[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60296-60297]
[FR Doc No: 2021-23689]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0042]

TUV Rheinland of North America, Inc.: 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 TUV
Rheinland of North America, Inc., 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 16, 2021.

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.
    Docket: To read or download comments or other material in the
docket, go to https://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the https://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 (202) 693-
2350 (TTY<PHONE_NUMBER>) for assistance in locating docket
submissions.
    Instructions: All submissions must include the agency name and the
OSHA docket number (OSHA-2007-0042). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data. For further information on submitting
comments, see the ``Public Participation'' heading in the section of
this notice titled SUPPLEMENTARY INFORMATION.
    Extension of comment period: Submit requests for an extension of
the comment period on or before November 16, 2021 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, 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) 693-2110 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    OSHA is providing notice that TUV Rheinland of North America, Inc.
(TUVRNA), is applying for an expansion of current recognition as a
NRTL. TUVRNA 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 TUVRNA, 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.
    TUVRNA currently has eight facilities (sites) recognized by OSHA
for product testing and certification, with the headquarters located
at: TUV Rheinland of North America, Inc., 12 Commerce Road, Newtown,
Connecticut 06470. A complete list of TUVRNA sites recognized by OSHA
is available at https://www.osha.gov/nationally-recognized-testing-laboratory-program/tuv.

II. General Background on the Application

    TUVRNA submitted an application, dated May 14, 2019 (OSHA-2007-
0042-0055), 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 did
not perform any on-site reviews in relation to this application.
    Table 1 shows the test standard found in TUVRNA's application for
expansion for testing and certification of products under the NRTL
Program.

  Table 1--Proposed Appropriate Test Standard for Inclusion in TUVRNA's
                        NRTL Scope of Recognition
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           Test standard                     Test standard title
------------------------------------------------------------------------
UL 60332-2-40.....................  Household and Similar Electrical
                                     Appliances--Safety--Part 2-40:
                                     Particular Requirements for
                                     Electrical Heat Pumps, Air-
                                     Conditioners and Dehumidifiers.
------------------------------------------------------------------------

III. Preliminary Finding on the Application

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

IV. Public Participation

    OSHA welcomes public comment as to whether TUVRNA 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-2007-0042 (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 TUVRNA'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.

IV. Authority and Signature

    James S. Frederick, Acting 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 25, 2021.
James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-23689 Filed 10-29-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Page 34971]
[FR Doc No: 2011-14750]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI11-8-000]

City of Dover, NH; Notice of Declaration of Intention and
Soliciting Comments, Protests, and/or Motions To Intervene

    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI11-8-000.
    c. Date Filed: May 24, 2011.
    d. Applicant: City of Dover, New Hampshire.
    e. Name of Project: Effluent Outfall Hydraulic Energy Harvester
Project (Outfall Project).
    f. Location: The Effluent Outfall Hydraulic Energy Harvester
Project will be located on an outfall pipe discharging effluence from a
wastewater treatment plant located in the City of Dover, Strafford
County, New Hampshire.
    g. Filed Pursuant to: section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Henry Russell, Walker Wellington, P.O. Box
308, 95 Brewery Lane/Unit 9, Portsmouth, NH 03802; Telephone:
(603) 498-2384; FAX:<PHONE_NUMBER>; e-mail:
www.Henry@walkerwellington,com.
    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and motions: July 8,
2011.
    All documents should be filed electronically via the Internet. See
18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be filed with: Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. Please include the docket number
(DI11-8-000) on any comments, protests, and/or motions filed.
    k. Description of Project: The Outfall Project would consist of an
in-line hydraulic energy harvester, placed on the outfall pipe that
discharges treated effluence from the city's wastewater treatment
plant. The source of water for power generation comes from the city's
sewer system, supplemented with water from gravel-packed wells. The
unit is expected to generate between 5 kW and 15 kW. The generated
power will be used on-site to operate ventilation and lighting
equipment at the treatment facility.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the proposed project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing 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. 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, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>,
or TTY, contact<PHONE_NUMBER>. A copy is also available for inspection
and reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, and/or Motions To Intervene--Anyone may
submit comments, a protest, and a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210, .211, .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, and/or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', and/
or ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: June 8, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-14750 Filed 6-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Pages 3795-3796]
[FR Doc No: 2019-02146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0361]

Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of a
New Drug Application for OMONTYS (peginesatide) Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of new drug application (NDA) 202799 for OMONTYS (peginesatide)
Injection, held by Takeda Pharmaceuticals U.S.A., Inc. (Takeda USA).
Takeda Development Center America, Inc., on behalf of Takeda USA,
requested withdrawal of approval of this application under relevant FDA
regulations and, in so doing, has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of February 13, 2019.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NDA 202799 for OMONTYS (peginesatide)
Injection, 1 milligram (mg)/0.5 milliliter (mL), 2 mg/0.5 mL, 3 mg/0.5
mL, 4 mg/0.5 mL, 5 mg/0.5 mL, 6 mg/0.5 mL, 10 mg/mL, and 20 mg/2 mL,
was received on May 8, 2011, under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)). FDA approved NDA
202799 on March 27, 2012, for treatment of anemia due to chronic kidney
disease in adult patients on dialysis.
    On February 23, 2013, Affymax, Inc. and Takeda voluntarily recalled
all lots of OMONTYS and suspended its marketing as a result of
postmarketing reports of serious hypersensitivity reactions, including
anaphylaxis, which can be life-threatening or fatal.
    Takeda subsequently requested that FDA withdraw approval of NDA
202799 under 21 CFR 314.150(d) (Sec.  314.150(d)) and waived its
opportunity for a hearing. Accordingly, under Sec.  314.150(d),
approval of NDA 202799, and all amendments and supplements thereto, is
withdrawn. Distribution of OMONTYS (peginesatide) Injection, 1 mg/0.5
mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, 6 mg/0.5 mL, 10
mg/mL, and 20 mg/2 mL, without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: February 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02146 Filed 2-12-19; 8:45 am]
BILLING CODE 4164-01-P