[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5531-5532]
[DOCID:fr30ja08-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13030-000]

Aberdeen Hydro, LLC; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

January 24, 2008.
    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: P-13030-000.
    c. Date Filed: September 20, 2007.
    d. Applicant: Aberdeen Hydro, LLC.
    e. Name of the Project: Aberdeen Lock and Dam Hydroelectric
Project.
    f. Location: The project would be located on the Tombigbee River in
Monroe County, Mississippi. The Aberdeen Lock and Dam is owned and
maintained by the U.S. Army Corps of Engineers.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Mr. Brent Smith, Symbiotics, LLC, P.O. Box
535, Rigby, ID 83442, Phone<PHONE_NUMBER>.
    i. FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-13030-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would utilize the
existing U.S. Army Corps of Engineers' Aberdeen Lock and Dam and would
consist of: (1) A proposed powerhouse containing three generating units
with a total installed capacity of 20-megawatts; (2) a switchyard; (3)
a proposed 2-mile-long, 46-kV transmission line; and (4) appurtenant
facilities. The proposed project would have an estimated annual
generation of 36-gigawatts and would be sold to a local utility.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<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. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .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, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. 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.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-1633 Filed 1-29-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 7, 2009 (Volume 74, Number 87)]
[Notices]
[Page 21361-21362]
[DOCID:fr07my09-53]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8791-4; Docket ID No. EPA-HQ-ORD-2009-0210]

Draft Toxicological Review of 1,4-Dioxane: In Support of the
Summary Information in the Integrated Risk Information System (IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a public comment period for the external
review draft document titled, ``Toxicological Review of 1,4-Dioxane: In
Support of Summary Information on the Integrated Risk Information
System (IRIS).'' The public comment period and the external peer-review
workshop, which will be scheduled at a later date and announced in the
Federal Register, are separate processes that provide opportunities for
all interested parties to comment on the document. EPA intends to
forward the public comments that are submitted in accordance with this
notice to the external peer-review panel prior to the meeting for their
consideration. When finalizing the draft document, EPA intends to
consider any public comments that EPA receives in accordance with this
notice.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination.
    The draft document and EPA's peer-review charge are available via
the Internet on the NCEA home page under the Recent Additions and the
Data and Publications menus at http://www.epa.gov/ncea.

DATES: The 60-day public comment period begins May 7, 2009, and ends
July 6, 2009. Technical comments should be in writing and must be
received by EPA by July 6, 2009. EPA intends to submit comments from
the public received by this date for consideration by the external peer
review panel.

ADDRESSES: The draft ``Toxicological Review of 1,4-Dioxane: In Support
of Summary Information on the Integrated Risk Information System
(IRIS)'' is available via the Internet on the National Center for
Environmental Assessment's (NCEA) home page under the Recent Additions
and the Data and Publications menus at http://www.epa.gov/ncea. A
limited number of paper copies are available from NCEA's Information
Management Team, telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If
you are requesting a paper copy, please provide your name, mailing
address, and the document title, ``Toxicological Review of 1,4-Dioxane:
In Support of Summary Information on the Integrated Risk Information
System (IRIS).''
    Comments may be submitted electronically via http://
www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>    If you have questions about the document, contact Eva D. McLanahan,
Hazardous Pollutant Assessment Group (HPAG), National Center for
Environmental Assessment, 109 T.W. Alexander Dr., Research Triangle
Park, NC 27709; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Summary of Information About the Integrated Risk Information System
(IRIS)

    IRIS is a database that contains potential adverse human health
effects information that may result from chronic (or lifetime) exposure
to specific chemical substances found in the environment. The database
(available on the Internet at http://www.epa.gov/iris) contains
qualitative and quantitative health effects information for more than
540 chemical substances that may be used to support the first two steps
(hazard identification and dose-response evaluation) of a risk
assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS data to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

II. How To Submit Technical Comments to the Docket at http://
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0210 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center's Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit one
unbound original with pages numbered consecutively, and three copies of
the comments. For attachments, provide an index, number pages
consecutively with the comments, and submit an unbound original and
three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0210. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The

http://www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: April 7, 2009.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
 [FR Doc. E9-10656 Filed 5-6-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42407-42411]
[FR Doc No: 2020-15137]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance and reissuance of Emergency Use Authorizations (EUAs) (the
Authorizations) for certain medical devices related to the Coronavirus
Disease 2019 (COVID-19) public health emergency. FDA has issued, and in
some cases reissued, the Authorizations listed in this document under
the Federal Food, Drug, and Cosmetic Act (FD&C Act). These
Authorizations contain, among other things, conditions on the emergency
use of the authorized products. The Authorizations follow the February
4, 2020, determination by Secretary of Health and Human Services (HHS)
that there is a public health emergency that has a significant
potential to affect national security or the health and security of
U.S. citizens living abroad, and that involves the virus that causes
COVID-19, and the subsequent declarations on February 4, 2020, March 2,
2020, and March 24, 2020, that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection
and/or diagnosis of the virus that causes COVID-19, personal
respiratory protective devices, and medical devices, including
alternative products used as medical devices, respectively, subject to
the terms of any authorization issued under the FD&C Act. These
Authorizations, which include an explanation of the reasons for
issuance and reissuance, are listed in this document, and are available
on FDA's website at the links indicated.

DATES: These Authorizations are applicable on their date of issuance.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent.

See the SUPPLEMENTARY INFORMATION section for electronic access to the
Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355,
360(k), 360b, or 360e) or section 351 of the PHS Act (42 U.S.C. 262),
or conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) That an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent; and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied.
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    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. The Authorizations

    Having concluded that the criteria for the issuance and, in some
cases reissuance, of the following Authorizations under section 564(c)
of the FD&C Act are met, FDA has authorized the emergency use of the
following products for diagnosing, treating, or preventing COVID-19
subject to the terms of each Authorization. The Authorizations in their
entirety, including any authorized fact sheets and other written
materials, are available on the internet from the FDA web page entitled
``Emergency Use Authorization,'' available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The lists that follow include
Authorizations issued, in some cases reissued, from April 11, 2020,
through May 15, 2020, and we have included explanations of the reasons
for their issuance, as required by section 564(h)(1) of the FD&C Act.
FDA is

hereby announcing the following Authorizations for in vitro
diagnostics: \3\
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    \3\ As set forth in the EUAs for these devices, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the devices may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the devices, when used for diagnosing COVID-19, outweigh the known
and potential risks of such devices; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
devices.
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     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 Total Reagent Pack, issued April 14, 2020;
     Chembio Diagnostic System, Inc.'s DPP COVID-19 IgM/IgG
System, issued April 14, 2020;
     Mount Sinai Laboratory's COVID-19 [enzyme-linked
immunosorbent assay] ELISA IgG Antibody Test, issued April 15, 2020;
     Maccura Biotechnology (USA) LLC's SARS-CoV-2 Fluorescent
PCR Kit, issued April 15, 2020;
     GenoSensor, LLC's GS COVID-19 RT-PCR KIT, issued April 16,
2020;
     KorvaLabs Inc.'s Curative-Korva SARS-CoV-2 Assay, issued
April 16, 2020;
     Fosun Pharma USA Inc.'s Fosun COVID-19 RT-PCR Detection
Kit, issued April 17, 2020;
     OSANG Healthcare's GeneFinder COVID-19 Plus RealAmp Kit,
issued April 18, 2020;
     Trax Management Services Inc.'s PhoenixDx 2019-CoV, issued
April 20, 2020;
     Laboratory Corporation of America's COVID-19 RT-PCR Test,
reissued April 20, 2020 (original issuance March 16, 2020);
     Seegene, Inc.'s Allplex 2019-nCoV Assay, issued April 21,
2020;
     altona Diagnostics GmbH's RealStar SARS-CoV-2 RT-PCR Kits
U.S., issued April 22, 2020;
     SD Biosensor, Inc.'s STANDARD M nCoV Real-Time Detection
Kit, issued April 23, 2020;
     Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test,
issued April 24, 2020;
     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 IgG Reagent Pack, issued April 24, 2020;
     DiaSorin Inc.'s LIAISON SARS-CoV-2 S1/S2 IgG, issued April
24, 2020;
     Abbott Laboratories Inc.'s SARS-CoV-2 IgG assay, issued
April 26, 2020;
     SEASUN BIOMATERIALS's U-TOP COVID-19 Detection Kit, issued
April 27, 2020;
     Bio-Rad Laboratories, Inc's Platelia SARS-CoV-2 Total Ab
assay, issued April 29, 2020;
     Rheonix, Inc.'s Rheonix COVID-19 MDx Assay, issued April
29, 2020;
     LabGenomics Co., Ltd.'s LabGun COVID-19 RT-PCR Kit, issued
April 29, 2020;
     Wadsworth Center, New York State Department of Health's
New York SARS-CoV Microsphere Immunoassay for Antibody Detection,
issued April 30, 2020;
     BioFire Diagnostics, LLC's BioFire Respiratory Panel 2.1
(RP2.1), issued May 1, 2020;
     Bio-Rad Laboratories, Inc.'s Bio-Rad SARS-CoV-2 ddPCR
Test, issued May 1, 2020;
     Roche Diagnostics's Elecsys Anti-SARS-CoV-2, issued May 2,
2020;
     Sansure BioTech Inc.'s Novel Coronavirus (2019-nCoV)
Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing), issued May 4,
2020;
     EUROIMUN US Inc.'s Anti-SARS-CoV-2 ELISA (IgG), issued May
4, 2020;
     Fast Track Diagnostics Luxembourg S.[aacute].r.l's. (a
Siemens Healthineers Company) FTD SARS-CoV-2, issued May 5, 2020;
     BioM[eacute]rieux SA's SARS-COV-2 R-GENE, issued May 6,
2020;
     Sherlock BioSciences, Inc.'s Sherlock CRISPR SARS-CoV-2
Kit, issued May 6, 2020;
     OPTI Medical Systems, Inc.'s OPTI SARS-CoV-2 RT PCR Test,
issued May 6, 2020;
     Zymo Research Corp.'s Quick SARS-Cov-2rRT-PCR Kit, issued
May 7, 2020;
     Rutgers Clinical Genomics Laboratory at RUCDR Infinite
Biologics-Rutgers University's Rutgers Clinical Genomics Laboratory
TaqPath SARS-CoV-2 Assay, reissued May 7, 2020 (original issuance April
10, 2020);
     Gnomegen LLC's Gnomegen COVID-19-RT-qPCR Detection Kit,
issued May 8, 2020;
     Quidel Corporation's Sofia 2 SARS Antigen FIA, issued May
8, 2020;
     Abbott Molecular Inc.'s Alinity m SARS-CoV-2 assay, issued
May 11, 2020;
     1drop Inc.'s 1copy COVID-19 qPR Multi Kit, issued May 11,
2020;
     Applied DNA Sciences, Inc.'s Linea COVID-19 Assay Kit,
issued May 13, 2020;
     GeneMatrix, Inc.'s NeoPlex COVID-19 Detection Kit, issued
May 14, 2020;
     Hologic, Inc., Aptima SARS-CoV-2 assay, issued May 14,
2020;
     Assurance Scientific Laboratories' Assurance SARS-CoV-2
Panel, issued May 15, 2020;
     Fulgent Therapeutics, LLC's Fulgent COVID-19 by RT-PCR
Test, issued May 15, 2020; and
     Certain SARS-CoV-2 Antibody Tests (lateral flow or ELISA
tests) that are for use in laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a, to perform
moderate or high complexity tests, issued on April 28, 2020 (a current
list of tests included under this EUA is available at https://www.fda.gov/media/137471/download).
    FDA is hereby announcing the following Authorizations for personal
respiratory protective devices: \4\
---------------------------------------------------------------------------

    \4\ As set forth in the EUAs, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is either reasonable to believe that the authorized
respirators may be effective in preventing healthcare personnel
(HCP) exposure to pathogenic biological airborne particulates during
Filtering Facepiece Respirator (FFR) shortages, and that the known
and potential benefits of the authorized respirators, when used to
prevent HCP exposure to such particulates during FFR shortages
during COVID-19, outweigh the known and potential risks of such
products, and (3) there is no adequate, approved, and available
alternative to the emergency use of this product.
---------------------------------------------------------------------------

     Certain Non-[National Institute of Industrial and
Occupational Safety]NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China, reissued May 7, 2020, (original
issuance April 3, 2020). A current list of respirators included under
this EUA is available at https://www.fda.gov/media/136663/download).
    FDA is hereby announcing the following Authorizations for other
medical devices:
     B. Braun Medical, Inc.'s B. Braun Space and Outlook Pumps,
issued April 11, 2020; \5\
---------------------------------------------------------------------------

    \5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the B. Braun Space and Outlook Pumps may be effective for use
in the tracheal delivery of continuous nebulized medications into a
nebulizer to treat COVID-19 patients of all ages and for the ground
medical transport use of the Infusomat Space Volumetric Infusion
Pump System, and that the known and potential benefits of the B.
Braun Space and Outlook Pumps for these uses, outweigh the known and
potential risks of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     Advanced Sterilization Products, Inc.'s ASP STERRAD
Sterilization Systems, issued April 11, 2020; \6\
---------------------------------------------------------------------------

    \6\ As set forth in this EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the ASP STERRAD Sterilization Systems may be effective at
preventing exposure to pathogenic airborne particulates when there
are insufficient supplies of N95 respirators during the COVID-19
pandemic by decontaminating, for a maximum of two decontamination
cycles per respirator, compatible N95 respirators that are
contaminated or potentially contaminated with SARS-CoV-2 or other
pathogenic microorganisms, and that the known and potential benefits
of the Sterilization Systems, when used to decontaminate compatible
N95 respirators for single-user reuse by HCP to prevent exposure to
pathogenic airborne particulates during N95 respirator shortages
during the COVID-19 pandemic, outweigh the known and potential
risks; and (3) there is no adequate, approved, and available
alternative to the emergency use of this product.

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

     Certain Face Shields, reissued April 13, 2020 (original
issuance April 9, 2020); \7\
---------------------------------------------------------------------------

    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the authorized face shields may be effective at preventing HCP
exposure to fluid biological airborne particulates during face
shield shortages by providing minimal or low barrier HCP protection
to the wearer, and that the known and potential benefits of face
shields, when used to prevent HCP exposure to such particulates
during face shield shortages during COVID-19 outweigh the known and
potential risks of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     Synapse Biomedical, Inc.'s TransAeris Diaphragm Pacing
System, issued April 13, 2020; \8\
---------------------------------------------------------------------------

    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective for emergency use to treat
patients by assisting in weaning patients off ventilators in
healthcare settings during the COVID-19 pandemic, and that the known
and potential benefits of the such product, for such use, outweigh
the known and potential risks of such product; and (3) there is no
adequate, approved, and available alternative.
---------------------------------------------------------------------------

     Stryker Instruments' STERIZONE VP4 Sterilizer, issued
April 14, 2020; \9\
---------------------------------------------------------------------------

    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the STERIZONE VP4 N95 Respirator Decontamination Cycle may be
effective at preventing exposure to pathogenic airborne particulates
by decontaminating, for a maximum of two decontamination cycles per
respirator, compatible N95 respirators that are contaminated or
potentially contaminated with SARS-CoV-2 or other pathogenic
microorganisms, and that the known and potential benefits of this
device, when used as described, outweigh the known and potential
risks; and (3) there is no adequate, approved, and available
alternative to the emergency use of the STERIZONE VP4 N95 Respirator
Decontamination Cycle for decontaminating compatible N95 respirators
for single-user reuse by HCPs during FFR shortages during the COVID-
19 pandemic.
---------------------------------------------------------------------------

     Lungpacer Medical USA, Inc.'s Lungpacer DPTS, issued April
14, 2020 (see footnote 8);
     ExThera Medical Corporation's Seraph 100 Microbind
Affinity Blood Filter, issued April 17, 2020; \10\
---------------------------------------------------------------------------

    \10\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Seraph 100 Microbind Affinity Blood Filter device may be
effective in treating patients 18 years of age or older with
confirmed COVID-19 admitted to the intensive care unit (ICU) with
confirmed or imminent respiratory failure, and that the known and
potential benefits of the Seraph 100 Microbind Affinity Blood Filter
device, when used to treat such patients, outweigh the known and
potential risks of the device; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     Certain Face Masks, issued April 18, 2020, and reissued
April 24, 2020; \11\
---------------------------------------------------------------------------

    \11\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the authorized face masks may be effective as source control to
help prevent the spread of SARS-CoV-2 by infected individuals who
may or may not have symptoms of COVID-19 during the COVID-19
pandemic, and that the known and potential benefits of face masks,
when used in accordance with the scope of this authorization,
outweigh the known and potential risks of such product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of this product.
---------------------------------------------------------------------------

     Sterilucent, Inc.'s Sterilucent Sterilizer System, issued
April 20, 2020; \12\
---------------------------------------------------------------------------

    \12\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Sterilucent Sterilization System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCPs to prevent exposure to pathogenic biological airborne
particulates, and that the known and potential benefits of this
device, when used as described, outweigh the known and potential
risks of the use of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     Philips Medizin Systeme Boeblingen GmbH's IntelliVue
Patient Monitors, issued April 21, 2020; \13\
---------------------------------------------------------------------------

    \13\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the IntelliVue Patient Monitors may be effective in preventing
COVID-19 exposure in healthcare providers, through use of remote
patient monitoring, and that the known and potential benefits of
such products, for such use, outweigh the known and potential risks
of the IntelliVue Patient Monitors; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     ALung Technologies, Inc.'s Hemolung RAS, issued April 22,
2020; \14\
---------------------------------------------------------------------------

    \14\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Hemolung RAS may be effective in treating lung failure when
used as described in the Scope of Authorization, and that the known
and potential benefits of the Hemolung RAS for treating these
patients, outweigh the known and potential risks; and (3) there is
no adequate, approved, and available alternative to the emergency
use of this product.
---------------------------------------------------------------------------

     Baxter Healthcare Corp.'s oXiris Set device, issued April
23, 2020; \15\
---------------------------------------------------------------------------

    \15\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the oXiris Set device may be effective in treating patients 18
years of age or older with confirmed COVID-19 admitted to the ICU
with confirmed or imminent respiratory failure in need of blood
purification, including use in continuous renal replacement therapy,
and that the known and potential benefits of the oXiris Set device,
when used to treat such patients, outweigh the known and potential
risks of the oXiris Set device; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     VitalConnect, Inc.'s VitalPatch, issued April 26, 2020;
\16\
---------------------------------------------------------------------------

    \16\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in remotely monitoring and detecting QT interval changes of an ECG
in patients who are undergoing treatment in a hospital setting for
COVID-19 with drugs that can prolong QT intervals and may cause life
threatening arrhythmias (e.g., hydroxychloroquine or chloroquine,
especially when used in combination with azithromycin), the known
and potential benefits of product for such use, outweigh the known
and potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of this product.
---------------------------------------------------------------------------

     Fresenius Medical Care's multiFiltrate PRO System and
multiBic/multiPlus Solutions to provide continuous renal replacement
therapy, issued May 1, 2020; \17\
---------------------------------------------------------------------------

    \17\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness and multiple organ failure, including acute kidney injury,
to humans infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable to believe
that your multiFiltrate PRO System and multiBic/multiPlus Solutions
may be effective in delivering CRRT in an acute care environment,
and that the known and potential benefits of the multiFiltrate PRO
System and multiBic/multiPlus Solutions, for such use, outweigh the
known and potential risks; and (3) there is no adequate, approved,
and available alternative to the emergency use of this product.
---------------------------------------------------------------------------

     Liberate Medical, LLC's VentFree, issued May 1, 2020; \18\
---------------------------------------------------------------------------

    \18\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that VentFree may be effective for emergency use by HCP in
healthcare settings to treat adult patients by reducing disuse
atrophy of the abdominal wall muscles, which may reduce the number
of days of ventilator support in patients who require mechanical
ventilation during the COVID-19 pandemic, and that the known and
potential benefits of the such products, for such use, outweigh the
known and potential risks of such product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of this product.

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

     Certain Protective Barrier Enclosures, issued May 1, 2020;
\19\
---------------------------------------------------------------------------

    \19\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the authorized protective barrier enclosures may be effective
at preventing HCP exposure to pathogenic biological airborne
particulates by providing an extra layer of barrier protection in
addition to PPE when caring for or performing medical procedures on
patients who are known or suspected to have COVID-19 in healthcare
settings and that the known and potential benefits of protective
barrier enclosures, for such use, outweigh the known and potential
risks of such product; and, (3) there is no adequate, approved, and
available alternative to the emergency use of this product.
---------------------------------------------------------------------------

     PhsiolGuard Corp. Ltd.'s PhysiolGuard ECG-QT Analysis
System, issued May 5, 2020 (refer to footnote 15);
     Duke University Health System's Duke Decontamination
System, issued May 7, 2020; \20\
---------------------------------------------------------------------------

    \20\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Duke Decontamination System may be effective at
decontaminating compatible N95 respirators for reuse by HCPs to
prevent exposure to SARS-CoV-2 and other pathogenic biological
airborne particulates, and that the known and potential benefits of
this product, when used as described, outweigh the known and
potential risks of the use of such product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of this product.
---------------------------------------------------------------------------

     Comunale's Patient Isolation Transport Unit, issued May 8,
2020; \21\
---------------------------------------------------------------------------

    \21\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the PITU may be effective in preventing HCP exposure to
pathogenic biological airborne particulates by providing an extra
layer of barrier protection in addition to PPE, and that the known
and potential benefits of such products, when used by HCP for
temporary isolation and transport of patients with suspected or
confirmed diagnosis of COVID-19 requiring airborne or droplet
isolation precautions in healthcare settings to prevent HCP exposure
to pathogenic biological airborne particulates by providing an extra
layer of barrier protection in addition to PPE, outweigh the known
and potential risks of the PITU; and (3) there is no adequate,
approved, and available alternative to the emergency use of this
product.
---------------------------------------------------------------------------

     Ascom (US) Inc.'s teleCARE IP Nurse Call System, issued
May 11, 2020; \22\
---------------------------------------------------------------------------

    \22\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the use of the teleCARE IP Nurse Call System in healthcare
environments may be effective for preventing COVID-19 exposure in
healthcare providers by enabling remote communication between
patients and healthcare providers, and, for those patients utilizing
a ventilator, remote monitoring of ventilator status updates to
alert the healthcare provider. FDA concluded that the known and
potential benefits of the teleCARE IP Nurse Call System, for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of this product.
---------------------------------------------------------------------------

     Eko Devices, Inc.'s Eko ELEFT, issued May 11, 2020; \23\
---------------------------------------------------------------------------

    \23\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the ELEFT may be effective for use by HCP to provide an
assessment of LVEF for use as a diagnostic aid to screen for
potential cardiac complications associated with COVID-19 or
underlying cardiac conditions that may affect clinical management of
COVID-19, in adult patients having or suspected of having COVID-19
and that the known and potential benefits of ELEFT, for such use,
outweigh the known and potential risks; and (3) there is no
adequate, approved, and available alternative to the emergency use
of this product.
---------------------------------------------------------------------------

     Certain Infusion Pumps and Infusion Pump Accessories,
issued May 13, 2020; \24\
---------------------------------------------------------------------------

    \24\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that authorized infusion pumps and infusion pump accessories may be
effective for use by HCPs to treat conditions caused by COVID-19
with the controlled infusion of medications, TPN, and/or other
fluids, and that the known and potential benefits of such products,
for such use outweigh the known and potential risks of such
products; and (3) there is no adequate, approved, and available
alternative to the emergency use of this product.
---------------------------------------------------------------------------

     G Medical Innovations Ltd.'s VSMS Patch, issued May 14,
2020; \25\ and
---------------------------------------------------------------------------

    \25\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the VSMS Patchmay be effective
in remotely monitoring QT interval prolongation on an ECG in
patients who are undergoing treatment in a hospital setting for
COVID-19 with drugs that can prolong QT intervals and may cause
life-threatening arrhythmias (e.g., hydroxychloroquine or
chloroquine, especially when used in combination with azithromycin),
the known and potential benefits of the VSMS Patch, for such use,
outweigh the known and potential risks; and (3) there is no
adequate, approved, and available alternative to the emergency use
of this product.
---------------------------------------------------------------------------

     Everlywell Inc.'s Everlywell COVID-19 Test Home Collection
Kit, issued May 15, 2020.\26\
---------------------------------------------------------------------------

    \26\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect and transport human specimens so
that an authorized laboratory can detect SARS-CoV-2 RNA from the
home-collected human specimen, and that the known and potential
benefits of the product when used for such use, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15137 Filed 7-13-20; 8:45 am]
BILLING CODE 4164-01-P


Proposed Rule: Mandatory Reporting of Greenhouse Gas Emissions

Meeting Documentation  Meetings with IBM

Date	Staff Contact Information (Name, email, phone #)	Name of
Organization (Attach list of all attendees names and emails if possible)
	Summary of Discussion (e.g., applicability, reporting requirements,
etc.)	Written Comments Provided?

Did they also submit to Docket?	Date sent to EPA- CCD

Discussions from October 2009 to March 2010.  	Kirsten Cappel,
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>,
(202) 343-9556	IBM:

• David Speed<EMAIL_ADDRESS>
• Jay Dietrich

<EMAIL_ADDRESS>
• Janet Doyle<EMAIL_ADDRESS>
• EPA and EPA contractors 	Discussions included:

• Methods for tracking gas usage by process.

• Methods for tracking gas consumption including the use of heel
factors.

• Refinement of semiconductor manufacturing process categories and
availability of emission factors.

• Abatement system destruction or removal efficiency testing.

	NA 	March 10, 2010


[Federal Register Volume 88, Number 104 (Wednesday, May 31, 2023)]
[Notices]
[Page 34874]
[FR Doc No: 2023-11518]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4685-DR; Docket ID FEMA-2023-0001]

Georgia; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Georgia (FEMA-4685-DR), dated January 16, 2023, and
related determinations.

DATES: This change occurred on May 3, 2023.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Judy Kruger, of
FEMA is appointed to act as the Federal Coordinating Officer for this
disaster.
    This action terminates the appointment of Manny J. Toro as Federal
Coordinating Officer for this disaster.

    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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-11518 Filed 5-30-23; 8:45 am]
BILLING CODE 9111-23-P


                                             SEQ CHAPTER \h \r 1

DRAFT

SUPPORTING STATEMENT

FOR

INFORMATION COLLECTION REQUEST

Focus Group and Consumer Survey Research for Improving Fuel Economy
Label Design and Content

EPA ICR 2343.01

December, 2009

Compliance and Innovative Strategies Division

Office of Transportation and Air Quality

Office of Air and Radiation

U.S. Environmental Protection Agency

Part A

1.  Identification of the Information Collection

 	(a) Title of the Information Collection

Focus Group and Consumer Survey Research for Improving Fuel Economy
Label Design and Content

(b) Short Characterization/Abstract

This is a request to conduct focus group and consumer survey research
for the Environmental Protection Agency (EPA).  As required under the
Energy Policy and Conservation Act (EPCA), EPA has promulgated
regulations which specify the design and content of fuel economy labels
that are affixed on the windows of all cars and light trucks sold in the
U.S.  Ref. 49 U.S.C. 32908(b).

EPA is responsible for developing the fuel economy labels that are
posted on window stickers of all new light duty cars and trucks sold in
the U.S. and, beginning with the 2011 model year, on all new medium-duty
passenger vehicles (a category that includes large sport-utility
vehicles and passenger vans).

In 2006 EPA updated how the window sticker fuel economy values are
calculated to better reflect typical real-world driving patterns and
provide more realistic fuel economy estimates. Since then, increasing
market penetration of advanced technology vehicles, in particular
plug-in hybrid electric vehicles and electric vehicles, will require new
metrics to effectively convey information to consumers.  EPA has
initiated a rulemaking action that will amend the way in which fuel
economy estimates are calculated and/or displayed, particularly for
advanced technology vehicles.

EPA plans to conduct a limited set of voluntary focus groups and
consumer surveys over the course of the rulemaking to solicit
information from a diverse group of consumers regarding what information
displayed on the fuel economy label will best serve the intended purpose
of providing consumers with useful and meaningful information about the
vehicles they are considering to purchase.

2.  Need for and Use of the Collection

	(a) Need/Authority for the Collection

The consumer survey and focus group research information is needed by
EPA to assist the Agency in determining the design and content of fuel
economy labels that are understood by and useful to prospective car
buyers.

.

	(b) Practical Utility/Users of the Data

The consumer survey and focus group research will be used by EPA to
better understand what information displayed on the fuel economy label
– especially with respect to advanced technology vehicles – will be
most useful and understandable to consumers.   The data gathered will be
used along with comments received during the proposal period of the fuel
economy labeling regulations to assist EPA's final determination of the
label design and content to specify in those regulations.

3.  Non-duplication, Consultations, and Other Collection Criteria

	(a) Non-duplication

EPA is not requesting information that is anyway duplicative of other
information being collected by any other entity.

	(b) Public Notice Prior to Submission to OMB

EPA is soliciting public comment as required by the Paperwork Reduction
Act via a Federal Register notice published in early December, 2009.

	(c) Consultations

In conducting the focus group research, EPA will contract the services
of a professional market research firm, who will assist in developing
and pre-testing the surveys and in conducting the focus groups.

	(d) Effects of Less Frequent Collection

N/A

	(e) General Guidelines

The information collected under this action adheres to OMB's general
guidelines for information collections.

	(f) Confidentiality

Resulting reports from the market research will not be considered
confidential.  The identity of participants will be confidential.

	(g) Sensitive Questions

No sensitive questions will be asked.  The collection complies with the
Privacy Act and OMB Circular A-108.

4.  The Respondents and the Information Requested

	(a) Respondents/NAICS Codes

In general, respondents will consist of randomly selected citizens.
Some screening may be done to ensure that the respondents may have some
familiarity with fuel economy and fuel economy labels.  For example,
respondents could be randomly selected from records of people who have
recently purchased a vehicle.  The locations of the focus groups have
not been determined, but will most likely be in more than one location
to prevent geographical bias. EPA will rely on the judgment and
expertise of the contractor hired to design and conduct the surveys and
focus groups to determine the geographic locations of the groups, as
well as the appropriate level of screening.

	(b) Information Requested

		(i) Data items

Survey data will be collected from recent new car buyers.  The surveys
have not yet been developed, but will be developed and appropriately
pre-tested by a contractor under direction from EPA with the goal of
producing statistically robust results.  In general, the surveys will
gather information about the following three issues:

Vehicle buying process and the role of fuel economy information in that
process

Consumer comprehension and reactions regarding different liquid fuel
metrics (i.e., economy vs. consumption)

Preferences regarding label metrics for PHEVs and EVs

Focus groups will explore the same three topics, producing data more
qualitative in nature. Groups will be asked about their car-buying
process and the role of fuel economy, what they know and understand
about the EPA fuel economy label, and the usefulness of the label in its
current form.  They will be asked about how the label could be improved,
and the groups will explore the possibility of displaying more
information on the label, and specifically about a fuel consumption
metric such as gallons per 100 miles.  Groups will also discuss advanced
technology vehicles such as plug-in hybrid electric vehicles and what
the label should display in order to be most helpful to consumers.

		(ii) Respondent Activities

Surveys would be designed to take a respondent no longer than 12
minutes. Focus groups conducted would generally take no longer than 2
hours per group.  EPA is allotting an additional 2.5 hours per
respondent for travel and telephone screening.

5. The Information Collected--Agency Activities, Collection Methodology,
and Information Management

	(a) Agency Activities

In coordination with the contractor, the Agency will review and analyze
the information collected and develop a final report.  Upon completion
of the final report, it will be distributed to interested parties.  EPA
would use the information collected as an aid to determine the final
format of the fuel economy label.

	(b) Collection Methodology and Management

The survey data will be analyzed using the SPSS statistical package and
summarized in a final report by the contractor. The focus groups will be
recorded audibly and video-taped.  In addition, the contractor
moderating the groups will take notes.  The recorded information will be
used by the contractor to develop a final report.

	(c) Small Entity Flexibility

Small entity flexibilities are not needed for this information
collection activity.  Participation in focus groups would be strictly on
a voluntary basis.

	(d) Collection Schedule

The surveys and focus groups will be conducted prior to the publication
of the proposed fuel economy labeling regulation.  The actual dates are
to be determined.

6.	Estimating the Burden and Cost of the Collection

	(a) Estimating Respondent Burden

The burden for respondents participating in the surveys is estimated to
be 12 minutes per respondent.  The burden for respondents participating
in the focus groups is estimated to be 4.5 hours per respondent.  This
includes 2.5 hours for travel and telephone screening and 2 hours for
participation in the focus group.

	(b)	Estimating Respondent Costs

	(i) Labor costs

Labor rates on a per hour basis are estimated as $29.31/hour. This rate
was taken from the Bureau of Labor Statistics Civilian Worker Cost Table
which was most recently updated in June of 2009
(http://stats.bls.gov/news.release/ecec.t02.htm).  This table estimates
the costs per hour worked for employee compensation and costs as a
percent of total compensation for the civilian workforce by occupational
and industry group.  According to this table, the average hourly total
compensation for the civilian worker is $29.31/hour.  The total labor
cost per survey respondent, based on 0.2 burden-hours (12 minutes), is
estimated to be $5.86.  The total labor cost per focus group
participant, based on 4.5 burden hours, is estimated to be $131.90.

(ii) Estimating Capital and Operations and Maintenance Costs

Respondents will bear no capital and operations and maintenance costs.

	(c)	Estimating Agency Burden and Cost

EPA's burden and cost includes the cost of overseeing a contractor to
design and administer the surveys and focus groups.  The estimated EPA
personnel effort needed is 0.3 FTE, which amounts to about 624 hours of
effort.  The hourly cost is estimated at $57.22, based on an average of
hourly costs for managerial, technical and secretarial costs.  The total
Agency cost is estimated at $35,705.

	(d) & (e)	Total Burden Hours and Cost

Table 1

	SURVEYS

NO. OF RESPONDENTS			10,800

		TOTAL BURDEN HOURS 				2160

		TOTAL LABOR COST   			$63,310

		OPERATING & MAINTENANCE COST	0

		CAPITALIZED/START-UP COST		0

	FOCUS GROUPS

NO. OF RESPONDENTS			120

		TOTAL BURDEN HOURS 				540

		TOTAL LABOR COST   			$15,827

		OPERATING & MAINTENANCE COST	0

		CAPITALIZED/START-UP COST		0

	EPA

		EMPLOYEES		0.3

		HOURS		624

		LABOR COST	$35,705

	(f)	Burden Statement

Section 6(d) & (e) presents the total estimated burden for implementing
the proposed information collection requirements.

Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal Agency.  This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collection, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control number for EPA’s regulations are
listed in 40 CFR Part 9 and 48 CFR Chapter 15.

To comment on the Agency’s need for this information, the accuracy of
the provided estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No
EPA-HQ-OAR-2009-0865, which is available for public viewing at the Air
and Radiation Docket and Information Center in the EPA Docket Center
(EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington,
D.C.  The Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays.  The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air and Radiation Docket and Information Center
is<PHONE_NUMBER>.  To submit comments to EPA’s electronic public
docket, go directly to the Federal Docket Management System at
http://www.regulations.gov and follow the online instructions for
submitting comments.  Direct your comments to Docket ID No.
EPA-HQ-OAR-2009-0865.  The system is an “anonymous access” system,
which means we will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Office for EPA. Please include
the EPA Docket ID No. EPA-HQ-OAR-2009-0865 in any correspondence.

Part B of Supporting Statement

1) Introduction to Part B

For reasons explained in Part A, EPA will conduct a series of surveys
and focus groups to assess consumer behavior and attitudes towards fuel
economy and EPA’s fuel economy label.

2) Sections 1 and 2: Survey Objectives, Key Variables, and Survey Design

Survey Objectives:  Surveys and focus groups have three fundamental
objectives:

Inform EPA of the vehicle buying process and the role of fuel economy
information in that process

Evaluate consumer comprehension and reactions regarding different liquid
fuel metrics (i.e., economy vs. consumption)

Evaluate consumer preferences regarding label metrics for advanced
technology vehicles such as electric vehicles and plug-in hybrid
electric vehicles

Key Variables: N/A

Survey Design: Surveys and focus group materials have not yet been
developed, but will be done by a contractor under direction from EPA.

3) Sections 3 - 5:

Pretests: The contractor performing the surveys will appropriately
pre-test the surveys.

Pilot Tests: N/A

Collection Methods:  Focus Groups, Internet and telephone surveys.

Analyzing Survey Results:  Survey results will be quantitatively
analyzed using appropriate statistical methods and software.  Focus
group results will be qualitatively analyzed. Group reactions will be
noted and compared.  Common comments about specific aspects of the label
content and designs will be noted.  Any common preferences expressed
will be noted.

Attachment I

Legal Authority & Regulatory Citations

Clean Air Act:

42 U.S.C. 7525.  Motor Vehicle and Motor Vehicle Engine Compliance
Testing and Certification;   42 U.S.C. 7542.  Records and Reports

Energy Policy and Conservation Act:

49 U.S.C. 32908	Fuel Economy Information

Regulatory Citations:

40 CFR Part 600 Fuel Economy of Motor Vehicles.

 PAGE

 PAGE   8


[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)]
[Proposed Rules]
[Pages 21670-21673]
[FR Doc No: 2015-08918]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2015-0178]
RIN 1625-AA00

Safety Zone, Volvo Ocean Race Newport; East Passage, Narragansett
Bay, RI

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a safety zone in the
navigable waters of the East Passage, Narragansett Bay, RI, during the
Volvo Ocean Race Newport marine event. This safety zone is intended to
safeguard mariners from the hazards associated with high-speed, high-
performance sailing vessels competing in inshore races on the waters of
the East Passage, Narragansett Bay, RI. Vessels would be prohibited
from entering into, transiting through, mooring, or anchoring within
this safety

zone during periods of enforcement unless authorized by the Captain of
the Port (COTP), Southeastern New England or the COTP's designated
representative.

DATES: Comments and related material must be received by the Coast
Guard on or before April 27, 2015. Requests for public meetings must be
received by the Coast Guard on or before April 27, 2015.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0178 using any one of the following methods:
    (1) Federal e-Rulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.

See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for further instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT:  If you have questions on this
proposed rule, contact Mr. Edward G. LeBlanc, Waterways Management
Division at Coast Guard Sector Southeastern New England, telephone 401-
435-2351, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2015-0178), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2015-0178] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2015-0178) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    The Coast Guard has not promulgated a rule for past iterations of
this event.

C. Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C. 1231; 50 U.S.C.
191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland
Security Delegation No. 0170.1, which collectively authorize the Coast
Guard to define safety zones.
    This rule is necessary to provide for the safety of life and
navigation, for both participants and spectators involved with the
Volvo Ocean Race Newport in the vicinity of Newport, RI.

D. Discussion of Proposed Rule

    The Volvo Ocean Race is a 40,000 mile, eight-month, round the world
race with stops in several major international sailing ports. As part
of the event, high-speed sailing vessels will participate in daily
inshore races from 12-17 May, 2015, in the East Passage of Narragansett
Bay in the vicinity of Newport, RI. As these races are part of a world-
wide event they are expected to generate national and international
media coverage, and attract spectators on a number of recreational and
excursion vessels.
    The Coast Guard is establishing this safety zone, in conjunction
with the Volvo Ocean Race Newport, to ensure the protection of the
maritime public and event participants from the hazards associated with
large-scale marine events. The Coast Guard anticipates some concern
with the proposed safety zone by mariners, especially commercial vessel
operators, that vessel transits through the East Passage of
Narragansett Bay may be restricted for a portion of each day for 6
consecutive days.
    The East Passage of Narragansett Bay is the site of many marine
events each year. As a result, vessel traffic, particularly
recreational vessel traffic, is frequently required to utilize the West

Passage of Narragansett Bay. Accordingly, the West Passage of
Narragansett Bay may be a viable option for recreational vessels as
well as many tug/barge combinations and smaller commercial vessels
during the Volvo Ocean Race Newport.
    Regardless, the Coast Guard anticipates that some commercial and/or
recreational vessels may still need to transit the East Passage of
Narragansett Bay for a variety of reasons, including destination,
familiarity with the waterway, tide restrictions, etc. Vessels may be
able to continue transits through the East Passage, even during
enforcement of the safety zone, as there will be sufficient room for
most recreational vessels, and some commercial vessels, to pass to the
west of the safety zone. Also, the Coast Guard routinely works with the
local marine pilot organization and shipping agents to coordinate
vessel transits during marine events in the East Passage, and will
continue to do so for the entire event to avoid major interruptions to
shipping schedules.
    The Coast Guard proposes to add a temporary safety zone under 33
CFR 165.T01-0178. The safety zone will extend from Newport Harbor in
the vicinity of Fort Adams, across the East Passage to west of Rose
Island, and will encompass the East Passage south to the vicinity of
Castle Hill. The safety zone will be enforced only during times of
actual sailing vessel racing.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

1. Executive Order 12866 and Executive Order 13563

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    We expect the adverse economic impact of this proposed rule to be
minimal. Although this regulation may have some adverse impact on the
public, the potential impact will be minimized for the following
reasons: Although the safety zone will be in effect for 8 hours each
day for 6 consecutive days, vessels will only be restricted from the
zone in the East Passage of Narragansett Bay during those limited
periods when the races are actually ongoing; during periods when there
is no actual racing (e.g., racing vessels are transiting from the pier
to the racing site; downtime between races, etc.) vessels may be
allowed to transit through the safety zone; there is an alternate
route, the West Passage of Narragansett Bay, that does not add
substantial transit time, is already routinely used by mariners, and
will not be affected by this safety zone; many vessels, especially
recreational vessels, may transit in all portions of the affected
waterway except for those areas covered by the proposed safety zone;
and vessels may enter or pass through the affected waterway with the
permission of the COTP or the COTP's representative.
    Notification of the Volvo Ocean Race Newport and the associated
safety zone will be made to mariners through the Rhode Island Port
Safety Forum, local Notice to Mariners, event sponsors, and local media
well in advance of the event.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: Owners or operators of vessels intending
to transit, fish, or anchor in the East Passage of Narragansett Bay,
RI, during the Volvo Ocean Race Newport sailing races.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the person listed under FOR
FURTHER INFORMATION CONTACT. The Coast Guard will not retaliate against
small entities that question or complain about this proposed rule or
any policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of

Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action appears to be
one of a category of actions which do not individually or cumulatively
have a significant effect on the human environment.
    A preliminary environmental analysis checklist supporting this
determination is available in the docket where indicated under
ADDRESSES. This proposed rule involves the establishment of a temporary
safety zone in conjunction with the Volvo Ocean Race Newport event, a
high-speed, high-performance sailing vessel racing event. It appears
that this action will qualify for Coast Guard Categorical Exclusion
(34)(g), as described in figure 2-1 of the Commandant Instruction.
    We seek any comments or information that may lead to the discovery
of a significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T01-0178 to read as follows:

Sec.  165.T01-0178  Safety Zone for Volvo Ocean Race Newport, East
Passage, Narragansett Bay, RI.

    (a) Location. The following area is a safety zone: From an east-
west line across the East Passage of Narragansett Bay at the Newport
Bridge south to the COLREGS demarcation line between Brenton Pt and
Beavertail Pt.
    (b) Enforcement period. Vessels will be prohibited from entering
this safety zone, when enforced, during the Volvo Ocean Race Newport
sailing vessel racing event between 9 a.m. and 5 p.m. from Tuesday, May
12, 2015 to Sunday, May 17, 2015.
    (c) Definitions. The following definitions apply to this section:
    (1) Designated representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port, Sector
Southeastern New England (COTP), to act on his or her behalf. The
designated representative may be on an official patrol vessel or may be
on shore and will communicate with vessels via VHF-FM radio or
loudhailer. In addition, members of the Coast Guard Auxiliary may be
present to inform vessel operators of this regulation.
    (2) Official patrol vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP.
    (3) Patrol commander. The Coast Guard may patrol each safety zone
under the direction of a designated Coast Guard Patrol Commander. The
Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by
the call sign ``PATCOM.''
    (4) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (d) Regulations. (1) The general regulations contained in Sec.
165.23 as well as the following regulations apply to the safety zone
established in conjunction with the Volvo Ocean Race Newport, East
Passage, Narragansett Bay, Newport, RI. These regulations may be
enforced for the duration of the event.
    (2) No later than 8 a.m. each day of the event, the Coast Guard
will announce via Safety Marine Information Broadcasts and local media
the times and duration of each sailing race scheduled for that day, and
the precise area(s) of the safety zone that will be enforced.
    (3) Vessels may not transit through or within the safety zone
during periods of enforcement without Patrol Commander approval.
Vessels permitted to transit must operate at a no-wake speed, in a
manner which will not endanger participants or other crafts in the
event.
    (4) Spectators or other vessels shall not anchor, block, loiter, or
impede the movement of event participants or official patrol vessels in
the safety zone unless authorized by an official patrol vessel.
    (5) The Patrol Commander may control the movement of all vessels in
the safety zone. When hailed or signaled by an official patrol vessel,
a vessel shall come to an immediate stop and comply with the lawful
directions issued. Failure to comply with a lawful direction may result
in expulsion from the area, citation for failure to comply, or both.
    (6) The Patrol Commander may delay or terminate the Volvo Ocean
Race at any time to ensure safety. Such action may be justified as a
result of weather, traffic density, spectator operation or participant
behavior.

    Dated: March 27, 2015.
J.T. Kondratowicz,
Captain, U.S. Coast Guard, Captain of the Port Southeastern New
England.
[FR Doc. 2015-08918 Filed 4-17-15; 8:45 am]
 BILLING CODE 9110-04-P