Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute, 91948 [2016-30368]

Download as PDF 91948 Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased: (a) Before October 1, 1995; (b) to comply with requirements not associated with the information collection; (c) for reasons other than to provide information or keep records for the Government; or (d) as part of customary and usual business or private practices. We will summarize written responses to this notice and address them in our submission for OMB approval. Please note that the comments submitted in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this IC. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB. Public Disclosure Statement: OMB regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act, 44 U.S.C. 3501–3521, require that interested members of the public and affected agencies be given an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8 (d) and 1320.12(a)). This notice identifies an information collection that the BOEM plans to submit to OMB for approval. The Paperwork Reduction Act provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. Public Availability of Comments: Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: December 9, 2016. Deanna Meyer-Pietruszka, Chief, Office of Policy, Regulation, and Analysis. [FR Doc. 2016–30353 Filed 12–16–16; 8:45 am] BILLING CODE 4310–MR–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before February 17, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. The Attorney General has delegated her 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 1301.33(a), this is notice that on March 13, 2015, Research Triangle Institute, Kenneth S. Rehder, Hermann Building, East Institute Drive, P.O. Box 12194, Research Triangle Park, North Carolina 27709–2194 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ sradovich on DSK3GMQ082PROD with NOTICES The company will manufacture marihuana (7360) and tetrahydrocannabinols (7370) for use by their researchers under the above-listed controlled substances as Active Pharmaceutical Ingredients (API) for clinical trials. 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: December 3, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016–30368 Filed 12–16–16; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 20:55 Dec 16, 2016 Jkt 241001 Comments are encouraged and will be accepted for 60 days until February 17, 2017. [OMB Number 1121—NEW] Agency Information Collection Activities; Proposed Collection Comments Requested; New Collection: Death in Custody Reporting Act Collection Bureau of Justice Assistance, Department of Justice. ACTION: 60-day notice. AGENCY: The Department of Justice (DOJ), Bureau of Justice Assistance will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 I I DATES: DEPARTMENT OF JUSTICE SUMMARY: 7360 7370 Schedule If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Chris Casto, Bureau of Justice Assistance, 810 Seventh Street NW., Washington, DC 20531 (email: DICRAComments@usdoj.gov; telephone: 202–616–6500). SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information FOR FURTHER INFORMATION CONTACT: E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Page 91948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30368]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Research 
Triangle Institute

ACTION: Notice of application.

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

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 in accordance with 21 CFR 
1301.33(a) on or before February 17, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 1301.33(a), this is notice that on March 
13, 2015, Research Triangle Institute, Kenneth S. Rehder, Hermann 
Building, East Institute Drive, P.O. Box 12194, Research Triangle Park, 
North Carolina 27709-2194 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
      Controlled substance           Drug code           Schedule
------------------------------------------------------------------------
Marihuana.......................            7360  I
Tetrahydrocannabinols...........            7370  I
------------------------------------------------------------------------

    The company will manufacture marihuana (7360) and 
tetrahydrocannabinols (7370) for use by their researchers under the 
above-listed controlled substances as Active Pharmaceutical Ingredients 
(API) for clinical trials.
    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: December 3, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-30368 Filed 12-16-16; 8:45 am]
 BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.