[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Notices]
[Page 18223]
[DOCID:fr21ap09-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-24-000]

Atmos Energy Corporation; Notice of Informational Rate Filing

April 14, 2009.
    Take notice that on April 9, 2009, Atmos Energy Corporation
(Atmos), filed an informational rate filing in Docket No. PR09-24-000.
Atmos states that the purpose of the filing is to present information
consistent with the Commission's authority under 15 U.S.C. 717i (a) in
order to allow the Commission to monitor Atmos' jurisdictional rates
under Section 5 of the Natural Gas Act. Atmos further states that it
seeks no change in its existing rates and charges or the previously
approved terms and conditions upon which it provides service.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the
``eLibrary'' link and is 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Friday, April 24, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-9074 Filed 4-20-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 225 (Wednesday, November 21, 2012)]
[Notices]
[Pages 69819-69820]
[FR Doc No: 2012-28268]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-368-000]

The Proctor & Gamble Paper Products Company; 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 The Proctor & Gamble Paper Products Company'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 December 5, 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: November 15, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-28268 Filed 11-20-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Rules and Regulations]
[Page 28175]
[FR Doc No: 2015-11941]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2015-0282]

Eighth Coast Guard District Annual Marine Event; Mayor's Hike,
Bike and Paddle; Ohio River 602.0-603.5; Louisville, KY

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Mayor's Hike, Bike and Paddle
marine event for all waters of the Ohio River, beginning at mile marker
602.0 and ending at 603.5, Louisville, KY. This rule will be enforced
from 9:00 a.m. to 12:30 p.m. on May 25, 2015.
    This action is necessary to protect persons, property, and
infrastructure from potential damage and safety hazards associated with
the Mayor's Hike, Bike and Paddle. During the enforcement period,
deviation from the regulations is prohibited unless specifically
authorized by the Captain of the Port (COTP) Ohio Valley or a
designated representative.

DATES: The regulations in 33 CFR 100.801, Table 1, Line 35 will be
enforced from 9:00 a.m. to 12:30 p.m. on May 25, 2015.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email Petty Officer James C. Robinson, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>or Petty
Officer Stephen F. McConnell, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the ``Mayor's
Hike, Bike and Paddle'' marine event in 33 CFR 100.801, Table 1, Line
35 from 9:00 a.m. to 12:30 p.m. on May 25, 2015. These regulations can
be found in the Code of Federal Regulations, at 33 CFR 100.801.
    Under the provisions of 33 CFR 100.801, a vessel may not enter the
regulated area, unless it receives permission from the COTP Ohio Valley
or a designated representative. Spectator vessels may safely transit
outside the regulated area but may not anchor, block, loiter in, or
impede the transit of official patrol vessels. The Coast Guard may be
assisted by other Federal, State, or local law enforcement agencies in
enforcing this regulation.
    This document is issued under authority of 5 U.S.C. 552(a), and 33
U.S.C. 1233. In addition to this document in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of this enforcement period via the Local Notice to
Mariners (LNM) and Broadcast Notice to Mariners (BNM). If the COTP Ohio
Valley determines that the regulated area need not be enforced for the
full duration stated in the notice, he or she may use a BNM to grant
general permission to enter the regulated area.

    Dated: April 22, 2015.
R.V. Timme,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2015-11941 Filed 5-15-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18618-18619]
[FR Doc No: 2013-07088]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0184]

National Offshore Safety Advisory Committee; Vacancies

AGENCY: United States Coast Guard, DHS.

ACTION: Request for applications.

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SUMMARY: The United States Coast Guard is requesting applications from
qualified candidates seeking consideration for appointment as members
to the National Offshore Safety Advisory Committee (NOSAC). NOSAC
advises the Secretary of the Department of Homeland Security (DHS) on
matters and actions concerning activities directly involved with or in
support of the exploration of offshore mineral and energy resources
insofar as they relate to matters within Coast Guard jurisdiction.

DATES: Applicants should submit a cover letter and resume in time to
reach the Alternate Designated Federal Officer (ADFO) on or before May
28, 2013.

ADDRESSES: Applicants should send their cover letter and resume via one
of the following methods:
     By mail: Commandant (CG-OES-2), Attn: Vessel and Facility
Operations Standards, U.S. Coast Guard, 2100 Second Street SW., STOP
7126, Washington, DC 20593-7126; or
     By phone:<PHONE_NUMBER>; or
     By fax:<PHONE_NUMBER>; or

     By email<EMAIL_ADDRESS>    This notice, is available in our online docket, USCG-2013-0184, at
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Scott E. Hartley, ADFO of NOSAC;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>or Commander Rob Smith, Designated Federal
Officer (DFO) of NOSAC; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: NOSAC is governed by the Federal Advisory
Committee Act (FACA), 5 U.S.C. App. (Pub. L. 92-463) and was
established under the authority of Title 6 U.S.C. Section 451 to advise
the Secretary of DHS on matters and actions concerning activities
directly involved with or in support of the exploration of offshore
mineral and energy resources insofar as they relate to matters within
Coast Guard jurisdiction.
    The Committee expects to meet twice a year: April in New Orleans,
LA and November in Houston, TX.
    We will consider applications for the six positions listed below
that will become vacant on January 31, 2014:
    (a) One member representing companies, organizations, enterprises
or similar entities engaged in the production of petroleum;
    (b) One member representing companies, organizations, enterprises
or similar entities engaged in offshore drilling;
    (c) One member representing companies, organizations, enterprises
or similar entities engaged in the support, by offshore supply vessels
or other vessels, of offshore operations;
    (d) One member representing companies, organizations, enterprises
or similar entities providing safety and training services to the
offshore industry;
    (e) One member representing companies, organizations, enterprises
or similar entities providing environmental protection, compliance or
response services to the offshore industry; and
    (f) One member representing companies, organizations, enterprises
or similar entities engaged in offshore oil exploration and production
on the Outer Continental Shelf of Alaska.
    To be eligible, applicants for positions (a-f) should be employed
by companies, organizations, enterprises or similar entities, have
expertise, knowledge and experience regarding the technology, equipment
and techniques that are used or are being developed for use in the
exploration for, and the recovery of, offshore mineral resources.
    Registered lobbyists are not eligible to serve on federal advisory
committees. Registered lobbyists are lobbyists required to comply with
provisions contained in the Lobbying Disclosure Act of 1995 (Pub. L.
104-65, as amended).
    Each NOSAC member serves a term of office up to three years.
Members may be considered to serve a maximum of three consecutive
terms. All members serve at their own expense and receive no salary or
reimbursement of travel expenses, or other compensation from the
Federal Government.
    DHS does not discriminate in employment on the basis of race,
color, religion, sex, national origin, political affiliation, sexual
orientation, gender identity, marital status, disabilities and genetic
information, age, membership in an employee organization, or any other
non-merit factor.
    If you are interested in applying to become a member of NOSAC, send
a cover letter stating the position you wish to represent, providing
your expertise, knowledge and experience that qualify you for service
on NOSAC. In addition, please include a Curriculum Vitae (CV) or resume
containing your current home address, a current email address, a
current telephone number, your qualifications and work experience.
During the vetting process, applicants may be asked by the White House
Liaison Office through the United States Coast Guard to provide their
date of birth and social security number. To visit our online docket,
go to http://www.regulations.gov, enter the docket number for this
notice (USCG-2013-0184) in the Search box, and click ``Go''. Please do
not post your resume on this site.

    Dated: March 21, 2013.
J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2013-07088 Filed 3-26-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18558-18559]
[FR Doc No: 2011-7846]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0464] (Formerly Docket No. 2006D-0331)

Guidance for Institutional Review Boards, Clinical Investigators,
and Sponsors: Exception From Informed Consent for Emergency Research;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Institutional Review
Boards, Clinical Investigators, and Sponsors: Exception from Informed
Consent for Emergency Research.'' This guidance is intended to assist
institutional review boards (IRBs), clinical investigators, and
sponsors in the development, conduct, and oversight of research
involving FDA-regulated products (e.g., drugs, biological products,
devices) in emergency settings when an exception from the informed
consent requirements is requested under the Code of Federal Regulations
(CFR). FDA determined that

guidance is needed in interpreting and complying with these
regulations, particularly in the areas of planning and conducting
community consultation and public disclosure activities, and the
establishment of informed consent procedures to be used when feasible.
The guidance announced in this notice finalizes the draft guidance of
the same title, dated July 2006.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002 (1-888-463-6332 or 301-796-
3400), or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448 (1-800-835-4709 or<PHONE_NUMBER>); or the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993 (1-800-
638-2041 or<PHONE_NUMBER>). Send one self-addressed adhesive label to
assist the office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sara Goldkind, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled
``Guidance for Institutional Review Boards, Clinical Investigators, and
Sponsors: Exception From Informed Consent for Emergency Research.''
This guidance is intended to assist IRBs, clinical investigators, and
sponsors in the development, conduct, and oversight of research
involving FDA-regulated products (e.g., drugs, biological products,
devices) in emergency settings when an exception from the informed
consent requirements is requested under title 21 of the CFR (21 CFR
50.24). The exception applies to investigations to determine the safety
and/or effectiveness of FDA-regulated products used in emergency
settings (emergency research). These investigations involve human
subjects who have a life-threatening medical condition (for which
available treatments are unproven or unsatisfactory), and who, because
of their condition (e.g., traumatic brain injury), cannot give informed
consent. The research involves an investigational product that, to be
effective, must be administered before informed consent from the
subjects' legally authorized representatives can be obtained.
    In the Federal Register of August 29, 2006 (71 FR 51198), FDA
announced the availability of the draft guidance of the same title,
dated July 2006. The same Federal Register (71 FR 51143) announced a
public hearing, held on October 11, 2006, on emergency research
conducted without informed consent under FDA's emergency research
regulations.
    FDA received numerous comments on the draft guidance. All comments
received during the comment period, questions received by Agency staff
related to implementation of the regulations, and information presented
at the public hearing have been carefully reviewed and, where
appropriate, incorporated into the guidance. A summary of changes
includes the following: (1) Additional discussion of the goals and
purpose of community consultation and public disclosure, information
that should be included, and how community consultation and public
disclosure activities may be implemented; (2) clarification of
``unproven'' and ``unsatisfactory'' with respect to available therapy;
and (3) discussion of trial design issues (e.g., study endpoints,
therapeutic window. This guidance incorporates comments received on
earlier drafts of the guidance document, questions received by Agency
staff related to implementation of the regulations, and information
presented at the October 11, 2006, public meeting on emergency research
studies.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 56 have been approved under
OMB control number 0910-0130, the collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014, and the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078. Modifications to these approved
information collection requirements are underway or will be made at the
time that each information collection is renewed. The Agency believes
that this is appropriate because this guidance has only a minor impact
on these existing collections of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 29, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7846 Filed 4-1-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31873-31874]
[FR Doc No: 2019-14172]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-1366]

Determination That CLAFORAN (Cefotaxime Sodium) for Injection,
500 Milligrams/Vial, 1 Gram/Vial, 2 Grams/Vial and 10 Grams/Vial, Was
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 or Agency) has
determined that CLAFORAN (cefotaxime sodium) for injection, 500
milligrams (mg)/vial, 1 gram (g)/vial, 2 g/vial and 10 g/vial, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Beth Holck, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6217, 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.
    CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial,
2 g/vial and 10 g/vial, is the subject of NDA 050547, held by US
Pharmaceutical Holdings II LLC, and initially approved on March 11,
1981. CLAFORAN is indicated for the treatment of patients with serious
bacterial infections in eight different organ systems caused by
susceptible strains of microorganisms, as specified in the labeling.
    In a letter dated February 9, 2018, US Pharmaceutical Holdings II
LLC notified FDA that CLAFORAN (cefotaxime for injection) 500 mg/vial,
1 g/vial, 2 g/vial and 10 g/vial was being discontinued, and FDA moved
the drug product to the ``Discontinued Drug Product List'' section of
the Orange Book.

    Cardinal Health Regulatory Sciences submitted a citizen petition
dated January 31, 2019 (Docket No. FDA-2019-P-1366), under 21 CFR
10.30, requesting that the Agency determine whether CLAFORAN
(cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and
10 g/vial, was 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 CLAFORAN (cefotaxime sodium) for injection,
500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial was not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that CLAFORAN (cefotaxime sodium)
for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of CLAFORAN
(cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and
10 g/vial from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that this drug product was
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/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. FDA will not begin procedures to
withdraw approval of approved ANDAs that refer to this drug product.
Additional ANDAs for this drug product may also 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 this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14172 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40735-40736]
[FR Doc No: 2020-14570]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket Number NHTSA-2011-0084]

Agency Information Collection Activities; Notice and Request for
Comment; Compliance Labeling of Retroreflective Materials for Heavy
Trailer Conspicuity

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

ACTION: Request for public comment on the reinstatement of a previously
approved collection of information.

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SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval on the reinstatement of a previously approved collection
of information on Federal Motor Vehicle Safety Standard (FMVSS) No.
108. Before a Federal agency can collect certain information from the
public, it must receive approval from the OMB. Under procedures
established by the Paperwork Reduction Act of 1995, before seeking OMB
approval, Federal agencies must solicit public comment on proposed
collections of information, including extensions and reinstatement of
previously approved collections. This document describes a collection
of labeling information on FMVSS No. 108, for which NHTSA intends to
seek OMB approval (OMB Control number 2127-0569). The labeling
requirement is for retroreflective sheeting material.

DATES: Comments must be received on or before September 8, 2020.

ADDRESSES: You may submit comments [identified by Docket No. NHTSA-
2011-0084] by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments. Mail: Docket Management Facility; M-30, U.S. Department of
Transportation, West Building Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590 between 9 a.m.
and 5 p.m. Eastern Time, Monday through Friday, except Federal
holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, please be sure to
mention the docket number of this document and identify the proposed
collection of information for which a comment is provided, by
referencing its OMB clearance number.
    Note: All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Anyone is able to search the electronic form of all comments received
into any of our dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT:  Complete copies of each request for
collection of information may be obtained at no charge from Andrei
Denes, U.S. Department of Transportation, NHTSA, 1200 New Jersey Avenue
SE, Washington, DC 20590. Mr. Denes's telephone number is (202) 366-
1810, and fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before a proposed collection of information is submitted to OMB for
approval, Federal agencies must first publish a document in the Federal
Register providing a 60-day comment period and otherwise consult with
members of the public and affected agencies concerning each proposed
collection of information. The OMB has promulgated regulations
describing what must be included in such a document. In compliance with
these requirements, NHTSA asks for public comments on the following
proposed collection of information:
    Title: 49 CFR 571.108, Standard No. 108; Lamps, reflective devices,
and associated equipment; Compliance Labeling of Retroreflective
Materials Heavy Trailer Conspicuity.
    OMB Control Number: 2127-0569.
    Type of Request: Reinstatement of a previously approved collection.
    Type of Review Requested: Regular.
    Length of Approval Requested: Three Years.
    Abstract: 49 U.S.C. 30111, 30112, and 30117 of the National Traffic
and Motor Vehicle Safety Act of 1966 authorize the issuance of Federal
Motor Vehicle Safety Standards (FMVSS). The agency, in prescribing a
FMVSS, considers available relevant motor vehicle safety data and
consults with other agencies, as it deems appropriate. Further, the
statute mandates that, in issuing any FMVSS, the agency considers
whether the standard is ``reasonable, practicable and appropriate for
the particular type of motor vehicle or motor vehicle equipment for
which it is prescribed,'' and whether such a standard will contribute
to carrying out the purpose of the Act. The Secretary is authorized to
issue such rules and regulations as deemed necessary to carry out these
requirements. Under this authority, the agency issued FMVSS No. 108,
specifying labeling requirements to aid the agency in achieving many of
its safety goals.
    This notice requests comments on the labeling requirements of FMVSS
No. 108, ``Lamp, reflective devices and

associated equipment,'' which requires that the inscription ``DOT-C2'',
``DOT-C3'', or ``DOT-C4'', as appropriate, constituting a certification
that the retroreflective sheeting conforms to the requirements of the
standard, appear at least once on the exposed surface of each white or
red segment of retroreflective sheeting, and at least once every 300 mm
on retroreflective sheeting that is white only. The characters must be
not less than 3 mm high, and must be permanently stamped, etched,
molded, or printed in indelible ink.
    Affected Public: Manufacturers of conspicuity grade retroreflective
materials.
    Estimated Number of Respondents: 3.
    The respondents are likely to be manufacturers of the conspicuity
material. The agency estimates that currently there are three
manufacturers producing conspicuity material.
    Frequency: As needed.
    Number of Responses: 190,000,000.
    It is estimated that there are 2.34 million trailers and 0.54
million truck tractors that require new conspicuity tape annually. On
average, a trailer requires approximately 60 ft. of reflective tape and
a truck tractor requires about 4 ft. The labels are to be placed at
intervals varying between 150 mm and 300 mm on rolls of retroreflective
conspicuity tape. Considering the length of tape required per trailer
and truck tractor, and that the labeling is applied on average every 9
in. (225 mm), a total number of 80 labels per trailer and 6 labels per
truck tractor are required. Therefore, it is estimated that 190 million
labels will be required annually (2.34 million trailers x 80 labels +
0.54 million truck tractors x 6 labels).
    Estimated Total Annual Burden Hours: 3 hours.
    The compliance symbol labeling program imposes only a minor hour
burden per respondent, or three total hours, for the collection or
reporting based on a maximum time required to ensure that the correct
inscription is being applied to the sheeting by the printing presses.
The application of symbols is performed by automated equipment
incorporated in the production process of the retroreflective sheeting.
    Estimated Total Annual Burden Cost: $4,000.
    The cost to respondents is estimated based on information that was
supplied by the respondents regarding the cost of supplying or
modifying printing rollers to apply the label. The cost to
manufacturers of applying the label requirement is the maintenance and
amortization of printing rollers and the additional dye or ink
consumed. The labels are printed during the normal course of steady
flow manufacturing operations and do not add additional time to the
production process.
    Two methods of printing the label are in use. One method uses the
same roller that applies the dye to the red segments of the material
pattern. The roller is resurfaced annually using a computerized etching
technique. The label was incorporated in the software to drive the
roller resurfacing in 1993, and there is no additional cost to continue
the printing of the label. In fact, costs would be incurred to
discontinue the label.
    The second method uses a separate roller and dye to apply the
label. The manufacturer using this technique reported that the rollers
have been in service for five years without detectable wear and
predicted a service life of at least fifteen years. Four rollers
costing about $2,500 each are used for a total of $10,000. If all three
manufacturers chose to use this method, a total of 12 rollers would be
used for a total cost of $30,000. A straight-line depreciation of the
rollers over 15 years ($30,000 divided by 15 years) equals $2,000 per
year. The total cost of the dye required is derived from the number of
labels required to be printed yearly and the dye required for each
label. The total number of labels printed annually is about 190
million. Therefore, at a cost of approximately $40 per gallon of dye
and using about 0.001 milliliters of dye per label, the total cost of
dye to print all the labels is estimated to be $2,000 (190 million
labels x $40/gal x 0.001 ml x 0.000264172 ml/gal). With the yearly cost
to replace the rollers of $2,000 and an annual allowance of $2,000 for
dye, the annual total industry cost of maintaining the label is about
$4,000.
    Estimated annual cost burden:

Additional cost of maintaining printing rollers with added label--$0
Annual cost of separate printing rollers for label (where used)--$2,000
Annual cost of additional dye or ink--$2,000
Total annual respondent cost--$4,000

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual        Annual       Est. total annual
               Number of rollers                   Cost of each      Total cost      Depreciation        labels       additional dye   cost to maintain
                                                      roller          rollers       over 15 years      (million)        allowance            label
--------------------------------------------------------------------------------------------------------------------------------------------------------
12.............................................          $2,500          $30,000           $2,000              190           $2,000              $4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.

(Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35; and delegation of authority at 49 CFR 1.95 and 501.8)

Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2020-14570 Filed 7-6-20; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Notices]
[Page 16458-16459]
[DOCID:fr01ap10-65]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0402; FRL-9132-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Plastic Parts and
Products Surface Coating (Renewal), EPA ICR Number 2044.04, OMB Control
Number 2060-0537

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before May 3, 2010.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2009-0402, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at:

Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Robert C. Marshall, Jr., Office of
Compliance, Mail Code: 2223A, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-7021; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 8, 2009 (74 FR 32580), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2009-0402, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Plastic Parts and Products Surface Coating
(Renewal).
    ICR Numbers: EPA ICR Number 2044.04, OMB Control Number 2060-0537.
    ICR Status: This ICR is scheduled to expire on April 30, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: Entities potentially affected by this action are the
owners or operators of plastic parts and products surface coating
facilities. The affected entities are subject to the General Provisions
of the NESHAP at 40 CFR part 63, subpart A, and any changes, or
additions to the Provisions specified at 40 CFR part 63, subpart PPPP.
Owners or operators of the affected facilities must submit a one-time-
only report of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports, at a minimum, are required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 91
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Plastic parts and products surface
coating facilities.
    Estimated Number of Respondents: 828.
    Frequency of Response: Initially, occasionally, and semiannually.
    Estimated Total Annual Hour Burden: 320,917.
    Estimated Total Annual Cost: $27,444,633, which includes
$27,180,233 in labor costs, $16,000 in capital/startup costs, and
$248,400 in operation and maintenance (O&M) costs.
    Changes in the Estimates: There is a small decrease in the total
estimated burden currently identified in the OMB Inventory of Approved
ICR Burdens. This change in burden from the most recently approved ICR
is due to an adjustment. Minor calculation errors in the previous ICR
were corrected.

    Dated: March 22, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-7316 Filed 3-31-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 29, 2008 (Volume 73, Number 19)]
[Rules and Regulations]
[Page 5095]
[DOCID:fr29ja08-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

Drawbridge Operation Regulations

CFR Correction

    In Title 33 of the Code of Federal Regulations, Parts 1 to 124,
revised as of July 1, 2007, in part 117, under ILLINOIS, on page 587,
reinstate Sec.  117.397 to read as follows:

Sec.  117.397  Wabash River.

    The draws of each bridge across the Wabash River shall open on
signal if at least 72 hours notice is given.
[FR Doc. 08-55502 Filed 1-28-08; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41854]
[DOCID:fr19jy10-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-1731-000]

Great Bay Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

July 13, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Great Bay Energy I, LLC's application for market-based rate authority,
with an accompanying rate tariff, 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 August 2, 2010.
    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 St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding 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 e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-17553 Filed 7-16-10; 8:45 am]
BILLING CODE 6717-01-P