[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Proposed Rules]
[Pages 69729-69730]
[FR Doc No: 2016-24209]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9086; Airspace Docket No. 15-AEA-7]
RIN 2120-AA66

Proposed Amendment of Air Traffic Service (ATS) Routes; Eastern
United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify area navigation (RNAV) routes
Q-39 and Q-67, in the eastern United States. The modifications would
provide a more efficient airway design within a portion of the airspace
assigned to the Indianapolis Air Route Traffic Control Center (ARTCC).

DATES: Comments must be received on or before November 21, 2016.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1
(800) 647-5527 or<PHONE_NUMBER>. You must identify FAA Docket No. FAA-
2016-9086 and Airspace Docket No. 15-AEA-7 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays. The Docket Office (telephone: 1 (800)
647-5527), is on the ground floor of the building at the above address.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the air traffic service route Q-39 and Q-67 in
the eastern United States to maintain the efficient flow of air
traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-
2016-9086 and Airspace Docket No. 15-AEA-7) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2016-9086 and Airspace Docket No. 15-AEA-7.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also accessed through the FAA's Web page at http://www.faa.gov/air_Traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during

normal business hours at the office of the Eastern Service Center,
Federal Aviation Administration, Room 210, 1701 Columbia Ave., College
Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this proposed rule. FAA Order 7400.11A
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to modify the alignment of RNAV routes Q-
39 and Q-67 in the eastern United States. The proposed modifications
would expand the availability of area navigation routes and provide a
more efficient airway design within Indianapolis ARTCC's airspace. The
proposed route changes are outlined below.
    Q-39 RNAV route Q-39 extends between the CLAWD, NC waypoint (WP)
and the WISTA, WV, WP. The FAA proposes to shift the alignment of the
route slightly to the east bypassing the WISTA WP to cross the TARCI,
WV, WP (located at lat. 38[deg]16'36.08 N., long. 081[deg]18'34.08 W.);
then the route would continue northward to a new ASERY, WV, WP (located
at lat. 38[deg]28'35.97 N., long. 081[deg]17'34.14'' W.).
    Q-67 RNAV route Q-67 extends between the SMTTH, TN, WP to the
COLTZ, OH, fix. In its current alignment, the route proceeds from the
JONEN, KY, WP northward to the COLTZ, OH, fix. The FAA proposes to
eliminate the segment between the JONEN WP and the CLOTZ fix and
replace it with a segment from the JONEN WP to the DARYN, WV, WP
(located at lat. 38[deg]46'07.80'' N., long. 082[deg]00'57.92'' W.).
The DARYN WP is located near the Henderson, WV VORTAC.
    These route modifications are being proposed to enhance the
efficiency of the route structure.
    RNAV routes are published in paragraph 2006 of FAA Order 7400.11A
dated August 3, 2016, and effective September 15, 2016, which is
incorporated by reference in 14 CFR 71.1. The RNAV routes listed in
this document will be subsequently published in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.

* * * * *

Q-39 CLAWD, NC to ASERY, WV [Amended]
CLAWD, NC              WP                    (Lat. 36[deg]25'08.98'' N., long. 081[deg]08'49.75'' W.)
TARCI, WV              WP                    (Lat. 38[deg]16'36.08'' N., long. 081[deg]18'34.08'' W.)
ASERY, WV              WP                    (Lat. 38[deg]28'35.97'' N., long. 081[deg]17'34.14'' W.)

Q-67 SMTTH, TN to DARYN, WV [Amended]
SMTTH, TN              WP                    (Lat. 35[deg]54'41.57'' N., long. 084[deg]00'19.74'' W.)
CEMEX, KY              WP                    (Lat. 36[deg]45'44.94'' N., long. 083[deg]23'33.58'' W.)
IBATE, KY              WP                    (Lat. 36[deg]59'12.36'' N., long. 083[deg]13'40.36'' W.)
TONIO, KY              FIX                   (Lat. 37[deg]15'15.20'' N., long. 083[deg]01'47.53'' W.)
JONEN, KY              WP                    (Lat. 37[deg]59'08.91'' N., long. 082[deg]32'46.19'' W.)
DARYN, WV              WP                    (Lat. 38[deg]46'07.80'' N., long. 082[deg]00'57.92'' W.)

* * * * *

    Issued in Washington, DC, on September 29, 2016.
M. Randy Willis,
Acting Manager, Airspace Policy Group.
[FR Doc. 2016-24209 Filed 10-6-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Page 57025]
[FR Doc No: 2015-23971]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission Advisory Committee on Small and Emerging
Companies will hold a public meeting on Wednesday, September 23, in
Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F
Street NE., Washington, DC.
    The meeting will begin at 9:30 a.m. (EDT) and will be open to the
public. Seating will be on a first-come, first-served basis. Doors will
open at 9:00 a.m. Visitors will be subject to security checks. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
    On September 2, 2015, the Commission published notice of the
Committee meeting (Release No. 33-9899), indicating that the meeting is
open to the public and inviting the public to submit written comments
to the Committee. This Sunshine Act notice is being issued because a
majority of the Commission may attend the meeting.
    The agenda for the meeting includes matters relating to rules and
regulations affecting small and emerging companies under the federal
securities laws.
    For further information, please contact the Office of the Secretary
at<PHONE_NUMBER>.

    Dated: September 16, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-23971 Filed 9-17-15; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 121 (Monday, June 24, 2013)]
[Notices]
[Pages 37807-37808]
[FR Doc No: 2013-15023]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0664; FRL-9533-5]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Commercial Ethylene
Oxide Sterilization and Fumigation Operations (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before July 24, 2013.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2012-0664, to: (1) EPA online, using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 17, 2012 (77 FR 63813), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to both EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2012-0664, which is available for either public
viewing online at http://www.regulations.gov, or in person viewing at
the Enforcement and Compliance Docket in the EPA Docket Center (EPA/
DC), EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC.
The EPA 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 Enforcement and Compliance Docket is (202)
566-1752.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to either submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidentiality of Business Information (CBI), or
other information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NESHAP for Commercial Ethylene Oxide Sterilization and
Fumigation Operations (Renewal).
    ICR Numbers: EPA ICR Number 1666.09, OMB Control Number 2060-0283.
    ICR Status: This ICR is scheduled to expire on June 30, 2013. Under
OMB regulations, the Agency may continue to either conduct or sponsor
the collection of information while this submission is pending at OMB.
    Abstract: The affected entities are subject to the General
Provisions of the

NESHAP at 40 CFR part 63, subpart A, and any changes, or additions to
the Provisions specified at 40 CFR part 63, subpart O.
    Owners or operators of the affected facilities must submit initial
notification, performance tests, and periodic reports and results.
Owners or operators are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. Reports are required semiannually at
a minimum.
    Respondents/Affected Entities: Owners or operator of commercial
ethylene oxide sterilization and fumigation operations.
    Estimated Number of Respondents: 122. ``Burden'' is defined at 5
VFR 1320.3(b).
    Frequency of Response: Initially, occasionally and semiannually.
    Estimated Total Annual Hour Burden: 8,887.
    Estimated Total Annual Cost: $1,524,913, which includes $860,413 in
labor costs, $65,000 in capital/startup costs, and $599,500 in
operation and maintenance (O&M) costs.
    Changes in the Estimates: There is an adjustment increase in burden
for both the respondents and the Agency from the most recently approved
ICR. This is not due to any program changes. The increase is due to an
update in labor rates and an increase of three respondents subject to
the regulation since the last ICR. This results in an increase in
respondent and Agency labor hours, costs, and total O&M costs.

Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. 2013-15023 Filed 6-21-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Rules and Regulations]
[Pages 23846-23847]
[FR Doc No: 2013-09555]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2013-0244]

Drawbridge Operation Regulations; Saugatuck River, Westport, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Route 136 Bridge across the Saugatuck River, mile 1.3, at Westport,
Connecticut. The deviation is necessary to facilitate emergency
repairs. Under this temporary deviation, the bridge owner requires a 24
hour advance notice for bridge openings through June 1, 2013.

DATES: This deviation is effective from May 4, 2013 through June 1,
2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0244] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Ms. Judy Leung-Yee, Project Officer,
First Coast Guard District<EMAIL_ADDRESS>or (212) 668-
7165. If you have questions on viewing the docket, call Barbara
Hairston, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Route 136 Bridge has a vertical
clearance of 6 feet at mean high water in the closed position. The
existing drawbridge operating regulations are found at 33 CFR
117.221(c).
    The bridge owner, Connecticut Department of Transportation,
requested a 24 hour advance notice requirement for bridge openings to
facilitate emergency repairs to the mechanical and electrical
components at the bridge.
    We previously authorized the above request from March 5, 2013
through May 3, 2013; however, an additional 29 days will be necessary
in order to finish storm related repairs from Hurricane Sandy last
October. The bridge can operate manually in the event of an emergency
situation.
    Under this temporary deviation at least a 24 hour advance notice
shall be required for bridge openings at the Route 136 Bridge, mile
1.3, across the Saugatuck River at Westport, Connecticut, from May 4,
2013 through June 1, 2013.
    The Saugatuck River is predominantly a recreational waterway.
During the time period that this temporary deviation will be in effect
the impact on navigation will be minimal.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
repair period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 10, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-09555 Filed 4-22-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53064-53067]
[FR Doc No: 2021-20754]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]

Revocation of Three Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of 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
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the
Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation
of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID-19
2SF Test, and Guardant Health Inc. (Guardant) for the Guardant-19. FDA
revoked Gravity's Authorization on July 21, 2021, Matmacorp's
Authorization on August 3, 2021, and Guardant's Authorization on August
6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The
revocations, which include an explanation of the reasons for each
revocation, are reprinted in this document.

DATES: Gravity's Authorization is revoked as of July 21, 2021.
Matmacorp's Authorization is revoked as of August 3, 2021. Guardant's
Authorization is revoked as of August 6, 2021.

ADDRESSES: Submit written requests for single copies of the revocations
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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

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,
nuclear, and radiological 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. On June 1, 2020, FDA issued an EUA to Gravity for the
Gravity Diagnostics COVID-19 Assay. Notice of the issuance of this
Authorization was published in the Federal Register on November 20,
2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act.
On August 21, 2020, FDA issued an EUA to Guardant for the Guardant-19.
Notice of the issuance of this Authorization was published in the
Federal Register on November 20, 2020 (85 FR 74346), as required by
section 564(h)(1) of the FD&C Act. On December 17, 2020, FDA issued an
EUA to Matmacorp, for the MatMaCorp COVID-19 2SF Test. Notice of the
issuance of this Authorization was published in the Federal Register on
April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the
FD&C Act. The authorization of a device for emergency use under section
564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act,
be revoked when the criteria under section 564(c) of the FD&C Act for
issuance of such authorization are no longer met (section 564(g)(2)(B)
of the FD&C Act), or other circumstances make such revocation
appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Requests

    On March 11, 2021, and reconfirmed July 12, 2021, Gravity requested
the revocation of, and on July 21, 2021, FDA revoked, the Authorization
for the Gravity Diagnostics COVID-19 Assay. Because Gravity notified
FDA that it is no longer using the Gravity Diagnostics COVID-19 Assay
and requested FDA revoke the Authorization, FDA has determined that it
is appropriate to protect the public health or safety to revoke this
Authorization. On July 29, 2021, Matmacorp requested the revocation of,
and on August 3, 2021, FDA revoked, the Authorization for the MatMaCorp
COVID-19 2SF Test. Because Matmacorp notified FDA that it

will no longer be distributing the MatMaCorp COVID-19 2SF Test as of
July 31, 2021, and requested FDA revoke the Authorization effective
that day, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization. On August 2,
2021, Guardant requested the revocation of, and on August 6, 2021, FDA
revoked, the Authorization for the Guardant-19. Because Guardant
requested that FDA revoke the Authorization, FDA has determined that it
is appropriate to protect the public health or safety to revoke this
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/, https://www.fda.gov/media/151030/download,
https://www.fda.gov/media/151349/download, and https://www.fda.gov/media/151378/download.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUAs for Gravity's Gravity Diagnostics COVID-19 Assay,
Matmacorp's MatMaCorp COVID-19 2SF Test, and Guardant's Guardant-19.
The revocations in their entirety follow and provide an explanation of
the reasons for each revocation, as required by section 564(h)(1) of
the FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN24SE21.001

[GRAPHIC] [TIFF OMITTED] TN24SE21.002

    Dated: September 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20754 Filed 9-23-21; 8:45 am]
BILLING CODE 4164-01-C