Controlled Substances: Proposed Adjustments to the Aggregate Production Quotas for Difenoxin, Diphenoxylate (for conversion), and Marijuana, 18867-18869 [2015-08042]

Download as PDF Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices COLORADO Park County Tarryall Rural Historic Landscape, Cty. Rd. 77, Mileposts 2.4 to 41.8, Jefferson, 15000170 Mecklenburg County Outen, R.F., Pottery, 430 Jefferson St., Matthews, 15000183 OHIO San Juan County Sound Democrat Mill and Mine and Silver Queen Mine, (Mining Resources of San Juan County, Colorado MPS) Address Restricted, Silverton, 15000171 Hamilton County United States Post Office and Court House, 100 E. 5th St., Cincinnati, 15000184 MARYLAND Ottawa County Perry’s Victory and International Peace Memorial (Boundary Increase), 93 Delaware Ave., Put-in-Bay, 15000185 Baltimore Independent city TENNESSEE McDonogh Place Historic District, N. Broadway, E. Eager, McDonogh & E. Chase Sts., Baltimore, 15000172 Grundy County Christ Episcopal Church, 530 10th St., Tracy City, 15000186 Charles County Shelby County One Hundred North Main Building, 100 N. Main St. Mall, Memphis, 15000187 Mallows Bay—Widewater Historic and Archeological District, Off Charles County shoreline at Sandy Pt., Nanjemoy, 15000173 WEST VIRGINIA Marion County Dunbar School, 103 High St., Fairmont, 15000188 MISSOURI St. Louis Independent city Woodward and Tierman Printing Company Building, 1519 Tower Grove Ave., St. Louis, 15000174 NEW HAMPSHIRE Coos County WISCONSIN Sheboygan County Prange, Eliza, House, 605 Erie Ave., Sheboygan, 15000189 WYOMING Burgess, George E., School—Notre Dame High Schol, 411 School St., Berlin, 15000175 NEW JERSEY Teton County Hardeman Barns, 5450 W. WY 22, Wilson, 15000190 Sussex County [FR Doc. 2015–08007 Filed 4–7–15; 8:45 am] Waterloo Village (Boundary Increase), Musconetcong R. & Cty. Rd. 604, Byram Township, 15000176 which were made in FY 2014. The inventory information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 by the Office of Management and Budget’s Office of Federal Procurement Policy (OFPP). OFPP’s guidance is available at https://www.whitehouse.gov/sites/ default/files/omb/procurement/memo/ service-contract-inventories-guidance11052010.pdf. The FY 2014 inventory planned analysis provides information on which functional areas will be reviewed by the agency. The United States International Trade Commission has posted its FY 2014 inventory, FY 2014 planned analysis, and FY 2013 inventory analysis at the following link: https://www.usitc.gov/procurement/. FOR FURTHER INFORMATION CONTACT: Questions regarding the service contract inventory should be directed to Debra Bridge, U.S. International Trade Commission, Office of Procurement, 500 E Street SW., Washington, DC 20436, or at 202–205–2004 or debra.bridge@ usitc.gov. By order of the Commission. Dated: April 3, 2015. Lisa R. Barton, Secretary to the Commission. BILLING CODE 4312–51–P INTERNATIONAL TRADE COMMISSION BILLING CODE 7020–02–P Drug Enforcement Administration Bronx County [Docket No. DEA–411N] Public Availability of FY 2013 Service Contract Inventory Analysis, FY 2014 Service Contract Inventory, and FY 2014 Service Contract Inventory Planned Analysis Crotona Play Center, 1700 Fulton Ave., Bronx, 15000177 Suffolk County Sylvester Manor, 80 N. Ferry Rd., Shelter Island, 15000178 U.S. International Trade Commission. ACTION: Notice. AGENCY: NORTH CAROLINA Ashe County Ashe County Memorial Hospital, (Ashe County, North Carolina, c. 1799–1955 MPS) 410 McConnell St., Jefferson, 15000179 Belhaven Commercial Historic District, 260– 292 E. Main & 246–288, 251–279 Pamlico Sts., Belhaven, 15000180 Guilford County Willis, James H. and Anne B., House, 707 Blair St., Greensboro, 15000181 Harnett County Erwin Commercial Historic District, 100 Denim Drive, 101–127 E. H & 103–111 S. 13th Sts., Erwin, 15000182 17:55 Apr 07, 2015 Jkt 235001 In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111–117), the U.S. International Trade Commission is publishing this notice to advise the public of the availability of the FY 2013 Service Contract Inventory Analysis, the FY 2014 Service Contract Inventory, and the FY 2014 Service Contract Inventory Planned Analysis. The FY 2013 inventory analysis provides information on specific service contract actions that were analyzed as part of the FY 2013 inventory. The 2014 inventory provides information on service contract actions over $25,000 SUMMARY: Beaufort County VerDate Sep<11>2014 [FR Doc. 2015–08050 Filed 4–7–15; 8:45 am] DEPARTMENT OF JUSTICE NEW YORK asabaliauskas on DSK5VPTVN1PROD with NOTICES 18867 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Controlled Substances: Proposed Adjustments to the Aggregate Production Quotas for Difenoxin, Diphenoxylate (for conversion), and Marijuana Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. AGENCY: The Drug Enforcement Administration is proposing to adjust the established 2015 aggregate production quota for difenoxin, diphenoxylate (for conversion), and marijuana which are schedule I and II controlled substances under the Controlled Substances Act. DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13. Electronic comments must be submitted, and written comments must be postmarked, on or before May 8, SUMMARY: E:\FR\FM\08APN1.SGM 08APN1 18868 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–411N’’ on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone (202) 598–6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration for public inspection online at https:// www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ‘‘PERSONAL IDENTIFYING VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 INFORMATION’’ in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. Comments containing personal identifying information and confidential business information identified and located as directed above will generally be made available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to https:// www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document is available at https:// www.regulations.gov for easy reference. Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801–971. Titles II and III are referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ respectively, and are collectively referred to as the ‘‘Controlled Substances Act’’ or the ‘‘CSA’’ for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Section 306 of the CSA (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 for each basic class of controlled substance listed in schedules I and II each year. The Attorney General has delegated this function to the Administrator of the DEA, 28 CFR 0.100. Background The DEA established the initial 2015 aggregate production quotas and assessments of annual need on September 8, 2014 (79 FR 53216). That notice stipulated that, as provided for in 21 CFR 1303.13, all aggregate production quotas and assessments of annual need are subject to adjustment. Based on unanticipated medical, scientific, research, and industrial needs of the United States the DEA proposes to adjust the established 2015 aggregate production quotas for the schedule I and II controlled substances difenoxin, diphenoxylate (for conversion), and marijuana to be manufactured in the United States in 2015. The adjustment is necessary to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. In proposing the adjustment, the Administrator has taken into account the following criteria in accordance with 21 CFR 1303.13: (1) Changes in demand for the basic class, changes in the national rate of net disposal for the class, and changes in the rate of net disposal by the registrants holding individual manufacturing quotas for the class; (2) whether any increased demand or changes in the national and/or individual rates of net disposal are temporary, short term, or long term; (3) whether any increased demand for that class can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand will result in excessive inventory accumulation by all persons registered to handle the class; and (5) other factors affecting the medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Administrator finds relevant. Analysis for Adjusting the Established 2015 Aggregate Production Quota for Difenoxin and Diphenoxylate (for Conversion) Since the establishment of the initial 2015 aggregate production quotas, the DEA has received requests from DEA registered manufacturers to manufacture difenoxin and diphenoxylate (for conversion) to support the manufacture E:\FR\FM\08APN1.SGM 08APN1 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices of prescription drug products approved by the Food and Drug Administration (FDA) for the treatment of chronic diarrhea and for the treatment of diarrhea associated with irritable bowel syndrome (IBS).1 These FDA approved products have not been manufactured since 2009 due to FDA-regulated manufacturing issues and there is no existing generic or therapeutic equivalent. Dated: April 1, 2015. Michele M. Leonhart, Administrator. Analysis for Adjusting the Established 2015 Aggregate Production Quota for Marijuana Since the establishment of the initial 2015 aggregate production quotas, the DEA has received notification from DEA registered manufacturers that research and product development involving cannabidiol, is increasing beyond that previously anticipated for 2015. The associated product development activities are related to process validation and commercialization activities, including qualification activities related to potential U.S. Food and Drug Administration submission support. Additionally, the DEA has also received notification from the National Institute on Drug Abuse (NIDA) that it required additional supplies of marijuana to be manufactured in 2015 to provide for ongoing and anticipated research efforts involving marijuana. NIDA is a component of the National Institutes of Health and the U.S. Department of Health and Human Services which oversees the cultivation, production and distribution of researchgrade marijuana on behalf of the United States Government, pursuant to the Single Convention on Narcotic Drugs (March 30, 1961, 18 UST 1407). The Administrator, therefore, proposes to adjust the 2015 aggregate production quotas for difenoxin, diphenoxylate (for conversion), and marijuana, expressed in grams of anhydrous acid or base, as follows: Notice of Intent To Grant a Partially Exclusive License Basic classschedule I asabaliauskas on DSK5VPTVN1PROD with NOTICES Difenoxin ... Marijuana .. Previously established 2015 quota 50 g 125,000 g Basic classschedule II Previously established 2015 quota Diphenoxylate (for conversion). Adjusted 2015 quota 9,000 g 400,000 g Zero ............ Adjusted 2015 quota 75,000 g 1 Difenoxin (schedule I) is the active pharmaceutical ingredient in the diarrhea preparation (schedule V). VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 [FR Doc. 2015–08042 Filed 4–7–15; 8:45 am] BILLING CODE 4410–09–P NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (15–026)] National Aeronautics and Space Administration. ACTION: Notice of Intent to Grant Partially Exclusive License. AGENCY: This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). NASA hereby gives notice of its intent to grant a partially exclusive license in the United States to practice the invention described and claimed in U.S. Patent No. 7,086,593 B2 titled ‘‘Magnetic Field Response Measurement Acquisition System,’’ NASA Case No. LAR–16908–1; U.S. Patent No. 7,159,774 B2 titled ‘‘Magnetic Field Response Measurement Acquisition System,’’ NASA Case No. LAR–17280–1; U.S. Patent No. 7,075,295 B2 titled ‘‘Magnetic Field Response Sensor for Conductive Media,’’ NASA Case No. LAR–16571–1; U.S. Patent No. 7,589,525 B2 titled ‘‘Magnetic Field Response Sensor for Conductive Media,’’ NASA Case No. LAR–16571–2; U.S. Patent No. 7,759,932 B2 titled ‘‘Magnetic Field Response Sensor for Conductive Media,’’ NASA Case No. LAR–16571–3; U.S. Patent No. 8,430,327 B2 titled ‘‘Wireless Sensing System Using OpenCircuit, Electrically-Conductive SpiralTrace Sensor,’’ NASA Case No. LAR– 17294–1; U.S. Patent No. 7,683,797 B2 titled ‘‘Damage Detection/Locating System Providing Thermal Protection,’’ NASA Case No. LAR–17295–1; U.S. Patent No. 7,902,815 B2 titled ‘‘Wireless System and Method for Collecting Motion and Non-Motion Related Data of a Rotating System,’’ NASA Case No. LAR–17433–1; U.S. Patent No. 8,042,739 B2 titled ‘‘Wireless Tamper Detection Sensor and Sensing System,’’ NASA Case No. LAR–17444–1; U.S. Patent No. 7,711,509 B2 titled ‘‘Method of Calibrating a Fluid-Level Measurement System,’’ NASA Case No. LAR–17480–1; U.S. Patent No. 7,814,786 B2 titled ‘‘Wireless Sensing System for Non-Invasive Monitoring of Attributes of Contents in a Container,’’ NASA Case No. LAR–17488–1; U.S. Patent No. 8,673,649 B2 titled ‘‘Wireless SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 18869 Chemical Sensor and Sensing Method for Use Therewith,’’ NASA Case No. LAR–17579–1; U.S. Patent Application No. 14/215,793 titled ‘‘Wireless Chemical Sensor and Sensing Method for Use Therewith,’’ NASA Case No. LAR–17579–2; U.S. Patent No. 8,167,204 B2 titled ‘‘Wireless Damage Location Sensing System,’’ NASA Case No. LAR–17593–1; U.S. Patent No. 8,179,203 B2 titled ‘‘Wireless Electrical Device Using Open-Circuit Elements Having No Electrical Connections,’’ NASA Case No. LAR–17711–1; U.S. Patent Application No. 14/193,861 titled ‘‘Wireless Temperature Sensing Having No Electrical Connections and Sensing Method for Use Therewith,’’ NASA Case No. LAR–17747–1–CON; U.S. Patent Application No. 13/796,626 titled ‘‘Method of Mapping Anomalies in Homogenous Material,’’ NASA Case No. LAR–17848–1 to GLSEQ, LLC having its principal place of business in Owens Cross Roads, Alabama. The fields of use may be limited to, but not necessarily be limited to, safety related and non-safety related instrumentation and control systems for nuclear facilities, including advanced safety related and non-safety related instrumentation systems for severe accident monitoring within nuclear power plants and nuclear storage facilities. The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective partially exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective partially exclusive license may be granted unless, within fifteen (15) days from the date of this published notice, NASA receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Competing applications completed and received by NASA within fifteen (15) days of the date of this published notice will also be treated as objections to the grant of the contemplated partially exclusive license. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. DATES: Objections relating to the prospective license may be submitted to Patent Counsel, Office of Chief Counsel, NASA Langley Research Center, MS 30, ADDRESSES: E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18867-18869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08042]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-411N]


Controlled Substances: Proposed Adjustments to the Aggregate 
Production Quotas for Difenoxin, Diphenoxylate (for conversion), and 
Marijuana

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration is proposing to adjust the 
established 2015 aggregate production quota for difenoxin, 
diphenoxylate (for conversion), and marijuana which are schedule I and 
II controlled substances under the Controlled Substances Act.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.13. Electronic comments must be submitted, 
and written comments must be postmarked, on or before May 8,

[[Page 18868]]

2015. Commenters should be aware that the electronic Federal Docket 
Management System will not accept comments after 11:59 p.m. Eastern 
Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-411N'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal which provides the ability to type short comments directly into 
the comment field on the Web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate electronic submissions are not 
necessary and are discouraged. Should you wish to mail a paper comment 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/ODXL, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want made publicly available in the 
first paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
has so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document is available at https://www.regulations.gov for easy reference.

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Section 306 of the CSA (21 U.S.C. 826) requires the Attorney 
General to establish aggregate production quotas for each basic class 
of controlled substance listed in schedules I and II each year. The 
Attorney General has delegated this function to the Administrator of 
the DEA, 28 CFR 0.100.

Background

    The DEA established the initial 2015 aggregate production quotas 
and assessments of annual need on September 8, 2014 (79 FR 53216). That 
notice stipulated that, as provided for in 21 CFR 1303.13, all 
aggregate production quotas and assessments of annual need are subject 
to adjustment.
    Based on unanticipated medical, scientific, research, and 
industrial needs of the United States the DEA proposes to adjust the 
established 2015 aggregate production quotas for the schedule I and II 
controlled substances difenoxin, diphenoxylate (for conversion), and 
marijuana to be manufactured in the United States in 2015. The 
adjustment is necessary to provide for the estimated medical, 
scientific, research, and industrial needs of the United States, lawful 
export requirements, and the establishment and maintenance of reserve 
stocks.
    In proposing the adjustment, the Administrator has taken into 
account the following criteria in accordance with 21 CFR 1303.13: (1) 
Changes in demand for the basic class, changes in the national rate of 
net disposal for the class, and changes in the rate of net disposal by 
the registrants holding individual manufacturing quotas for the class; 
(2) whether any increased demand or changes in the national and/or 
individual rates of net disposal are temporary, short term, or long 
term; (3) whether any increased demand for that class can be met 
through existing inventories, increased individual manufacturing 
quotas, or increased importation, without increasing the aggregate 
production quota; (4) whether any decreased demand will result in 
excessive inventory accumulation by all persons registered to handle 
the class; and (5) other factors affecting the medical, scientific, 
research, and industrial needs of the United States and lawful export 
requirements, as the Administrator finds relevant.

Analysis for Adjusting the Established 2015 Aggregate Production Quota 
for Difenoxin and Diphenoxylate (for Conversion)

    Since the establishment of the initial 2015 aggregate production 
quotas, the DEA has received requests from DEA registered manufacturers 
to manufacture difenoxin and diphenoxylate (for conversion) to support 
the manufacture

[[Page 18869]]

of prescription drug products approved by the Food and Drug 
Administration (FDA) for the treatment of chronic diarrhea and for the 
treatment of diarrhea associated with irritable bowel syndrome 
(IBS).\1\ These FDA approved products have not been manufactured since 
2009 due to FDA-regulated manufacturing issues and there is no existing 
generic or therapeutic equivalent.
---------------------------------------------------------------------------

    \1\ Difenoxin (schedule I) is the active pharmaceutical 
ingredient in the diarrhea preparation (schedule V).
---------------------------------------------------------------------------

Analysis for Adjusting the Established 2015 Aggregate Production Quota 
for Marijuana

    Since the establishment of the initial 2015 aggregate production 
quotas, the DEA has received notification from DEA registered 
manufacturers that research and product development involving 
cannabidiol, is increasing beyond that previously anticipated for 2015. 
The associated product development activities are related to process 
validation and commercialization activities, including qualification 
activities related to potential U.S. Food and Drug Administration 
submission support.
    Additionally, the DEA has also received notification from the 
National Institute on Drug Abuse (NIDA) that it required additional 
supplies of marijuana to be manufactured in 2015 to provide for ongoing 
and anticipated research efforts involving marijuana. NIDA is a 
component of the National Institutes of Health and the U.S. Department 
of Health and Human Services which oversees the cultivation, production 
and distribution of research-grade marijuana on behalf of the United 
States Government, pursuant to the Single Convention on Narcotic Drugs 
(March 30, 1961, 18 UST 1407).
    The Administrator, therefore, proposes to adjust the 2015 aggregate 
production quotas for difenoxin, diphenoxylate (for conversion), and 
marijuana, expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                            Previously
         Basic class-schedule I             established    Adjusted 2015
                                            2015 quota         quota
------------------------------------------------------------------------
Difenoxin...............................            50 g         9,000 g
Marijuana...............................       125,000 g       400,000 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                         Previously
      Basic class-schedule II         established 2015     Adjusted 2015
                                            quota              quota
------------------------------------------------------------------------
Diphenoxylate (for conversion)....  Zero................        75,000 g
------------------------------------------------------------------------


    Dated: April 1, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-08042 Filed 4-7-15; 8:45 am]
 BILLING CODE 4410-09-P
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