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)

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.

[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]


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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.

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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