Adjusted Aggregate Production Quotas for Difenoxin, Diphenoxylate (for Conversion), and Marijuana, 34693-34695 [2015-14910]

Download as PDF 34693 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices management strategies for Fire Island National Seashore for the next 15 to 20 years to support the protection of important natural resources and processes; significant recreation resources; cultural resources of national, state, and local significance; and residential communities. The park is composed of two distinct units—the barrier island that runs parallel to the south shore of Long Island and the 613-acre William Floyd Estate situated on the south shore of Long Island near the east end of Fire Island. To address the specific needs of these two distinct units, the Draft GMP/ EIS includes two sets of alternatives. One addresses park-wide alternatives for Fire Island National Seashore with a primary emphasis on the barrier island and includes a no-action alternative and two action alternatives. The other set of alternatives focuses specifically on the William Floyd Estate and includes a noaction and a single action alternative. The Draft GMP/EIS also incorporates plans for the Otis Pike High Dunes Fire Island Wilderness and includes a draft Wilderness Stewardship Plan for public review concurrent with the Draft GMP/ EIS. FOR FURTHER INFORMATION CONTACT: Ellen Carlson, NPS/Northeast Region, 15 State Street, Boston, MA 02019. Phone: (617) 223–5048. Email: Fire_Island_ GMP@nps.gov. Dated: June 1, 2015. Michael A. Caldwell, Regional Director, Northeast Region, National Park Service. [FR Doc. 2015–14927 Filed 6–16–15; 8:45 am] BILLING CODE 4310–WV–P continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. Background The Commission, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)), instituted these reviews on April 1, 2014 (79 FR 18311) and determined on July 7, 2014 that it would conduct full reviews (79 FR 42049, July 18, 2014). Notice of the scheduling of the Commission’s reviews and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register on November 14, 2014 (79 FR 68299). The hearing was held in Washington, DC, on March 26, 2015, and all persons who requested the opportunity were permitted to appear in person or by counsel. The Commission made these determinations pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on June 11, 2015. The views of the Commission are contained in USITC Publication 4538 (June 2015), entitled Citric Acid and Certain Citrate Salts from Canada and China: Investigation Nos. 701–TA–456 and 731–TA–1151– 1152 (Review). By order of the Commission. Issued: June 12, 2015. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2015–14863 Filed 6–16–15; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION DEPARTMENT OF JUSTICE [Investigation Nos. 701–TA–456 and 731– TA–1151–1152 (Review)] Drug Enforcement Administration asabaliauskas on DSK5VPTVN1PROD with NOTICES Citric Acid and Certain Citrate Salts From Canada and China [Docket No. DEA–392] Determination On the basis of the record 1 developed in the subject five-year reviews, the United States International Trade Commission (‘‘Commission’’) determines, pursuant to the Tariff Act of 1930, that revocation of the countervailing duty order on citric acid and certain citrate salts from China and the antidumping duty orders on citric acid and certain citrate salts from China and Canada would be likely to lead to 1 The record is defined in sec. 207.2(f) of the Commission’s Rules of Practice and Procedure (19 CFR 207.2(f)). VerDate Sep<11>2014 18:47 Jun 16, 2015 Jkt 235001 Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc. ACTION: Notice of registration. PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 Controlled substance Tetrahydrocannabinols (7370) ..... Ecgonine (9180) ........................... Morphine (9300) ........................... Thebaine (9333) ........................... Schedule I II II II The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator controls which are DEA exempt products. In reference to drug code 7370 the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Dated: June 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–14912 Filed 6–16–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Siemens Healthcare Diagnostics, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and published in SUMMARY: the Federal Register on January 26, 2015, 80 FR 3982, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 514, Newark, Delaware 19702 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Siemens Healthcare Diagnostics, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed: Drug Enforcement Administration [Docket No. DEA–411F] Adjusted Aggregate Production Quotas for Difenoxin, Diphenoxylate (for Conversion), and Marijuana Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: E:\FR\FM\17JNN1.SGM 17JNN1 34694 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices This final order establishes the adjusted 2015 aggregate production quotas for difenoxin, diphenoxylate (for conversion), and marijuana. DATES: This order is effective June 17, 2015. SUMMARY: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Legal Authority The 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 purposes 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 Controlled Substances Act (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 for annual need on September 8, 2014 (79 FR 53216). That notice stipulated that, as provided for in 21 CFR 1303.13 and 21 CFR 1315.13, 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 proposed 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 notice of proposed adjustment was published in the Federal Register on Wednesday, April 8, 2015 (80 FR 18867). All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas on or before May 8, 2015. Comments Received Two companies, one institution of higher education, and five private citizens submitted timely comments in response to the proposed adjustment of these three controlled substances. The comments from the institution of higher education and one of the private citizens were in support of the proposed increases for these three controlled substances. The two companies and one private citizen supported the proposed adjustment and requested further increases to the APQs to support research, additional product development efforts, and increases in manufacturing demands. Further comments received from three private citizens were outside the scope of the proposed APQ notice. The DEA appreciates the support for this adjusted 2015 aggregate production quota for difenoxin, diphenoxylate (for conversion), and marijuana, which is intended to provide for the estimated scientific, research, and industrial needs of the United States. Determination for Adjusting the Aggregate Production Quotas for Difenoxin, Diphenoxylate (for Conversion), and Marijuana In accordance with 21 CFR 1303.13, the DEA has taken into consideration the above comments along with the relevant 2014 year-end inventories, initial 2015 manufacturing quotas, 2015 export requirements, actual and projected 2015 sales, research and product development requirements, and information derived from additional applications for manufacturing quota received since the April 8, 2015 publication of the notice of proposed adjustments to the aggregate production quotas for difenoxin, diphenoxylate (for conversion), and marijuana. Upon consideration of the above, the Acting Administrator has determined to increase the 2015 aggregate production quotas for difenoxin and marijuana beyond that which was previously proposed. Regarding the aggregate production quota for diphenoxylate (for conversion), the Acting Administrator has determined that the proposed aggregate production quota adjustment for this substance is sufficient to meet the current 2015 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate reserve stock. Pursuant to the above, the Acting Administrator hereby establishes the 2015 aggregate production quotas for difenoxin, diphenoxylate (for conversion), and marijuana, expressed in grams of anhydrous acid or base, as follows: Previously established 2015 quota (g) Basic class—schedule I asabaliauskas on DSK5VPTVN1PROD with NOTICES Difenoxin .................................................................................................................................................................. Marijuana ................................................................................................................................................................. Diphenoxylate (for conversion) ................................................................................................................................ 18:47 Jun 16, 2015 Jkt 235001 PO 00000 Frm 00089 Fmt 4703 50 125,000 Previously established 2015 quota (g) Basic class—schedule II VerDate Sep<11>2014 Adjusted 2015 quota (g) Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1 11,000 658,000 Adjusted 2015 quota (g) 0 75,000 34695 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices Dated: June 11, 2015. Chuck Rosenberg, Acting Administrator. Background [FR Doc. 2015–14910 Filed 6–16–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–410F] Controlled Substances: 2015 Established Aggregate Production Quotas for Three Temporarily Controlled Synthetic Cannabinoids Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: This final order establishes the initial 2015 aggregate production quotas for three temporarily controlled synthetic cannabinoids: N-(1-amino-3methyl-1-oxobutan-2-yl)-1(cyclohexylmethyl)-1H-indazole-3carboxamide (AB-CHMINACA), N-(1amino-3-methyl-1-oxobutan-2-yl)-1pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1yl)methanone (THJ-2201). DATES: Effective June 17, 2015. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: SUMMARY: Section 306 of the Controlled Substances Act (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 and for ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this authority to the Administrator of the DEA. 28 CFR 0.100(b). On January 30, 2015, the DEA published in the Federal Register a final order to temporarily place three synthetic cannabinoids, N-(1-amino-3methyl-1-oxobutan-2-yl)-1(cyclohexylmethyl)-1H-indazole-3carboxamide (AB-CHMINACA), N-(1amino-3-methyl-1-oxobutan-2-yl)-1pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1yl)methanone (THJ-2201), into schedule I of the CSA (80 FR 5042), making all regulatory controls pertaining to schedule I controlled substances applicable to AB-CHMINACA, ABPINACA, and THJ-2201, including the requirement to obtain a manufacturing quota pursuant to 21 CFR part 1303. The 2015 aggregate production quotas for AB-CHMINACA, AB-PINACA, and THJ-2201 represent those quantities that may be manufactured in the United States in 2015 to provide for the estimated scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. On March 20, 2015, the DEA published a notice titled, ‘‘Controlled Substances: 2015 Proposed Aggregate Production Quotas for Three Temporarily Controlled Synthetic Cannabinoids’’ in the Federal Register (80 FR 15034). That notice proposed the 2015 aggregate production quotas for AB-CHMINACA, AB-PINACA, and THJ2201. Interested persons were invited to comment on or object to the proposed aggregate production quotas for ABCHMINACA, AB-PINACA, and THJ2201 on or before April 20, 2015. No comments were received. Analysis for 2015 Established Aggregate Production Quotas In determining the 2015 aggregate production quotas for N-(1-amino-3methyl-1-oxobutan-2-yl)-1(cyclohexylmethyl)-1H-indazole-3carboxamide (AB-CHMINACA), N-(1amino-3-methyl-1-oxobutan-2-yl)-1pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1yl)methanone (THJ-2201), the DEA has taken into consideration the factors set forth at 21 CFR 1303.11, pursuant to 21 U.S.C. 826(a), and other relevant factors, including 2015 export requirements, industrial use, applications for quotas, as well as information on research and product development requirements. Pursuant to 21 U.S.C. 826 and in accordance with 21 CFR 1303.11, the Acting Administrator hereby establishes the 2015 aggregate production quotas for AB-CHMINACA, AB-PINACA, and THJ2201, expressed in grams of anhydrous acid or base, as follows: Established 2015 quota (g) Basic class—schedule I N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) ................................. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) .......................................................... [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) .................................................................................. asabaliauskas on DSK5VPTVN1PROD with NOTICES In accordance with 21 CFR 1303.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2015 aggregate production quotas for AB-CHMINACA, ABPINACA, and THJ-2201 as needed. Dated: June 11, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015–14909 Filed 6–16–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:47 Jun 16, 2015 Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Mylan Technologies, Inc. ACTION: Jkt 235001 Notice of registration. Mylan Technologies, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Technologies, Inc. registration as an importer of those controlled substances. SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 By notice dated February 11, 2015, and published in the Federal Register on February 19, 2015, 80 FR 8902, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Mylan Technologies, Inc. to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE 15 15 15 E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34693-34695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14910]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-411F]


Adjusted Aggregate Production Quotas for Difenoxin, Diphenoxylate 
(for Conversion), and Marijuana

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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

[[Page 34694]]

SUMMARY: This final order establishes the adjusted 2015 aggregate 
production quotas for difenoxin, diphenoxylate (for conversion), and 
marijuana.

DATES: This order is effective June 17, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The 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 purposes 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 Controlled Substances Act (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 for annual need on September 8, 2014 (79 FR 53216). 
That notice stipulated that, as provided for in 21 CFR 1303.13 and 21 
CFR 1315.13, 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 proposed 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 notice of proposed adjustment was published 
in the Federal Register on Wednesday, April 8, 2015 (80 FR 18867). All 
interested persons were invited to comment on or object to the proposed 
adjusted aggregate production quotas on or before May 8, 2015.

Comments Received

    Two companies, one institution of higher education, and five 
private citizens submitted timely comments in response to the proposed 
adjustment of these three controlled substances. The comments from the 
institution of higher education and one of the private citizens were in 
support of the proposed increases for these three controlled 
substances. The two companies and one private citizen supported the 
proposed adjustment and requested further increases to the APQs to 
support research, additional product development efforts, and increases 
in manufacturing demands. Further comments received from three private 
citizens were outside the scope of the proposed APQ notice. The DEA 
appreciates the support for this adjusted 2015 aggregate production 
quota for difenoxin, diphenoxylate (for conversion), and marijuana, 
which is intended to provide for the estimated scientific, research, 
and industrial needs of the United States.

Determination for Adjusting the Aggregate Production Quotas for 
Difenoxin, Diphenoxylate (for Conversion), and Marijuana

    In accordance with 21 CFR 1303.13, the DEA has taken into 
consideration the above comments along with the relevant 2014 year-end 
inventories, initial 2015 manufacturing quotas, 2015 export 
requirements, actual and projected 2015 sales, research and product 
development requirements, and information derived from additional 
applications for manufacturing quota received since the April 8, 2015 
publication of the notice of proposed adjustments to the aggregate 
production quotas for difenoxin, diphenoxylate (for conversion), and 
marijuana. Upon consideration of the above, the Acting Administrator 
has determined to increase the 2015 aggregate production quotas for 
difenoxin and marijuana beyond that which was previously proposed. 
Regarding the aggregate production quota for diphenoxylate (for 
conversion), the Acting Administrator has determined that the proposed 
aggregate production quota adjustment for this substance is sufficient 
to meet the current 2015 estimated medical, scientific, research, and 
industrial needs of the United States and to provide for adequate 
reserve stock.
    Pursuant to the above, the Acting Administrator hereby establishes 
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 (g)     quota (g)
------------------------------------------------------------------------
Difenoxin...............................              50          11,000
Marijuana...............................         125,000         658,000
------------------------------------------------------------------------


------------------------------------------------------------------------
                                            Previously
        Basic class--schedule II            established    Adjusted 2015
                                          2015 quota (g)     quota (g)
------------------------------------------------------------------------
Diphenoxylate (for conversion)..........               0          75,000
------------------------------------------------------------------------



[[Page 34695]]

    Dated: June 11, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-14910 Filed 6-16-15; 8:45 am]
 BILLING CODE 4410-09-P
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