Health (OASH), in Marijuana for use in research can be
FOR FURTHER INFORMATION CONTACT: consultation with the National Institutes obtained through the NIDA Drug Supply
Shelley B. Gordon, Senior Public Health of Health (NIH) and FDA, determined Program. All applicants must fulfill the
Analyst, Health Resources and Services that the PHS review overlaps in several following criteria:
Administration, HIV/AIDS Bureau, important ways with FDA’s IND process For non-NIH funded human research
Division of Policy and Data, 5600 and is no longer necessary to support projects:
Fishers Lane, Room 7C–26, Rockville, the conduct of scientifically-sound
studies into the potential therapeutic 1. Demonstrate scientific validity and
Maryland 20857, telephone (301) 443– ethical soundness through review by the
9684, fax (301) 443–3343, or email uses of marijuana. The PHS review
committee considers the following: FDA’s IND process. Research protocols
sgordon@hrsa.gov. will undergo a scientific review which
Research quality; incorporation of
Jackie Painter, elements of good clinical and laboratory assures the safety and rights of subjects
Director, Division of the Executive Secretariat. research practices; emphasis on and the scientific quality of the clinical
[FR Doc. 2015–15283 Filed 6–22–15; 8:45 am] adequate and well-controlled clinical investigations, and assesses the
studies; and development of dosage likelihood that investigations will yield
BILLING CODE 4165–15–P
forms of marijuana that would be an data capable of meeting the statutory
standards for drug marketing approval;
alternative to smoked marijuana. The
DEPARTMENT OF HEALTH AND and
FDA’s IND review process considers
HUMAN SERVICES 2. Possess a DEA registration for
similar research characteristics: marijuana, a Schedule I controlled
Adherence to good clinical and substance under the CSA.
Announcement of Revision to the laboratory practices; whether pivotal
Department of Health and Human clinical trials to support the marketing For NIH-funded projects:
Services Guidance on Procedures for of proposed drug products are adequate 1. Demonstrate scientific validity and
the Provision of Marijuana for Medical and well-controlled; and the therapeutic ethical soundness through the NIH grant
Research as Published on May 21, benefits and risks to study subjects, review process which consists of three
1999. favoring dosage forms that would steps: (1) The NIH peer review system,
AGENCY: Office of the Secretary, Office provide measured and consistent dosing which assesses the scientific and
of the Assistant Secretary for Health, to patients as well as reduced exposure technical merit of all grant applications;
Department of Health and Human to potentially harmful constituents. (2) the National Advisory Council of the
Services. Therefore, while not identical, the two funding institute, comprising eminent
processes have similar goals (e.g., scientists as well as public members;
ACTION: Notice.
guiding research on drug development and (3) the funding institute’s Director,
SUMMARY: Announcement of the and assuring appropriate treatment of who makes the final funding decision
elimination of the Public Health Service human subjects), share similar criteria on the merit of an application, based on
(PHS) review of non-federally funded for protocol reviews, and possess peer review, public health significance,
research protocols involving marijuana similar capacity to engage with federal and institute priorities. To find studies
and the utilization of the existing Food experts for consultation. Based on these approved through the NIH review
and Drug Administration (FDA) considerations, and in order to process go to: http://projectreporter.
Investigational New Drug (IND) process streamline the application and approval nih.gov/reporter.cfm;
for drug development. processes for cannabis research, the 2. Have an active-status IND
committee that conducts the PHS application on file with the FDA (for
DATES: Effective June 2015.
review shall be eliminated. Below are human research only), which has been
ADDRESSES: Not applicable.
mstockstill on DSK4VPTVN1PROD with NOTICES
instructions for researchers interested in evaluated by FDA and found safe to
FOR FURTHER INFORMATION CONTACT: the acquisition of cannabis for medical proceed. For additional information go
Christine Cichetti, Office of the research. Complete guidance can be to: http://www.fda.gov/Drugs/
Assistant Secretary for Health, U.S. found on the NIH/National Institute on DevelopmentApprovalProcess/How
Department of Health and Human Drug Abuse (NIDA) Web site: (http:// DrugsareDevelopedandApproved/
Services; telephone (202) 619–0242; www.drugabuse.gov/researchers/ ApprovalApplications/Investigational
email: Christine.Cichetti@ research-resources/nida-drug-supply- NewDrugINDApplication/default.htm;
samhsa.hhs.gov. program). and
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![Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices 35961
3. Possess a DEA registration for Contact Person: Rita Anand, Ph.D., Dated: June 17, 2015.
marijuana, a Schedule I controlled Scientific Review Officer, Scientific Review Michelle Trout,
substance under the CSA. Branch, Eunice Kennedy Shriver National Program Analyst, Office of Federal Advisory
Once the above steps have been Institute of Child Health And Human Committee Policy.
completed, investigators should contact Development, NIH, 6100 Executive
[FR Doc. 2015–15303 Filed 6–22–15; 8:45 am]
Boulevard, Room 5B01, Bethesda, MD
the NIDA Drug Supply Program to place 20892–9304, (301) 496–1487, anandr@ BILLING CODE 4140–01–P
an order for marijuana with specific mail.nih.gov.
characteristics with regard to (Catalogue of Federal Domestic Assistance
concentrations of delta-9-tetrahydro- Program Nos. 93.864, Population Research; DEPARTMENT OF HEALTH AND
cannabinol (THC), cannabidiol (CBD), 93.865, Research for Mothers and Children; HUMAN SERVICES
and other cannabinoids. The program 93.929, Center for Medical Rehabilitation
official will verify that the application is Research; 93.209, Contraception and National Institutes of Health
complete (with all the above-mentioned Infertility Loan Repayment Program, National
steps fulfilled), and forward the order Institutes of Health, HHS) National Institute of Environmental
on to the contractor responsible for Health Sciences; Notice of Closed
Dated: June 17, 2015.
shipping the marijuana. While not Meetings
Michelle Trout,
required in all cases, it is recommended Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the
that researchers contact the NIDA Drug Committee Policy. Federal Advisory Committee Act, as
Supply Program early in the planning of amended (5 U.S.C. App.), notice is
[FR Doc. 2015–15301 Filed 6–22–15; 8:45 am]
a study to obtain information on specific hereby given of the following meetings.
BILLING CODE 4140–01–P
strains of marijuana available so that The meetings will be closed to the
this information can be included in the public in accordance with the
protocol and IND (http:// DEPARTMENT OF HEALTH AND provisions set forth in sections
www.drugabuse.gov/researchers/ HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
research-resources/nida-drug-supply- as amended. The grant applications and
program). National Institutes of Health the discussions could disclose
Dated: June 17, 2015. confidential trade secrets or commercial
Karen B. DeSalvo, National Center For Complementary & property such as patentable material,
Acting Assistant Secretary for Health. Integrative Health; Notice of Closed and personal information concerning
Meeting individuals associated with the grant
[FR Doc. 2015–15479 Filed 6–22–15; 8:45 am]
BILLING CODE 4150–28–P applications, the disclosure of which
Pursuant to section 10(d) of the
would constitute a clearly unwarranted
Federal Advisory Committee Act, as
invasion of personal privacy.
amended (5 U.S.C. App.), notice is
DEPARTMENT OF HEALTH AND Name of Committee: National Institute of
hereby given of the following meeting.
HUMAN SERVICES Environmental Health Sciences Special
The meeting will be closed to the Emphasis Panel—NIEHS Outstanding New
National Institutes of Health public in accordance with the Environmental Scientist Review Meeting.
provisions set forth in sections Date: July 16, 2015.
Eunice Kennedy Shriver National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8:00 a.m. to 5:00 p.m.
Institute of Child Health and Human as amended. The grant applications and Agenda: To review and evaluate grant
Development; Notice of Closed the discussions could disclose applications.
Meeting confidential trade secrets or commercial Place: Hilton Garden Inn Durham
Southpoint, 7007 Fayetteville Road, Durham,
Pursuant to section 10(d) of the property such as patentable material, NC 27713.
Federal Advisory Committee Act, as and personal information concerning Contact Person: Janice B. Allen, Ph.D.,
amended (5 U.S.C. App.), notice is individuals associated with the grant Scientific Review Officer, Scientific Review
hereby given of the following meeting. applications, the disclosure of which Branch, Division of Extramural Research and
The meeting will be closed to the would constitute a clearly unwarranted Training, Nat. Institute of Environmental
invasion of personal privacy. Health Science, P.O. Box 12233, MD EC–30/
public in accordance with the Room 3170 B, Research Triangle Park, NC
provisions set forth in section 552b(c)(4) Name of Committee: National Center for 27709, 919/541–7556.
and 552b(c)(6), Title 5 U.S.C., as Complementary and Integrative Health Name of Committee: National Institute of
amended. The grant applications and Special Emphasis Panel Clinical Research. Environmental Health Sciences Special
the discussions could disclose Date: July 16, 2015. Emphasis Panel—Review of Conferences in
confidential trade secrets or commercial Time: 12:00 p.m. to 5:00 p.m. Environmental Health.
Agenda: To review and evaluate grant Date: July 16, 2015.
property such as patentable material,
applications. Time: 12:00 p.m. to 5:00 p.m.
and personal information concerning Place: National Institutes of Health,
individuals associated with the grant Agenda: To review and evaluate grant
Democracy Two, Suite 401, 6707 Democracy applications.
applications, the disclosure of which Boulevard, Bethesda, MD 20892 (Virtual Place: NIEHS/National Institutes of Health,
would constitute a clearly unwarranted Meeting). Keystone Building, 530 Davis Drive, Research
invasion of personal privacy. Contact Person: Hungyi Shau, Ph.D., Triangle Park, NC 27709, (Telephone
Name of Committee: National Institute of Scientific Review Officer, National Center for Conference Call).
Complementary and Integrative Health, Contact Person: Sally Eckert-Tilotta, Ph.D.,
mstockstill on DSK4VPTVN1PROD with NOTICES
Child Health and Human Development
Special Emphasis Panel; CHRCDA/K12. National Institutes of Health, 6707 Scientific Review Officer, Nat. Institute of
Date: July 21, 2015. Democracy Boulevard, Suite 401, Bethesda, Environmental Health Sciences, Office of
Time: 8:00 a.m. to 5:00 p.m. MD 20892, Phone: 301–402–1030, Program Operations, Scientific Review
Agenda: To review and evaluate grant Hungyi.Shau@nih.gov. Branch, P.O. Box 12233, Research Triangle
applications. (Catalogue of Federal Domestic Assistance Park, NC 27709, (919) 541–1446, eckertt1@
Place: Doubletree Hotel Bethesda, Program Nos. 93.213, Research and Training niehs.nih.gov.
(Formerly Holiday Inn Select), 8120 in Complementary and Alternative Medicine, (Catalogue of Federal Domestic Assistance
Wisconsin Avenue, Bethesda, MD 20814. National Institutes of Health, HHS) Program Nos. 93.115, Biometry and Risk
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Document Created: 2018-02-22 11:15:32
Document Modified: 2018-02-22 11:15:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Effective June 2015. | |
| Contact | Christine Cichetti, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services; telephone (202) 619-0242; email: [email protected] | |
| FR Citation | 80 FR 35960 |
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