82 FR 56993 - Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 230 (December 1, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 230 (December 1, 2017)
| Page Range | 56993-56994 | |
| FR Document | 2017-25916 |
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)] [Notices] [Pages 56993-56994] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25916] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc. AGENCY: Drug Enforcement Administration, Department of Justice. [[Page 56994]] 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 January 30, 2018. 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 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 1301.33(a), this is notice that on August 11, 2017, Nanosyn, Inc., Nanoscale Combinatorial Synthesis, 3331-B Industrial Drive, Santa Rosa, California 95403 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Oxymorphone............................ 9652 II Fentanyl............................... 9801 II ------------------------------------------------------------------------ The company is a contract manufacturer. At the request of the company's customers, it manufactures derivatives of controlled substances in bulk form. Dated: November 24, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-25916 Filed 11-30-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices 56993
The Status of Respondent’s State substances.’’ With respect to a ‘‘an individual who practices
License practitioner, the DEA has also long held medicine,’’ and a ‘‘licensed physician’’
On May 9, 2017, the Executive that the possession of authority to is a physician ‘‘who is licensed by the
Director of the Maryland State Board of dispense controlled substances under Board [of Physicians] to practice
Physicians signed a 34-page Order the laws of the State in which a medicine.’’ West’s MD Code Ann.,
summarily suspending Respondent’s practitioner engages in professional Health Occupations, § 14–101(m) and (i)
license to practice medicine. GX 3. The practice is a fundamental condition for (2017). Further, in Maryland, to
obtaining and maintaining a ‘‘practice medicine’’ means ‘‘to engage
Order of Summary Suspension
practitioner’s registration. See, e.g., . . . in medical (i) Diagnosis; (ii)
discussed numerous complaints against
James L. Hooper, M.D., 76 FR 71,371 Healing; (iii) Treatment; or (iv)
Respondent, including complaints about
(2011), pet. for rev. denied, 481 Fed. Surgery.’’ Id. at § 14–101(o)(1)(i-iv).
Respondent’s controlled substance
Appx. 826 (4th Cir. 2012); Frederick Thus, in Maryland, a physician may be
prescribing practices, the conclusions of
Marsh Blanton, M.D., 43 FR 27,616, authorized to dispense controlled
an independent peer review agency that
27,617 (1978). substances only if he is licensed to
Respondent did not meet quality This rule derives from the text of two practice medicine.
standards for pain medicine, and provisions of the CSA. First, Congress In this case, the Maryland State Board
allegations concerning Respondent’s defined the term ‘‘ ‘practitioner’ [to] of Physicians suspended Respondent’s
unprofessional conduct. Id. The Order mean[ ] a physician . . . or other person license to practice medicine.
of Summary Suspension concluded that licensed, registered, or otherwise Consequently, Respondent is not
Respondent acted unprofessionally in permitted, by . . . the jurisdiction in currently eligible to handle controlled
his pain medicine practice, among other which he practices . . ., to distribute, substances in the State of Maryland, the
areas, and determined that the public dispense, . . . [or] administer . . . a State in which he is registered with the
health, safety, or welfare imperatively controlled substance in the course of Agency and, therefore, he is not entitled
required the emergency action of the professional practice.’’ 21 U.S.C. to maintain his DEA registration.
suspension of Respondent’s medical 802(21). Second, in setting the Hooper, supra; Blanton, supra.
license. Id. at 31–32. The terms of the requirements for obtaining a Accordingly, I will order that
Order of Summary Suspension included practitioner’s registration, Congress Respondent’s registration be revoked
the requirement that Respondent directed that ‘‘[t]he Attorney General and that any pending application for the
surrender his original Maryland license shall register practitioners . . . if the renewal or modification of his
D26832 and his current license renewal applicant is authorized to dispense . . . registration be denied. 21 U.S.C.
certificate. Id. at 33. controlled substances under the laws of 824(a)(3).
On July 11, 2017, the DEA Diversion the State in which he practices.’’ 21
Investigator assigned to the Order
U.S.C. 823(f). Because Congress has
investigation of Respondent clearly mandated that a practitioner Pursuant to the authority vested in me
(hereinafter, DI) signed a Declaration. possess State authority in order to be by 21 U.S.C. 824(a), as well as 28 CFR
GX 4. In that Declaration, the DI stated deemed a practitioner under the CSA, 0.100(b), I order that DEA Certificate of
that Respondent’s license to practice the DEA has held repeatedly that Registration AS2145476 issued to Kofi
medicine in Maryland was suspended revocation of a practitioner’s registration E. Shaw-Taylor, M.D., be, and it hereby
effective May 9, 2017 and that is the appropriate sanction whenever he is, revoked. I further order that any
Respondent ‘‘currently has no authority is no longer authorized to dispense pending application of Kofi E. Shaw-
to practice medicine in Maryland.’’ Id. controlled substances under the laws of Taylor, M.D., to renew or modify this
at 1. the State in which he practices. See, registration, as well as any other
Respondent’s hearing request e.g., Hooper, supra, 76 FR at 71,371–72; pending application by him for
admitted that the Maryland State Board Sheran Arden Yeates, M.D., 71 FR registration in the State of Maryland, be,
of Physicians summarily suspended 39,130, 39,131 (2006); Dominick A. and it hereby is, denied. This order is
Respondent’s Maryland medical license. Ricci, M.D., 58 FR 51,104, 51,105 (1993); effective immediately.2
GX 5, at 1. Respondent did not submit Bobby Watts, 53 FR 11,919, 11,920 Dated: November 20, 2017.
any evidence that his Maryland medical (1988); Blanton, supra, 43 FR at 27,617. Robert W. Patterson,
license was reinstated. Respondent, According to Maryland Department of Acting Administrator.
thus, admitted that he currently is not Health regulations, a ‘‘prescription for a
[FR Doc. 2017–25922 Filed 11–30–17; 8:45 am]
authorized to practice medicine in controlled dangerous substance may be
BILLING CODE 4410–09–P
Maryland. issued only by an individual
Accordingly, I find that Respondent practitioner who is . . . [a]uthorized to
currently is without authority to engage prescribe controlled dangerous DEPARTMENT OF JUSTICE
in the practice of medicine in Maryland, substances in the State of Maryland, in
the State in which he is registered. which the practitioner is licensed to Drug Enforcement Administration
practice the practitioner’s profession.’’
Discussion [Docket No. DEA–392]
MD Code Regs. 10.19.03.07B(1)(a)
Pursuant to 21 U.S.C. 824(a)(3), the (2017). The Maryland Department of
Bulk Manufacturer of Controlled
Attorney General is authorized to Health regulations define an ‘‘individual
Substances Application: Nanosyn, Inc.
suspend or revoke a registration issued practitioner’’ to be a ‘‘physician . . . or
under section 823 of the Controlled
sradovich on DSK3GMQ082PROD with NOTICES
other individual licensed, registered, or AGENCY:Drug Enforcement
Substances Act (hereinafter, CSA), otherwise permitted by . . . the Administration, Department of Justice.
‘‘upon a finding that the registrant . . . jurisdiction in which the individual
has had his State License or registration practitioner practices, to dispense a 2 For the same reasons the Maryland State Board
suspended [or] revoked by competent controlled dangerous substance in the of Physicians of the Maryland Department of Health
and Mental Hygiene suspended Respondent’s
State authority and is no longer course of professional practice.’’ MD Maryland Medical License summarily, I find that
authorized by State law to engage in the Code Regs. 10.19.03.02C(7)(a) (2017). the public interest necessitates that this Order be
. . . dispensing of controlled Under Maryland law, a ‘‘physician’’ is effective immediately. 21 CFR 1316.67.
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![56994 Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
ACTION: Notice of application. DEPARTMENT OF JUSTICE for distribution to its customers.
Placement of this drug code onto the
DATES: Registered bulk manufacturers of Drug Enforcement Administration company’s registration does not
the affected basic classes, and [Docket No. DEA–392] translate into automatic approval of
subsequent permit applications to
applicants therefore, may file written
Importer of Controlled Substances import controlled substances. Approval
comments on or objections to the
Application: ABBVIE LTD of permit applications will occur only
issuance of the proposed registration on when the registrant’s business activity is
or before January 30, 2018. ACTION: Notice of application. consistent with what is authorized
ADDRESSES: Written comments should under 21 U.S.C 952(a)(2). Authorization
be sent to: Drug Enforcement DATES: Registered bulk manufacturers of will not extend to the import of FDA
Administration, Attention: DEA Federal the affected basic classes, and approved or non-approved finished
Register Representative/DRW, 8701 applicants therefore, may file written dosage forms for commercial sale.
Morrissette Drive, Springfield, Virginia comments on or objections to the Dated: November 24, 2017.
22152. issuance of the proposed registration on Demetra Ashley,
or before January 2, 2018. Such persons
Acting Assistant Administrator.
SUPPLEMENTARY INFORMATION: The may also file a written request for a
[FR Doc. 2017–25921 Filed 11–30–17; 8:45 am]
Attorney General has delegated his hearing on the application on or before
January 2, 2018. BILLING CODE 4410–09–P
authority under the Controlled
Substances Act to the Administrator of ADDRESSES: Written comments should
the Drug Enforcement Administration be sent to: Drug Enforcement DEPARTMENT OF JUSTICE
(DEA), 28 CFR 0.100(b). Authority to Administration, Attention: DEA Federal
Register Representative/DRW, 8701 [OMB Number 1110–XXXX]
exercise all necessary functions with
respect to the promulgation and Morrissette Drive, Springfield, Virginia
Agency Information Collection
implementation of 21 CFR part 1301, 22152. All requests for hearing must be
Activities; Proposed eCollection
incident to the registration of sent to: Drug Enforcement
eComments Requested; Approval of a
manufacturers, distributors, dispensers, Administration, Attn: Administrator,
New Collection
importers, and exporters of controlled 8701 Morrissette Drive, Springfield,
substances (other than final orders in Virginia 22152. All requests for hearing AGENCY: Laboratory Division Federal
should also be sent to: (1) Drug Bureau of Investigation Laboratory
connection with suspension, denial, or
Enforcement Administration, Attn: Division Survey of Forensic Science
revocation of registration) has been
Hearing Clerk/LJ, 8701 Morrissette Services, Federal Bureau of
redelegated to the Assistant
Drive, Springfield, Virginia 22152; and Investigation, Department of Justice.
Administrator of the DEA Diversion (2) Drug Enforcement Administration, ACTION: 60-Day Notice.
Control Division (‘‘Assistant Attn: DEA Federal Register
Administrator’’) pursuant to section 7 of Representative/DRW, 8701 Morrissette SUMMARY: The Department of Justice
28 CFR part 0, appendix to subpart R. Drive, Springfield, Virginia 22152. (DOJ), Federal Bureau of Investigation
In accordance with 21 CFR SUPPLEMENTARY INFORMATION: The
(FBI), Laboratory Division (LD) will be
1301.33(a), this is notice that on August Attorney General has delegated his submitting the following information
11, 2017, Nanosyn, Inc., Nanoscale authority under the Controlled collection request to the Office of
Combinatorial Synthesis, 3331–B Substances Act to the Administrator of Management and Budget (OMB) for
Industrial Drive, Santa Rosa, California the Drug Enforcement Administration review and approval in accordance with
95403 applied to be registered as a bulk (DEA), 28 CFR 0.100(b). Authority to the Paperwork Reduction Act of 1995.
exercise all necessary functions with The proposed information collection is
manufacturer for the basic classes of
respect to the promulgation and published to obtain comments from the
controlled substances:
implementation of 21 CFR part 1301, public and affected agencies.
Drug incident to the registration of DATES: Comments are encouraged and
Controlled substance Schedule will be accepted for 60 days until
code manufacturers, distributors, dispensers,
importers, and exporters of controlled January 30, 2018.
Oxymorphone ................. 9652 II substances (other than final orders in FOR FURTHER INFORMATION CONTACT: If
Fentanyl .......................... 9801 II connection with suspension, denial, or you have additional comments,
revocation of registration) has been especially on the estimated public
The company is a contract redelegated to the Assistant burden or associated response time,
manufacturer. At the request of the Administrator of the DEA Diversion suggestions, or need a copy of the
company’s customers, it manufactures Control Division (‘‘Assistant proposed information collection
derivatives of controlled substances in Administrator’’) pursuant to section 7 of instrument with instructions or
bulk form. 28 CFR part 0, appendix to subpart R additional information, please contact
In accordance with 21 CFR Cary Oien, United States Department of
Dated: November 24, 2017. Justice, Federal Bureau of Investigation,
1301.34(a), this is notice that on October
Demetra Ashley, 27, 2016, ABBVIE, LTD, Carr. #2, KM Laboratory Division, 2501 Investigation
Acting Assistant Administrator. 58.0 Cruce Davila, C/O PO Box 278, Parkway, Quantico, VA 22135
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2017–25916 Filed 11–30–17; 8:45 am] Barceloneta, Puerto Rico 00617 applied SUPPLEMENTARY INFORMATION: This
BILLING CODE 4410–09–P to be registered as an importer of process is conducted in accordance with
tapentadol (9780), a basic class of 5 CFR. Written comments and
controlled substance in schedule II. suggestions from the public and affected
The company plans to import an agencies concerning the proposed
intermediate form of tapentadol (9780) collection of information are
to bulk manufacture tapentadol (9780) encouraged. Your comments should
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Document Created: 2018-10-25 10:45:39
Document Modified: 2018-10-25 10:45:39
| 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 January 30, 2018. | |
| FR Citation | 82 FR 56993 |
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