[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Page 29779]
[FR Doc No: 2018-13705]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-174-000]

American Municipal Power, Inc.; Notice of Filing

    Take notice that on June 19, 2018, American Municipal Power, Inc.
submitted a filing of proposed cost-based revenue requirement for the
provision of Reactive Supply and Voltage Control from Generation or
Other Sources Service under Schedule 2 of the Midwest Independent
Transmission System Operator, Inc. Open Access Transmission Tariff.
    Any person desiring 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, 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 comment date. On or
before the comment date, it is not necessary to 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 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line 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 website 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 protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 pm Eastern Time on July 10, 2018.

    Dated: June 20, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-13705 Filed 6-25-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Pages 72794-72795]
[FR Doc No: 2023-23324]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0013]

SolarPTL, LLC: Application for Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the application of SolarPTL,
LLC, for expansion of the scope of recognition as a Nationally
Recognized Testing Laboratory (NRTL) and presents the agency's
preliminary finding to grant the application.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before November 7, 2023.

ADDRESSES: Comments may be submitted as follows:
    Electronically: You may submit comments, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for submitting comments.
    Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2010-0013). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
https://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public,
or submitting materials that contain personal information (either about
themselves or others), such as Social Security numbers and birthdates.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov. Documents in the docket
(including this Federal Register notice) are listed in the http://www.regulations.gov index; however, some information (e.g., copyrighted
material) is not publicly available to read or download through the
website. All submissions, including copyrighted material, are available
for inspection through the OSHA Docket Office. Contact the OSHA Docket
Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>) for assistance in
locating docket submissions.
    Extension of comment period: Submit requests for an extension of
the comment period on or before November 7, 2023 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW, Room N-3653, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2300 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    OSHA is providing notice that SolarPTL, LLC. (PTL), is applying for
an expansion of current recognition as a NRTL. PTL requests the
addition of one test standard to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial
recognition, as well as for an expansion or renewal of recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including PTL, which details that NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    PTL currently has one facility (site) recognized by OSHA for
product testing and certification, with the headquarters located at:
SolarPTL, LLC, 1107 West Fairmont Drive, Tempe, Arizona 85282. A
complete listing of PTL's scope of recognition is available at https://www.osha.gov/nationally-recognized-testing-laboratory-program/solarptl.

II. General Background on the Application

    PTL submitted an application, dated June 1, 2021 (OSHA-2010-0013-
0005), to expand recognition as a NRTL to include one additional test
standard. OSHA staff performed a detailed analysis of the application
packet and reviewed other pertinent information. OSHA performed an on-
site assessment related to this application on August 16-17, 2022,
where OSHA found nonconformances with the requirements of 29 CFR 1910.
PTL addressed the nonconformances adequately and OSHA has no objection
to the addition of this standard to the scope of recognition.
    Table 1 shows the test standard found in PTL's application for
expansion for testing and certification of products under the NRTL
Program.

 Table 1--Proposed Appropriate Test Standard for Inclusion in PTL's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 3703...........................  Standard for Solar Trackers.
------------------------------------------------------------------------

III. Preliminary Finding on the Application

    PTL submitted an acceptable application for expansion of the scope
of recognition. OSHA's review of the application file and pertinent
documentation preliminarily indicates that PTL can meet the
requirements prescribed by 29 CFR 1910.7 for expanding its recognition
to include the addition of the test standard shown in Table 1, above,
for NRTL testing and certification. This preliminary finding does not
constitute an interim or temporary approval of PTL's application.
    OSHA seeks public comment on this preliminary determination.

V. Public Participation

    OSHA welcomes public comment as to whether PTL meets the
requirements of 29 CFR 1910.7 for expansion of recognition as a NRTL.
Comments should consist of pertinent written documents and exhibits.
    Commenters needing more time to comment must submit a request in
writing, stating the reasons for the request by the due date for
comments. OSHA will limit any extension to 10 days unless the requester
justifies a longer time period. OSHA may deny a request for an
extension if it is not adequately justified.
    To review copies of the exhibits identified in this notice, as well
as comments submitted to the docket, contact the Docket Office,
Occupational Safety and Health Administration, U.S. Department of
Labor. These materials also are generally available online at https://www.regulations.gov under Docket No. OSHA-2010-0013 (for further
information, see the ``Docket'' heading in the section of this notice
titled ADDRESSES).
    OSHA staff will review all comments to the docket submitted in a
timely manner. After addressing the issues raised by these comments,
staff will make a recommendation to the Assistant Secretary of Labor
for Occupational Safety and Health on whether to grant PTL's
application for expansion of the scope of recognition. The Assistant
Secretary will make the final decision on granting the application. In
making this decision, the Assistant Secretary may undertake other
proceedings prescribed in Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of the final decision in the
Federal Register.

VI. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020),
and 29 CFR 1910.7.

    Signed at Washington, DC, on October 17, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-23324 Filed 10-20-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54108-54109]
[FR Doc No: 2016-19292]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4272-DR; Docket ID FEMA-2016-0001]

Texas; Amendment No. 8 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Texas (FEMA-4272-DR), dated June 11, 2016, and related
determinations.

DATES: Effective Date: August 1, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Texas is hereby amended to include the following area
among those

areas determined to have been adversely affected by the event declared
a major disaster by the President in his declaration of June 11, 2016.

    Hall County for Public Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-19292 Filed 8-12-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59633-59634]
[FR Doc No: 2016-20778]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Risperidone; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry on generic
risperidone injection, entitled ``Bioequivalence Recommendations for
Risperidone.'' The recommendations provide specific guidance on the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for risperidone injection.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Bioequivalence Recommendations for Risperidone;
Draft Guidance for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
will be publicly viewable at http://www.regulations.gov or at the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002,
301-796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process to
develop and disseminate product-specific BE recommendations and to
provide a meaningful opportunity for the public to consider and comment
on those recommendations. This notice announces the availability of
draft BE recommendations for generic risperidone injection.
    FDA initially approved new drug application 021346 for RISPERDAL
CONSTA (risperidone) LONG-ACTING INJECTION in October 2003. Currently,
there are no approved ANDAs for this product. In February 2010, FDA
issued a draft guidance for industry on BE recommendations for generic
risperidone injection. In August 2013 and May 2015, we issued revised
draft guidances on the same subject. We are now issuing another
revision of the draft guidance for industry on BE recommendations for
generic risperidone injection (Draft Guidance on Risperidone).
    In February 2011, Johnson & Johnson Pharmaceutical Research and
Development, LLC, manufacturer of RISPERDAL CONSTA LONG-ACTING
INJECTION, the reference listed drug, submitted a citizen petition
requesting that FDA require that any ANDA referencing RISPERDAL CONSTA
LONG-ACTING INJECTION meet certain requirements, including requirements
related to demonstrating BE (Docket No. FDA-2011-P-0086). FDA is
reviewing the issues raised in the petition. FDA will consider any
comments on the revised draft BE recommendations in responding to the
petition.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the design of
BE studies to support ANDAs for risperidone injection. It does not
establish any rights for any person is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20778 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P