Importer of Controlled Substances Application: Sanyal Biotechnology, LLC, 13953 [2019-06854]

Download as PDF 13953 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices Written nominations must be postmarked by April 29, 2019. ADDRESSES: Please address and submit your nomination letters via U.S. mail or hand delivery to Mr. Jerome Ford, Assistant Director—Migratory Birds; Neotropical Migratory Bird Conservation Act Advisory Group; U.S. Fish and Wildlife Service; 5275 Leesburg Pike, MS:MB; Falls Church, VA 22041–3803. FOR FURTHER INFORMATION CONTACT: Kari Duncan by email (preferred) at kari_ duncan@fws.gov, by telephone at 703– 358–1784, by U.S. mail at the address in ADDRESSES, or via the Federal Relay Service at 1–800–877–8339. SUPPLEMENTARY INFORMATION: DATES: Background The Neotropical Migratory Bird Conservation Act (NMBCA or Act; 16 U.S.C. 6101 et seq.), promotes long-term conservation of neotropical migratory birds and their habitats through a competitive grants program by promoting partnerships and local conservation efforts, and achieving habitat protection in 36 countries. The goals of NMBCA include perpetuating healthy bird populations, providing financial resources for bird conservation, and fostering international cooperation. Because the greatest conservation need is south of the U.S. border, the Act requires that at least 75 percent of NMBCA funding supports projects outside the United States. Under the Act (16 U.S.C. 6106), the Secretary may convene an advisory group consisting of individuals representing public and private organizations actively involved in the conservation of neotropical migratory birds. Accordingly, since 2006, an advisory group has assisted in administration of the NMBCA. jbell on DSK30RV082PROD with NOTICES Advisory Group Duties The NMBCA Advisory Group provides advice to the Director of the U.S. Fish and Wildlife Service on progress toward program goals and on neotropical migratory bird conservation priorities, conducts outreach to partners to encourage collaboration and cooperative planning, communicates the need for program support, and contributes to a long-term strategic vision. Under statutory procedures established in the Act, the Advisory Group typically meets once a year to discuss the strategic direction and management of the NMBCA program. Advisory Group Membership As a whole, the Advisory Group shall have expertise in migratory bird VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 conservation and management throughout the Western Hemisphere. Currently, the Advisory Group includes Directors of State fish and wildlife agencies representing the four migratory bird flyways, the Director of the U.S. Fish and Wildlife Service, the Secretary of the Board of the National Fish and Wildlife Foundation, and nonprofit organizations engaged in migratory bird conservation activities. In the event that an appointment lapses, members continue to serve until reappointed or replaced. Nomination Method and Eligibility The Secretary seeks nominations for individuals who have expertise in migratory bird conservation and management throughout the Western Hemisphere to be considered to fill one vacancy to serve as a member of the Advisory Group. The member will be appointed to a three-year term that will expire on March 31, 2022. Nominations should include a resume that provides contact information and a description of the nominee’s qualifications that would enable the Department of the Interior to make an informed decision regarding the candidate’s suitability to serve on the Advisory Group. Dated: April 2, 2019. James W. Kurth, Deputy Director, U.S. Fish and Wildlife Service. [FR Doc. 2019–06828 Filed 4–5–19; 8:45 am] BILLING CODE 4333–15–P Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sanyal Biotechnology, LLC Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 8, 2019. Such persons may also file a written request for a hearing on the application on or before May 8, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, DATES: PO 00000 Frm 00092 Fmt 4703 Sfmt 9990 The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on January 7, 2019, Sanyal Biotechnology, LLC, 700 West Olney Road, Marioneaux Lab— Room 3159, Norfolk, Virginia 23507– 1607 applied to be registered as an importer of the following basic class of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance DEPARTMENT OF JUSTICE ACTION: 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Drug code Marihuana Extract Tetrahydrocannabinols. 7350 7370 Schedule I I The company plans to import finished dosage unit products containing marihuana extract for clinical trial studies. These cannabis extracts compounds are listed under drug code 7350. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or nonapproved finished dosage forms for commercial sale. Dated: March 21, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–06854 Filed 4–5–19; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Page 13953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06854]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Sanyal 
Biotechnology, LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before May 8, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before May 8, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
January 7, 2019, Sanyal Biotechnology, LLC, 700 West Olney Road, 
Marioneaux Lab--Room 3159, Norfolk, Virginia 23507-1607 applied to be 
registered as an importer of the following basic class of controlled 
substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Marihuana Extract....................         7350  I
Tetrahydrocannabinols................         7370  I
------------------------------------------------------------------------

    The company plans to import finished dosage unit products 
containing marihuana extract for clinical trial studies. These cannabis 
extracts compounds are listed under drug code 7350. No other activity 
for these drug codes is authorized for this registration. Approval of 
permit applications will occur only when the registrant's business 
activity is consistent with what is authorized under 21 U.S.C. 
952(a)(2). Authorization will not extend to the import of FDA-approved 
or non-approved finished dosage forms for commercial sale.

    Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06854 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P