[Federal Register Volume 85, Number 199 (Wednesday, October 14, 2020)]
[Notices]
[Pages 65035-65036]
[FR Doc No: 2020-22660]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP20-1233-000]

Rover Pipeline, LLC; Notice of Initiation of Section 5 Proceeding

    On October 5, 2020, the Commission issued an order in Docket No.
RP20-1233-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C.
717d, instituting an investigation into whether the public interest
requires abrogation or modification of a firm transportation agreement
and an interruptible transportation agreement between Rover and
Gulfport (Gulfport TSAs). Rover Pipeline LLC, 173 FERC 61,019 (2020).
    Any interested person desiring to be heard in Docket No. RP20-1233-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, in
accordance with Rule 214 of the Commission's Rules of Practice and
Procedure, 18 CFR 385.214 (2020), within 30 days of the date of
issuance of the order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all

interested persons an opportunity to view and/or print the contents of
this document via the internet through the Commission's Home Page
(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. At this time, the Commission has suspended access to
Commission's Public Reference Room, due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact FERC
at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFile link at
http://www.ferc.gov. In lieu of electronic filing, you may submit a
paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.

    Dated: October 6, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-22660 Filed 10-13-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13368-13369]
[FR Doc No: 2022-04728]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2022-0016]

Non-Traditional and Emerging Transportation Technology (NETT)
Council; Request for Comment

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice; request for comment.

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SUMMARY: The Office of the Secretary of Transportation (OST) invites
public comment on projects, issues, or topics that DOT should consider
through the Non-Traditional and Emerging Transportation Technology
(NETT) Council. Public comments will inform the Department's future
efforts with the NETT Council.

DATES: Comments are requested by April 8, 2022. See the SUPPLEMENTARY
INFORMATION section on ``Public Participation,'' below, for more
information about written comments.

ADDRESSES:
    Written Comments: Comments should refer to the docket number above
and be submitted by one of the following methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: 1200 New Jersey Avenue SE, West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.
ET, Monday through Friday, except Federal Holidays.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the SUPPLEMENTARY INFORMATION section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided.
    Privacy Act: Except as provided below, all comments received into
the docket will be made public in their entirety. The comments will be
searchable 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 should not include information in
your comment that you do not want to be made public. You may review
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78) or at https://www.transportation.gov/privacy.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Please contact us at
[email protected] or David Carter ([email protected], 202-366-
4813) for questions. Office hours are from 8 a.m. to 5 p.m., EST,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION: Section 25008 of the Infrastructure
Investment and Jobs Act (Pub. L. 117-58) authorizes the NETT Council to
address coordination on emerging technology issues across all modes of
transportation. The NETT Council shall (1) identify and resolve
jurisdictional and regulatory gaps or inconsistencies associated with
nontraditional and emerging transportation technologies, modes, or
projects pending or brought before the Department of Transportation to
reduce, to the maximum extent practicable, impediments to the prompt
and safe deployment of new and innovative transportation technology,
including with respect to safety oversight, environmental review, and
funding and financing issues; (2) coordinate the response of the
Department of Transportation to nontraditional and emerging
transportation technology projects; (3) engage with stakeholders in
nontraditional and emerging transportation technology projects; and (4)
develop and establish Department of Transportation-wide processes,
solutions, and best practices for identifying and managing
nontraditional and emerging transportation technology projects.
    DOT is focused on improving safety, economic strength and creating
good-paying jobs with the choice of a union, equity, climate, and
resilience. DOT is also modernizing a transportation system of the
future through research and innovation--all while maintaining the
highest standards in organizational excellence. DOT is seeking public
comments to help inform the future work and direction of the NETT
Council. The questions below are meant to guide commenters; however,
commenters are invited to provide their views or general comments
related to how the Council evaluates transportation innovation, and
relevant innovations for it to focus on. If relevant, please provide
technical information, regulatory citations, data, or other evidence to
support your comments.

The NETT Council's Work

    1. How can the NETT Council most effectively serve as an entry
point for nontraditional and emerging innovation and technologies ready
for integration into the transportation system?
    2. What has worked well, and not well, about the current structure
and activities of the NETT Council?

Considering a Range of Perspectives in the NETT Council's Analyses

    3. How can the NETT Council best incorporate the perspective of and
engage with other Federal agencies and a broad range of stakeholders
(e.g., academia, labor unions, state, local, and tribal governments,
private sector) to fully understand potential issues and opportunities
related to transportation innovation?
    4. How can the NETT Council more effectively reflect inputs from a
broad range of transportation stakeholders to assess the positive and
negative consequences of transportation innovation?
    5. Are there additional stakeholders the NETT Council's analysis
should reflect?
    6. Are there stakeholder groups that have been marginalized in
transportation technology innovation that should be better represented
in the NETT Council's analysis and work?

Priority Technologies and Innovations for the NETT Council To Review

    7. Using DOT's authorities, what nontraditional and emerging
innovation and technologies should NETT Council prioritize for analysis
as most impactful, positive or negative, for the transportation system?
What emerging innovations have the most significant potential impact on
DOT's strategic goals of safety, economic strength & global
competitiveness, including creating good-paying jobs, equity, climate
and sustainability, transformation, and organizational excellence?
    8. What emerging innovations face gaps in focus, support, and/or
regulation under DOT's existing regulatory frameworks, and should be
reviewed by the NETT Council?
    9. What emerging transportation technologies should the NETT
Council evaluate for their potential to contribute to ensuring American
workers and

domestic sourcing and supply chains are strengthened rather than
weakened through transportation innovation, including advancing
activities under the President's Made in America Executive Order 14005,
dated January 25, 2021, and the President's Executive Order 14017 on
America's Supply Chains, dated February 24, 2021?
    10. What other pressing issues, challenges, and opportunities for
transportation innovation should be addressed through the NETT Council?

Public Participation

How do I prepare and submit comments?

    Your comments must be written in English. To ensure that your
comments are filed correctly in the docket, please include the docket
number of this document in your comments.
    Please submit one copy (two copies if submitting by mail or hand
delivery) of your comments, including the attachments, to the docket
following the instructions given above under ADDRESSES. Please note, if
you are submitting comments electronically as a PDF (Adobe) file, we
ask that the documents submitted be scanned using an Optical Character
Recognition (OCR) process, thus allowing the agency to search and copy
certain portions of your submissions.

How do I submit confidential business information?

    Any submissions containing Confidential Information must be
delivered to OST in the following manner:
     Submitted in a sealed envelope marked ``confidential
treatment requested'';
     Document(s) or information that the submitter would like
withheld should be marked ``PROPIN''; Accompanied by an index listing
the document(s) or information that the submitter would like the
Departments to withhold. The index should include information such as
numbers used to identify the relevant document(s) or information,
document title and description, and relevant page numbers and/or
section numbers within a document; and
     Submitted with a statement explaining the submitter's
grounds for objecting to disclosure of the information to the public.
    OST will treat such marked submissions as confidential under the
FOIA and will not include it in the public docket. OST also requests
that submitters of Confidential Information include a non-confidential
version (either redacted or summarized) of those confidential
submissions in the public docket. In the event that the submitter
cannot provide a non-confidential version of its submission, OST
requests that the submitter post a notice in the docket stating that it
has provided OST with Confidential Information. Should a submitter fail
to docket either a non-confidential version of its submission or to
post a notice that Confidential Information has been provided, we will
note the receipt of the submission on the docket, with the submitter's
organization or name (to the degree permitted by law) and the date of
submission.

Will the Agency consider late comments?

    OST will consider all comments received before the close of
business on the comment closing date indicated above under DATES. To
the extent possible, the agency will also consider comments received
after that date.

How can I read the comments submitted by other people?

    You may read the comments received at the address given above under
WRITTEN COMMENTS. The hours of the docket are indicated above in the
same location. You may also see the comments on the internet,
identified by the docket number at the heading of this notice, at
http://www.regulations.gov.

    Issued in Washington, DC, on March 2, 2022, under authority
delegated at 49 CFR 1.25a.
Vincent Gerard White Jr.,
Senior Advisor for Innovation.
Michael Paris Shapiro,
Deputy Assistant Secretary for Economic Policy.
[FR Doc. 2022-04728 Filed 3-8-22; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12138-12140]
[FR Doc No: 2013-03950]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0019]

Greenkraft Inc.; Receipt of Application for Temporary Exemption
From FMVSS No. 108

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

ACTION: Notice of receipt of petition for a temporary exemption from
Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps,
Reflective Devices, and Associated Equipment.

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SUMMARY: In accordance with the procedures in 49 CFR Part 555,
Greenkraft, Inc. has applied for a temporary exemption for its 1061 and
1082 model trucks from the requirements of paragraph S7 of FMVSS No.
108 applicable to headlamps. The basis of the application is that the
exemption would make development or field evaluation of a low-emission
vehicle easier without unreasonably lowering the safety performance of
the vehicle.
    NHTSA is publishing this notice of receipt of the application in
accordance with the requirements of 49 U.S.C. 30113(b)(2), and has made
no judgment on the merits of the application.

DATES: You should submit your comments not later than March 25, 2013.

FOR FURTHER INFORMATION CONTACT: Thomas Healy, Office of the Chief
Counsel, NCC-112, National Highway Traffic Safety Administration, 1200
New Jersey Avenue SE., West Building 4th Floor, Room W41-212,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>.
    Comments: We invite you to submit comments on the application
described above. You may submit comments identified by the docket
number at the heading of this notice by any of the following methods:
     Web Site: http://www.regulations.gov. Follow the
instructions for submitting comments on the electronic docket site by
clicking

on ``Help and Information'' or ``Help/Info.''
     Fax: 1-202-493-2251.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, Room W12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590.
     Hand Delivery: 1200 New Jersey Avenue SE., West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below. We
will consider all comments received before the close of business on the
comment closing date indicated above. To the extent possible, we will
also consider comments filed after the closing date.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. Telephone:<PHONE_NUMBER>.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.dot.gov/privacy.html.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information, to the Chief Counsel, NHTSA,
at the address given under FOR FURTHER INFORMATION CONTACT. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above. When you send a comment containing information
claimed to be confidential business information, you should include a
cover letter setting forth the information specified in our
confidential business information regulation (49 CFR Part 512).

SUPPLEMENTARY INFORMATION:

I. Statutory Basis for Temporary Exemptions

    The National Traffic and Motor Vehicle Safety Act (Safety Act),
codified as 49 U.S.C. Chapter 301, authorizes the Secretary of
Transportation to exempt, on a temporary basis and under specified
circumstances, motor vehicles from a motor vehicle safety standard or
bumper standard. This authority is set forth at 49 U.S.C. 30113. The
Secretary has delegated the authority in this section to NHTSA.
    NHTSA established 49 CFR part 555, Temporary Exemption from Motor
Vehicle Safety and Bumper Standards, to implement the statutory
provisions concerning temporary exemptions. A vehicle manufacturer
wishing to obtain an exemption from a standard must demonstrate in its
application (A) that an exemption would be in the public interest and
consistent with the Safety Act and (B) that the manufacturer satisfies
one of the following four bases for an exemption: (i) Compliance with
the standard would cause substantial economic hardship to a
manufacturer that has tried to comply with the standard in good faith;
(ii) the exemption would make easier the development or field
evaluation of a new motor vehicle safety feature providing a safety
level at least equal to the safety level of the standard; (iii) the
exemption would make the development or field evaluation of a low-
emission motor vehicle easier and would not unreasonably lower the
safety level of that vehicle; or (iv) compliance with the standard
would prevent the manufacturer from selling a motor vehicle with an
overall safety level at least equal to the overall safety level of
nonexempt vehicles.
    For an exemption petition to be granted on the basis that the
exemption would make the development or field evaluation of a low-
emission motor vehicle easier and would not unreasonably lower the
safety level of the vehicle, the petition must include specified
information set forth at 49 CFR 555.6(c). The main requirements of that
section include: (1) Substantiation that the vehicle is a low-emission
vehicle; (2) documentation establishing that a temporary exemption
would not unreasonably degrade the safety of a vehicle; (3)
substantiation that a temporary exemption would facilitate the
development or field evaluation of the vehicle; (4) a statement of
whether the petitioner intends to conform to the standard at the end of
the exemption period; and (5) a statement that not more than 2,500
exempted vehicles will be sold in the United States in any 12-month
period for which an exemption may be granted.

II. Greenkraft's Petition

    Greenkraft is petitioning the agency for a temporary exemption from
the provisions in FMVSS No. 108 applicable to headlamp photometry on
the basis that ``the exemption would make the development or field
evaluation of a low-emission motor vehicle easier and would not
unreasonably lower the safety level of that vehicle.'' 49 U.S.C.
30113(b)(3)(B)(iii). The agency received Greenkraft's petition October
24, 2012. Greenkraft has requested that, if granted, the exemption
period begin immediately.
    Greenkraft plans to produce trucks that run on compressed natural
gas engines with a gross vehicle weight rating (GVWR) of over 14,000
pounds under the requested exemption. Greenkraft is requesting a three-
year exemption and plans to produce 2,300 vehicles during the exemption
period. Greenkraft states in the petition that it plans to comply with
FMVSS No. 108 at the end of the exemption period.

A. Low Emission Vehicle

    In order to be eligible for a temporary exemption on the grounds
that the exemption would make development or field evaluation of a low-
emission vehicle easier without unreasonably lowering the safety
performance of the vehicle, the applicant must substantiate that the
vehicle is a low-emission vehicle. In order to qualify as a low-
emission vehicle, the vehicle must meet the applicable standards for
new motor vehicles under the Clean Air Act, 42 U.S.C. 7521, et seq. and
emit an air pollutant in an amount significantly below one of those
standards. The Environmental Protection Agency's (EPA) regulations
issued pursuant to the Clean Air Act establish exhaust emissions
thresholds for heavy-duty low-emission vehicles. These exhaust emission
thresholds require that a heavy duty low emission vehicle emit combined
emissions of oxides of nitrogen and nonmethane hydrocarbons (or
nonmethane hydrocarbon equivalent) of 3.8 grams or less per brake
horsepower-hour or combined emissions of oxides of nitrogen and
nonmethane hydrocarbons (or nonmethane hydrocarbon equivalent) of 3.5
grams or less per brake horsepower-hour when tested (certified) on fuel

meeting the specifications of California certification fuel. 40 CFR
88.105-94.
    Greenkraft submitted a certification from the California
Environmental Protection Agency's Air Resources Board to substantiate
that the vehicle that is the subject of the application is a low
emissions vehicle. The Air Resources Board certification states that
the vehicle's combined emissions of oxides of nitrogen and nonmethane
hydrocarbons are 0.13 grams per brake horsepower-hour.

B. Statement That a Temporary Exemption Would Not Unreasonably Degrade
Safety

    The requirements from which Greenkraft seeks a temporary exemption
are the Upper Beam 3 requirements in Table XVIII and Lower
Beam 3V requirements in Table XIX-b. Greenkraft states in its
application for a temporary exemption that the only difference between
Greenkraft's low-emission vehicle if exempted and a compliant vehicle
is that the headlamps on Greenkraft's low-emission vehicle fail to meet
the minimum candela requirements for two upper beam test points and six
lower beam test points and exceeds the maximum candela requirement for
one upper beam test point for visually/optically aimed headlamps.
Greenkraft attached to its application for an exemption a test report
from a test laboratory showing that the headlamps on the vehicles that
would be the subject of the exemption fail to meet the upper and lower
beam requirements for optically and visually aimed headlamps.
Greenkraft states in the application that granting the exemption would
not unreasonably degrade the safety of the vehicle because the lamps
provide ``excellent illumination'' even though they do not comply with
the photometric requirements of FMVSS No. 108.

C. Substantiation That a Temporary Exemption Would Facilitate the
Development of a Low Emissions Vehicle

    Greenkraft states that a temporary exemption would facilitate the
development of low-emission vehicles by allowing Greenkraft to redesign
the headlamp without interrupting the development of the vehicle while
the headlamp is being redesigned. Greenkraft further claims that, by
beginning development promptly, it can receive critical data and test
results to further the development of natural gas powered vehicles.

D. Public Interest

    Greenkraft states that granting the temporary exemption would be in
the public interest because the exemption would help increase the
availability of low-emission natural gas power vehicles to businesses
in the United States. Greenkraft states that this would reduce the
United States' dependence on foreign oil.

III. Issuance of Notice of Final Action

    Upon receiving a petition, NHTSA conducts an initial review of the
petition with respect to whether the petition is complete and whether
the petitioner appears to be eligible to apply for the requested
petition. The agency has tentatively concluded that the petition is
complete and that the petitioner is eligible to apply for the requested
exemption. The agency has not made any judgment on the merits of the
application and is placing a non-confidential copy of the petition in
the docket.
    We are providing a 30-day comment period. After considering public
comments and other available information, we will publish a notice of
final action on the application in the Federal Register.

    Issued in Washington, DC, on February 12, 2013 under authority
delegated in 49 CFR 1.95.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2013-03950 Filed 2-20-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Rules and Regulations]
[Pages 79304-79308]
[FR Doc No: 2013-31216]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-0487]

Cardiovascular Devices; Reclassification of External Counter-
Pulsating Devices for Treatment of Chronic Stable Angina; Effective
Date of Requirement for Premarket Approval for External Counter-
Pulsating Devices for Other Specified Intended Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify external counter-pulsating (ECP) devices for
treatment of chronic stable angina that is refractory to optimal anti-
anginal medical therapy and without options for revascularization,
which is a preamendments class III device, into class II (special
controls), and to require the filing of a premarket approval
application (PMA) or a notice of completion of a product development
protocol (PDP) for ECP devices for other intended uses specified in
this proposed order.

DATES: This order is effective December 30, 2013.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Public Law 112-144), establishes a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type may be marketed without submission of a PMA
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval or until the device is
subsequently reclassified into class I or class II. Section 515(b)(1)
of the FD&C Act directs FDA to issue an order requiring premarket
approval for a preamendments class III device.
    Although, under the FD&C Act, the manufacturer of a class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a PDP, in practice, the option of filing a
notice of completion of a PDP has not been used. For simplicity,
although corresponding requirements for PDPs remain available to
manufacturers in response to this final order under section 515(b) of
the FD&C Act, this document will refer only to the requirement for the
filing and receiving approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) of the FD&C Act, changing the
mechanism for reclassifying a device from rulemaking to an
administrative order. Section 608(b) of FDASIA (126 Stat. 1056) amended
section 515(b) of the FD&C Act, changing the process for requiring
premarket approval for a preamendments class III device from rulemaking
to an administrative order.

A. Reclassification

    FDA is reclassifying ECP devices for treatment of chronic stable
angina that is refractory to optimal anti-anginal medical therapy and
without options for revascularization from class III to class II.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g.,
General Medical

Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers
Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474
U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This can include information
from clinical and preclinical tests or studies that demonstrate the
safety or effectiveness of the device but does not include descriptions
of methods of manufacture or product composition and other trade
secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order reclassifying a device. Specifically, prior to
the issuance of a final order reclassifying a device, the following
must occur: (1) Publication of a proposed order in the Federal
Register; (2) a meeting of a device classification panel described in
section 513(b) of the FD&C Act; and (3) consideration of comments to a
public docket. FDA held a meeting of a device classification panel
described in section 513(b) of the FD&C Act with respect to external-
counter pulsating devices on December 5, 2012. The panel recommended
that ECP devices intended for treatment of chronic stable angina that
is refractory to optimal anti-anginal medical therapy and without
options for revascularization be reclassified to class II with special
controls. The panel agreed with FDA's conclusion that the available
scientific evidence is adequate to support the safety and effectiveness
of ECP devices for treatment of chronic stable angina that is
refractory to optimal anti-anginal medical therapy and without options
for revascularization. The panel further agreed that the special
controls identified by FDA were appropriate to mitigate the relevant
risks to health for this use. FDA published a proposed order in the
Federal Register of May 21, 2013 (78 FR 29672). FDA received and has
considered one comment on this proposed order as discussed in section
II of this document. Therefore, FDA has met the requirements under
section 513(e)(1) of the FD&C Act.

B. Requirement for Premarket Approval Application

    FDA is requiring PMAs for ECP devices for Certain Specified
Intended Uses. For the purposes of this final order, the term ``Certain
Specified Intended Uses'' includes the following intended uses:
     Unstable angina pectoris;
     Acute myocardial infarction;
     Cardiogenic shock;
     Congestive heart failure;
     Postoperative treatment of patients who have undergone
coronary artery bypass surgery;
     Peripheral arterial disease associated with the following:
Ischemic ulcers rest pain or claudication, threatened gangrene,
insufficient blood supply at an amputation site, persisting ischemia
after embolectomy or bypass surgery, and/or pre- and post-arterial
reconstruction to improve runoff;
     Diabetes complicated by peripheral arterial disease or
other conditions possibly related to arterial insufficiency including
the following: Nocturnal leg cramps and/or necrobiosis diabeticorum;
     Venous diseases, including the following: Prophylaxis of
deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or
induration (e.g., stasis dermatitis) associated with chronic venous
stasis, venous stasis ulcers, and/or thrombophlebitis;
     Athletic injuries, including the following: Charley
horses, pulled muscles, and/or edematous muscles; and
     Necrotizing cellulitis.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order requiring PMAs. Specifically, prior to the
issuance of a final order requiring premarket approval for a
preamendments class III device, the following must occur: (1)
Publication of a proposed order in the Federal Register; (2) a meeting
of a device classification panel described in section 513(b) of the
FD&C Act; and (3) consideration of comments from all affected
stakeholders, including patients, payors, and providers. As discussed
in this document, FDA has met the requirements under section 515(b)(1)
of the FD&C Act.
    FDA held a meeting of a device classification panel described in
section 513(b) of the FD&C Act with respect to external-counter
pulsating devices on December 5, 2012. The panel recommended that ECP
devices for Certain Specified Intended Uses remain in class III. The
panel supported FDA's conclusion that because the safety and
effectiveness of ECP devices for Certain Specified Intended Uses has
not been established through adequate scientific evidence, the device
presents a potential unreasonable risk of injury given that the benefit
of ECP devices for these uses is unknown. In addition, there was
insufficient information to establish special controls for these uses.
    FDA published a proposed order in the Federal Register of May 21,
2013 (78 FR 29672), that satisfied the requirements of section
515(b)(2) of the FD&C Act, which provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA or a declared completed PDP and the benefit to the
public from the use of the device, (3) an opportunity for the
submission of comments on the proposed order and the proposed findings,
and (4) an opportunity to request a change in the classification of the
device based on new information relevant to the classification of the
device. FDA received and has considered one comment on this proposed
order as discussed in section II of this document.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued under section 515(b) of the FD&C Act prior to the enactment
of FDASIA is considered to be a final order for purposes of section
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval
for the device, or 30 months after final classification of the device
under section 513 of the FD&C Act, whichever is later. For ECP devices,
the preamendments class III devices that are the subject of this final
order, the later of these two time periods is the 90-day period. Since
these devices were classified in 1980, the 30-month period

has expired (45 FR 7966; February 5, 1980). Therefore, section
501(f)(2)(B) of the FD&C Act requires that a PMA for such device be
filed within 90 days of the date of issuance of this final order. If a
PMA is not filed for such device within 90 days after the issuance of
this final order, the device will be deemed adulterated under section
501(f) of the FD&C Act.
    Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Other enforcement actions include, but are
not limited to, the following: Shipment of devices in interstate
commerce will be subject to injunction under section 302 of the FD&C
Act (21 U.S.C. 332) and the individuals responsible for such shipment
will be subject to prosecution under section 303 of the FD&C Act (21
U.S.C. 333). FDA requests that manufacturers take action to prevent the
further use of devices for which no PMA has been filed.

II. Public Comments in Response to the Proposed Order

    In response to the May 21, 2013, proposed order to reclassify ECP
devices for treatment of chronic stable angina that is refractory to
optimal anti-anginal medical therapy and without options for
revascularization, and require the filing of a PMA or a notice of
completion of a PDP for ECP devices for Certain Specified Intended
Uses, FDA received one comment. The comment supported FDA's intent to
call for PMAs for ECP devices for Certain Specified Intended Uses, but
disagreed with FDA's intent to reclassify ECP devices intended for
treatment of chronic stable angina that is refractory to optimal anti-
anginal medical therapy and without options for revascularization,
stating, ``Since the law specifies that high-risk devices are
considered class III, we see no justification for down-classifying this
obviously high-risk device used for the high-risk indication of chronic
stable angina, and all other indications. We believe that high-risk
cardiac devices should remain class III devices and be subjected to PMA
because they are life-supporting and life-sustaining.'' The commenter
further notes that ``Currently available clinical evidence does not
prove safety and effectiveness for these devices for any indication,''
and that, ``Special controls are not enough to ensure safety and
effectiveness.'' FDA disagrees with this comment. According to section
513(a)(1)(C) of the FD&C Act, a class III device is defined as a device
which (1) ``cannot be classified as a class I device because
insufficient information exists to determine that the application of
general controls are sufficient to provide reasonable assurance of the
safety and effectiveness of the device,'' and (2) ``cannot be
classified as a class II device because insufficient information exists
to determine that the special controls . . . would provide reasonable
assurance of its safety and effectiveness,'' and (3) ``is purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health,'' or (4) ``presents a potential unreasonable risk of
illness or injury.'' FDA does not believe that ECP devices are
considered life-supporting devices, a viewpoint which was supported by
the panel members at the December 5, 2012, device classification panel
meeting (the 2012 Panel). In addition, FDA believes that the available
evidence supports a reasonable assurance of safety and effectiveness,
that special controls, in addition to general controls, would be
sufficient to provide such assurance, and there is not an unreasonable
risk of illness or injury for ECP devices intended for treatment of
chronic stable angina that is refractory to optimal anti-anginal
medical therapy and without options for revascularization. The 2012
Panel agreed with FDA's conclusions and further agreed that the special
controls identified by FDA were appropriate to mitigate the relevant
risks to health. Therefore, FDA disagrees that ECP devices intended for
treatment of chronic stable angina that is refractory to optimal anti-
anginal medical therapy and without options for revascularization
should be classified as class III devices. FDA believes that the
identified special controls mitigate the risks to health and provide a
reasonable assurance of safety and effectiveness for this patient
population.
    The commenter further notes that ``having two different
classifications for the same device, based on different indications,
does not provide adequate safeguards for patients, or sufficient
evidence-based guidelines for physicians. Instead, it provides an
incentive for companies to use the easier approval pathway, the 510(k)
process rather than the PMA pathway, knowing that physicians can use
the implant off label for any indication that they choose.'' FDA
disagrees with this comment. FDA does not regulate the practice of
medicine but rather regulates the use of a device as indicated by the
party offering the device for interstate commerce. The indications for
ECP devices are limited by the codified classification. Also, ECP
devices are not implants as referred to by the commenter.

III. The Final Order

    Under sections 513(e) and 515(b) of the FD&C Act, FDA is adopting
its findings as published in the preamble to the proposed order (78 FR
29672). FDA is issuing this final order to require the filing of a PMA
or a notice of completion of a PDP for ECP devices intended for Certain
Specified Intended Uses (see section I.B of this document):
    In addition, FDA is issuing this final order to reclassify ECP
devices for treatment of chronic stable angina that is refractory to
optimal anti-anginal medical therapy and without options for
revascularization from class III to class II and establish special
controls. This final order will revise 21 CFR part 870.
    Under the final order, a PMA or a notice of completion of a PDP is
required to be filed on or before 90 days after the date of publication
of the final order in the Federal Register, for any of these class III
preamendments devices that were in commercial distribution before May
28, 1976, or that has been found by FDA to be substantially equivalent
to such a device on or before 90 days after the date of publication of
the final order in the Federal Register. An approved PMA or a declared
completed PDP is required to be in effect for any such devices on or
before 180 days after FDA files the application. Any other class III
preamendments device subject to this order that was not in commercial
distribution before May 28, 1976, is required to have an approved PMA
or a declared completed PDP in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of the class
III preamendments devices is not filed on or before the 90th day past
the effective

date of this regulation, that device will be deemed adulterated under
section 501(f)(1)(A) of the FD&C Act, and commercial distribution of
the device must cease immediately. The device may, however, be
distributed for investigational use, if the requirements of the IDE
regulations (part 812) are met.
    Following the effective date of this final order, firms submitting
a 510(k) premarket notification for a ECP device intended for treatment
of chronic stable angina that is refractory to optimal anti-anginal
medical therapy and without options for revascularization will need
either to: (1) Comply with the particular mitigation measures set forth
in the codified special controls or (2) use alternative mitigation
measures, but demonstrate to the Agency's satisfaction that those
alternative measures identified by the firm will provide at least an
equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of ECP devices for treatment of chronic stable angina
that is refractory to optimal anti-anginal medical therapy and without
options for revascularization, and therefore, this device type is not
exempt from premarket notification requirements.
    An applicant whose device was legally in commercial distribution
before May 28, 1976, or whose device has been found to be substantially
equivalent to such a device, who does not intend to market such device
for any one or more Certain Specified Intended Uses, may remove such
intended uses from the device's labeling by initiating a correction
within 90 days after issuance of any final order based on this
proposal. 21 CFR part 806.10(a)(2) requires a device manufacturer or
importer initiating a correction to remedy a violation of the FD&C Act
that may present a risk to health to submit a written report of the
correction to FDA.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subpart B,
have been approved under OMB control number 0910-0231; and the
collections of information under 21 CFR part 801 have been approved
under OMB control number 0910-0485.

VI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices and section
515(b) of the FD&C Act provided for FDA to issue regulations to require
approval of an application for premarket approval for preamendments
devices or devices found to be substantially equivalent to
preamendments devices. Although sections 513(e) and 515(b) as amended
require FDA to issue final orders rather than regulations, FDASIA also
provides for FDA to revoke previously issued regulations by order. FDA
will continue to codify reclassifications and requirements for approval
of an application for premarket approval in the Code of Federal
Regulations. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act,
as amended by FDASIA, in this final order, we are revoking the
requirements in Sec.  870.5225 related to the classification of
external counter-pulsating devices for chronic stable angina that is
refractory to optimal anti-anginal medical therapy and without options
for revascularization as class III devices and codifying the
reclassification of these devices into class II.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Revise Sec.  870.5225 to read as follows:

Sec.  870.5225  External counter-pulsating device.

    (a) Identification. An external counter-pulsating device is a
noninvasive, prescription device used to assist the heart by applying
positive or negative pressure to one or more of the body's limbs in
synchrony with the heart cycle.
    (b) Classification. (1) Class II (special controls) when the device
is intended for the treatment of chronic stable angina that is
refractory to optimal anti-anginal medical therapy and without options
for revascularization. The special controls for this device are:
    (i) Nonclinical performance evaluation of the device must
demonstrate a reasonable assurance of safety and effectiveness for
applied pressure, synchronization of therapy with the appropriate phase
of the cardiac cycle, and functionality of alarms during a device
malfunction or an abnormal patient condition;
    (ii) Reliabilities of the mechanical and electrical systems must be
established through bench testing under simulated use conditions and
matched by appropriate maintenance schedules;
    (iii) Software design and verification and validation must be
appropriately documented;
    (iv) The skin-contacting components of the device must be
demonstrated to be biocompatible;
    (v) Appropriate analysis and testing must be conducted to verify
electrical safety and electromagnetic compatibility of the device; and
    (vi) Labeling must include a detailed summary of the device-related
and procedure-related complications pertinent to use of the device.
    (2) Class III (premarket approval) for the following intended uses:
Unstable angina pectoris; acute myocardial infarction; cardiogenic
shock; congestive heart failure; postoperative treatment of patients
who have undergone coronary artery bypass surgery; peripheral arterial
disease associated with ischemic ulcers rest pain or claudication,
threatened gangrene, insufficient blood supply at an amputation site,
persisting ischemia after embolectomy or bypass surgery, and/or pre-
and post-arterial

reconstruction to improve runoff; diabetes complicated by peripheral
arterial disease or other conditions possibly related to arterial
insufficiency including nocturnal leg cramps and/or necrobiosis
diabeticorum; venous diseases, including prophylaxis of deep vein
thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration
(e.g., stasis dermatitis) associated with chronic venous stasis, venous
stasis ulcers, and/or thrombophlebitis; athletic injuries, including
Charley horses, pulled muscles and/or edematous muscles; necrotizing
cellulitis.
    (c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before March 31, 2014, for any external counter-pulsating device, with
an intended use described in paragraph (b)(2) of this section, that was
in commercial distribution before May 28, 1976, or that has, on or
before March 31, 2014, been found to be substantially equivalent to any
external counter-pulsating device, with an intended use described in
paragraph (b)(2) of this section, that was in commercial distribution
before May 28, 1976. Any other external counter-pulsating device with
an intended use described in paragraph (b)(2) of this section shall
have an approved PMA or declared completed PDP in effect before being
placed in commercial distribution.

    Dated: December 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31216 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Notices]
[Page 13538]
[FR Doc No: 2021-04844]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1254-000]

Genbright LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Genbright LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 23, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: March 3, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-04844 Filed 3-8-21; 8:45 am]
BILLING CODE 6717-01-P