83_FR_14569 83 FR 14504 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

83 FR 14504 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 65 (April 4, 2018)

Page Range14504-14505
FR Document2018-06872

Federal Register, Volume 83 Issue 65 (Wednesday, April 4, 2018) 
[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14504-14505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06872]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, 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 4, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before May 4, 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 sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests 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

[[Page 14505]]

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 17, 2018, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, 
Philadelphia, Pennsylvania 19114 applied to be registered as an 
importer of Gamma Hydroxybutyric Acid (2010), a basic class of 
controlled substance listed in schedule I.
    The company plans to import finished dosage unit products 
containing gamma-hydroxybutyric acid for clinical trials, research, and 
analytical activities.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under to 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 27, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06872 Filed 4-3-18; 8:45 am]
 BILLING CODE 4410-09-P

14504 Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices physician and surgeon’’ in 802(21). Second, in setting the pending application for any other Pennsylvania. GX 3, at 1, 2. The Board requirements for obtaining a registration in the Commonwealth of also directed Registrant to ‘‘surrender practitioner’s registration, Congress Pennsylvania, be, and it hereby is, his wall certificate(s), biennial renewal directed that ‘‘[t]he Attorney General denied. This Order is effective certificate(s) and wallet card(s)’’ to state shall register practitioners . . . if the immediately.3 authorities upon service of the Order. applicant is authorized to dispense . . . Dated: March 26, 2018. Id. at 2. On October 6, 2017, the Board controlled substances under the laws of Robert W. Patterson, issued an ‘‘Order Granting Continuance the State in which [s]he practices.’’ 21 Acting Administrator. and Continuing Suspension’’ stating U.S.C. 823(f). Because Congress has [FR Doc. 2018–06870 Filed 4–3–18; 8:45 am] that Registrant had ‘‘agree[d] to toll the clearly mandated that a practitioner BILLING CODE 4410–09–P 180-day limit for the immediate and possess state authority in order to be temporary suspension of [his] license deemed a practitioner under the Act, . . . and [his] license shall remain DEA has held repeatedly that revocation DEPARTMENT OF JUSTICE SUSPENDED until a preliminary of a practitioner’s registration is the hearing is rescheduled or upon further appropriate sanction whenever he is no Drug Enforcement Administration order of the State Board of Medicine.’’ longer authorized to dispense controlled GX 4, at 1. In light of the passage of time substances under the laws of the State [Docket No. DEA–392] since the effective date of the Order, I in which he engages in professional have queried the Pennsylvania Medical practice. See, e.g., Calvin Ramsey, 76 FR Importer of Controlled Substances Board’s website regarding the status of 20034, 20036 (2011); Sheran Arden Application: Catalent Pharma Registrant’s medical license, and I take Yeates, M.D., 71 FR 39130, 39131 Solutions, LLC official notice 2 that Registrant’s (2006); Dominick A. Ricci, 58 FR 51104, ACTION: Notice of application. Pennsylvania medical license remains 51105 (1993); Bobby Watts, 53 FR suspended as of the date of this 11919, 11920 (1988); Blanton, 43 FR DATES: Registered bulk manufacturers of decision. Based on the above, I find that 27616 (1978). the affected basic classes, and Registrant does not currently have Moreover, because ‘‘the controlling applicants therefore, may file written authority under the laws of question’’ in a proceeding brought comments on or objections to the Pennsylvania to dispense controlled under 21 U.S.C. 824(a)(3) is whether the issuance of the proposed registration on substances. holder of a DEA registration ‘‘is or before May 4, 2018. Such persons currently authorized to handle may also file a written request for a Discussion controlled substances in the [S]tate,’’ hearing on the application on or before Pursuant to 21 U.S.C. 824(a)(3), the Hooper, 76 FR at 71371 (quoting Anne May 4, 2018. Attorney General is authorized to Lazar Thorn, 62 FR 12847, 12848 ADDRESSES: Written comments should suspend or revoke a registration issued (1997)), the Agency has also long held be sent to: Drug Enforcement under section 823 of Title 21, ‘‘upon a that revocation is warranted even where Administration, Attention: DEA Federal finding that the registrant . . . has had a practitioner has lost his state authority Register Representative/DRW, 8701 his State license . . . suspended [or] by virtue of the State’s use of summary Morrissette Drive, Springfield, Virginia revoked . . . by competent State process and the State has yet to provide 22152. All requests for hearing must be authority and is no longer authorized by a hearing to challenge the suspension. sent to: Drug Enforcement State law to engage in the . . . Bourne Pharmacy, 72 FR 18273, 18274 Administration, Attn: Administrator, dispensing of controlled substances.’’ (2007); Wingfield Drugs, 52 FR 27070, 8701 Morrissette Drive, Springfield, With respect to a practitioner, DEA has 27071 (1987). Thus, it is of no Virginia 22152. All requests for hearing long held that the possession of consequence that the Pennsylvania should also be sent to: (1) Drug authority to dispense controlled Medical Board has suspended Enforcement Administration, Attn: substances under the laws of the State Registrant’s state license and that Hearing Clerk/LJ, 8701 Morrissette in which a practitioner engages in Registrant may prevail in a future state Drive, Springfield, Virginia 22152; and professional practice is a fundamental hearing. What is consequential is the (2) Drug Enforcement Administration, condition for obtaining and maintaining fact that Registrant is not currently Attn: DEA Federal Register a registration. See, e.g., James L. Hooper, authorized to dispense controlled Representative/DRW, 8701 Morrissette 76 FR 71371 (2011), pet. for rev. denied, substances in Pennsylvania, the State in Drive, Springfield, Virginia 22152. 481 Fed. Appx. 826 (4th Cir. 2012); see which he is registered. I will therefore SUPPLEMENTARY INFORMATION: The also Frederick Marsh Blanton, 43 FR revoke his DEA registration, deny any 27616 (1978) (‘‘State authorization to Attorney General has delegated his pending application to modify his dispense or otherwise handle controlled authority under the Controlled registration, or any pending application substances is a prerequisite to the Substances Act to the Administrator of for any other registration in the Drug Enforcement Administration issuance and maintenance of a Federal Pennsylvania. (DEA), 28 CFR 0.100(b). Authority to controlled substances registration.’’). This rule derives from the text of two Order exercise all necessary functions with provisions of the CSA. First, Congress Pursuant to the authority vested in me respect to the promulgation and defined ‘‘the term ‘practitioner’ [to] by 21 U.S.C. 823(f) and 824(a), as well implementation of 21 CFR part 1301, mean[] a . . . physician . . . or other as 28 CFR 0.100(b), I order that DEA incident to the registration of person licensed, registered or otherwise Certificate of Registration No. manufacturers, distributors, dispensers, importers, and exporters of controlled amozie on DSK30RV082PROD with NOTICES permitted, by . . . the jurisdiction in BN8871231 and DATA-Waiver which he practices . . . to distribute, Identification Number XN8871231, substances (other than final orders in dispense, [or] administer . . . a issued to Mehdi Nikparvarfard, M.D., connection with suspension, denial, or controlled substance in the course of be, and it hereby is, revoked. I further 3 For the same reasons that led the Pennsylvania professional practice.’’ 21 U.S.C. order that any pending application of Board of Medicine to suspend Registrant’s license, Mehdi Nikparvarfard to renew or I find that the public interest necessitates that this 2 See supra footnote 1. modify the above registration, or any Order be effective immediately. 21 CFR 1316.67. VerDate Sep<11>2014 18:12 Apr 03, 2018 Jkt 244001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1

Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices 14505 revocation of registration) has been Attn: DEA Federal Register engage in transactions that would redelegated to the Assistant Representative/DRW, 8701 Morrissette otherwise be prohibited provided the Administrator of the DEA Diversion Drive, Springfield, Virginia 22152. conditions stated there in are met. This Control Division (‘‘Assistant SUPPLEMENTARY INFORMATION: The notice includes the following proposed Administrator’’) pursuant to section 7 of Attorney General has delegated his exemptions: D–11890, Liberty Media 28 CFR part 0, appendix to subpart R. authority under the Controlled 401(k) Savings Plan; D–11931, CLS In accordance with 21 CFR Substances Act to the Administrator of Investments, LLC and Affiliates. 1301.34(a), this is notice that on January the Drug Enforcement Administration DATES: All interested persons are invited 17, 2018, Catalent Pharma Solutions, (DEA), 28 CFR 0.100(b). Authority to to submit written comments or requests LLC, 3031 Red Lion Road, Philadelphia, exercise all necessary functions with for a hearing on the pending Pennsylvania 19114 applied to be respect to the promulgation and exemptions, unless otherwise stated in registered as an importer of Gamma implementation of 21 CFR part 1301, the Notice of Proposed Exemption, Hydroxybutyric Acid (2010), a basic incident to the registration of within 45 days from the date of class of controlled substance listed in manufacturers, distributors, dispensers, publication of this Federal Register schedule I. importers, and exporters of controlled Notice. The company plans to import finished substances (other than final orders in ADDRESSES: Comments and requests for dosage unit products containing gamma- connection with suspension, denial, or a hearing should state: (1) The name, hydroxybutyric acid for clinical trials, revocation of registration) has been address, and telephone number of the research, and analytical activities. redelegated to the Assistant Approval of permit applications will person making the comment or request, Administrator of the DEA Diversion and (2) the nature of the person’s occur only when the registrant’s Control Division (‘‘Assistant business activity is consistent with what interest in the exemption and the Administrator’’) pursuant to section 7 of manner in which the person would be is authorized under to 21 U.S.C. 28 CFR part 0, appendix to subpart R. 952(a)(2). Authorization will not extend adversely affected by the exemption. A In accordance with 21 CFR request for a hearing must also state the to the import of FDA approved or non- 1301.34(a), this is notice that on approved finished dosage forms for issues to be addressed and include a February 6, 2018 Wildlife Laboratroies general description of the evidence to be commercial sale. Inc., 1230 West Ash, Suite D Windsor, presented at the hearing. Dated: March 27, 2018. CO 80550 applied to be registered as an All written comments and requests for Susan A. Gibson, importer of the following basic classes a hearing (at least three copies) should Deputy Assistant Administrator. of controlled substances: be sent via mail to the Employee [FR Doc. 2018–06872 Filed 4–3–18; 8:45 am] Benefits Security Administration Controlled (EBSA), Office of Exemption BILLING CODE 4410–09–P Drug code Schedule substance Determinations, U.S. Department of Etorphine HCl ....... 9059 II Labor, 200 Constitution Avenue NW, DEPARTMENT OF JUSTICE Thiafentanil ........... 9729 II Suite 400, Washington, DC 20210. Attention: Application No.ll, stated Drug Enforcement Administration The company plans to import the in each Notice of Proposed Exemption [Docket No. DEA–392] listed controlled substances for or via private delivery service or courier distribution to its customers. to the Employee Benefits Security Importer of Controlled Substances Dated: March 27, 2018. Administration (EBSA), Office of Application: Wildlife Laboratories Inc. Exemption Determinations, U.S. Susan A. Gibson, Department of Labor, 122 C St. NW, ACTION: Notice of application. Deputy Assistant Administrator. Suite 400, Washington, DC 20001. [FR Doc. 2018–06871 Filed 4–3–18; 8:45 am] Attention: Application No.ll, stated DATES: Registered bulk manufacturers of BILLING CODE 4410–09–P in each Notice of Proposed Exemption. the affected basic classes, and Interested persons are also invited to applicants therefore, may file written submit comments and/or hearing comments on or objections to the DEPARTMENT OF LABOR requests to EBSA via email or FAX. Any issuance of the proposed registration on such comments or requests should be or before May 4, 2018. Such persons Employee Benefits Security sent either by email to: e-OED@dol.gov, may also file a written request for a Administration by FAX to (202) 693–8474, or online hearing on the application on or before through http://www.regulations.gov by May 4, 2018. Proposed Exemptions From Certain the end of the scheduled comment Prohibited Transaction Restrictions ADDRESSES: Written comments should period. The applications for exemption be sent to: Drug Enforcement AGENCY: Employee Benefits Security and the comments received will be Administration, Attention: DEA Federal Administration, Labor. available for public inspection in the Register Representative/DRW, 8701 ACTION: Notice of Proposed Exemptions. Public Documents Room of the Morrissette Drive, Springfield, Virginia Employee Benefits Security 22152. All requests for hearing must be SUMMARY: This document contains Administration, U.S. Department of sent to: Drug Enforcement notices of pendency before the Labor, Room N–1515, 200 Constitution Administration, Attn: Administrator, Department of Labor (the Department) of Avenue NW, Washington, DC 20210. amozie on DSK30RV082PROD with NOTICES 8701 Morrissette Drive, Springfield, proposed exemptions from certain of the Warning: All comments will be made Virginia 22152. All request for hearing prohibited transaction restrictions of the available to the public. Do not include should also be sent to: (1) Drug Employee Retirement Income Security any personally identifiable information Enforcement Administration, Attn: Act of 1974 (ERISA or the Act) and/or (such as Social Security number, name, Hearing Clerk/LJ, 8701 Morrissette the Internal Revenue Code of 1986 (the address, or other contact information) or Drive, Springfield, Virginia 22152; and Code). If granted, these proposed confidential business information that (2) Drug Enforcement Administration, exemptions allow designated parties to you do not want publicly disclosed. All VerDate Sep<11>2014 18:12 Apr 03, 2018 Jkt 244001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1


Document Created: 2018-11-01 09:10:37
Document Modified: 2018-11-01 09:10:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered 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 4, 2018. Such persons may also file a written request for a hearing on the application on or before May 4, 2018.
FR Citation83 FR 14504 
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