[Federal Register: October 10, 2007 (Volume 72, Number 195)]
[Notices]
[Page 57551-57552]
[DOCID:fr10oc07-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12817-000]

Free Flow Power Corporation; Notice of Application Accepted for
Filing and Soliciting Motions to Intervene, Protests, and Comments

October 2, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12817-000.
    c. Date filed: July 23, 2007.
    d. Applicant: Free Flow Power Corporation.
    e. Name of Project: Duncan Point Project.
    f. Location: The project would be located on the Mississippi River
in West Baton Rouge, East Baton Rouge, and Iberville Parishes. The
project uses no dam or impoundment.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Dan Irvin, Free Flow Power Corporation,
69 Bridge Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12817-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project consists of: (1)
2,250 proposed 20 kilowatt Free Flow generating units having a total
installed capacity of 45 megawatts, (2) a proposed transmission line;
and (3) appurtenant facilities. The Free Flow Power Corporation's
project would have an average annual generation of 197.1 gigawatt-hours
and be sold to a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the

competing application itself, or a notice of intent to file such an
application, to the Commission on or before the specified comment date
for the particular application (see 18 CFR 4.36). Submission of a
timely notice of intent allows an interested person to file the
competing preliminary permit application no later than 30 days after
the specified comment date for the particular application. A competing
preliminary permit application must conform with 18 CFR 4.30 and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``COMPETING
APPLICATION'', ``RECOMMENDATIONS FOR TERMS AND CONDITIONS'',
``PROTEST'', OR ``MOTION TO INTERVENE'', as applicable, and the Project
Number of the particular application to which the filing refers. Any of
the above-named documents must be filed by providing the original and
the number of copies provided by the Commission's regulations to: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-19895 Filed 10-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 909-910]
[FR Doc No: 2020-00076]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5550]

Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 23 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 7, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040448.................  Phentermine           Elite Laboratories,
                               Hydrochloride (HCl)   Inc., 165 Ludlow
                               Capsules USP, 30      Ave., Northvale, NJ
                               milligrams (mg).      07647.
ANDA 060272.................  E-Mycin               Arbor
                               (erythromycin)        Pharmaceuticals,
                               Delayed-Release       LLC, 6 Concourse
                               Tablets USP, 250 mg   Parkway, Suite
                               and 333 mg.           1800, Atlanta, GA
                                                     30328.
ANDA 061639.................  E.E.S. 200             Do.
                               (erythromycin
                               ethylsuccinate) for
                               Oral Suspension,
                               Equivalent to (EQ)
                               200 mg base/5
                               milliliters
                               (mL).E.E.S. 400
                               (erythromycin
                               ethylsuccinate) for
                               Oral Suspension, EQ
                               400 mg base/5 mL.
ANDA 062290.................  EryDerm               Arbor
                               (erythromycin)        Pharmaceuticals,
                               Topical Solution      LLC.
                               USP, 2%.
ANDA 062304.................  Pediamycin             Do.
                               (erythromycin
                               ethylsuccinate)
                               Oral Suspension
                               USP, EQ 200 mg base/
                               5 mL Pediamycin 400
                               (erythromycin
                               ethylsuccinate)
                               Oral Suspension
                               USP, EQ 400 mg base/
                               5 mL.
ANDA 062659.................  Claforan ADD-Vantage  Sanofi-Aventis U.S.,
                               (cefotaxime) for      LLC, 55 Corporate
                               Injection USP, EQ 1   Dr., Bridgewater,
                               gram (g) base/vial    NJ 08807.
                               and EQ 2 g base/
                               vial.
ANDA 070347.................  Hydro-Ride            Par Pharmaceutical,
                               (amiloride HCl and    Inc., One Ram Ridge
                               hydrochlorothiazide   Rd., Spring Valley,
                               ) Tablets, EQ 5 mg    NY 10977.
                               Anhydrous/50 mg.
ANDA 071142.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.3 mg/
                               15 mg.
ANDA 071178.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.2 mg/
                               15 mg.
ANDA 071179.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.1 mg/
                               15 mg.
ANDA 073191.................  Triamterene and       CASI
                               Hydrochlorothiazide   Pharmaceuticals,
                               Capsules USP, 50 mg/  Inc., c/o Target
                               25 mg.                Health, Inc., 261
                                                     Madison Ave., 24th
                                                     Floor, New York, NY
                                                     10016.
ANDA 073416.................  E-Z Scrub             Becton, Dickinson
                               (chlorhexidine        and Co., 9450 South
                               gluconate) Sponge,    State St., Sandy,
                               4%.                   UT 84070.
ANDA 076075.................  Econazole Nitrate     CASI
                               Cream, 1%.            Pharmaceuticals,
                                                     Inc., c/o Target
                                                     Health, Inc.
ANDA 076192.................  Ribavirin Capsules     Do.
                               USP, 200 mg.
ANDA 076514.................  Midodrine HCl          Do.
                               Tablets USP, 2.5
                               mg, 5 mg, and 10 mg.

ANDA 078665.................  Next Choice           Foundation Consumer
                               (levonorgestrel)      Healthcare, LLC,
                               Tablets, 0.75 mg.     1190 Omega Dr.,
                                                     Pittsburgh, PA
                                                     15205.
ANDA 086809.................  Spironolactone        CASI
                               Tablets USP, 25 mg.   Pharmaceuticals,
                                                     Inc., c/o Target
                                                     Health, Inc.
ANDA 087143.................  Acetasol HC           Actavis Mid
                               (hydrocortisone and   Atlantic, LLC,
                               acetic acid) Otic     Subsidiary of Teva
                               Solution USP, 1%      Pharmaceuticals
                               and 2%.               USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 088432.................  Meperidine HCl        ICU Medical, Inc.,
                               Injection USP, 10     600 North Field
                               mg/mL.                Dr., Lake Forest,
                                                     IL 60045.
ANDA 090288.................  Naratriptan Tablets   CASI
                               USP, EQ 1 mg base     Pharmaceuticals,
                               and EQ 2.5 mg base.   Inc., c/o Target
                                                     Health, Inc.
ANDA 091597.................  Gemcitabine for       Sagent
                               Injection USP, EQ     Pharmaceuticals,
                               200 mg base/vial      Inc., 1901 North
                               and EQ 1 g base/      Roselle Rd.,
                               vial.                 Schaumburg, IL
                                                     60195.
ANDA 200670.................  Next Choice One Dose  Foundation Consumer
                               (levonorgestrel)      Healthcare, LLC.
                               Tablets, 1.5 mg.
ANDA 203384.................  Epinastine HCl        CASI
                               Ophthalmic            Pharmaceuticals,
                               Solution, 0.05%.      Inc., c/o Target
                                                     Health, Inc.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
February 7, 2020. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on February 7, 2020 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00076 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Notices]
[Page 16743-16744]
[DOCID:fr28mr08-154]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Vehicle Theft Prevention
Standard; Nissan

AGENCY: National Highway Traffic Safety Administration (NHTSA)
Department of Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the Nissan North America, Inc.'s
(Nissan) petition for exemption of the Rogue vehicle line in accordance
with 49 CFR Part 543, Exemption from the Theft Prevention Standard.
This petition is granted because the agency has determined that the
antitheft device to be placed on the line as standard equipment is
likely to be as effective in reducing and deterring motor vehicle theft
as compliance with the parts-marking requirements of the Theft
Prevention Standard (49 CFR Part 541). Nissan requested confidential
treatment for the information and attachments it submitted in support
of its petition. In a letter dated November 6, 2007, the agency granted
the petitioner's request for confidential treatment.

DATES: The exemption granted by this notice is effective beginning with
the 2009 model year.

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, West
Building, W43-439, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Ms. Ballard's phone number is<PHONE_NUMBER>. Her fax number is (202)
493-2990.

SUPPLEMENTARY INFORMATION: In a petition dated October 26, 2007, Nissan
requested exemption from the parts-marking requirements of the theft
prevention standard (49 CFR Part 541) for the MY 2009 Nissan Rogue
vehicle line. The petition requested an exemption from parts-marking
pursuant to 49 CFR Part 543, Exemption from Vehicle Theft Prevention
Standard, based on the installation of an antitheft device as standard
equipment for the entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant
exemptions for one of its vehicle lines per model year. Nissan's
submission is considered a complete petition as required by 49 CFR
543.7, in that it meets the general requirements contained in 543.5 and
the specific content requirements of 543.6.
    Nissan's petition provided a detailed description and diagram of
the identity, design, and location of the components of the antitheft
device for the new vehicle line. Although specific details of the
system's operation, design, effectiveness and durability have been
accorded confidential treatment, NHTSA is, for the purposes of this
petition, disclosing the following general information. Nissan will
install its passive, transponder-based immobilizer device as standard
equipment on its Rogue vehicle line beginning with MY 2009. Key
components of the antitheft device are an engine electronic control
module (ECM), a passive immobilizer and a transponder key. The
immobilizer system prevents normal operation of the vehicle without the
use of the key. Nissan's antitheft device will also have an alarm
feature. Nissan stated that its alarm system is activated by opening
any door without the use of a key. Upon activation of the alarm, the
head lamps will flash and the horn will sound. Nissan also provided its
own test

information on the reliability and durability of its proposed device.
Nissan based its belief that the device is reliable and durable since
the device complied with the specific requirements for each test.
    Nissan compared the device proposed for its vehicle line with other
devices which NHTSA has determined to be as effective in reducing and
deterring motor vehicle theft as would compliance with the parts-
marking requirements. Nissan stated that its antitheft device will be
no less effective than those devices in the lines for which NHTSA has
already granted full exemption from the parts-marking requirements.
    Nissan stated that NHTSA's theft data have shown a decline in theft
rates for vehicle lines that have been equipped with antitheft devices
similar to that which Nissan proposes to install on the new line.
Nissan stated that based on the agency's theft rate data, the Buick
Rivera and the Oldsmobile Aurora vehicles equipped with the PASS-Key
and PASS-Key II systems experienced a significant reduction in theft
rates from 1987 to 1996. Nissan concluded that the data indicates that
the immobilizer was effective in contributing to the theft rate
reduction for these lines. Nissan stated that based on NHTSA's theft
data for 1987 through 1996, the average theft rate for the Buick
Riviera and the Oldsmobile Aurora vehicles without the immobilizer was
4.8970 and 5.0760, respectively and 1.4288 and 2.0955 after
installation of the immobilizer device. Further review of the agency's
theft data published through the 2005 MY revealed that, while there is
some variation, the theft rates for both lines continued to stay below
the median theft rate of 3.5826. The agency agrees that the device is
substantially similar to devices in other vehicles lines for which the
agency has already granted exemptions.
    The agency also notes that the device will provide the five types
of performance listed in Sec.  543.6(a)(3): Promoting activation;
attracting attention to the efforts of unauthorized persons to enter or
operate a vehicle by means other than a key; preventing defeat or
circumvention of the device by unauthorized persons; preventing
operation of the vehicle by unauthorized entrants; and ensuring the
reliability and durability of the device.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7(b), the agency grants
a petition for an exemption from the parts-marking requirements of part
541 either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of part 541. The agency
finds that Nissan has provided adequate reasons for its belief that the
antitheft device will reduce and deter theft. This conclusion is based
on the information Nissan provided about its device.
    For the foregoing reasons, the agency hereby grants in full
Nissan's petition for exemption for the Rogue vehicle line from the
parts-marking requirements of 49 CFR Part 541, beginning with the 2009
model year vehicles. The agency notes that 49 CFR Part 541, Appendix A-
1, identifies those lines that are exempted from the Theft Prevention
Standard for a given model year. 49 CFR Part 543.7(f) contains
publication requirements incident to the disposition of all Part 543
petitions. Advanced listing, including the release of future product
nameplates, the beginning model year for which the petition is granted
and a general description of the antitheft device is necessary in order
to notify law enforcement agencies of new vehicle lines exempted from
the parts-marking requirements of the Theft Prevention Standard.
    If Nissan decides not to use the exemption for this line, it must
formally notify the agency, and, thereafter, the line must be fully
marked as required by 49 CFR Parts 541.5 and 541.6 (marking of major
component parts and replacement parts).
    NHTSA notes that if Nissan wishes in the future to modify the
device on which this exemption is based, the company may have to submit
a petition to modify the exemption. Part 543.7(d) states that a Part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the anti-theft device on which the
line's exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that Part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend Part 543 to require the submission of a
modification petition for every change to the components or design of
an antitheft device. The significance of many such changes could be de
minimis. Therefore, NHTSA suggests that if the manufacturer
contemplates making any changes the effects of which might be
characterized as de minimis, it should consult the agency before
preparing and submitting a petition to modify.

    Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: March 24, 2008.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
 [FR Doc. E8-6493 Filed 3-27-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Page 52016]
[FR Doc No: 2012-21085]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-2493-000]

Emera Energy Services Subsidiary No. 7 LLC; Supplemental Notice
That Initial Market-Based Rate Filing Includes Request for Blanket
Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Emera Energy Services Subsidiary No. 7 LLC's application for market-
based rate authority, with an accompanying rate schedule, noting that
such application includes a request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is September 10, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 21, 2012.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-21085 Filed 8-27-12; 8:45 am]
BILLING CODE 6717-01-P