[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62946-62947]
[FR Doc No: 2018-26406]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Commercial Air
Tour Operator Reports

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on September 19, 2018. The commercial air tour operational
data provided to the FAA and the National Park Service will be used by
the agencies as background information useful in the development of air
tour management plans and voluntary agreements for purposes of meeting
the mandate of the National Parks Air Tour Management Act (NPATMA) of
2000.

DATES: Written comments should be submitted by January 4, 2019.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
[email protected], or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0750.
    Title: Commercial Air Tour Operator Reports.
    Form Numbers: There are no FAA forms associated with this
collection of information.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on September 19, 2018 (83 FR 47395). One comment was
received. The FAA Modernization and Reform Act of 2012 included
amendments to the National Parks Air Tour Management Act (NPATMA) of
2000. One of these amendments required commercial air tour operators
conducting tours over national park units to report on the number of
operations they conduct and any such other information prescribed by
the FAA Administrator and the Director of the National Park Service
(NPS).
    Respondents: Approximately 75 air tour operators.
    Frequency: Information is collected quarterly, or annually for park
units with 50 or fewer tours per year.
    Estimated Average Burden per Response: 15 hours.
    Estimated Total Annual Burden: 2,540 hours.

    Issued in Washington, DC on November 29, 2018.
Barbara Hall,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2018-26406 Filed 12-4-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21308-21310]
[FR Doc No: 2014-08415]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71912; File No. SR-NYSEArca-2014-33]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending the NYSE
Arca Equities Schedule of Fees and Charges for Exchange Services To
Raise the Fee and Fee Cap for Market and Auction-Only Orders Executed
in an Opening, Market Order or Trading Halt Auction; Modify the Fees
Charges for Routing Orders To The New York Stock Exchange LLC; and
Modify Certain Credits in the Basic Rate Pricing

April 9, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 26, 2014, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Equities Schedule of
Fees and Charges for Exchange Services (``Fee Schedule'') to (i) raise
the fee and fee cap for Market and Auction-Only Orders executed in an
Opening, Market Order or Trading Halt Auction; (ii) modify the fees
that it charges for routing orders to the New York Stock Exchange LLC
(``NYSE''); and (iii) modify certain credits in the Basic Rate pricing.
The Exchange proposes to implement the changes on April 1, 2014. The
text of the proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule to (i) raise the
fee and fee cap for Market and Auction-Only Orders executed in an
Opening, Market Order or Trading Halt Auction; (ii) modify the fees
that it charges for routing orders to the NYSE; and (iii) modify
certain credits in the Basic Rate pricing. The Exchange proposes to
implement the changes on April 1, 2014.
    The Exchange currently charges $0.0005 per share for Market and
Auction-Only Orders executed in an Opening, Market Order or Trading
Halt Auction. The Exchange proposes to raise this fee from $0.0005 to
$0.0010 per share. The Exchange also proposes to raise the monthly fee
cap for Market and Auction-Only Orders executed in an Opening, Market
Order or Trading Halt Auction. Currently, the fees are capped at
$15,000. The Exchange proposes to raise the fee cap to $20,000. These
changes are consistent with changes proposed by the NYSE to become
effective on April 1, 2014.\4\
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    \4\ See SR-NYSE-2014-18.
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    The NYSE introduced modifications to its transaction fee
structures, including changes to the rates for taking liquidity, which
became effective on March 1, 2014.\5\ In addition, the NYSE is
proposing modifications to its at the opening or at the opening only
orders to become effective on April 1, 2014.\6\ The Exchange's current
fees for routing orders in securities with a per share price of $1.00
or more to the NYSE are closely related to the NYSE's fees for taking
liquidity in such securities, and the Exchange is proposing an
adjustment to its routing fees to maintain the existing relationship to
the new fees in place at the NYSE.
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    \5\ See Securities Exchange Act Release No. 71684 (March 11,
2014), 78 FR 14758 (March 17, 2014) (SR-NYSE-2014-09) (the ``NYSE
Fee Filing'').
    \6\ See supra note 4.
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    Currently, the NYSE charges a transaction fee for certain
transactions in securities with a per share price of $1.00 or more
based on the characteristics of the transaction. Among other changes,
the NYSE Fee Filing proposed to increase the charge for transactions
that do not have a specified per share charge based on their
characteristics (``all other'' transactions). The NYSE Fee Filing
increased the per share charge for all other non-floor broker
transactions (i.e., when taking liquidity from the Exchange) from
$0.0025 to $0.0026 per transaction.
    Currently, for the Exchange's Tier 1, Tier 2, Tier 3, Step Up Tier
1, and Step Up Tier 2 customers, the fee for routing orders in Tape A
securities to the NYSE outside the book is equal to the previous NYSE
fee of $0.0025 per share for all other non-floor broker transactions in
securities with a per share price of $1.00 or more, and the fee for
routing such orders to the NYSE for non-tier (i.e., Basic Rate)
customers is $0.0027 per share.\7\ Consequently, the Exchange is
proposing to increase each of those fees by $0.0001 to $0.0026 per
share and $0.0028 per share, respectively, consistent with the $0.0001
increase in the NYSE fee for all other non-floor broker transactions.
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    \7\ The other tiers in the Fee Schedule do not specify a fee for
routing orders in Tape A securities to the NYSE outside the book.
However, such tiers provide that if a fee (or credit) is not
included in the tier, the relevant tiered or Basic Rate applies
based on a firm's qualifying levels. Accordingly, for orders in Tape
A securities routed to the NYSE outside the book, ETP Holders and
Market Makers that qualify for another tier would default to the
Tier 1, Tier 2, Tier 3, Step Up Tier 1, Step Up Tier 2 or Basic Rate
that applied to them based on their qualifying levels.
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    In addition, the Exchange currently charges $0.0023 per share for
Primary Sweep Orders \8\ in Tape A securities that

are routed outside the book to the NYSE that remove liquidity from the
NYSE.\9\ In order to maintain the existing relationship to the other
Exchange routing fees that are being adjusted upward, the Exchange is
also proposing to increase this fee by $0.0001, to $0.0024 per share.
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    \8\ A Primary Sweep Order is a Primary Only (``PO'') Order
(i.e., a market or limit order that is to be routed to the primary
market) that first sweeps the NYSE Arca book. See NYSE Arca Equities
Rules 7.31(x) and (kk).
    \9\ This charge is included in the provisions for Tier 1, Tier
2, and the Basic Rate. The other tiers in the Fee Schedule do not
specify a fee for Primary Sweep Orders in Tape A securities that are
routed outside the book to the NYSE that remove liquidity from the
NYSE. Accordingly, for such orders ETP Holders and Market Makers
that qualify for another tier would default to the Tier 1, Tier 2 or
Basic Rate that applied to them based on their qualifying levels.
See supra note 7.
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    For Primary Only Plus (``PO+'') orders,\10\ the current Exchange
fee for orders routed to the NYSE that remove liquidity from the NYSE
is $0.0025 per share, which is equal to the current NYSE fee for all
other non-floor broker transactions in securities with a per share
price of $1.00 or more.\11\ Consequently, the Exchange is proposing to
increase its fees for routing PO+ orders to the NYSE that remove
liquidity by the same amount ($0.0001) as the increase in the
corresponding NYSE fees. The proposed new fee for PO+ orders routed to
the NYSE that remove liquidity is $0.0026 per share. This change would
maintain the current relationship with the NYSE rates.
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    \10\ A PO+ Order is a PO Order that is entered for participation
in the primary market, other than for participation in the primary
market opening or primary market re-opening. See NYSE Arca Equities
Rule 7.31(x)(3).
    \11\ This charge is included in the provisions for Tier 1, Tier
2, and the Basic Rate. The other tiers in the Fee Schedule do not
specify a fee for PO+ orders routed outside the book to the NYSE
that remove liquidity. Accordingly, for such orders ETP Holders and
Market Makers that qualify for another tier would default to the
Tier 1, Tier 2 or Basic Rate that applied to them based on their
qualifying levels. See supra note 7.
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    Consistent with the fee change proposed by the NYSE,\12\ the
Exchange proposes to amend the Fee Schedule to increase the Tier 1,
Tier 2, Tier 3, and Basic Rate fee for PO and PO+ Orders in Tape A
securities that are routed to the NYSE that execute in the opening or
closing auction, from $0.00095 to $0.0010 per share.
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    \12\ See supra note 4.
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    Under the current Basic Rate pricing, the credit for adding
liquidity in Tape A and Tape C securities is set at $0.0021 per share,
and the credit for adding liquidity in Tape B securities is set at
$0.0022 per share. The Exchange proposes to lower the credit for adding
liquidity in Tape A, Tape B, and Tape C securities to $0.0020 per
share.
    The proposed changes are not otherwise intended to address any
other issues, and the Exchange is not aware of any problems that ETP
Holders would have in complying with the proposed changes.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\13\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\14\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed fee and fee cap increases
for Market and Auction-Only Orders executed in an Opening, Market Order
or Trading Halt Auction are reasonable because they are the same as the
fees and fee caps imposed by at least one other exchange and proposed
by the Exchange's affiliate, the NYSE.\15\ In addition, the proposed
fee changes are equitable and not unfairly discriminatory because they
apply uniformly to all similarly situated ETP Holders.
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    \15\ See NASDAQ Rule 7018 and supra note 4.
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    The Exchange believes that the proposed changes to routing fees are
reasonable because the Exchange's fees for routing orders to the NYSE
are closely related to the NYSE's fees for its members for taking
liquidity, and the fee increases are consistent with the changes in
effect and proposed by the NYSE to increase its fees for taking
liquidity. The proposed changes will result in maintaining the existing
relationship between the two sets of fees. In addition, the Exchange
believes that the proposed rule change is reasonable, equitable, and
not unfairly discriminatory because it would result in an increase in
the per share fee for orders, Primary Sweep Orders, and PO+ Orders
routed to the NYSE, thereby aligning the rate that the Exchange charges
to ETP Holders with the rate that the Exchange is charged by the NYSE.
Accordingly, the Exchange is proposing this increase so that the rate
it charges to ETP Holders reflects the rate that the Exchange is
charged by the NYSE. In addition, the proposed changes are equitable
and not unfairly discriminatory because the fee increases apply
uniformly across pricing tiers and all similarly situated ETP Holders
would be subject to the same fee structure.
    The Exchange believes that the proposed changes to the Basic Rate
pricing credits for providing liquidity in Tape A, Tape B, and Tape C
securities are reasonable because the credits are consistent with the
credits offered by at least two other exchanges.\16\ In addition, the
proposed credits are equitable and not unfairly discriminatory because
they apply uniformly to all similarly situated ETP Holders.
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    \16\ See NASDAQ Rule 7018 and EDGX Exchange, Inc. Fee Schedule
available at www.directedge.com/Portals/0/01Trading/EDGX%20Fee%20Schedule/2014/EDGX%20Fee%20Schedule%20-%2003.05.14.pdf.
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    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition. For these reasons, the Exchange
believes that the proposal is consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\17\ the Exchange
does not believe that the proposed rule change will impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. In particular, the proposed routing fee
changes would not place a burden on competition because the Exchange is
seeking to align its fees with the fees charged by the NYSE.\18\ In
addition, the proposed changes to the Exchange's fee and fee cap for
Market and Auction-Only Orders executed in an Opening, Market Order or
Trading Halt Auction and Basic Rate pricing credits are consistent with
the fees and credits imposed by other exchanges.\19\
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    \17\ 15 U.S.C. 78f(b)(8).
    \18\ See supra notes 4-5.
    \19\ See supra notes 15-16.
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    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change promotes a competitive environment.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \20\ of the Act and subparagraph (f)(2) of Rule
19b-4 \21\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \22\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \22\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-33 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2014-33. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal offices of NYSE. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-NYSEArca-2014-33, and should be submitted on or before May 6, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Secretary.
[FR Doc. 2014-08415 Filed 4-14-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Notices]
[Pages 2163-2167]
[FR Doc No: 2022-00521]

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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 Becton, Dickinson & Company (BD) for the
BioGX SARS-CoV-2 Reagents for BD MAX System, Boston Medical Center for
the BMC-CReM COVID-19 Test, and Akron Children's Hospital for the Akron
Children's Hospital SARS-CoV-2 Assay. FDA revoked these Authorizations
on December 8, 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: The Authorizations for the BioGX SARS-CoV-2 Reagents for BD MAX
System, BMC-CReM COVID-19 Test, and Akron Children's Hospital SARS-CoV-
2 Assay are revoked as of December 8, 2021.

ADDRESSES: Submit written requests for a single copy 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) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
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 April 2, 2020, FDA issued an
EUA to BD for the BioGX SARS-CoV-2 Reagents for BD MAX System, subject
to the terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on June 5, 2020 (85
FR 34638), as required by section 564(h)(1) of the FD&C Act. On July
10, 2020, FDA issued an EUA to Boston Medical Center for the BMC-CReM
COVID-19 Test, subject to the terms of the Authorization. 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 September 29, 2020, FDA issued an EUA to Akron
Children's Hospital for the Akron Children's Hospital SARS-CoV-2 Assay,
subject to the terms of the Authorization. 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.
Subsequent updates to the Authorizations were made available on FDA's
website. 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 December 3, 2021, FDA received a request from BD for the
revocation of, and on December 8, 2021, FDA revoked, the Authorization
for the BioGX SARS-CoV-2 Reagents for BD MAX System. Because BD
notified FDA that BD discontinued the sale of the authorized product
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 October 4, 2021 (and reconfirmed December 6, 2021),
FDA received a request from Boston Medical Center for the revocation
of, and on December 8, 2021, FDA revoked, the Authorization for the
BMC-CReM COVID-19 Test. Because Boston Medical Center notified FDA that
the BMC-CReM COVID-19 Test is no longer performed pursuant to the EUA
and requested FDA withdraw the Authorization, FDA has determined that
it is appropriate to protect the public health or safety to revoke this
Authorization. On December 3, 2021, FDA received a request from Akron
Children's Hospital for the revocation of, and on December 8, 2021, FDA
revoked, the Authorization for the Akron Children's Hospital SARS-CoV-2
Assay. Because Akron Children's Hospital notified FDA that it stopped
performing the Akron Children's Hospital SARS-CoV-2 Assay and 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/.

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 BD's BioGX SARS-CoV-2 Reagents for BD MAX
System, Boston Medical Center's BMC-CReM COVID-19 Test, and Akron
Children's Hospital's Akron Children's Hospital SARS-CoV-2 Assay. 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.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN13JA22.000

[GRAPHIC] [TIFF OMITTED] TN13JA22.001

[GRAPHIC] [TIFF OMITTED] TN13JA22.002

    Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00521 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32749-32750]
[FR Doc No: 2017-14898]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2017-56]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, this aspect of the FAA's regulatory activities.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before August 7, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0584
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building

Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Deana Stedman, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>; or Alphonso
Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington, on July 7, 2017.
Victor Wicklund
Manager, Transport Standards Staff.

Petition for Exemption

    Docket No.: FAA-2017-0584.
    Petitioner: Embraer.
    Section of 14 CFR Affected: Sec.  25.981(a)(3).
    Description of Relief Sought: In accordance with FAA Policy PS-ANM-
25.981-02, dated June 24, 2014, the petitioner seeks an exemption from
the requirements of 14 CFR 25.981(a)(3) with respect to fuel tank
ignition prevention for the Model ERJ 190-300, 190-400, and 190-500
airplanes.
[FR Doc. 2017-14898 Filed 7-14-17; 8:45 am]
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[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Page 77516]
[FR Doc No: 2014-30149]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.

DATES: Date and Time: The meeting will be held on February 27, 2015,
from 8 a.m. to 6 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002,
<EMAIL_ADDRESS>301-796-6875, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On February 27, 2015, the committee will discuss, make
recommendations and vote on information regarding the premarket
approval application (PMA) panel-track supplement to expand the
indication for use for the Radiesse Injectable Implant (Radiesse)
device to include subdermal implantation for hand augmentation to
correct volume deficit in the hands. The proposed indication for use
for the Radiesse device, as stated in the PMA is as follows:
    The Radiesse device is for hand augmentation to correct volume
deficit in the hands.
    FDA has previously approved the Radiesse device for the following
two indications for use: The Radiesse device is indicated for subdermal
implantation for the correction of moderate to severe facial wrinkles
and folds, such as nasolabial folds. It is also indicated for subdermal
implantation for restoration and/or correction of the signs of facial
fat loss (lipoatrophy) in people with human immunodeficiency virus. The
Radiesse device remains unchanged from the current FDA approved
version.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 3, 2015. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before January 26, 2015. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by January 27, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Annmarie Williams at
<EMAIL_ADDRESS>or<PHONE_NUMBER> at least 7 days in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 17, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-30149 Filed 12-23-14; 8:45 am]
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