[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12377-12378]
[FR Doc No: 2018-05671]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG18-53-000.
    Applicants: Meadow Lake Wind Farm VI LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Meadow Lake Wind Farm VI LLC.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5202.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: EG18-54-000.
    Applicants: Prairie Queen Wind Farm LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Prairie Queen Wind Farm LLC.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5207.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: EG18-55-000.
    Applicants: Turtle Creek Wind Farm LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Turtle Creek Wind Farm LLC.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5212.
    Comments Due: 5 p.m. ET 4/4/18.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER18-1059-000.
    Applicants: Shiloh I Wind Project, LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5163.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1060-000.
    Applicants: South Chestnut LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5164.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1061-000.
    Applicants: Star Point Wind Project LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5166.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1062-000.
    Applicants: Streator-Cayuga Ridge Wind Power LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5167.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1063-000.
    Applicants: Trimont Wind I LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5168.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1064-000.
    Applicants: Twin Buttes Wind LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5169.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1065-000.
    Applicants: Casselman Windpower LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5171.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1066-000.
    Applicants: Moraine Wind II LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5173.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1067-000.
    Applicants: Elk River Windfarm, LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5177.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1068-000.
    Applicants: Lyonsdale Biomass, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5179.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1069-000.
    Applicants: ReEnergy Ashland LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5180.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1070-000.
    Applicants: ReEnergy Black River LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5181.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1071-000.
    Applicants: ReEnergy Fort Fairfield LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5182.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1072-000.
    Applicants: MinnDakota Wind LLC.
    Description: Compliance filing: Compliance 2018 to be effective 5/
14/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5184.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1073-000.
    Applicants: ReEnergy Livermore Falls LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5188.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1074-000.
    Applicants: ReEnergy Stratton LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5190.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1075-000.
    Applicants: Public Service Company of New Mexico.
    Description: Sec.  205(d) Rate Filing: eTariff Administrative
Filing of OATT Revisions to be effective 11/1/2013.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5196.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1076-000.
    Applicants: GASNA 6P, LLC.
    Description: Baseline eTariff Filing: GASNA 6P, LLC MBR Tariff to
be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5200.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1077-000.
    Applicants: GASNA 36P, LLC.
    Description: Baseline eTariff Filing: GASNA 36P, LLC MBR Tariff to
be effective 3/15/2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5201.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER18-1078-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Require Phasor
Measuring Units at New Generator Interconnections to be effective 5/13/
2018.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5205.
    Comments Due: 5 p.m. ET 4/4/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 15, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-05671 Filed 3-20-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Notices]
[Pages 16912-16913]
[FR Doc No: 2013-06193]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0024]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemptions; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 8 individuals for
exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. They are unable to meet the vision requirement in
one eye for various reasons. The exemptions will enable these
individuals to operate commercial motor vehicles (CMVs) in interstate
commerce without meeting the prescribed vision requirement in one eye.
If granted, the exemptions would enable these individuals to qualify as
drivers of commercial motor vehicles (CMVs) in interstate commerce.

DATES: Comments must be received on or before April 18, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0024 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow theon-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on December
29, 2010 (75 FR 82132), or you may visit http://www.gpo.gov/fdsys/pkg/FR-2010-12-29/pdf/2010-32876.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' FMCSA can renew exemptions at the end of each
2-year period. The 8 individuals listed in this notice have each
requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Tom Campbell

    Mr. Campbell, age 57, has enucleation in his right eye due to a
traumatic incident in 1985. The visual acuity in his right eye is no
light perception, and in his left eye, 20/20. Following an examination
in 2012, his ophthalmologist noted, ``Mr. Campbell has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Campbell reported that he has driven straight trucks for
6 years, accumulating 60,000 miles. He holds a Class A Commercial
Driver's License (CDL) from Pennsylvania. His driving record for the
last 3 years shows no crashes and one conviction for a moving violation
in a CMV; he exceeded the speed limit by 23 miles per hour.

Joe Cunningham

    Mr. Cunningham, 61, has had histoplasmosis in his left eye since
2000. The visual acuity in his right eye is 20/20, and in his left eye,
20/400. Following an examination in 2012, his optometrist noted, ``He
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Cunningham reported that he has driven
straight trucks for 22 years, accumulating 264,000 miles. He holds an
operator's license from Indiana. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Dolan A. Gonzalez, Jr.

    Mr. Gonzalez, 37, has had amblyopia in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/200,
and in his left eye, 20/20. Following an examination in 2012, his
optometrist noted, ``Due to the long-standing nature of these
conditions and Dolan's history of previously performing as a commercial
driver, it should have no further effect on his driving skills as these
are stable and non-progressive.'' Mr. Gonzalez reported that he has
driven straight trucks for 6 years, accumulating 156,000 miles. He
holds an operator's license from Florida. His driving record for the
last 3 years shows no crashes but one conviction for a moving violation
in a CMV; he passed through/around a barrier.

Paul R. Harpin

    Mr. Harpin, 55, has had amblyopia in his right eye since childhood.
The best corrected visual acuity in his right eye is 20/100, and in his
left eye, 20/15. Following an examination in 2013, his optometrist
noted, ``I certify that he has sufficient vision to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Harpin reported
that he has driven straight trucks for 18 years, accumulating 540,000
miles, and tractor-trailer combinations for 15 years, accumulating
375,000 miles. He holds a Class A CDL from Arizona. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Terry L. Lipscomb

    Mr. Lipscomb, 42, has had refractive amblyopia in his left eye
since childhood. The best corrected visual acuity in his right eye is
20/20, and in his left eye, 20/60. Following an examination in 2012,
his optometrist noted, ``In my opinion, Mr. Lipscomb has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Lipscomb reported that he has driven straight trucks for
1 year, accumulating 11,500 miles, and tractor-trailer combinations for
11 years, accumulating 185,900 miles. He holds an operator's license
from Alabama. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Donald G. Reed

    Mr. Reed, 51, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20, and in his
left eye, 20/150. Following an examination in 2012, his optometrist
noted, ``In my professional opinion this patient should have no
problems from his eyes or vision to affect his duties as a professional
truck driver.'' Mr. Reed reported that he has driven straight trucks
for 12 years, accumulating 1 million miles, and tractor-trailer
combinations for 4 years, accumulating 813,000 miles. He holds a Class
A CDL from Illinois. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Randy T. Richardson

    Mr. Richardson, 60, has had refractive amblyopia in his right eye
since birth. The best corrected visual acuity in his right eye is 20/
70, and in his left eye, 20/20. Following an examination in 2013, his
optometrist noted, ``He can identify traffic signals without difficulty
and has sufficient vision to operate a commercial vehicle.'' Mr.
Richardson reported that he has driven straight trucks for 36 years,
accumulating 1.6 million miles. He holds a Class A CDL from Kansas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

James E. Smith

    Mr. Smith, 56, has had refractive amblyopia in his left eye since
birth. The best corrected visual acuity in his right eye is 20/20, and
in his left eye, 20/400. Following an examination in 2012, his
optometrist noted, ``I have recently examined James E. Smith and I
found his vision sufficient to perform the driving task to operate a
commercial vehicle as his vision has been stable, he has been safely
operating a commercial vehicle for years.'' Mr. Smith reported that he
has driven straight trucks for 20 years, accumulating 1 million miles,
and tractor-trailer combinations for 25, accumulating 2.5 million
miles. He holds a Class A CDL from Illinois. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business April 18, 2013. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: March 8, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-06193 Filed 3-18-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49327-49328]
[FR Doc No: 2014-19713]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1510]

Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot
Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial;
and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension),
Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable
3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED
(leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and
7.5 mg/vial, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for leuprolide acetate for depot
suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5
mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements
are met. However, in considering whether to file an ANDA for leuprolide
acetate for depot suspension, future applicants are advised that they
may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for
depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON
DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/
vial and 7.5 mg/vial, for bioequivalence testing because the product
has not been commercially available for a number of years. An ANDA
applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate
for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or
LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable
7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact
the Office of Generic Drugs for a determination of what is necessary to
show bioavailability and the same therapeutic effect.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.

    LUPRON DEPOT-PED (leuprolide acetate for depot suspension),
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED
(leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and
7.5 mg/vial, are the subject of NDA 020263, held by Abbvie Endocrine,
Inc., and initially approved on April 16, 1993. LUPRON DEPOT-PED is
indicated for treatment of children with central precocious puberty.
    In a report dated January 30, 1999, Abbvie notified FDA that LUPRON
DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75
mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for
depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were being
discontinued, and FDA moved the drug products to the ``Discontinued
Drug Product List'' section of the Orange Book.
    Joan Janulis, on behalf of Lachmann Consultant Services, Inc.,
submitted a citizen petition dated November 4, 2013 (Docket No. FDA-
2013-P-1510), under 21 CFR 10.30, requesting that the Agency determine
whether LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 7.5 mg/vial; and
LUPRON DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/vial, were
withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that LUPRON DEPOT-PED, Injectable 3.75 mg/vial and
7.5 mg/vial; and LUPRON DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/
vial, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON
DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/vial, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of LUPRON DEPOT-PED,
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED,
Injectable 7.5 mg/vial and 7.5 mg/vial, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that the products were not withdrawn from sale for
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LUPRON DEPOT-PED,
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED,
Injectable 7.5 mg/vial and 7.5 mg/vial, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to LUPRON DEPOT-PED, Injectable 3.75
mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED, Injectable 7.5 mg/vial
and 7.5 mg/vial, may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for these drug products should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: August 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19713 Filed 8-19-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63059]
[FR Doc No: 2022-22599]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2544-051]

Hydro Technology System, Inc.; Notice of Soliciting Scoping
Comments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Minor License.
    b. Project No.: 2544-051.
    c. Date filed: December 27, 2021.
    d. Applicant: Hydro Technology System, Inc.
    e. Name of Project: Meyers Falls Project.
    f. Location: On the Colville River, Stevens County, Washington. The
project does not occupy federal land.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Ben Hendrickson, Hydro Technology System,
Inc., PO Box 245, Kettle Falls, WA 99141;<PHONE_NUMBER> or email at
[email protected].
    i. FERC Contact: Maryam Zavareh at<PHONE_NUMBER>, or email at
[email protected].
    j. Deadline for filing scoping comments: November 11, 2022.
    The Commission strongly encourages electronic filing. Please file
scoping comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. All filings must clearly identify the project name and
docket number on the first page: Meyers Falls Hydroelectric Project (P-
2544-051).
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on 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. This application is not ready for environmental analysis at this
time.
    l. The project consists of the following existing facilities: (1) a
10-acre reservoir; (2) a 24.5-foot-high, 306-foot-long, concrete and
earth-fill embankment dam;(3) a 100-foot-long concrete spillway section
containing five 20 feet 3.5 inch wide, 6 feet high bulkheads; (3) a 46-
foot-wide, 20-foot-deep, 360-foot-long intake channel with a 19-foot-
wide and 11-foot-deep trashrack at the entrance point; (4) a 4-foot-
diameter, 323-foot-long steel penstock conveying flow from intake to
powerhouse; (5) a 31.5-foot-wide, 55.5-foot-long, 15.5-foot-high steel
reinforced concrete powerhouse containing two generating units with a
total installed capacity of 1.2 megawatts; (7) a 4,600-foot-long, 13.8-
kilovolt transmission line; and (8) appurtenant facilities. The Meyers
Falls Project is operated in a run-of-river mode with an average annual
generation of 7,883 megawatt-hours per year.
    Hydro Technology Systems Inc proposes to continue to operate the
project in a run-of-river mode.
    m. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents via the internet through
the Commission's Home Page (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, contact
FERC at [email protected] or call toll-free,<PHONE_NUMBER> or
TYY,<PHONE_NUMBER>.
    n. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. Scoping Process: Commission staff will prepare either an
environmental assessment (EA) or an Environmental Impact Statement
(EIS) that describes and evaluates the probable effects of the
licensee's proposed action and alternatives. The EA or EIS will
consider both site-specific and cumulative environmental impacts and
reasonable alternatives to the proposed action. The Commission's
scoping process will help determine the required level of analysis and
satisfy the National Environmental Policy Act (NEPA) scoping
requirements, irrespective of whether the Commission prepares an EA or
an EIS.
    At this time, we do not anticipate holding on-site scoping
meetings. Instead, we are soliciting written comments and suggestions
on the preliminary list of issues and alternatives to be addressed in
the NEPA document, as described in scoping document 1 (SD1), issued
October 12, 2022.
    Copies of the SD1 outlining the subject areas to be addressed in
the NEPA document were distributed to the parties on the Commission's
mailing list and the applicant's distribution list. Copies of SD1 may
be viewed on the web 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 1-866-
208-3676 or for TTY,<PHONE_NUMBER>.

    Dated: October 12, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-22599 Filed 10-17-22; 8:45 am]
BILLING CODE 6717-01-P


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                      S SEPCO"                 To<EMAIL_ADDRESS><EMAIL_ADDRESS>
<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>
<EMAIL_ADDRESS>Carey Johnston/DC/USEPA/US@EPA
                      03/26/2002 09:46         cc:       Timothy Connor/DC/USEPA/US@EPA, Deborah
                      AM                        Nagle/DC/USEPA/US@EPA, Tom Wall/DC/USEPA/US@EPA,
<EMAIL_ADDRESS>
                                               Subject:  RE: Phase III Cooling Water Intake Structure
                                                Rulemaking and Offsh       ore and Coastal Oil and Gas
                                                Extraction Facilities

Carey,
Thanks very much for including us in the data gathering phase and
providing
this good summary of the issue.  We stongly support rulemaking that
considers the uniqueness of offshore oil and gas activities and analyzes
the
true impacts.  I agree with your approach to have a conference call to
set
things in motion and identify the right people and to be followed by a
meeting later.

I am available next week April 3 (pm), April 4 (am), April 5 (all day)
for a
conference call.
Kent Satterlee, III
Shell Exploration and Production Company (SEPCo)
Regulatory Affairs
P.O. Box 61933
New Orleans, LA.  70161
Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>

> ----------
> From:
> ÃÃJohnston.Carey<EMAIL_ADDRESS>> Sent:            Thursday, March 21, 2002 9:30 AM
> To<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>> Satterlee, Kent S SEPCO<EMAIL_ADDRESS>><EMAIL_ADDRESS>> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS>><EMAIL_ADDRESS><EMAIL_ADDRESS>> Subject:         Phase III Cooling Water Intake Structure Rulemaking
and
> Offshore and Coastal Oil and Gas Extraction Facilities
>
> <<File: ch6.pdf>><<File: manufacture.pdf>>
> MEMORANDUM
>
> FROM:  Carey A. Johnston, P.E.
>                 U.S. EPA, Office of Water
>                 ph:<PHONE_NUMBER>
>                 fx:<PHONE_NUMBER>
><EMAIL_ADDRESS>>
> TO:       Alan Spackman, International Association of Drilling
> Contractors (IADC)
>               Kent Satterlee, Offshore Operators Committee (OOC)
>               Roger Claff, American Petroleum Institute (API)
>               Susan Gregersen, USDOE/OFE
>               Robert LaBelle, USDOI/MMS/Environmental Division
>               Bud Danenberger, USDOI/MMS/ Engineering & Operations
> Division
>
> DATE: March 21, 2002
>
> RE:       Phase III Cooling Water Intake Structure Rulemaking and
> Offshore and Coastal Oil and
>               Gas Extraction Facilities
>
>
__________________________________________________________________________

> _
>
> As you may already know, EPA has postponed decision-making regarding
> cooling water intake structures for offshore and coastal oil and gas
> extraction facilities:
>
>      "In response to these industry comments, EPA will propose and
take
> final action on regulations for new offshore and coastal oil and gas
> facilities, as defined at 40 CFR 435.10 and 40 CFR 435.40, in the
Phase
> III section 316(b) rule. EPA is deferring regulation of these
facilities
> due to the unique  engineering, cost, and economic issues associated
> with offshore and coastal drilling rigs, ships, and platforms." (66 FR
> 65311).
>
> EPA is required under a court-order to issue a Phase III proposal by
> June 15, 2003 with final action by December 15, 2004. Phase III will
> examine potential regulatory controls on new and existing oil and gas
> extraction facilities that employ a cooling water intake structure as
> well as other existing manufacturing facilities (but not existing
power
> plants which are covered in Phase II).
>
> A summary of EPA's current analysis of offshore and coastal oil and
gas
> extraction facilities cooling water intake structures can be found in
> the Technical Development Document for the Phase I rule
> (EPA-821-R-01-036;
> ÃÃwww.epa.gov/waterscience/316b/technical/technicaldd.htmlÄÄ) at Chapter
6.
> I've attached this chapter to this e-mail message.
>
> (See attached file: ch6.pdf)
>
> The Phase III proposal date (June 15, 2003) is a long time away.
> However, proceeding that date is a three month Federal Agency review
and
> an equally long internal Agency review. Now is a good time to start
> discussing the level of detail and types of information the Agency
will
> need in order make a decision for offshore and coastal oil and gas
> extraction facilities. EPA will need this additional information as a
> basis for determining the level of controls necessary (if any) for
these
> cooling water intake structures. Please note, the Agency has made no
> decisions about whether any controls are necessary for this segment of
> the industry. The information that the Agency has already analyzed is
a
> good first effort. However, a more detailed investigation is warranted
> in order to support a final Agency action.
>
> One suggestion is to modify an existing EPA survey we sent out to
> existing manufacturing facilities and tailor it towards offshore and
> coastal oil and gas extraction facilities (see
> ÃÃhttp://www.epa.gov/ost/316b/question/manufacture.pdfÄÄ  - also
attached).
> The modified survey could be sent to the top dozen or so drilling
> contractors which own the vast majority of the fixed and mobile
coastal
> and offshore facilities.
>
> (See attached file: manufacture.pdf)
>
> I am suggesting that we could either meet in person or over
> teleconference (or both). One possibility is to have a teleconference
> with a follow-up small technical meeting in Houston, TX or Washington,
> DC. Please let me know if you have any other ideas on how to jump
start
> this process. Thank you and I look forward to speaking with you soon.
>


[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80456-80457]
[FR Doc No: 2015-32359]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket ID PHMSA-2015-0213]

Pipeline Safety: Random Drug Testing Rate; Contractor Management
Information System Reporting; and Obtaining Drug and Alcohol Management
Information System Sign-In Information

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of Calendar Year 2016 Minimum Annual Percentage Rate for
Random Drug Testing; Reminder for Operators to Report Contractor
Management Information System (MIS) Data; and Reminder of Method for
Operators to Obtain User Name and Password for Electronic Reporting.

-----------------------------------------------------------------------

SUMMARY: PHMSA has determined that the minimum random drug testing rate
for covered employees will remain at 25 percent during calendar year
2016. Operators are reminded that drug and alcohol testing information
must be submitted for contractors performing or ready to perform
covered functions. For calendar year 2015 reporting, PHMSA will not
attempt to mail the ``user name'' and ``password'' for the Drug and
Alcohol Management Information System (DAMIS) to operators, but will
make the user name and password available in the PHMSA Portal (https://portal.phmsa.dot.gov/pipeline).

DATES: Effective January 1, 2016, through December 31, 2016.

FOR FURTHER INFORMATION CONTACT: Blaine Keener, Director of Safety Data
Systems and Analysis, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Notice of Calendar Year 2016 Minimum Annual Percentage Rate for Random
Drug Testing

    Operators of gas, hazardous liquid, and carbon dioxide pipelines
and operators of liquefied natural gas facilities must randomly select
and test a percentage of covered employees for prohibited drug use.
Pursuant to 49 CFR 199.105(c)(2), (3), and (4), the PHMSA
Administrator's decision on whether to change the minimum annual random
drug testing rate is based on the reported random drug test positive
rate for the pipeline industry. The data considered by the
Administrator comes from operators' annual submissions of MIS reports
required by Sec.  199.119(a). If the reported random drug test positive
rate is less than one percent, the Administrator may continue the
minimum random drug testing rate at 25 percent. In calendar year 2014,
the random drug test positive rate was less than one percent.
Therefore, the PHMSA minimum annual random drug testing selection rate
will remain at 25 percent for calendar year 2016.

Reminder for Operators To Report Contractor MIS Data

    On January 19, 2010, PHMSA published an Advisory Bulletin (75 FR
2926) implementing the annual collection of contractor MIS drug and
alcohol testing data. An operator's report to PHMSA is not considered
complete until an MIS report is submitted for each contractor that
performed covered functions as defined in 49 CFR part Sec.  199.3.

Reminder of Method for Operators To Obtain User Name and Password for
Electronic Reporting

    In previous years, PHMSA attempted to mail the DAMIS user name and
password to operator staff with responsibility for submitting DAMIS
reports. Based on the number of phone calls to PHMSA each year
requesting this information, the mailing process has not been
effective. Pipeline operators have been submitting reports required by
Parts 191 and 195 through the PHMSA Portal (https://portal.phmsa.dot.gov/pipeline) since 2011. Each company with an Office
of Pipeline Safety issued Operator Identification Number should employ
staff with access to the PHMSA Portal.
    The user name and password required for an operator to access DAMIS
and enter calendar year 2015 data will be available to all staff with
access to the PHMSA Portal in late December 2015. When the DAMIS user
name and password is available in the Portal, all registered users will
receive an email to that effect. Operator staff with responsibility for
submitting DAMIS reports should coordinate with registered Portal users
to obtain the DAMIS user name and password. Registered Portal users for
an operator typically include the U.S. Department of Transportation
Compliance Officer and staff or consultants with responsibility for
submitting annual and incident reports on PHMSA F 7000- and 7100-series
forms.
    For operators that have failed to register staff in the PHMSA
Portal for Part 191 and 195 reporting purposes, operator staff
responsible for submitting DAMIS reports can register in the Portal by
following the instructions at: http://opsweb.phmsa.dot.gov/portal_message/PHMSA_Portal_Registration.pdf .
    Pursuant to Sec. Sec.  199.119(a) and 199.229(a), operators with 50
or more covered employees, including both operator and contractor
staff, are required to submit DAMIS reports annually. Operators with
less than 50 total covered employees are required to report only upon
written request from PHMSA. If an operator has submitted a calendar
year 2013 or later DAMIS report with less than 50 total covered
employees, the PHMSA Portal message may state that no calendar year
2015 DAMIS report is required. Some of these operators may have grown
to more than 50 covered employees during calendar year 2015. The Portal
message will include instructions for how these operators can obtain a
calendar year 2015 DAMIS user name and password.

    Authority: 49 U.S.C. 5103, 60102, 60104, 60108, 60117, and
60118; 49 CFR 1.53.

    Issued in Washington, DC, on December 18, 2015, under authority
delegated in 49 CFR Part 1.97.
Alan K. Mayberry,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2015-32359 Filed 12-23-15; 8:45 am]
 BILLING CODE 4910-60-P