83 FR 39127 - Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 153 (August 8, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 153 (August 8, 2018)
| Page Range | 39127-39128 | |
| FR Document | 2018-16939 |
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)] [Notices] [Pages 39127-39128] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16939] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc. 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 on or before September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be [[Page 39128]] sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 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 June 29, 2018, Clinical Supplies Management Holdings, Inc., 342 42nd Street South, Fargo, North Dakota 58103-1132 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Marihuana.............................. 7360 I Tetrahydrocannabinols.................. 7370 I ------------------------------------------------------------------------ The company plans to import the listed controlled substances to manufacture bulk controlled substances for use in clinical trials only. Dated: July 31, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-16939 Filed 8-7-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 39127
appropriate Indian Tribes or Native Suffolk County, NY. In 1926, the town cannot be reasonably traced between the
Hawaiian organizations, and has of Southampton donated the human Native American human remains and
determined that there is no cultural remains, which consist of the cranial any present-day Indian Tribe.
affiliation between the human remains fragments of one adult, to the Museum • Authoritative governmental
and any present-day Indian Tribes or of the American Indian, Heye documents, including the Shinnecock
Native Hawaiian organizations. Foundation. They were accessioned into Indian Nation’s federal recognition
Representatives of any Indian Tribe or the collection of the Department of decision, state agreements, and local
Native Hawaiian organization not Physical Anthropology of the Museum property records indicate that the land
identified in this notice that wish to of the American Indian, Heye from which the Native American human
request transfer of control of these Foundation that same year. In 1956, the remains were removed is the aboriginal
human remains should submit a written human remains were transferred to Dr. land of the Shinnecock Indian Nation.
request to the NYU College of Dentistry. Theodore Kazamiroff, NYU College of • Pursuant to 43 CFR 10.11(c)(1), the
If no additional requestors come Dentistry. No known individuals were disposition of the human remains may
forward, transfer of control of the identified. No associated funerary be to the Shinnecock Indian Nation.
human remains to the Indian Tribes or objects are present. The age of the
Additional Requestors and Disposition
Native Hawaiian organizations stated in human remains cannot be determined
this notice may proceed. from the available information. Forensic Representatives of any Indian Tribe or
DATES: Representatives of any Indian examination revealed diagnostic Native Hawaiian organization not
Tribe or Native Hawaiian organization features of an individual with Native identified in this notice that wish to
not identified in this notice that wish to American ancestry. Without any request transfer of control of these
request transfer of control of these information about the site or age of the human remains should submit a written
human remains should submit a written remains, no identifiable earlier group request with information in support of
request with information in support of can be determined. the request to Dr. Louis Terracio, NYU
the request to the NYU College of Shinnecock Hills, which lies near the College of Dentistry, 345 East 24th
Dentistry at the address in this notice by northeastern end of Long Island, is not Street, New York, NY 10010, telephone
included in any treaties, Acts of (212) 998–9717, email louis.terracio@
September 7, 2018.
Congress, or Executive Orders that nyu.edu, by September 7, 2018. After
ADDRESSES: Dr. Louis Terracio, NYU
establish aboriginal land. The area is, that date, if no additional requestors
College of Dentistry, 345 East 24th however, within territory that was long have come forward, transfer of control
Street, New York, NY 10010, telephone recognized by the tribe, the town of of the human remains to the Shinnecock
(212) 998–9717, email louis.terracio@ Southampton, and the state of New York Indian Nation may proceed.
nyu.edu. as Shinnecock land. In 1703, the The NYU College of Dentistry is
SUPPLEMENTARY INFORMATION: Notice is Shinnecock and town of Southampton responsible for notifying the Shinnecock
here given in accordance with the reached an agreement in which the Indian Nation that this notice has been
Native American Graves Protection and Shinnecock held a 1,000 year lease of published.
Repatriation Act (NAGPRA), 25 U.S.C. approximately 3,500 acres, including Dated: June 29, 2018.
3003, of the completion of an inventory Shinnecock Hills. The area was Melanie O’Brien,
of human remains under the control of subsequently referred to as the
Manager, National NAGPRA Program.
the NYU College of Dentistry, New York Shinnecock Reservation in various state
[FR Doc. 2018–16920 Filed 8–7–18; 8:45 am]
City, NY. The human remains were and local documents. The Shinnecock
removed from Shinnecock Hills, Suffolk BILLING CODE 4312–52–P
renegotiated their lease in 1859 and
County, Long Island, NY. relinquished the lands at Shinnecock
This notice is published as part of the Hills in exchange for fee title to the land
National Park Service’s administrative at Shinnecock Neck. The current DEPARTMENT OF JUSTICE
responsibilities under NAGPRA, 25 Shinnecock Reservation, which no
U.S.C. 3003(d)(3) and 43 CFR 10.11(d). longer includes Shinnecock Hills, was Drug Enforcement Administration
The determinations in this notice are placed into trust after the tribe was [Docket No. DEA–392]
the sole responsibility of the museum, federally recognized in 2010. The
institution, or Federal agency that has Department of Interior proposed finding Importer of Controlled Substances
control of the Native American human on the Shinnecock petition for federal Application: Clinical Supplies
remains. The National Park Service is recognition identifies Shinnecock Hills Management Holdings, Inc.
not responsible for the determinations as part of the pre-1859 Shinnecock
in this notice. Reservation. ACTION: Notice of application.
Consultation Determinations Made by the NYU DATES: Registered bulk manufacturers of
A detailed assessment of the human College of Dentistry the affected basic classes, and
remains was made by the NYU College Officials of the NYU College of applicants therefore, may file written
of Dentistry professional staff in Dentistry have determined that: comments on or objections to the
consultation with representatives of the • Pursuant to 25 U.S.C. 3001(9), the issuance of the proposed registration on
Delaware Nation, Oklahoma; Delaware human remains described in this notice or before September 7, 2018. Such
Tribe of Indians; Shinnecock Indian are Native American based on persons may also file a written request
for a hearing on the application on or
sradovich on DSK3GMQ082PROD with NOTICES
Nation; and Stockbridge Munsee diagnostic cranial features observed
Community, Wisconsin. during forensic examination. before September 7, 2018.
• Pursuant to 25 U.S.C. 3001(9), the ADDRESSES: Written comments should
History and Description of the Remains human remains described in this notice be sent to: Drug Enforcement
At an unknown date, human remains represent the physical remains of one Administration, Attention: DEA Federal
representing, at minimum, one individual of Native American ancestry. Register Representative/DRW, 8701
individual were removed from an • Pursuant to 25 U.S.C. 3001(2), a Morrissette Drive, Springfield, Virginia
unknown site in Shinnecock Hills, relationship of shared group identity 22152. All requests for hearing must be
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![39128 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
sent to: Drug Enforcement Drug Administration, Attn: Administrator,
Controlled substance Schedule
Administration, Attn: Administrator, code 8701 Morrissette Drive, Springfield,
8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing
Marihuana ..................... 7360 I should also be sent to: (1) Drug
Virginia 22152. All request for hearing
Tetrahydrocannabinols 7370 I
should also be sent to: (1) Drug Enforcement Administration, Attn:
Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette
The company plans to import the
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and
listed controlled substances to
Drive, Springfield, Virginia 22152; and manufacture bulk controlled substances (2) Drug Enforcement Administration,
(2) Drug Enforcement Administration, for use in clinical trials only. Attn: DEA Federal Register
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette
Dated: July 31, 2018. Drive, Springfield, Virginia 22152.
Representative/DRW, 8701 Morrissette John J. Martin,
Drive, Springfield, Virginia 22152. Comments and requests for hearings on
Assistant Administrator. applications to import narcotic raw
SUPPLEMENTARY INFORMATION: The [FR Doc. 2018–16939 Filed 8–7–18; 8:45 am] material are not appropriate. 72 FR
Attorney General has delegated his BILLING CODE 4410–09–P 3417, (January 25, 2007)
authority under the Controlled SUPPLEMENTARY INFORMATION: The
Substances Act to the Administrator of Attorney General has delegated his
the Drug Enforcement Administration DEPARTMENT OF JUSTICE
authority under the Controlled
(DEA), 28 CFR 0.100(b). Authority to Substances Act to the Administrator of
Drug Enforcement Administration
exercise all necessary functions with the Drug Enforcement Administration
respect to the promulgation and [Docket No. DEA–392] (DEA), 28 CFR 0.100(b). Authority to
implementation of 21 CFR part 1301, exercise all necessary functions with
Importer of Controlled Substances
incident to the registration of respect to the promulgation and
Application: AndersonBrecon Inc.
manufacturers, distributors, dispensers, implementation of 21 CFR part 1301,
importers, and exporters of controlled ACTION: Notice of application. incident to the registration of
substances (other than final orders in manufacturers, distributors, dispensers,
connection with suspension, denial, or DATES: Registered bulk manufacturers of importers, and exporters of controlled
revocation of registration) has been the affected basic classes, and substances (other than final orders in
redelegated to the Assistant applicants therefore, may file written connection with suspension, denial, or
Administrator of the DEA Diversion comments on or objections to the revocation of registration) has been
Control Division (‘‘Assistant issuance of the proposed registration on redelegated to the Assistant
Administrator’’) pursuant to section 7 of or before September 7, 2018. Such Administrator of the DEA Diversion
28 CFR part 0, appendix to subpart R. persons may also file a written request Control Division (‘‘Assistant
for a hearing on the application on or Administrator’’) pursuant to section 7 of
In accordance with 21 CFR before September 7, 2018. 28 CFR part 0, appendix to subpart R.
1301.34(a), this is notice that on June ADDRESSES: Written comments should In accordance with 21 CFR
29, 2018, Clinical Supplies Management be sent to: Drug Enforcement 1301.34(a), this is notice that on May 2,
Holdings, Inc., 342 42nd Street South, Administration, Attention: DEA Federal 2018, AndersonBrecon Inc., 5775
Fargo, North Dakota 58103–1132 Register Representative/DRW, 8701 Logistics Parkway, Rockford, Illinois
applied to be registered as an importer Morrissette Drive, Springfield, Virginia 61109 applied to be registered as an
of the following basic classes of 22152. All requests for hearing must be importer of the following basic class of
controlled substances: sent to: Drug Enforcement controlled substance:
Drug
Controlled substance Schedule
code
Tetrahydrocannabinols ......................................................................................................................................... 7370 I
The company plans to import the Dated: July 31, 2018. SUMMARY: Registrants listed below have
listed controlled substances for clinical John J. Martin, applied for and been granted
trial only. Approval of permit Assistant Administrator. registration by-the Drug Enforcement
applications will occur only when the [FR Doc. 2018–16937 Filed 8–7–18; 8:45 am] Administration (DEA) as importers of
registrant’s business activity is BILLING CODE 4410–09–P various classes of schedule I or II
consistent with what is authorized controlled substances.
under 21 U.S.C. 952(a)(2).
DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: The
Authorization will not extend to the companies listed below applied to be
import of FDA approved or non- Drug Enforcement Administration registered as importers of various basic
approved finished dosage forms for classes of controlled substances.
[Docket No. DEA–392]
commercial sale. Information on previously published
sradovich on DSK3GMQ082PROD with NOTICES
Importer of Controlled Substances notices is listed in the table below. No
Registration comments or objections were submitted
and no requests for hearing were
ACTION: Notice of registration. submitted for these notices.
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Document Created: 2018-08-08 02:06:41
Document Modified: 2018-08-08 02:06:41
| 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 on or before September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018. | |
| FR Citation | 83 FR 39127 |
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