80 FR 61470 - Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 197 (October 13, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 197 (October 13, 2015)
| Page Range | 61470-61471 | |
| FR Document | 2015-25880 |
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)] [Notices] [Pages 61470-61471] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25880] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals 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 December 14, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy 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 August 6, 2015, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled Substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I Remifentanil (9739)........................ II ------------------------------------------------------------------------ [[Page 61471]] The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug codes 7360 marihuana and 7370 tetrahydrocannabinols the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration. Dated: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-25880 Filed 10-9-15; 8:45 am] BILLING CODE 4410-09-P
![61470 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
SUPPLEMENTARY INFORMATION: The Dated: October 2, 2015. Dated: October 2, 2015.
Attorney General has delegated her Louis J. Milione, Louis J. Milione,
authority under the Controlled Deputy Assistant Administrator. Deputy Assistant Administrator.
Substances Act to the Administrator of [FR Doc. 2015–25882 Filed 10–9–15; 8:45 am] [FR Doc. 2015–25879 Filed 10–9–15; 8:45 am]
the Drug Enforcement Administration BILLING CODE 4410–09–P BILLING CODE 4410–09–P
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE
implementation of 21 CFR part 1301,
incident to the registration of Drug Enforcement Administration Drug Enforcement Administration
manufacturers, distributors, dispensers, [Docket No. DEA–392]
importers, and exporters of controlled [Docket No. DEA–392]
substances (other than final orders in Bulk Manufacturer of Controlled
connection with suspension, denial, or Bulk Manufacturer of Controlled Substances Application: Apertus
revocation of registration) has been Substances Application: Cambridge Pharmaceuticals
redelegated to the Deputy Assistant Isotope Lab
Administrator of the DEA Office of ACTION: Notice of application.
Diversion Control (‘‘Deputy Assistant ACTION: Notice of application.
Administrator’’) pursuant to section 7 of DATES: Registered bulk manufacturers of
28 CFR part 0, appendix to subpart R. DATES: Registered bulk manufacturers of the affected basic classes, and
In accordance with 21 CFR the affected basic class, and applicants applicants therefore, may file written
1301.33(a), this is notice that on August therefore, may file written comments on comments on or objections to the
10, 2015, American Radiolabeled or objections to the issuance of the issuance of the proposed registration in
Chemicals, Inc., 101 Arc Drive, St. proposed registration in accordance accordance with 21 CFR 1301.33(a) on
Louis, Missouri 63146 applied to be with 21 CFR 1301.33(a) on or before or before December 14, 2015.
registered as a bulk manufacturer of the December 14, 2015. ADDRESSES: Written comments should
following basic classes of controlled ADDRESSES: Written comments should be sent to: Drug Enforcement
substances: be sent to: Drug Enforcement Administration, Attention: DEA Federal
Administration, Attention: DEA Federal Register Representative/ODXL, 8701
Controlled substance Schedule Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia
Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be
Gamma Hydroxybutyric Acid 22152. Request for hearings should be sent to: Drug Enforcement
(2010) ........................................ I sent to: Drug Enforcement
Ibogaine (7260) ............................ I
Administration, Attention: Hearing
Lysergic Acid diethylamide (7315) I
Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive,
Tetrahydrocannabinols (7370) ...... I Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
Dimethyltryptamine (7435) ........... I Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The
1-[1-(2- SUPPLEMENTARY INFORMATION: Attorney General has delegated her
Thienyl)cyclohexyl]piperidine The Attorney General has delegated authority under the Controlled
(7470) ........................................ I her authority under the Controlled Substances Act to the Administrator of
Dihydromorphine (9145) ............... I
Substances Act to the Administrator of the Drug Enforcement Administration
Heroin (9200) ................................ I
Normorphine (9313) ..................... I the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to
Amphetamine (1100) .................... II (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with
Methamphetamine (1105) ............ II exercise all necessary functions with respect to the promulgation and
Amobarbital (2125) ....................... II respect to the promulgation and implementation of 21 CFR part 1301,
Phencyclidine (7471) .................... II implementation of 21 CFR part 1301, incident to the registration of
Phenylacetone (8501) .................. II incident to the registration of manufacturers, distributors, dispensers,
Cocaine (9041) ............................. II manufacturers, distributors, dispensers, importers, and exporters of controlled
Codeine (9050) ............................. II importers, and exporters of controlled substances (other than final orders in
Dihydrocodeine (9120) ................. II
substances (other than final orders in connection with suspension, denial, or
Oxycodone (9143) ........................ II
Hydromorphone (9150) ................ II connection with suspension, denial, or revocation of registration) has been
Ecgonine (9180) ........................... II revocation of registration) has been redelegated to the Deputy Assistant
Hydrocodone (9193) ..................... II redelegated to the Deputy Assistant Administrator of the DEA Office of
Meperidine (9230) ........................ II Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant
Metazocine (9240) ........................ II Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of
Methadone (9250) ........................ II Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
Dextropropoxyphene, bulk (non- 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR
dosage forms) (9273) ............... II In accordance with 21 CFR 1301.33(a), this is notice that on August
Morphine (9300) ........................... II
1301.33(a), this is notice that on August 6, 2015, Apertus Pharmaceuticals, 331
Oripavine (9330) ........................... II
Thebaine (9333) ........................... II 7, 2015, Cambridge Isotope Lab, 50 Consort Drive, St. Louis, Missouri 63011
Oxymorphone (9652) .................... II Frontage Road, Andover, Massachusetts applied to be registered as a bulk
mstockstill on DSK4VPTVN1PROD with NOTICES
Phenazocine (9715) ..................... II 01810 applied to be registered as a bulk manufacturer of the following basic
Carfentanil (9743) ......................... II manufacturer of morphine (9300), a classes of controlled substances:
Fentanyl (9801) ............................ II basic class of controlled substance listed
in schedule II. Controlled Substance Schedule
The company plans to manufacture The company plans to utilize small
small quantities of the listed controlled quantities of the listed controlled Marihuana (7360) ......................... I
Tetrahydrocannabinols (7370) ..... I
substances as radiolabeled compounds substance in the preparation of Remifentanil (9739) ...................... II
for biochemical research. analytical standards.
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![Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61471
The company plans to manufacture functions of the agency, including respond: There are approximately
the above-listed controlled substances whether the information will have 27,225 respondents who will require an
in bulk for distribution to its customers. practical utility; average of 10 minutes (ranging from 5 to
In reference to drug codes 7360 —Evaluate the accuracy of the 15 minutes across all forms) to respond
marihuana and 7370 agency’s estimate of the burden of the to a single form each year.
tetrahydrocannabinols the company proposed collection of information, 6. An estimate of the total public
plans to bulk manufacture both as including the validity of the burden (in hours) associated with the
synthetic substances. methodology and assumptions used; collection: The total annual public
No other activity for these drug codes —Evaluate whether and if so how the burden hours for this information
is authorized for this registration. quality, utility, and clarity of the collection are estimated to be 5,075
Dated: October 2, 2015. information to be collected can be hours.
enhanced; and If additional information is required
Louis J. Milione,
—Minimize the burden of the contact: Jerri Murray, Department
Deputy Assistant Administrator. collection of information on those who Clearance Officer, United States
[FR Doc. 2015–25880 Filed 10–9–15; 8:45 am] are to respond, including through the Department of Justice, Justice
BILLING CODE 4410–09–P use of appropriate automated, Management Division, Policy and
electronic, mechanical, or other Planning Staff, Two Constitution
technological collection techniques or Square, 145 N Street NE., 3E.405B,
DEPARTMENT OF JUSTICE other forms of information technology, Washington, DC 20530.
[OMB Numbers 1121–0341] e.g., permitting electronic submission of Dated: October 6, 2015.
responses. Jerri Murray,
Agency Information Collection Overview of this information
Department Clearance Officer for PRA, U.S.
Activities; Proposed Collection; collection: Department of Justice.
Comments Requested; Revision of a 1. Type of Information Collection:
[FR Doc. 2015–25873 Filed 10–9–15; 8:45 am]
Currently Approved Collection: Office Revision of Existing Collection.
2. The Title of the Form/Collection: BILLING CODE 4410–18–P
for Victims of Crime Training and
Technical Assistance Center (OVC OVC TTAC Feedback Form Package.
TTAC) Feedback Form Package 3. The agency form number, if any,
and the applicable component of the DEPARTMENT OF LABOR
AGENCY: Office for Victims of Crime, Department sponsoring the collection:
Department of Justice. N/A. Office for Victims of Crime, Office Employment and Training
ACTION: 60-Day notice. of Justice Programs, Department of Administration
SUMMARY: The Department of Justice Justice. Renewal of the Native American
4. Affected public who will be asked
(DOJ), Office of Justice Programs, Office Employment and Training Council
or required to respond, as well as a brief
for Victims of Crime, will be submitting (NAETC) Charter
abstract:
the following information collection Primary: State, Local, or Tribal AGENCY: Employment and Training
request to the Office of Management and agencies/organizations. Other: Federal Administration, Labor.
Budget (OMB) for review and approval Government; Individuals or households; ACTION: Renewal of the Native American
in accordance with the Paperwork Not-for-profit institutions; Businesses or
Reduction Act of 1995. The following Employment and Training Council
other for-profit. (NAETC) Charter.
collections (1121–0336 and 1121–0342) Abstract: The Office for Victims of
will be discontinued and combined Crime Training and Technical SUMMARY: Notice is hereby given of the
with this revision of 1121–0341. Assistance Center (OVC TTAC) renewal of the Workforce Innovation
DATES: Comments are encouraged and Feedback Form Package is designed to and Opportunity Act (WIOA), section
will be accepted for 60 days until collect the data necessary to 166 Indian and Native American
December 14, 2015. continuously assess the satisfaction and Programs Charter that is necessary and
FOR FURTHER INFORMATION CONTACT: If outcomes of assistance provided in the public interest. Accordingly, the
you have comments, especially on the through OVC TTAC for both monitoring U.S. Department of Labor (the
estimated public burden or associated and accountability purposes to Department), Employment and Training
response time, suggestions, or need a continuously meet the needs of the Administration (ETA) has renewed the
copy of the proposed information victim services field. OVC TTAC will NAETC Charter for two years with
collection instrument with instructions give these forms to recipients of training revisions. The revisions are not
or additional information, please and technical assistance, scholarship intended to change the purpose or the
contact Shelby Jones Crawford, Program applicants, users of the Web site and Council’s original intent. The revisions
Manager, Office for Victims of Crime, call center, consultants/instructors include language regarding the use of
Office of Justice Programs, Department providing training, agencies requesting proxies and changes to the membership
of Justice, 810 7th Street NW., services, and other professionals balance plan. The Council Charter
Washington, DC 20530. receiving assistance from OVC TTAC. expired on September 9, 2015.
SUPPLEMENTARY INFORMATION: Written The purpose of this data collection will SUPPLEMENTARY INFORMATION:
comments and suggestions from the be to capture important feedback on the Background: Pursuant to WIOA
mstockstill on DSK4VPTVN1PROD with NOTICES
public and affected agencies concerning respondents’ satisfaction and outcomes section 166(i)(4)(C), the NAETC advises
the proposed collection of information of the resources provided. The data will the Secretary on the operation and
are encouraged. Your comments should then be used to advise OVC on ways to administration of the Native American
address one or more of the following improve the support that it provides to programs authorized under section 166
four points: the victim services field at-large. of WIOA. In addition, the Council
—Evaluate whether the proposed 5. An estimate of the total number of advises the Secretary on matters that
collection of information is necessary respondents and the amount of time promote the employment and training
for the proper performance of the estimated for an average respondent to needs of Indian and Native Americans,
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Document Created: 2018-02-27 08:48:10
Document Modified: 2018-02-27 08:48:10
| 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 | Notices | |
| 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 December 14, 2015. | |
| FR Citation | 80 FR 61470 |
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