Bulk Manufacturer of Controlled Substances Registration, 8116-8117 [2019-04025]

Download as PDF 8116 Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. Dated: February 18, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04031 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P 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 6, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: S&B Pharma Inc. ACTION: Notice of application. 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 February 28, 2017, S&B Pharma Inc., 405 South Motor Avenue, Azusa, California 91702–3232 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ Amphetamine .......................................................................................................................................................... Methamphetamine ................................................................................................................................................... Lisdexamfetamine ................................................................................................................................................... Methylphenidate ...................................................................................................................................................... Pentobarbital ........................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacture the listed controlled substances in bulk for use in product development and for commercial sales to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration. Dated: February 18, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04030 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on a previously published notice is listed below. No comments or objections were submitted for the notice. Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration Notice of registration. The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances. SUMMARY: Company FR Docket Eli-Elsohly Laboratories ........................................................ 83 FR 64159 ........................................................................ The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in VerDate Sep<11>2014 18:35 Mar 05, 2019 Jkt 247001 I I II II II II II II II II SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE ACTION: 7360 7370 1100 1105 1205 1724 2270 8333 9780 9801 Schedule effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Published December 13, 2018. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. E:\FR\FM\06MRN1.SGM 06MRN1 Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices Dated: February 26, 2019. John J. Martin, Assistant Administrator. approval of the information collection request. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2019–04025 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Agency Information Collection Activities; Submission for OMB Review; Comment Request, Reentry Employment Opportunities Evaluation, New Collection Office of the Assistant Secretary for Policy, Chief Evaluation Office, Department of Labor. ACTION: Notice of information collection; request for comment. AGENCY: The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents is properly assessed. Currently, the Department of Labor is soliciting comments concerning the collection of data about the Reentry Employment Opportunities Program. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed in the addressee section of this notice. DATES: Written comments must be submitted to the office listed in the addressee’s section below on or before May 6, 2019. ADDRESSES: You may submit comments by either one of the following methods: Email: ChiefEvaluationOffice@dol.gov; Mail or Courier: Jessica Lohmann, Chief Evaluation Office, OASP, U.S. Department of Labor, Room S–2312, 200 Constitution Avenue NW, Washington, DC 20210. Instructions: Please submit one copy of your comments by only one method. All submissions received must include the agency name and OMB Control Number identified above for this information collection. Comments, including any personal information provided, become a matter of public record. They will also be summarized and/or included in the request for OMB SUMMARY: VerDate Sep<11>2014 18:35 Mar 05, 2019 Jkt 247001 Jessica Lohmann by email at ChiefEvaluationOffice@dol.gov or by phone at (202) 693–5087. SUPPLEMENTARY INFORMATION: I. Background: The information collection activities described in this notice will provide data for the Reentry Employment Opportunities (REO) program evaluation. As part of the REO program, DOL awarded $78 million in Reentry Project (RP) grants in 2018, $73 million in RP grants during 2017, $31 million in Reentry Demonstration Project grants during 2016, and $21 million in Training to Work grants during 2015 and 2016. Although each grant program is distinctive, the overarching aim of the REO program is to improve employment outcomes and workforce readiness for people involved in the justice system by way of employment services, case management, and other supportive services. The REO program evaluation will involve grantees that received grants during 2016, 2017, and 2018. The evaluation will involve an implementation study and an impact study. The implementation study will address four main research questions: (1) How were programs implemented and what factors influenced implementation?; (2) What are the variations in the model, structure, partnerships, and services of the REO grants?; (3) How did implementation vary by organization type (such as an intermediary organization that operates in more than one state or a community-based organization) and target population?; and (4) What key program elements appear to be promising? Research questions for the impact study include: (1) What impact do grantees or strategies implemented by grantees have on participants’ outcomes, such as employment and recidivism?; (2) Does program effectiveness vary by grantee characteristics, such as population served and services offered?; and (3) To what extent do impacts vary across selected subpopulations, such as age group and type of offense? This Federal Register Notice provides the opportunity to comment on the following proposed REO evaluation data collection instruments: 1. Semi-structured inverview protocols. As part of the implementation study, which will be conducted in approximately 28 sites, the evaluation team will conduct semi-structured interviews with program administrators, frontline staff, and partners to understand how the program PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 8117 implementation has been developed, managed, and delivered. 2. Participant focus group protocols. As part of the implementation study, the evaluation team will conduct focus groups to gather information from participants. Participant focus groups will ask about participants’ reasons for enrolling, impressions of the program and the extent to which it has helped them prepare for employment. 3. Employer focus group protocols. As part of the implementation study, the evaluation team will conduct focus groups to gather information from employers. The focus groups with employers will enable an exploration of how the grantees are meeting the needs of employers. 4. Semi-structured telephone interview protocols. As part of the implementation study, the study team will conduct telephone interviews with approximately 58 sites that were not visited in person. These semi-structured interviews with program administrators will focus on understanding program implementation, challenges encountered, and their potential solutions. 5. Virtual focus group protocols. As part of the implementation study, the study team will conduct approximately 15 virtual focus groups, including approximately 135 REO program administrators in total. Each focus group will be topically focused to gather more in-depth information on a specific aspect of implementation, such as participant retention strategies, data management, or outcomes tracking. 6. Follow-up survey. Approximately 5 grantees will be selected for the impact study. Among the selected grantees, the survey will be administered to approximately 1,890 impact study participants and will allow us to capture respondents’ experiences in the program or in other services since enrollment in the study while measuring detailed information about study members’ employment experiences. Specifically, the survey will collect data about participants’ employment, earnings, credential attainment, skills attainment, recidivism and other topics of interest. II. Desired Focus of Comments: Currently, the Department of Labor is soliciting comments concerning the above data collection for the REO Evaluation. DOL is particularly interested in comments that do the following: Æ evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility; E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8116-8117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04025]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: The registrant listed below has applied for and been granted a 
registration by the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of various classes of schedule I and II controlled 
substances.

SUPPLEMENTARY INFORMATION: The company listed below applied to be 
registered as a bulk manufacturer of various basic classes of 
controlled substances. Information on a previously published notice is 
listed below. No comments or objections were submitted for the notice.

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                 Company                             FR Docket                          Published
----------------------------------------------------------------------------------------------------------------
Eli-Elsohly Laboratories.................  83 FR 64159.................  December 13, 2018.
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    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of this registrant to manufacture the 
applicable basic classes of controlled substances is consistent with 
the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer 
to the above listed company.


[[Page 8117]]


    Dated: February 26, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-04025 Filed 3-5-19; 8:45 am]
BILLING CODE 4410-09-P
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