81 FR 53846 - Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 156 (August 12, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 156 (August 12, 2016)
| Page Range | 53846-53848 | |
| FR Document | 2016-17955 |
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)] [Rules and Regulations] [Pages 53846-53848] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17955] Federal Register / Vol. 81 , No. 156 / Friday, August 12, 2016 / Rules and Regulations [[Page 53846]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA-447] Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Policy statement. ----------------------------------------------------------------------- SUMMARY: To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States. This policy statement explains how DEA will evaluate applications for such registration consistent with the CSA and the obligations of the United States under the applicable international drug control treaty. DATES: August 12, 2016. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Background Reasons for This Policy Statement There is growing public interest in exploring the possibility that marijuana or its chemical constituents may be used as potential treatments for certain medical conditions. The Federal Food, Drug and Cosmetic Act requires that before a new drug is allowed to enter the U.S. market, it must be demonstrated through adequate and well- controlled clinical trials to be both safe and effective for its intended uses. Congress long ago established this process, recognizing that it was essential to protect the health and welfare of the American people. Although no drug product made from marijuana has yet been shown to be safe and effective in such clinical trials, DEA--along with the Food and Drug Administration (FDA) and the National Institutes of Health (NIH)--fully supports expanding research into the potential medical utility of marijuana and its chemical constituents.\1\ --------------------------------------------------------------------------- \1\ There are two FDA-approved drugs that contain a synthetic form of dronabinol, which is one of the chemicals found in marijuana. These drugs are Marinol (which the FDA approved for the treatment of nausea and vomiting associated with cancer chemotherapy, and for the treatment of anorexia associated with weight loss in patients with AIDS) and Syndros (which was approved for the same indications as Marinol). --------------------------------------------------------------------------- There are a variety of factors that influence whether and to what extent such research takes place. Some of the key factors--such as funding--are beyond DEA's control.\2\ However, one of the ways DEA can help to facilitate research involving marijuana is to take steps, within the framework of the CSA and U.S. treaty obligations, to increase the lawful supply of marijuana available to researchers. --------------------------------------------------------------------------- \2\ Funding may actually be the most important factor in whether research with marijuana (or any other experimental drug) takes place. What appears to have been the greatest spike in marijuana research in the United States occurred shortly after the State of California enacted legislation in 1999 to fund such research. Specifically, in 1999, California enacted a law that established the ``California Marijuana Research Program'' to develop and conduct studies on the potential medical utility of marijuana. Cal. Health & Safety Code Sec. 11362.9. The state legislature appropriated a total of $9 million for the marijuana research studies. Over the next five years, DEA received applications for registration in connection with at least 17 State-sponsored pre-clinical or clinical studies of marijuana (all of which DEA granted). 74 FR 2101, 2105 (2009). However, it appears that once the State stopped funding the research, the studies ended. --------------------------------------------------------------------------- For nearly 50 years, the United States has relied on a single grower to produce marijuana used in research. This grower operates under a contract with the National Institute on Drug Abuse (NIDA). This longstanding arrangement has historically been considered by the U.S. Government to be the best way to satisfy our nation's obligations under the applicable international drug control treaty, as discussed in more detail below. For most of the nearly 50 years that this single marijuana grower arrangement has been in existence, the demand for research-grade marijuana in the United States was relatively limited-- and the single grower was able to meet such limited demand. However, in recent years, there has been greater public interest in expanding marijuana-related research, particularly with regard to certain chemical constituents in the plant known as cannabinoids. The term ``cannabinoids'' generally refers to those chemicals unique to the cannabis plant (marijuana).\3\ To date, more than 100 different cannabinoids have been found in the plant. One such cannabinoid--known as cannabidiol or CBD--has received increased attention in recent years. Although the effects of CBD are not yet fully understood by scientists, and research is ongoing in this area, some studies suggest that CBD may have uses in the treatment of seizures and other neurological disorders. A growing number of researchers have expressed interest in conducting research with extracts of marijuana that have a particular percentage of CBD and other cannabinoids. DEA fully supports research in this area. Based on discussions with NIDA and FDA, DEA has concluded that the best way to satisfy the current researcher demand for a variety of strains of marijuana and cannabinoid extracts is to increase the number of federally authorized marijuana growers. To achieve this result, DEA, in consultation with NIDA and FDA, has developed a new approach to allow additional marijuana growers to apply to become registered with DEA, while upholding U.S. treaty obligations and the CSA. This policy statement explains the new approach, provides details about the process by which potential growers may apply for a DEA registration, and describes the steps they must take to ensure their activity will be carried out in conformity with U.S. treaty obligations and the CSA. --------------------------------------------------------------------------- \3\ An acceptable and broader definition of ``cannabinoids'' includes not only those chemicals unique to the cannabis plant but also their derivatives and transformation products. --------------------------------------------------------------------------- The historical system, under which NIDA relied on one grower to supply marijuana on a contract basis, was designed primarily to supply marijuana for use in federally funded research--not for commercial product development. Thus, under the historical system, there was no clear legal pathway for commercial enterprises to produce marijuana for product development. In contrast, under the new approach explained in this policy statement, persons may become registered with DEA to grow marijuana not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development. Likewise, under the new approach, should the state of scientific knowledge advance in the future such that a marijuana-derived drug is shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States--independent of the NIDA contract process. Legal Considerations Applicable CSA Provisions Under the CSA, all persons who seek to manufacture or distribute a controlled substance must apply for a DEA registration. 21 U.S.C. 822(a)(1). Applications by persons seeking to grow [[Page 53847]] marijuana to supply researchers are governed by 21 U.S.C. 823(a); see generally 76 FR 51403 (2011); 74 FR 2101 (2009). Under section 823(a), for DEA to grant a registration, two conditions must be satisfied: (1) The registration must be consistent with the public interest (based on the enumerated criteria listed in section 823(a)) and (2) the registration must be consistent with U.S. obligations under the Single Convention on Narcotic Drugs, 1961 (Single Convention). An applicant seeking registration under section 823(a) has ``the burden of proving that the requirements for such registration pursuant to [this section] are satisfied.'' 21 CFR 1301.44(a). Although each application for registration that DEA receives will be evaluated individually based on its own merit, some general considerations warrant mention here. First, while it is DEA's intention to increase the number of registered marijuana growers who will be supplying U.S. researchers, the CSA does not authorize DEA to register an unlimited number of manufacturers. As subsection 823(a)(1) provides, DEA is obligated to register only the number of bulk manufacturers of a given schedule I or II controlled substance that is necessary to ``produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.'' See 74 FR at 2127-2130 (discussing meaning of subsection 823(a)(1)). This provision is based on the long-established principle that having fewer registrants of a given controlled substances tends to decrease the likelihood of diversion. Consistent with subsection 823(a)(1), DEA will evaluate each application it receives to determine whether adding such applicant to the list of registered growers is necessary to provide an adequate and uninterrupted supply of marijuana (including extracts and other derivatives thereof) to researchers in the United States.\4\ --------------------------------------------------------------------------- \4\ In making this determination, DEA will consult with NIH and FDA, as warranted. --------------------------------------------------------------------------- Second, as with any application submitted pursuant to section 823(a), in determining whether the proposed registration would be consistent with the public interest, among the factors to be considered are whether the applicant has previous experience handling controlled substances in a lawful manner and whether the applicant has engaged in illegal activity involving controlled substances. In this context, illegal activity includes any activity in violation of the CSA (regardless of whether such activity is permissible under State law) as well as activity in violation of State or local law. While past illegal conduct involving controlled substances does not automatically disqualify an applicant, it may weigh heavily against granting the registration. Third, given the in-depth nature of the analysis that the CSA requires DEA to conduct in evaluating these applications, applicants should anticipate that, in addition to the information requested in the application itself, they will be asked to submit other information germane to the application in accordance with 21 CFR 1301.15. This will include, among other things, detailed information regarding an applicant's past experience in the manufacture of controlled substances. In addition, applicants will be asked to provide a written explanation of how they believe they would be able to augment the nation's supply of research-grade marijuana within the meaning of subsection 823(a)(1). Applicants may be asked to provide additional written support for their application and other information that DEA deems relevant in evaluating the application under section 823(a). Treaty Considerations As stated above, DEA may only issue a registration to grow marijuana to supply researchers if the registration is consistent with U.S. obligations under the Single Convention. Although this policy document will not list all of the applicable requirements of the Single Convention,\5\ the following is a summary of some of the key considerations. --------------------------------------------------------------------------- \5\ A detailed explanation of the relevant Single Convention requirements can be found in 74 FR at 2114-2118. --------------------------------------------------------------------------- Under articles 23 and 28 of the Single Convention, a party (i.e., a country that is a signatory to the treaty) that allows the cultivation of cannabis for lawful uses (e.g., FDA-authorized clinical trials) must: (a) Designate the areas in which, and the plots of land on which, cultivation of the cannabis plant for the purpose of producing cannabis shall be permitted; (b) License cultivators authorized to cultivate cannabis; (c) Specify through such licensing the extent of the land on which the cultivation is permitted; (d) Purchase and take physical possession of all cannabis crops from all cultivators as soon as possible, but not later than four months after the end of the harvest; and (e) Have the exclusive right of importing, exporting, wholesale trading and maintaining stocks of cannabis. As DEA has stated in a prior publication, DEA carries out those functions of article 23, paragraph 2, that are encompassed by the DEA registration system (paragraphs (a) through (c) above), and NIDA carries out those functions relating to purchasing the marijuana and maintaining a monopoly over the wholesale distribution (paragraphs (d) and (e) above).\6\ 76 FR at 51409. --------------------------------------------------------------------------- \6\ In accordance with the CSA, DEA carries out functions that are indirectly related to those specified in article 23, paragraph 2(e). For example, DEA controls imports and exports of cannabis through the CSA registration and permitting system. --------------------------------------------------------------------------- As indicated, DEA's historical approach to ensuring compliance with the foregoing treaty requirements was to limit the registration of marijuana growers who supply researchers to those entities that operate under a contract with NIDA. Under this historical approach, the grower could be considered an extension of NIDA and thus all marijuana produced by the grower was effectively owned by NIDA, with NIDA controlling all distribution to researchers. However, as further indicated, DEA has concluded, based on discussions with NIDA and FDA, that it would be beneficial for research to allow additional marijuana growers outside the NIDA-contract system, provided this could be accomplished in a manner consistent with the CSA and the treaty. Toward this end, DEA took into account the following statement contained in the official commentary to the Single Convention: Countries . . . which produce . . . cannabis . . . , [i]n so far as they permit private farmers to cultivate the plants . . . , cannot establish with sufficient exactitude the quantities harvested by individual producers. If they allowed the sale of the crops to private traders, they would not be in a position to ascertain with reasonable exactitude the amounts which enter their controlled trade. The effectiveness of their control r[eacute]gime would thus be considerably weakened. In fact, experience has shown that permitting licensed private traders to purchase the crops results in diversion of large quantities of drugs into illicit channels. . . . [T]he acquisition of the crops and the wholesale and international trade in these agricultural products cannot be entrusted to private traders, but must be undertaken by governmental authorities in the producing countries. Article 23 . . . and article 28 . . . therefore require a government monopoly of the wholesale and international trade in the agricultural product in question in the country which authorizes its production. Commentary at 278 [[Page 53848]] Given the foregoing considerations, DEA believes it would be consistent with the purposes of articles 23 and 28 of the Single Convention for DEA to register marijuana growers outside of the NIDA- contract system to supply researchers, provided the growers agree that they may only distribute marijuana with prior, written approval from DEA. In other words, in lieu of requiring the growers to operate under a contract with NIDA, a registered grower will be permitted to operate independently, provided the grower agrees (through a written memorandum of agreement with DEA) that it will only distribute marijuana with prior, written approval from DEA. DEA believes this new approach will succeed in avoiding one of the scenarios the treaty is designed to prevent: Private parties trading in marijuana outside the supervision or direction of the federal government. Also, consistent with the purposes and structure of the CSA, persons who become registered to grow marijuana to supply researchers will only be authorized to supply DEA-registered researchers whose protocols have been determined by the Department of Health and Human Services (HHS) to be scientifically meritorious. See 21 U.S.C. 823(f). In 2015, HHS announced the details of its current policy for evaluating the merits of research protocols involving marijuana. 80 FR 35960 (2015). Finally, potential applicants should note that any entity granted a registration to manufacture marijuana to supply researchers will be subject to all applicable requirements of the CSA and DEA regulations, including those relating to quotas, record keeping, order forms, security, and diversion control. How To Apply for a Registration Persons interested in applying for a registration to become a bulk manufacturer of marijuana to supply legitimate researchers can find instructions and the application form by going to the DEA Office of Diversion Control Web site registration page at www.deadiversion.usdoj.gov/drugreg/index.html#regapps. Applicants will need to submit Form 225. Note Regarding the Nature of This Document This document is a general statement of DEA policy. While this document reflects how DEA intends to implement the relevant statutory and regulatory provisions, it does not establish a rule that is binding on any member of the public. Any person who applies for a registration to grow marijuana (as with any other applicant for registration under the CSA) is entitled to due process in the consideration of the application by the Agency. To ensure such due process, the CSA provides that, before taking action to deny an application for registration, DEA must serve upon the applicant an order to show cause why the application should not be denied, which shall provide the applicant with an opportunity to request a hearing on the application in accordance with the Administrative Procedure Act. 21 U.S.C. 824(c). Dated: July 25, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-17955 Filed 8-11-16; 8:45 am] BILLING CODE 4410-09-P
![53846 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations
DEPARTMENT OF JUSTICE There are a variety of factors that scientists, and research is ongoing in
influence whether and to what extent this area, some studies suggest that CBD
Drug Enforcement Administration such research takes place. Some of the may have uses in the treatment of
key factors—such as funding—are seizures and other neurological
21 CFR Part 1301 beyond DEA’s control.2 However, one of disorders. A growing number of
[Docket No. DEA–447] the ways DEA can help to facilitate researchers have expressed interest in
research involving marijuana is to take conducting research with extracts of
Applications To Become Registered steps, within the framework of the CSA marijuana that have a particular
Under the Controlled Substances Act and U.S. treaty obligations, to increase percentage of CBD and other
To Manufacture Marijuana To Supply the lawful supply of marijuana available cannabinoids. DEA fully supports
Researchers in the United States to researchers. research in this area. Based on
For nearly 50 years, the United States discussions with NIDA and FDA, DEA
AGENCY: Drug Enforcement has relied on a single grower to produce has concluded that the best way to
Administration, Department of Justice. marijuana used in research. This grower satisfy the current researcher demand
ACTION: Policy statement. operates under a contract with the for a variety of strains of marijuana and
National Institute on Drug Abuse cannabinoid extracts is to increase the
SUMMARY: To facilitate research (NIDA). This longstanding arrangement number of federally authorized
involving marijuana and its chemical has historically been considered by the marijuana growers. To achieve this
constituents, DEA is adopting a new U.S. Government to be the best way to result, DEA, in consultation with NIDA
policy that is designed to increase the satisfy our nation’s obligations under and FDA, has developed a new
number of entities registered under the the applicable international drug control approach to allow additional marijuana
Controlled Substances Act (CSA) to treaty, as discussed in more detail growers to apply to become registered
grow (manufacture) marijuana to supply below. For most of the nearly 50 years with DEA, while upholding U.S. treaty
legitimate researchers in the United that this single marijuana grower obligations and the CSA. This policy
States. This policy statement explains arrangement has been in existence, the statement explains the new approach,
how DEA will evaluate applications for demand for research-grade marijuana in provides details about the process by
such registration consistent with the the United States was relatively which potential growers may apply for
CSA and the obligations of the United limited—and the single grower was able a DEA registration, and describes the
States under the applicable to meet such limited demand. However, steps they must take to ensure their
international drug control treaty. in recent years, there has been greater activity will be carried out in
DATES: August 12, 2016. public interest in expanding marijuana- conformity with U.S. treaty obligations
FOR FURTHER INFORMATION CONTACT: related research, particularly with and the CSA.
Michael J. Lewis, Office of Diversion regard to certain chemical constituents The historical system, under which
Control, Drug Enforcement in the plant known as cannabinoids. NIDA relied on one grower to supply
Administration; Mailing Address: 8701 The term ‘‘cannabinoids’’ generally marijuana on a contract basis, was
Morrissette Drive, Springfield, Virginia refers to those chemicals unique to the designed primarily to supply marijuana
cannabis plant (marijuana).3 To date, for use in federally funded research—
22152; Telephone: (202) 598–6812.
more than 100 different cannabinoids not for commercial product
SUPPLEMENTARY INFORMATION: have been found in the plant. One such development. Thus, under the historical
Background cannabinoid—known as cannabidiol or system, there was no clear legal
CBD—has received increased attention
Reasons for This Policy Statement pathway for commercial enterprises to
in recent years. Although the effects of
produce marijuana for product
There is growing public interest in CBD are not yet fully understood by
development. In contrast, under the new
exploring the possibility that marijuana approach explained in this policy
or its chemical constituents may be used chemicals found in marijuana. These drugs are
statement, persons may become
Marinol (which the FDA approved for the treatment
as potential treatments for certain of nausea and vomiting associated with cancer registered with DEA to grow marijuana
medical conditions. The Federal Food, chemotherapy, and for the treatment of anorexia not only to supply federally funded or
Drug and Cosmetic Act requires that associated with weight loss in patients with AIDS)
other academic researchers, but also for
before a new drug is allowed to enter and Syndros (which was approved for the same
indications as Marinol). strictly commercial endeavors funded
the U.S. market, it must be 2 Funding may actually be the most important by the private sector and aimed at drug
demonstrated through adequate and factor in whether research with marijuana (or any product development. Likewise, under
well-controlled clinical trials to be both other experimental drug) takes place. What appears
the new approach, should the state of
safe and effective for its intended uses. to have been the greatest spike in marijuana
research in the United States occurred shortly after scientific knowledge advance in the
Congress long ago established this the State of California enacted legislation in 1999 future such that a marijuana-derived
process, recognizing that it was essential to fund such research. Specifically, in 1999, drug is shown to be safe and effective
to protect the health and welfare of the California enacted a law that established the
for medical use, pharmaceutical firms
American people. ‘‘California Marijuana Research Program’’ to
develop and conduct studies on the potential will have a legal means of producing
Although no drug product made from medical utility of marijuana. Cal. Health & Safety such drugs in the United States—
marijuana has yet been shown to be safe Code § 11362.9. The state legislature appropriated independent of the NIDA contract
and effective in such clinical trials, a total of $9 million for the marijuana research
process.
DEA—along with the Food and Drug studies. Over the next five years, DEA received
applications for registration in connection with at
Administration (FDA) and the National Legal Considerations
mstockstill on DSK3G9T082PROD with RULES4
least 17 State-sponsored pre-clinical or clinical
Institutes of Health (NIH)—fully studies of marijuana (all of which DEA granted). 74 Applicable CSA Provisions
supports expanding research into the FR 2101, 2105 (2009). However, it appears that once
potential medical utility of marijuana the State stopped funding the research, the studies Under the CSA, all persons who seek
ended. to manufacture or distribute a controlled
and its chemical constituents.1 3 An acceptable and broader definition of
‘‘cannabinoids’’ includes not only those chemicals
substance must apply for a DEA
1 There are two FDA-approved drugs that contain unique to the cannabis plant but also their registration. 21 U.S.C. 822(a)(1).
a synthetic form of dronabinol, which is one of the derivatives and transformation products. Applications by persons seeking to grow
VerDate Sep<11>2014 21:03 Aug 11, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4701 Sfmt 4700 E:\FR\FM\12AUR4.SGM 12AUR4](https://thefederalregister.org/doc/81_FR_54002/page/1.svg)
![Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations 53847
marijuana to supply researchers are violation of the CSA (regardless of (e) Have the exclusive right of
governed by 21 U.S.C. 823(a); see whether such activity is permissible importing, exporting, wholesale trading
generally 76 FR 51403 (2011); 74 FR under State law) as well as activity in and maintaining stocks of cannabis.
2101 (2009). Under section 823(a), for violation of State or local law. While As DEA has stated in a prior
DEA to grant a registration, two past illegal conduct involving controlled publication, DEA carries out those
conditions must be satisfied: (1) The substances does not automatically functions of article 23, paragraph 2, that
registration must be consistent with the disqualify an applicant, it may weigh are encompassed by the DEA
public interest (based on the heavily against granting the registration. registration system (paragraphs (a)
enumerated criteria listed in section Third, given the in-depth nature of through (c) above), and NIDA carries out
823(a)) and (2) the registration must be the analysis that the CSA requires DEA those functions relating to purchasing
consistent with U.S. obligations under to conduct in evaluating these the marijuana and maintaining a
the Single Convention on Narcotic applications, applicants should monopoly over the wholesale
Drugs, 1961 (Single Convention). An anticipate that, in addition to the distribution (paragraphs (d) and (e)
applicant seeking registration under information requested in the application above).6 76 FR at 51409.
section 823(a) has ‘‘the burden of itself, they will be asked to submit other As indicated, DEA’s historical
proving that the requirements for such information germane to the application approach to ensuring compliance with
registration pursuant to [this section] are in accordance with 21 CFR 1301.15. the foregoing treaty requirements was to
satisfied.’’ 21 CFR 1301.44(a). Although This will include, among other things, limit the registration of marijuana
each application for registration that detailed information regarding an growers who supply researchers to those
DEA receives will be evaluated applicant’s past experience in the entities that operate under a contract
individually based on its own merit, manufacture of controlled substances. In with NIDA. Under this historical
some general considerations warrant addition, applicants will be asked to approach, the grower could be
mention here. provide a written explanation of how considered an extension of NIDA and
First, while it is DEA’s intention to they believe they would be able to thus all marijuana produced by the
increase the number of registered augment the nation’s supply of research- grower was effectively owned by NIDA,
marijuana growers who will be grade marijuana within the meaning of with NIDA controlling all distribution to
supplying U.S. researchers, the CSA subsection 823(a)(1). Applicants may be researchers.
does not authorize DEA to register an asked to provide additional written However, as further indicated, DEA
unlimited number of manufacturers. As support for their application and other has concluded, based on discussions
subsection 823(a)(1) provides, DEA is information that DEA deems relevant in with NIDA and FDA, that it would be
obligated to register only the number of beneficial for research to allow
evaluating the application under section
bulk manufacturers of a given schedule additional marijuana growers outside
823(a).
I or II controlled substance that is the NIDA-contract system, provided this
necessary to ‘‘produce an adequate and Treaty Considerations could be accomplished in a manner
uninterrupted supply of these consistent with the CSA and the treaty.
As stated above, DEA may only issue
substances under adequately Toward this end, DEA took into account
a registration to grow marijuana to
competitive conditions for legitimate the following statement contained in the
supply researchers if the registration is
medical, scientific, research, and official commentary to the Single
consistent with U.S. obligations under
industrial purposes.’’ See 74 FR at Convention:
the Single Convention. Although this
2127–2130 (discussing meaning of
policy document will not list all of the Countries . . . which produce . . .
subsection 823(a)(1)). This provision is
applicable requirements of the Single cannabis . . . , [i]n so far as they permit
based on the long-established principle private farmers to cultivate the plants . . . ,
Convention,5 the following is a
that having fewer registrants of a given cannot establish with sufficient exactitude
summary of some of the key
controlled substances tends to decrease the quantities harvested by individual
considerations.
the likelihood of diversion. producers. If they allowed the sale of the
Consistent with subsection 823(a)(1), Under articles 23 and 28 of the Single crops to private traders, they would not be
DEA will evaluate each application it Convention, a party (i.e., a country that in a position to ascertain with reasonable
receives to determine whether adding is a signatory to the treaty) that allows exactitude the amounts which enter their
such applicant to the list of registered the cultivation of cannabis for lawful controlled trade. The effectiveness of their
growers is necessary to provide an uses (e.g., FDA-authorized clinical control régime would thus be considerably
trials) must: weakened. In fact, experience has shown that
adequate and uninterrupted supply of permitting licensed private traders to
marijuana (including extracts and other (a) Designate the areas in which, and
purchase the crops results in diversion of
derivatives thereof) to researchers in the the plots of land on which, cultivation
large quantities of drugs into illicit channels.
United States.4 of the cannabis plant for the purpose of . . . [T]he acquisition of the crops and the
Second, as with any application producing cannabis shall be permitted; wholesale and international trade in these
submitted pursuant to section 823(a), in (b) License cultivators authorized to agricultural products cannot be entrusted to
determining whether the proposed cultivate cannabis; private traders, but must be undertaken by
registration would be consistent with (c) Specify through such licensing the governmental authorities in the producing
the public interest, among the factors to extent of the land on which the countries. Article 23 . . . and article 28 . . .
therefore require a government monopoly of
be considered are whether the applicant cultivation is permitted;
the wholesale and international trade in the
has previous experience handling (d) Purchase and take physical agricultural product in question in the
controlled substances in a lawful possession of all cannabis crops from all
mstockstill on DSK3G9T082PROD with RULES4
country which authorizes its production.
manner and whether the applicant has cultivators as soon as possible, but not
engaged in illegal activity involving later than four months after the end of Commentary at 278
controlled substances. In this context, the harvest; and 6 In accordance with the CSA, DEA carries out
illegal activity includes any activity in functions that are indirectly related to those
5 A detailed explanation of the relevant Single specified in article 23, paragraph 2(e). For example,
4 Inmaking this determination, DEA will consult Convention requirements can be found in 74 FR at DEA controls imports and exports of cannabis
with NIH and FDA, as warranted. 2114–2118. through the CSA registration and permitting system.
VerDate Sep<11>2014 21:03 Aug 11, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\12AUR4.SGM 12AUR4](https://thefederalregister.org/doc/81_FR_54002/page/2.svg)
![53848 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations
Given the foregoing considerations, and Human Services (HHS) to be Note Regarding the Nature of This
DEA believes it would be consistent scientifically meritorious. See 21 U.S.C. Document
with the purposes of articles 23 and 28 823(f). In 2015, HHS announced the This document is a general statement
of the Single Convention for DEA to details of its current policy for of DEA policy. While this document
register marijuana growers outside of evaluating the merits of research reflects how DEA intends to implement
the NIDA-contract system to supply protocols involving marijuana. 80 FR the relevant statutory and regulatory
researchers, provided the growers agree 35960 (2015). provisions, it does not establish a rule
that they may only distribute marijuana that is binding on any member of the
with prior, written approval from DEA. Finally, potential applicants should
note that any entity granted a public. Any person who applies for a
In other words, in lieu of requiring the registration to grow marijuana (as with
growers to operate under a contract with registration to manufacture marijuana to
supply researchers will be subject to all any other applicant for registration
NIDA, a registered grower will be under the CSA) is entitled to due
permitted to operate independently, applicable requirements of the CSA and
DEA regulations, including those process in the consideration of the
provided the grower agrees (through a application by the Agency. To ensure
written memorandum of agreement with relating to quotas, record keeping, order
forms, security, and diversion control. such due process, the CSA provides
DEA) that it will only distribute that, before taking action to deny an
marijuana with prior, written approval How To Apply for a Registration application for registration, DEA must
from DEA. DEA believes this new serve upon the applicant an order to
approach will succeed in avoiding one Persons interested in applying for a show cause why the application should
of the scenarios the treaty is designed to registration to become a bulk not be denied, which shall provide the
prevent: Private parties trading in manufacturer of marijuana to supply applicant with an opportunity to request
marijuana outside the supervision or legitimate researchers can find a hearing on the application in
direction of the federal government. instructions and the application form by accordance with the Administrative
Also, consistent with the purposes going to the DEA Office of Diversion Procedure Act. 21 U.S.C. 824(c).
and structure of the CSA, persons who Control Web site registration page at
become registered to grow marijuana to Dated: July 25, 2016.
www.deadiversion.usdoj.gov/drugreg/ Chuck Rosenberg,
supply researchers will only be index.html#regapps. Applicants will
authorized to supply DEA-registered Acting Administrator.
need to submit Form 225.
researchers whose protocols have been [FR Doc. 2016–17955 Filed 8–11–16; 8:45 am]
determined by the Department of Health BILLING CODE 4410–09–P
mstockstill on DSK3G9T082PROD with RULES4
VerDate Sep<11>2014 21:03 Aug 11, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4701 Sfmt 9990 E:\FR\FM\12AUR4.SGM 12AUR4](https://thefederalregister.org/doc/81_FR_54002/page/3.svg)
Document Created: 2018-02-09 11:32:51
Document Modified: 2018-02-09 11:32:51
| 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 | Rules and Regulations | |
| Action | Policy statement. | |
| Dates | August 12, 2016. | |
| Contact | Michael J. Lewis, Office of Diversion | |
| FR Citation | 81 FR 53846 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR