80 FR 35974 - Importer of Controlled Substances Application: Midas Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 120 (June 23, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 120 (June 23, 2015)
| Page Range | 35974-35975 | |
| FR Document | 2015-15331 |
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)] [Notices] [Pages 35974-35975] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15331] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Midas Pharmaceuticals, Inc. ACTION: Notice of application. ----------------------------------------------------------------------- DATES: Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before July 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 23, 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 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, [[Page 35975]] 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 1301.34(a), this is notice that on January 12, 2015, Midas Pharmaceuticals, Inc., 300 Interpace Parkway, Suite 420, Parsippany, New Jersey 07054-1100 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in order to bulk manufacture controlled substance in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured APIs in bulk to its customers. Dated: June 12, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-15331 Filed 6-22-15; 8:45 am] BILLING CODE 4410-09-P
![35974 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
Rules of Practice and Procedure (19 CFR relief specifically requested by the directed to the Secretary to the
210.8(b)). complainant in this investigation would Commission and must include a full
FOR FURTHER INFORMATION CONTACT: Lisa affect the public health and welfare in statement of the reasons why the
R. Barton, Secretary to the Commission, the United States, competitive Commission should grant such
U.S. International Trade Commission, conditions in the United States treatment. See 19 CFR 201.6. Documents
500 E Street SW., Washington, DC economy, the production of like or for which confidential treatment by the
20436, telephone (202) 205–2000. The directly competitive articles in the Commission is properly sought will be
public version of the complaint can be United States, or United States treated accordingly. All nonconfidential
accessed on the Commission’s consumers. written submissions will be available for
Electronic Document Information In particular, the Commission is public inspection at the Office of the
System (EDIS) at EDIS,1 and will be interested in comments that: Secretary and on EDIS.5
available for inspection during official (i) Explain how the articles This action is taken under the
business hours (8:45 a.m. to 5:15 p.m.) potentially subject to the requested authority of section 337 of the Tariff Act
in the Office of the Secretary, U.S. remedial orders are used in the United of 1930, as amended (19 U.S.C. 1337),
International Trade Commission, 500 E States; and of sections 201.10 and 210.8(c) of
Street SW., Washington, DC 20436, (ii) identify any public health, safety, the Commission’s Rules of Practice and
telephone (202) 205–2000. or welfare concerns in the United States Procedure (19 CFR 201.10, 210.8(c)).
General information concerning the relating to the requested remedial Issued: June 18, 2015.
Commission may also be obtained by orders; By order of the Commission.
accessing its Internet server at United (iii) identify like or directly Lisa R. Barton,
States International Trade Commission competitive articles that complainant,
Secretary to the Commission.
(USITC) at USITC.2 The public record its licensees, or third parties make in the
[FR Doc. 2015–15368 Filed 6–22–15; 8:45 am]
for this investigation may be viewed on United States which could replace the
BILLING CODE 7020–02–P
the Commission’s Electronic Document subject articles if they were to be
Information System (EDIS) at EDIS.3 excluded;
Hearing-impaired persons are advised (iv) indicate whether complainant,
that information on this matter can be complainant’s licensees, and/or third DEPARTMENT OF JUSTICE
obtained by contacting the party suppliers have the capacity to
replace the volume of articles Drug Enforcement Administration
Commission’s TDD terminal on (202)
205–1810. potentially subject to the requested [Docket No. DEA–392]
SUPPLEMENTARY INFORMATION: The exclusion order and/or a cease and
desist order within a commercially Importer of Controlled Substances
Commission has received a complaint
reasonable time; and Application: Midas Pharmaceuticals,
and a submission pursuant to section
(v) explain how the requested Inc.
210.8(b) of the Commission’s Rules of
Practice and Procedure filed on behalf remedial orders would impact United
States consumers. ACTION: Notice of application.
of Reynolds Presto Products Inc. on June
17, 2015. The complaint alleges Written submissions must be filed no
DATES: Registered bulk manufacturers of
violations of section 337 of the Tariff later than by close of business, eight
the affected basic class, and applicants
Act of 1930 (19 U.S.C. 1337) in the calendar days after the date of
therefore, may file written comments on
importation into the United States, the publication of this notice in the Federal
or objections to the issuance of the
sale for importation, and the sale within Register. There will be further
proposed registration in accordance
the United States after importation of opportunities for comment on the
with 21 CFR 1301.34(a) on or before July
certain resealable packages with slider public interest after the issuance of any
23, 2015. Such persons may also file a
devices. The complaint names as final initial determination in this
written request for a hearing on the
respondents Interplast Group, Ltd. of investigation.
application pursuant to 21 CFR 1301.43
Persons filing written submissions
Livingston, NJ and Minigrip, LLC of on or before July 23, 2015.
must file the original document
Alpharetta, GA. The complainant ADDRESSES: Written comments should
electronically on or before the deadlines
requests that the Commission issue a be sent to: Drug Enforcement
stated above and submit 8 true paper
permanent general exclusion order, Administration, Attention: DEA Federal
copies to the Office of the Secretary by
cease and desist orders, and a bond Register Representative/ODXL, 8701
noon the next day pursuant to section
upon respondents’ alleged infringing Morrissette Drive, Springfield, Virginia
210.4(f) of the Commission’s Rules of
articles during the 60-day Presidential 22152. Request for hearings should be
Practice and Procedure (19 CFR
review period pursuant to 19 U.S.C. sent to: Drug Enforcement
210.4(f)). Submissions should refer to
§ 1337(j). Administration, Attention: Hearing
Proposed respondents, other the docket number (‘‘Docket No. 3072’’)
in a prominent place on the cover page Clerk/LJ, 8701 Morrissette Drive,
interested parties, and members of the Springfield, Virginia 22152.
public are invited to file comments, not and/or the first page. (See Handbook for
Electronic Filing Procedures, Electronic SUPPLEMENTARY INFORMATION: The
to exceed five (5) pages in length, Attorney General has delegated his
inclusive of attachments, on any public Filing Procedures.4) Persons with
questions regarding filing should authority under the Controlled
interest issues raised by the complaint Substances Act to the Administrator of
or section 210.8(b) filing. Comments contact the Secretary (202–205–2000).
mstockstill on DSK4VPTVN1PROD with NOTICES
Any person desiring to submit a the Drug Enforcement Administration
should address whether issuance of the (DEA), 28 CFR 0.100(b). Authority to
document to the Commission in
1 Electronic Document Information System confidence must request confidential exercise all necessary functions with
(EDIS): http://edis.usitc.gov. treatment. All such requests should be respect to the promulgation and
2 United States International Trade Commission implementation of 21 CFR part 1301,
(USITC): http://edis.usitc.gov. 4 Handbook for Electronic Filing Procedures:
3 Electronic Document Information System http://www.usitc.gov/secretary/fed_reg_notices/ 5 Electronic Document Information System
(EDIS): http://edis.usitc.gov. rules/handbook_on_electronic_filing.pdf. (EDIS): http://edis.usitc.gov.
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![Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices 35975
incident to the registration of Substances Act to the Administrator of destruction, and a synopsis of the
manufacturers, distributors, dispensers, the Drug Enforcement Administration completed restoration projects.
importers, and exporters of controlled (DEA), 28 CFR 0.100(b). Authority to NARA has determined that the
substances (other than final orders in exercise all necessary functions with backup tapes do not warrant further
connection with suspension, denial, or respect to the promulgation and retention. All required backup
revocation of registration) has been implementation of 21 CFR part 1301, restoration projects have taken place,
redelegated to the Deputy Assistant incident to the registration of NARA is preserving and permanently
Administrator of the DEA Office of manufacturers, distributors, dispensers, retaining the restored records, and we
Diversion Control (‘‘Deputy Assistant importers, and exporters of controlled have identified no further need to
Administrator’’) pursuant to section 7 of substances (other than final orders in preserve or maintain the backup tapes.
28 CFR part 0, appendix to subpart R. connection with suspension, denial, or This notice constitutes a final agency
In accordance with 21 CFR revocation of registration) has been action, as described in 44 U.S.C.
1301.34(a), this is notice that on January redelegated to the Deputy Assistant 2203(g)(3), and NARA will dispose of
12, 2015, Midas Pharmaceuticals, Inc., Administrator of the DEA Office of the described backup tapes on or after
300 Interpace Parkway, Suite 420, Diversion Control (‘‘Deputy Assistant the date below.
Parsippany, New Jersey 07054–1100 Administrator’’) pursuant to section 7 of DATES: NARA will dispose of the
applied to be registered as an importer 28 CFR part 0, appendix to subpart R. backup tapes on or after August 24,
of remifentanil (9739), a basic class of In accordance with 21 CFR 2015.
controlled substance listed in schedule 1301.34(a), this is notice that on FOR FURTHER INFORMATION CONTACT:
II. February 19, 2015, Wildlife Director of Presidential Libraries Susan
The company plans to import the Laboratories, Inc., 1230 W. Ash Street, K. Donius, by mail at National Archives
listed controlled substance in order to Suite D, Windsor, Colorado 80550 and Records Administration, Suite
bulk manufacture controlled substance applied to be registered as an importer 2200; 8601 Adelphi Road; College Park,
in Active Pharmaceutical Ingredient of the following basic classes of Maryland 20740–6001, by telephone at
(API) form. The company distributes the controlled substances: (301) 837–3250, by fax at (301) 837–
manufactured APIs in bulk to its 3199, or by email at
customers. Controlled substance Schedule elizabeth.fidler@nara.gov.
Dated: June 12, 2015.
Etorphine (except HCl) (9056) ..... I SUPPLEMENTARY INFORMATION: Public
Joseph T. Rannazzisi, Etorphine HCl (9059) ................... II comments: NARA published a
Deputy Assistant Administrator. ‘‘Presidential Records Act notice of
[FR Doc. 2015–15331 Filed 6–22–15; 8:45 am] The company plans to import the proposed disposal of Reagan and George
BILLING CODE 4410–09–P listed controlled substances for sale to H.W. Bush administration disaster
its customer. recovery backup tapes; request for
Dated: June 12, 2015. public comment’’ on February 6, 2015,
DEPARTMENT OF JUSTICE in the Federal Register (80 FR 6770) for
Joseph T. Rannazzisi,
a 45-day comment period. NARA
Drug Enforcement Administration Deputy Assistant Administrator.
received one written comment, in which
[FR Doc. 2015–15332 Filed 6–22–15; 8:45 am]
[Docket No. DEA–392] a concerned citizen suggested that
BILLING CODE 4410–09–P NARA should retain the
Importer of Controlled Substances ‘‘documentation’’ so that it can be made
Application: Wildlife Laboratories, Inc. available to the public.
NATIONAL ARCHIVES AND RECORDS NARA has considered the comment.
ACTION: Notice of application. ADMINISTRATION As described in the notice of proposed
DATES: Registered bulk manufacturers of [NARA–2015–039]
disposal, NARA is retaining the
the affected basic classes, and recovered records from the backup
applicants therefore, may file written Office of Presidential Libraries; tapes. All the Presidential and Federal
comments on or objections to the Disposal of Presidential Records records that were on the tapes have been
issuance of the proposed registration in restored, and NARA is permanently
AGENCY: National Archives and Records retaining those restored records. This is
accordance with 21 CFR 1301.34(a) on
Administration (NARA). in line with the commenter’s suggestion
or before July 23, 2015. Such persons
may also file a written request for a ACTION: Presidential Records Act notice and goal, so NARA believes no further
hearing on the application pursuant to of proposed disposal of Reagan and action is necessary in response to the
21 CFR 1301.43 on or before July 23, George H.W. Bush administration comment and is proceeding with
2015. disaster recovery backup tapes; final destruction of the backup tapes as
agency action. outlined in the proposal notice.
ADDRESSES: Written comments should
be sent to: Drug Enforcement SUMMARY: NARA is issuing final notice NARA action
Administration, Attention: DEA Federal that it intends to dispose of several NARA will dispose of 3,071 original
Register Representative/ODXL, 8701 collections of disaster recovery backup disaster recovery backup tapes created
Morrissette Drive, Springfield, Virginia tapes from the Ronald Reagan (Reagan) during the Reagan and GHW Bush
22152. Request for hearings should be
mstockstill on DSK4VPTVN1PROD with NOTICES
and George H.W. Bush (GHW Bush) administrations, and subsequent
sent to: Drug Enforcement administrations under the provisions of preservation copies of those media
Administration, Attention: Hearing 44 U.S.C. 2203(g)(3). NARA published (maintained for the Professional/Office
Clerk/LJ, 8701 Morrissette Drive, notice in the Federal Register (February Vision software (PROFS) system, the
Springfield, Virginia 22152. 6, 2015 (80 FR 6770)), proposing to Sperry/VAX All-in-One system, and for
SUPPLEMENTARY INFORMATION: The dispose of these backup tapes. That systems operated by the White House
Attorney General has delegated his initial notice contains a detailed Situation Support Staff (WHSSS) and
authority under the Controlled description of the tapes, the reasons for the White House Situation Room
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Document Created: 2018-02-22 11:15:07
Document Modified: 2018-02-22 11:15:07
| 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 class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before July 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 23, 2015. | |
| FR Citation | 80 FR 35974 |
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