[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Notices]
[Pages 22686-22688]
[FR Doc No: 2011-9776]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-3028-001.
    Applicants: BBPC, LLC.

    Description: BBPC, LLC submits tariff filing per 35.17(b): BBPC LLC
Substitute MBR Tariff to be effective 5/16/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5149.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3061-000.
    Applicants: Carolina Power & Light Company.
    Description: Joint Motion of Carolina Power & Light Company and
Duke Energy Carolinas, LLC to Add the Latter as Co-Applicant on Pending
Request for a Limited Waiver of Market-Based Tariff Restrictions.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5169.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 28, 2011.

    Docket Numbers: ER11-3187-001.
    Applicants: SBR Energy, LLC.
    Description: SBR Energy, LLC submits tariff filing per 35.17(b):
Amending Baseline New to be effective 5/1/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5016.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3350-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.13(a)(2)(iii: 2011-4-14--297-PSCo--Gunbarrel COM Agmt to
be effective 2/16/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5078.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3351-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits tariff filing per
35.13(a)(2)(iii: Conforming MR1--Appendix A Tariff Record to be
effective 3/16/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5090.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3352-000.
    Applicants: Public Service Electric and Gas Company, PJM
Interconnection, L.L.C.
    Description: Public Service Electric and Gas Company submits tariff
filing per 35.13(a)(2)(iii: PSE&G's Request for Incentive Rates for 5
Baseline Transmission Projects to be effective 6/14/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5119.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3353-000.
    Applicants: Alpha Gas and Electric.
    Description: Alpha Gas and Electric submits tariff filing per
35.13(a)(2)(iii: Market based rate tariff database to be effective 4/
15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5130.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3354-000.
    Applicants: Rockpile Energy LP.
    Description: Rockpile Energy LP submits tariff filing per 35.15:
Notice of Cancellation of Market-Based Rate Tariff to be effective 4/
15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5147.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3355-000.
    Applicants: Energy Endeavors LP.
    Description: Energy Endeavors LP submits tariff filing per 35.15:
Notice of Cancellation of Market-Based Rate Tariff for Energy Endeavors
LP to be effective 4/15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5148.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3356-000.
    Applicants: Gotham Energy Marketing LP.
    Description: Gotham Energy Marketing LP submits tariff filing per
35.15: Notice of Cancellation of Market Based Rate Tariff for Gotham
Energy Marketing LP to be effective 4/15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5150.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3357-000.
    Applicants: Big Bog Energy LP.
    Description: Big Bog Energy LP submits tariff filing per 35.15:
Notice of Cancellation of Market-Based Rate Tariff for Big Bog Energy
LP to be effective 4/15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5151.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3358-000.
    Applicants: Coaltrain Energy LP.
    Description: Coaltrain Energy LP submits tariff filing per 35.15:
Notice of Cancellation of Market-Based Rate Tariff for Coaltrain Energy
LP to be effective 4/15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5152.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Docket Numbers: ER11-3359-000.
    Applicants: Silverado Energy LP.
    Description: Silverado Energy LP submits tariff filing per 35.15:
Notice of Cancellation of Market-Based Rate Tariff for Silverado Energy
LP to be effective 4/15/2011.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5153.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-111-003.
    Applicants: Portland General Electric Company.
    Description: Compliance Filing of Portland General Electric
Company.
    Filed Date: 04/14/2011.
    Accession Number: 20110414-5064.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 05, 2011.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF11-222-000.
    Applicants: Harris Teeter, Inc.
    Description: Form 556--Notice of Self-Certification of Qualifying
Cogeneration Facility Status.
    Filed Date: 04/13/2011.
    Accession Number: 20110413-5168.
    Comment Date: None Applicable.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status

may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii).
Intervention and protests may be filed in response to notices of
qualifying facility dockets other than self-certifications and self-
recertifications.
    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 proceedings 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>.

    Dated: April 15, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-9776 Filed 4-21-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Page 45311]
[FR Doc No: 2020-15761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2020-N-0002]

New Animal Drugs; Withdrawal of Approval of Abbreviated New
Animal Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of an abbreviated new animal drug application (ANADA) at the sponsor's
request because the product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective July 28, 2020.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Hikma International Pharmaceuticals LLC,
P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has requested
that FDA withdraw approval of ANADA 200-323 for use of a 1-gram bolus
of phenylbutazone in horses because the product is no longer
manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food
and Drugs and in accordance with Sec.  514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of ANADA 200-323, and all supplements and amendments thereto, is hereby
withdrawn, effective July 28, 2020.
    Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.

    Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15761 Filed 7-27-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Notices]
[Page 32039]
[DOCID:fr05jn08-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1756-DR]

Oklahoma; Amendment No. 2 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 Oklahoma (FEMA-1756-DR), dated May 14, 2008, and
related determinations.

DATES: Effective Date: May 23, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, 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 Oklahoma is hereby amended to include the following
areas among the areas determined to have been adversely affected by the
catastrophe declared a major disaster by the President in his
declaration of May 14, 2008.

Craig, Latimer, and Pittsburg Counties for Individual 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
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-12518 Filed 6-4-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Notices]
[Pages 16832-16833]
[FR Doc No: 2021-06646]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2021-0180]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Report of
Inspections Required by Airworthiness Directive, Part 39

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves the member of the public that may
submit an Alternative Methods of Compliance (AMOC) request to the FAA
by using the Airworthiness Directives Development (ADD) External
website. The information to be collected will be used to support
publicly disseminated information to the FAA and/or is necessary
because this information supports the Department of Transpiration's
strategic goal to promote the public health and safety by working
toward eliminating transportation-related deaths and injuries.

DATES: Written comments should be submitted by June 1, 2021.

ADDRESSES: Please send written comments:

By Electronic Docket: www.regulations.gov (Enter docket number into
search field)
By mail: Robert Romero, 10101 Hillwood Parkway, 5N154, Fort Worth, TX
76177
By fax:<PHONE_NUMBER>

FOR FURTHER INFORMATION CONTACT: Robert Romero by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0056.
    Title: Report of Inspections Required by Airworthiness Directives,
Part 39.
    Form Numbers: There is no standard form to use for AMOC submission.
However, the public may access the ADD External website to submit an
AMOC request to the FAA.
    Type of Review: Renewal of an information collection.
    Background: Alternative Methods of Compliance (AMOC) are submitted
to the FAA by the general public. While anyone may submit an AMOC there
is no standard form to use. From Order 8110.103B Alternative Methods of
Compliance (AMOC), Section 32:

    3-2. AMOC Proposal. 14 CFR 39.19 states in part that ``anyone
may propose to FAA an alternative method of compliance or a change
in the compliance time, if the proposal provides an acceptable level
of safety.''
    a. Although a letter is preferred, AMOC proposals may be
submitted by other means, such as email, fax, or telephone. AMOC
proposals received by telephone must be documented.

    An AMOC Response Letter is written by an internal FAA user and sent
to the AMOC Requester. The template may be generated from the ADD
Dashboard and follows the latest Order. There is not an FAA or OMB
number on this template.
    A member of the public may submit an AMOC request to the FAA by
using the ADD External website. Registration is not needed to use this
website. External users must consent to the ``Terms of Use'' statement
before proceeding to the AMOC proposal web page. An AMOC is required if
an owner/operator of aircraft cannot comply with an AD or finds a
different method to comply with the actions specified in an AD, as
mandated by 14 CFR part 39.
    Respondents: The respondents are a member of the public who may
submit an AMOC request to FAA by using the ADD External website. We
estimate that 25 ADs yearly will require reports of information and
findings. The average AD affects about 1,120 owners/operators.
Therefore, 25 ADs times 1,120 owners/operators per year equal 28,000
reports.
    Frequency: As needed.
    Estimated Average Burden per Response: These reports, requiring an
average of 1 hour each to prepare, consume 28,000 reporting hours.

    Estimated Total Annual Burden: The total annualized cost to
respondents is $2,380,000. We base this on the 28,000 reporting hours
times an estimated hourly rate of $85/hour per respondent. The average
cost to the respondents per AD per year is $85.00 ($2,380,000 divided
by 28,000).

    Issued in Washington, DC, on March 03, 2021.
Patrick Idlett,
ASKME Program Manager, Office of Enterprise Program Management (AEM),
Project Portfolio Performance Division.
[FR Doc. 2021-06646 Filed 3-30-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)]
[Notices]
[Pages 86328-86329]
[FR Doc No: 2016-28762]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-38-000.
    Applicants: Helix Generation, LLC, TC Ravenswood, LLC, TC Ironwood
LLC, TransCanada Maine Wind Development Inc., Ocean State Power LLC,
TransCanada Power Marketing Ltd.
    Description: Joint Application of Helix Generation, LLC, et al. for
Approval Under Section 203 of the FPA.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5263.
    Comments Due: 5 p.m. ET 12/12/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2487-003; ER15-2380-001.
    Applicants: Pacific Summit Energy LLC, Willey Battery Utility, LLC.
    Description: Notice of Change in Status of Pacific Summit Energy
LLC, et al.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5203.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER16-1804-001.
    Applicants: Deepwater Block Island Wind, LLC.

    Description: Notice of Non-Material Change in Status of Deepwater
Block Island Wind, LLC.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5199.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-212-001.
    Applicants: Upper Michigan Energy Resources Corporation.
    Description: Tariff Amendment: Executed UMERC to Crystal Falls FERC
Rate Schedule No 4 to be effective 1/1/2017.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5195.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-388-000.
    Applicants: SunZia Transmission, LLC.
    Description: Report on the Open Solicitation and Selection Process
for Anchor Customers of SunZia Transmission, LLC.
    Filed Date: 11/18/16.
    Accession Number: 20161118-5133.
    Comments Due: 5 p.m. ET 12/9/16.

    Docket Numbers: ER17-401-000.
    Applicants: Pacific Summit Energy LLC.
    Description: Compliance filing: Notice of Change in Status and
Revised MBR Tariff to be effective 1/20/2017.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5193.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-402-000.
    Applicants: Willey Battery Utility, LLC.
    Description: Compliance filing: Notice of Change in Status and
Revised MBR Tariff to be effective 1/20/2017.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5194.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-403-000.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Notice of Cancellation of Interconnection Agreement,
Rate Schedule No. 200 of Niagara Mohawk Power Corporation.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5202.
    Comments Due: 5 p.m. ET 12/12/16.

    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: November 22, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-28762 Filed 11-29-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50870-50876]
[FR Doc No: 2023-16418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 059

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 059'' (Recognition List Number: 059), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable August 2, 2023.

ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 059.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
FDA will consider any comments received in determining whether to amend
the current listing of modifications to the list of recognized
standards, Recognition List Number: 059.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    An electronic copy of Recognition List Number: 059 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA-recognized consensus standards, including Recognition List Number:
059 modifications and other standards-related information. Submit
written requests for a single hard copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 059'' to Jianchao Zeng, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5572, Silver Spring, MD 20993,<PHONE_NUMBER>. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
of the FD&C Act allows FDA to recognize consensus standards developed
by international and national organizations for use in satisfying
portions of device premarket review submissions or other requirements.
    In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
Modifications to the initial list of recognized standards, as published
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
    These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains on its
website HTML and PDF versions of the list of FDA Recognized Consensus
Standards, available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
Additional information on the Agency's Standards and Conformity
Assessment Program is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 059

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 059'' to identify the current
modifications.
    In table 1, FDA describes the following modifications: (1) the
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that
involve new entries and consensus standards added as modifications to
the list of recognized standards under Recognition List Number: 059.

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                   Replacement
Old recognition    recognition   Title of standard \1\       Change
      No.              No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-67...........           1-153  NFPA 99:2021 Health    Withdrawn and
                                  Care Facilities Code.  replaced with
                                                         newer version.
1-78...........           1-154  ASME PVHO-1-2019       Withdrawn and
                                  Safety Standard for    replaced with
                                  Pressure Vessels for   newer version.
                                  Human Occupancy.
1-132..........           1-155  ISO 10079-2 Fourth     Withdrawn and
                                  edition 2022-03        replaced with
                                  Medical suction        newer version.
                                  equipment--Part 2:
                                  Manually powered
                                  suction equipment.
1-133..........           1-156  ISO 10079-3 Fourth     Withdrawn and
                                  edition 2022-03        replaced with
                                  Medical suction        newer version.
                                  equipment--Part 3:
                                  Suction equipment
                                  powered from a
                                  vacuum or positive
                                  pressure gas source.
1-142..........           1-157  ISO 10079-1 Fourth     Withdrawn and
                                  edition 2022-03        replaced with
                                  Medical suction        newer version.
                                  equipment--Part 1:
                                  Electrically powered
                                  suction equipment.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-93...........           2-297  ASTM F763-22 Standard  Withdrawn and
                                  Practice for Short-    replaced with
                                  Term Intramuscular     newer version.
                                  Screening of
                                  Implantable Medical
                                  Device Materials.
2-276..........           2-298  ISO 10993-18 Second    Withdrawn and
                                  edition 2020-01        replaced with
                                  Amendment 1:2022-05    newer version,
                                  Biological             including
                                  evaluation of          amendment.
                                  medical devices--
                                  Part 18: Chemical
                                  characterization of
                                  medical device
                                  materials within a
                                  risk management
                                  process [Including
                                  Amendment 1 (2022)].
2-289..........  ..............  ISO 10993-12 Fifth     Transition
                                  edition 2021-01        period
                                  Biological             extended.
                                  evaluation of
                                  medical devices--
                                  Part 12: Sample
                                  preparation and
                                  reference materials.
2-296..........  ..............  ISO 10993-10 Fourth    Transition
                                  edition 2021-11        period
                                  Biological             extended.
                                  evaluation of
                                  medical devices--
                                  Part 10: Tests for
                                  skin sensitization.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                     D. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
4-234..........           4-294  ANSI/ADA Standard No.  Withdrawn and
                                  139-2020 Dental Base   replaced with
                                  Polymers.              newer version.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
15-135.........           5-135  ISO 20417 First        New recognition
                                  edition 2021-04        number.
                                  Corrected version
                                  2021-12 Medical
                                  devices--Information
                                  to be supplied by
                                  the manufacturer.
5-99...........           5-136  ASTM D4332-22          Withdrawn and
                                  Standard Practice      replaced with
                                  for Conditioning       newer version.
                                  Containers,
                                  Packages, or
                                  Packaging Components
                                  for Testing.
5-104..........           5-137  IEC TR 60878 Edition   Withdrawn and
                                  4.0 2022-11            replaced with
                                  Graphical symbols      newer version.
                                  for electrical
                                  equipment in medical
                                  practice.
5-118..........           5-138  AAMI TIR66:2017/       New recognition
                                  (R)2020 Guidance for   number.
                                  the creation of
                                  physiologic data and
                                  waveform databases
                                  to demonstrate
                                  reasonable assurance
                                  of the safety and
                                  effectiveness of
                                  alarm system
                                  algorithms.
5-119..........           5-139  ISO 18250-3 First      New recognition
                                  edition 2018-06        number.
                                  Medical devices--
                                  Connectors for
                                  reservoir delivery
                                  systems for
                                  healthcare
                                  applications--Part
                                  3: Enteral
                                  application.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-29..........           19-48  IEEE ANSI/USEMCSC      Withdrawn and
                                  C63.27 American        replaced with
                                  National Standard      newer version.
                                  for Evaluation of
                                  Wireless Coexistence.
------------------------------------------------------------------------

          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-390..........  ..............  IEC 80601-2-35         Withdrawn. See 6-
                                  Edition 2.1 2016-04    483.
                                  CONSOLIDATED VERSION
                                  Medical electrical
                                  equipment-Part--2-
                                  35: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  heating devices
                                  using blankets, pads
                                  or mattresses and
                                  intended for heating
                                  in medical use
                                  [Including Amendment
                                  1 (2016)].
6-460..........           6-484  ASTM F3502-22a         Extent of
                                  Standard               recognition.
                                  Specification for      Withdrawn and
                                  Barrier Face           replaced with a
                                  Coverings.             newer version.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-291..........           7-313  CLSI EP27 2nd Edition  Extent of
                                  Constructing and       recognition.
                                  Interpreting an        Withdrawn and
                                  Error Grid for         replaced with
                                  Quantitative           newer version.
                                  Measurement
                                  Procedures.
7-303..........  ..............  CLSI M60 2nd Edition   Withdrawn. See 7-
                                  Performance            314.
                                  Standards for
                                  Antifungal
                                  Susceptibility
                                  Testing of Yeast.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-61...........           8-594  ISO 5832-6 Third       Withdrawn and
                                  Edition 2022-03        replaced with
                                  Implants for           newer version.
                                  surgery--Metallic
                                  materials--Part 6:
                                  Wrought cobalt-
                                  nickel-chromium-
                                  molybdenum alloy.
8-123..........           8-595  ISO 5832-5 Fourth      Withdrawn and
                                  Edition 2022-03        replaced with
                                  Implants for           newer version.
                                  surgery--Metallic
                                  materials--Part 5:
                                  Wrought cobalt-
                                  chromium-tungsten-
                                  nickel.
8-559..........           8-596  ASTM D412-16(2021)     Withdrawn and
                                  Standard Test          replaced with
                                  Methods for            newer version.
                                  Vulcanized Rubber
                                  and Thermoplastic
                                  Elastomers--Tension.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-4...........           18-21  ISO/TS 80004-6 Second  Withdrawn and
                                  edition 2021-03        replaced with
                                  Nanotechnologies--Vo   newer version.
                                  cabulary--Part 6:
                                  Nano-object
                                  characterization.
18-12..........           18-22  ISO 17200 First        Withdrawn and
                                  edition 2020-09        replaced with
                                  Nanotechnology--Nano   newer version.
                                  particles in powder
                                  form--Characteristic
                                  s and measurements.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-89...........  ..............  ISO 8638 Third         Withdrawn. See 9-
                                  edition 2010-07-01     140.
                                  Cardiovascular
                                  implants and
                                  extracorporeal
                                  systems--Extracorpor
                                  eal blood circuit
                                  for hemodialyzers,
                                  hemodialfilters, and
                                  hemofilters.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-37..........          10-132  ISO 10942 Third        Extent of
                                  edition 2022-01        recognition.
                                  Ophthalmic             Withdrawn and
                                  instruments--Direct    replaced with
                                  ophthalmoscopes.       newer version.
10-91..........          10-133  ISO 11979-10 Second    Withdrawn and
                                  edition 2018-03        replaced with
                                  Ophthalmic implants--  newer version.
                                  Intraocular lenses--
                                  Part 10: Clinical
                                  investigations of
                                  intraocular lenses
                                  for correction of
                                  ametropia in phakic
                                  eyes.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-264.........          11-394  ASTM F1820-22          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Determining the    newer version.
                                  Forces for
                                  Disassembly of
                                  Modular Acetabular
                                  Devices.
11-306.........          11-395  ASTM F1814-22          Withdrawn and
                                  Standard Guide for     replaced with
                                  Evaluating Modular     newer version.
                                  Hip and Knee Joint
                                  Components.
11-320.........          11-396  ISO 7206-13 First      Withdrawn and
                                  edition 2016-07-01     replaced with
                                  [Including             newer version
                                  AMD1:2022] Implants    including
                                  for surgery--Partial   amendment.
                                  and total hip joint
                                  prostheses--Part 13:
                                  Determination of
                                  resistance to torque
                                  of head fixation of
                                  stemmed femoral
                                  components
                                  [Including Amendment
                                  1 (2022)].
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-191.........  ..............  ISO 7176-16 Second     Withdrawn. See
                                  edition 2012-12-01     16-233.
                                  Wheelchairs--Part
                                  16: Resistance to
                                  ignition of postural
                                  support devices.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-113.........          12-346  ISO 12005 Third        Withdrawn and
                                  edition 2022-05        replaced with
                                  Lasers and laser-      newer version.
                                  related equipment--
                                  Test methods for
                                  laser beam
                                  parameters--Polariza
                                  tion.

12-295.........          12-347  IEC 60601-2-33         Extent of
                                  Edition 4.0 2022-08    recognition.
                                  Medical electrical     Withdrawn and
                                  equipment--Part 2-     replaced with
                                  33: Particular         newer version.
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  magnetic resonance
                                  equipment for
                                  medical diagnosis.
12-317.........          12-348  IEC 60601-2-54         Extent of
                                  Edition 2.0 2022-09    recognition.
                                  Medical electrical     Withdrawn and
                                  equipment--Part 2-     replaced with
                                  54: Particular         newer version.
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of X-ray
                                  equipment for
                                  radiography and
                                  radioscopy.
12-342.........          12-349  NEMA Digital Imaging   Withdrawn and
                                  and Communications     replaced with
                                  in Medicine (DICOM)    newer version.
                                  Set PS3.1-3.20 2022d.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-109.........          13-121  ANSI/AAMI/UL 2800-     Withdrawn and
                                  1:2022 Standard for    replaced with
                                  Medical Device         newer version.
                                  Interoperability.      See 13-125, 13-
                                                         126, 13-127.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-409.........          14-580  ISO 11137-2 Third      Withdrawn and
                                  edition 2013-06        replaced with
                                  [Including             newer version.
                                  AMD1:2022]
                                  Sterilization of
                                  health care
                                  products--Radiation-
                                  -Part 2:
                                  Establishing the
                                  sterilization dose
                                  [Including Amendment
                                  1 (2022)].
14-527.........          14-581  ASTM F2638-22          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Using Aerosol      newer version.
                                  Filtration for
                                  Measuring the
                                  Performance of
                                  Porous Packaging
                                  Materials as a
                                  Surrogate Microbial
                                  Barrier.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 059. These entries are of standards not
previously recognized by FDA.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                     Reference No. and
   Recognition No.        Title of standard \1\             date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-158................  Medical suction equipment-- ISO 10079-4 First
                        Part 4: General             edition 2021-08.
                        requirements.
1-159................  Respiratory equipment--     ISO 18778 Second
                        Particular requirements     edition 2022-06.
                        for basic safety and
                        essential performance of
                        infant cardiorespiratory
                        monitors.
1-160................  Medical electrical          ISO 80601-2-84 First
                        equipment--Part 2-84:       edition 2020-07.
                        Particular requirements
                        for the basic safety and
                        essential performance of
                        ventilators for the
                        emergency medical
                        services environment.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-183................  Cardiovascular implants     ISO 11658 First
                        and extracorporeal          edition 2012-05-15.
                        systems--Blood/tissue
                        contact surface
                        modifications for
                        extracorporeal perfusion
                        systems.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
4-295................  Evaluation of               ANSI/ADA Standard No.
                        biocompatibility of         41-2020.
                        medical devices used in
                        dentistry.
4-296................  Dentistry--Intra-oral       ISO 9873 Fourth
                        mirrors.                    edition 2019-03.
4-297................  Dentistry--Manual           ISO 20126 Third
                        toothbrushes--General       edition 2022-03.
                        requirements and test
                        methods.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
5-140................  Standard for verification   ASME V&V 10-2019.
                        and validation in
                        computational solid
                        mechanics.
5-141................  Standard for verification   ASME V&V 20-2009
                        and validation in           (R2021).
                        computational fluid
                        dynamics and heat
                        transfer.
------------------------------------------------------------------------

                         F. General II (ES/EMC)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
6-483................  Medical electrical          IEC 60601-2-35
                        equipment--Part 2-35:       Edition 2.0 2020-09.
                        Particular requirements
                        for the basic safety and
                        essential performance of
                        heating devices using
                        blankets, pads and
                        mattresses and intended
                        for heating in medical
                        use.
6-485................  Sterile hypodermic          ISO 7886-4 Second
                        syringes for single use--   Edition 2018-11.
                        Part 4: Syringes with re-
                        use prevention feature.
------------------------------------------------------------------------
                                 H. IVD
------------------------------------------------------------------------
7-314................  Performance Standards for   CLSI M27M44S, 3rd
                        Antifungal Susceptibility   Edition.
                        Testing of Yeasts.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-140................  Extracorporeal systems for  ISO 8637-2 First
                        blood purification--Part    Edition 2018-07.
                        2: Extracorporeal blood
                        circuit for
                        hemodialyzers,
                        hemodiafilters and
                        hemofilters.
9-141................  Extracorporeal systems for  ISO 8637-3 First
                        blood purification--Part    Edition 2018-07.
                        3: Plasmafilters.
9-142................  Standard test method for    ASTM D1894-14.
                        static and kinetic
                        coefficients of friction
                        of plastic film and
                        sheeting.
9-143................  Sterile urethral catheters  ISO 20696 First
                        for single use.             edition 2018-06
                                                    Corrected 2019-12.
9-144................  Sterile drainage catheters  ISO 20697 First
                        and accessory devices for   edition 2018-06
                        single use.                 Corrected 2019-09.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-397...............  Standard test method for    ASTM F3210-22e1.
                        fatigue testing of total
                        knee femoral components
                        under closing conditions.
11-398...............  Standard test methods for   ASTM F3574-22.
                        sacroiliac joint fusion
                        devices.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-233...............  Wheelchair seating--Part    ISO 16840-10 Second
                        10: Resistance to           edition 2021-06
                        ignition of postural        Corrected version
                        support devices--           2022-01.
                        Requirements and test
                        method.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-122...............  Health software and health  IEC 81001-5-1 Edition
                        IT systems safety,          1.0 2021-12.
                        effectiveness and
                        security--Part 5-1:
                        Security--Activities in
                        the product life cycle.
13-123...............  Manufacturer disclosure     ANSI/NEMA HN 1-2019.
                        statement for medical
                        device security.
13-124...............  Guidance on the             AAMI CR34971:2022.
                        application of ISO 14971
                        to artificial
                        intelligence and machine
                        learning.
13-125...............  Standard for risk concerns  ANSI/AAMI/UL 2800-1-
                        for interoperable medical   1:2022.
                        products.
13-126...............  Standard for interoperable  ANSI/AAMI/UL 2800-1-
                        item development life       2:2022.
                        cycle.
13-127...............  Standard for Interoperable  ANSI/AAMI/UL 2800-1-
                        item integration life       3:2022.
                        cycle.
13-128...............  IEEE/UL Standard for        IEEE Std 2621.2-2022/
                        wireless diabetes device    UL 2621-2:2022.
                        security: Information
                        security requirements for
                        connected diabetes
                        solutions.
------------------------------------------------------------------------

                              R. Sterility
------------------------------------------------------------------------
14-582...............  Sterilization of health     ISO/TS 11137-4 First
                        care products--Radiation--  edition 2020-06.
                        Part 4: Guidance on
                        process control.
14-583...............  Cleaning validation of      ANSI/AAMI ST98:2022.
                        health care products--
                        Requirements for
                        development and
                        validation of a cleaning
                        process for medical
                        devices..
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

    Dated: July 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16418 Filed 8-1-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Rules and Regulations]
[Pages 24936-24937]
[FR Doc No: 2018-11669]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0301]

Drawbridge Operation Regulation; Columbia River, Portland, OR and
Vancouver, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Interstate 5 (I-5) Bridges across
the Columbia River, mile 106.5, between Portland, OR, and Vancouver,
WA. The deviation is necessary to facilitate the movement of heavier
than normal roadway traffic associated with the Independence Day
fireworks show near the I-5 Bridges. This deviation allows the bridges
to remain in the closed-to-navigation position during the event.

DATES: This deviation is effective from 9 p.m. to 11:59 p.m. on July 4,
2018.

ADDRESSES: The docket for this deviation, USCG-2018-0301 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: Oregon Department of Transportation, the
bridge owner, requested a temporary deviation from the operating
schedule for the I-5 Bridges, mile 106.5, across the Columbia River
between Vancouver, WA, and Portland, OR, to facilitate safe passage of
participants in the Independence Day fireworks show event. The I-5
Bridges provides three designated navigation channels with vertical
clearances ranging from 39 to 72 feet above Columbia River Datum 0.0
while the lift spans are in the closed-to-navigation position. The I-5
Bridges operate in accordance with 33 CFR 117.869(a). The subject
bridges need not open to marine vessels during the deviation period
from 9 p.m. to 11:59 p.m. on July 4, 2018. The bridges shall operate in
accordance with 33 CFR 117.869(a) at all other times. Waterway usage on
this part of the Columbia River includes vessels ranging from large
commercial ships, tug and tow vessels to recreational pleasure craft.
    Vessels able to pass under the bridges in the closed-to-navigation
positions may do so at any time. The bridges will be able to open for
emergencies, and this part of the Columbia River has no alternate route
for vessels to pass. The Coast Guard will also inform the users of the
waterways through our Local and Broadcast Notices to Mariners of the
change in operating schedule for the

bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridges must return to
their regular operating schedule immediately at the end of the
effective period of this temporary deviation. This deviation from the
operating regulations is authorized under 33 CFR 117.35.

    Dated: May 23, 2018.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2018-11669 Filed 5-30-18; 8:45 am]
 BILLING CODE 9110-04-P


MEMORANDUM

DATE:		7/30/2015

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Madonna Narvaez, Region 10

SUBJECT:	National Caucus of Environmental Legislators (NCEL) 2015 National Issues Forum Cedarbrook Lodge Seattle, Washington
--------------------------------------------------------------------------------

SUMMARY

      On July 31, 2015, the National Caucus of Environmental Legislators (NCEL) will be held in Seattle, Washington.  Attendees will include legislators from 35 different states.

      Contact is:

      Jeff Mauk, Interim Executive Director
      NCEL, the National Caucus of Environmental Legislators
      218 D Street SE, 1st Floor
      Washington, DC 20003
<EMAIL_ADDRESS>| m:<PHONE_NUMBER> | t: @NCELenviro

ATTENDEES

Kate Kelly, Director, Office of Air, Waste and Toxics, R10

Please see attached agenda. Also attached is the presentation given by Kate Kelly.


[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Page 42828]
[FR Doc No: 2017-19262]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3382-EM; Docket ID FEMA-2017-0001]

Louisiana; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Louisiana (FEMA-3382-EM), dated August 28,
2017, and related determinations.

DATES: The declaration was issued August 28, 2017.

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: Notice is hereby given that, in a letter
dated August 28, 2017, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Louisiana resulting from Tropical Storm Harvey
beginning on August 27, 2017, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of Louisiana.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, William
J. Doran III, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Louisiana have been designated
as adversely affected by this declared emergency:

    Beauregard, Calcasieu, Cameron, Jefferson Davis, and Vermillion
Parishes for emergency protective measures (Category B), including
direct federal assistance, under the Public Assistance program.

    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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-19262 Filed 9-11-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: February 11, 2008 (Volume 73, Number 28)]
[Notices]
[Page 7740-7742]
[DOCID:fr11fe08-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-191-001]

Port Dolphin Energy, LLC; Notice of Limited Scoping for the
Proposed Port Dolphin Project and Request for Comments on Environmental
Issues

February 4, 2008.
    The Federal Energy Regulatory Commission (FERC or Commission) is
cooperating with the U.S. Coast Guard (Coast Guard), the lead federal
agency for environmental review of the Port Dolphin Project. This
proposal involves the construction and operation of an offshore
liquefied natural gas (LNG) deepwater port (under the jurisdiction of
the Coast Guard and the Maritime Administration) and associated
pipeline facilities, including about 3.9 miles of onshore pipeline
under the Commission's jurisdiction. FERC staff is assisting the Coast
Guard in its preparation of an environmental impact statement (EIS)
that will discuss the environmental impacts of the Port Dolphin
Project. This cooperative effort is to comply with the National

Environmental Policy Act of 1969 (NEPA), which requires the Commission
to take into account the environmental impact that could result from an
action whenever it considers the issuance of a Certificate of Public
Convenience and Necessity under section 7 of the Natural Gas Act.
    NEPA requires the FERC to discover and address concerns the public
may have about proposals under its review. This process is referred to
as ``scoping.'' On January 18, 2008, Port Dolphin Energy, LLC (Port
Dolphin) amended its application with the FERC regarding the proposed
onshore pipeline route. Thus, the FERC is opening a scoping period to
solicit input from the public and interested agencies limited to the
proposed onshore pipeline and related facilities (i.e., those under
FERC jurisdiction) in Manatee County, Florida. Your input will help
determine which issues need to be evaluated in the EIS.\1\ Please note
that the scoping period will close on March 5, 2008, and comments
should be limited to the onshore facilities described in this amended
docket. Details on how to submit comments are provided in the Public
Participation section of this notice.
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    \1\ For more information on the overall Port Dolphin Project or
the Coast Guard's EIS process, see the July 12, 2007 edition of the
Federal Register, page 38,116, ``Port Dolphin Energy, LLC, Port
Dolphin Energy Liquefied Natural Gas Deepwater Port License
Application'' under Department of Transportation/Maritime
Administration.
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    If you are a landowner receiving this notice, you may be contacted
by a pipeline company representative about the acquisition of an
easement to construct, operate, and maintain the proposed facilities.
Port Dolphin would seek to negotiate a mutually acceptable agreement.
However, if the project is approved by the Commission, that approval
conveys with it the right of eminent domain. Therefore, if easement
negotiations fail to produce an agreement, Port Dolphin could initiate
condemnation proceedings in accordance with Florida state law.
    This notice is being sent to affected landowners; federal, state,
and local government representatives and agencies; elected officials;
Native American tribes; other interested parties; and local libraries
and newspapers. State and local government representatives are asked to
notify their constituents of this proposed project and to encourage
them to comment on their areas of concern.\2\ If you received this
notice, you are on the environmental mailing list for this project and
will continue to receive project updates including the draft and final
EISs.
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    \2\ Comments submitted during the Coast Guard's scoping period
(July 12-August 13, 2007) for the project as originally proposed do
not need to be resubmitted.
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    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' addresses a number
of typically asked questions, including the use of eminent domain and
how to participate in the Commission's proceedings. It is available for
viewing on the FERC Internet Web site (http://www.ferc.gov).

Summary of the Proposed Project (FERC Jurisdictional Facilities)

    Port Dolphin proposes to construct about 3.93 miles of 36-inch-
diameter pipeline extending from the high water mark in Manatee County
(where the offshore pipeline comes ashore) to a new interconnection
station (also in Manatee County), where the pipeline would join with
the interstate Gulfstream Natural Gas Pipeline and the intrastate TECO/
Peoples Pipeline systems. Associated valves and appurtenant facilities
are also proposed.
    The general location of the proposed onshore pipeline is shown in
appendix 1.\3\
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    \3\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies are available on the
Commission's Internet Web site (http://www.ferc.gov) at the

``eLibrary'' link or from the Commission's Public Reference Room at
888 First Street, NE., Washington, DC 20426, or call<PHONE_NUMBER>.
For instructions on connecting to eLibrary, refer to the
``Additional Information'' section at the end of this notice. Copies
of the appendices were sent to all those receiving this notice in
the mail. Requests for detailed maps of the proposed facilities
should be made directly to Port Dolphin.
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Land Requirements for Construction

    The construction right-of-way would be 100 feet wide, of which 30
feet would be retained as permanent right-of-way. A total of about 63.6
acres of land would be affected by pipeline construction. Of this,
about 13.8 acres would be permanently impacted for operation. The
proposed interconnections would be constructed on property owned by
Port Dolphin and would encompass a 120-foot by 1,319-foot permanent
footprint. The valve station would encompass a 50-foot by 60-foot
permanent footprint.
    The majority (about 56 percent) of the land crossed by the pipeline
route is either classified as urban/industrial (e.g., commercial land
and other utility rights-of-way) or as agricultural/rangeland. The
remaining land comprises upland forest, wetland, and surface water
(e.g., ponds, canals, and ditches).

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. By becoming a commentor, your
concerns will be addressed in the EIS and considered by the Commission.
You should focus on the potential environmental effects of the
proposal, alternatives to the proposal including alternative pipeline
routes, and measures to avoid or lessen environmental impact. The more
specific your comments, the more useful they will be. Please carefully
follow these instructions to ensure that your comments are received in
time and properly recorded:
     Send an original and two copies of your letter to:
Kimberley D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First St., NE.; Room 1A, Washington, DC 20426.
     Label one copy of the comments for the attention of Gas
Branch 1.
     Reference Docket No. CP07-191-001.
     Mail your comments so that they will be received in
Washington, DC on or before March 5, 2008.
    The Commission encourages electronic filing of comments. See 18
Code of Federal Regulations 385.2001(a)(1)(iii) and the instructions on
the Commission's Internet Web site at http://www.ferc.gov under the

``eFiling'' link and the link to the User's Guide. Prepare your
submission in the same manner as you would if filing on paper and save
it to a file on your hard drive. Before you can file comments you will
need to create an account by clicking on ``Login to File'' and then
``New User Account.'' You will be asked to select the type of filing
you are making. This filing is considered a ``Comment on Filing.''

Becoming an Intervenor

    In addition to involvement in the EIS scoping process, you may want
to become an official party to the proceeding known as an
``intervenor.'' Intervenors play a more formal role in the process.
Among other things, intervenors have the right to receive copies of
case-related Commission documents and filings by other intervenors.
Likewise, each intervenor must send one electronic copy (using the
Commission's eFiling system) or 14 paper copies of its filings to the
Secretary of the Commission and must send a copy of its filings to all
other parties on the Commission's service list for this proceeding. If
you want to become an intervenor you must file a motion to intervene
according to Rule

214 of the Commission's Rules of Practice and Procedure (18 CFR
385.214) (see appendix 2).\4\ Only intervenors have the right to seek
rehearing of the Commission's decision.
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    \4\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
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    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your environmental comments considered.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the ``eLibrary''

link. Click on the eLibrary link, click on ``General Search'' and enter
the full docket number (i.e., CP07-191-001) in the docket number field.
Be sure you have selected an appropriate date range. For assistance,
please contact FERC Online Support at<EMAIL_ADDRESS>or
toll-free at 1-866-208-3676, or for TTY, contact<PHONE_NUMBER>. The
eLibrary link also provides access to the texts of formal documents
issued by the Commission, such as orders, notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-2422 Filed 2-8-08; 8:45 am]

BILLING CODE 6717-01-P