[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13385-13387]
[FR Doc No: 2012-5319]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2009-0271]

Identification of Interstate Motor Vehicles: New York City, Cook
County, and New Jersey Tax Identification Requirements; Petition for
Reconsideration.

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; Grant of petition for reconsideration.

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SUMMARY: The FMCSA grants a petition for reconsideration submitted by
the New York City Department of Finance (DOF) requesting
reconsideration of the Agency's previous determination that the
credential display requirement of New York City's Commercial Motor
Vehicle Tax (CMV Tax) is preempted. Federal law prohibits States and
their political subdivisions from requiring motor carriers to display
in or on commercial motor vehicles (CMVs) any form of identification
other than forms required by the Secretary of Transportation, with
certain exceptions. FMCSA has determined that the CMV Tax qualifies for
one of the statutory exceptions.

DATES: This decision is effective March 6, 2012.

FOR FURTHER INFORMATION CONTACT: Genevieve D. Sapir, Office of the
Chief Counsel, Federal Motor Carrier Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590,<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On February 25, 2008, the American Trucking Associations (ATA)
petitioned FMCSA to preempt Sec.  11-809 of New York City's
Administrative Code, which requires CMVs used principally in New

York City or in connection with a business carried on within New York
City to display a stamp evidencing payment of the city's CMV Tax. ATA
alleged that New York City's credential display requirement was
preempted under 49 U.S.C. 14506(a), which prohibits States from
requiring motor carriers to display in or on CMVs any form of
identification other than forms required by the Secretary of
Transportation. Section 14506(b), however, establishes several
exceptions to this prohibition [all statutory references are to title
49, United States Code]:

    (b) Exception.--Notwithstanding subsection (a), a State may
continue to require display of credentials that are required--
    (1) Under the International Registration Plan under section
31704;
    (2) Under the International Fuel Tax Agreement under section
31705 or under an applicable State law if, on October 1, 2006, the
State has a form of highway use taxation not subject to collection
through the International Fuel Tax Agreement;
    (3) Under a State law regarding motor vehicle license plates or
other displays that the Secretary determines are appropriate;
    (4) In connection with Federal requirements for hazardous
materials transportation under section 5103; or
    (5) In connection with the Federal vehicle inspection standards
under section 31136.

    In response to this and other petitions ATA submitted seeking
preemption of credential display requirements in New Jersey and Cook
County, Illinois, FMCSA published a notice in the Federal Register
seeking comment on whether the credential display requirements of New
York City, the State of New Jersey, and Cook County, Illinois should be
preempted (74 FR 53578, Oct. 19, 2009). FMCSA specifically requested
comment from the three jurisdictions, but neither New Jersey nor New
York City responded with comments. After the close of the comment
period, Cook County sent a letter conceding that its ordinance was
preempted under Sec.  14506.
    On October 20, 2010, FMCSA issued an order preempting all three
credential requirements (75 FR 64779). FMCSA's preemption analysis
focused solely on whether the exception in Sec.  14506(b)(3) applied.
However, in reaching this determination, FMCSA concluded that all of
the exceptions at Sec.  14506(b) could apply to political subdivisions
of States, including municipalities, if they otherwise meet the
statutory criteria (75 FR at 64780-81).
    On January 3, 2011, New York City's Department of Finance (DOF)
submitted a petition requesting reconsideration of FMCSA's preemption
determination. DOF's petition contended that New York City's credential
display requirement was based on a form of highway use taxation
excepted from preemption under Sec.  14506(b)(2). For the reasons set
forth below, FMCSA grants the DOF's petition for reconsideration.

Applicable Law

    New York City's CMV Tax has been in effect since 1960. See
Administrative Code of the City of New York, Title 11, Chapter 8.
Subject to several exemptions, the tax applies to both ``commercial
motor vehicle[s]'' and ``motor vehicle[s] for the transportation of
passengers'' that operate on a public highway or public street and are
``propelled by any power other than muscular power.'' Sec. Sec.  11-
801(2)-(4); 11-803. The tax applies to a ``commercial motor vehicle''
that is ``used principally in the city or used principally in
connection with a business carried on within the city.'' Sec.  11-
801(3). According to the DOF Web site, the term ``principally used in
the city'' means that 50% or more of a CMV's mileage during a year is
within New York City limits. See http://www.nyc.gov/html/dof/html/business/business_tax_cmvt.shtml. The tax also applies to a ``motor
vehicle for transportation of passengers'' that is ``used regularly,
even though not principally, in the city.'' Sec.  11-801(4). The tax
rate varies based on the class of the vehicle; for example, the annual
tax on a truck is based on maximum gross weight, in accordance with the
following classes: 10,000 pounds or less, $40; 10,001-12,500 pounds,
$200; 12,501-15,000 pounds, $275; and 15,000 pounds or over, $300, but
the annual tax on passenger vehicles is a flat rate of $400. Sec.  11-
802.a.1.(C). Subject to certain exceptions, the tax is paid to the
Commissioner of Finance on an annual basis. Sec.  11-808. However, the
tax on trucks registered in New York with a maximum gross weight not
exceeding 10,000 pounds and certain passenger vehicles is collected by
the Commissioner of Motor Vehicles when the vehicle registration is
renewed. Sec.  11-809.1(a). The Commissioner of Finance is authorized
to require that a tax decal or other indicia of payment be affixed to a
vehicle. Sec.  11-809(a); New York City Rules, Tit. 19, Sec.  6-09.
    Section 14506(a) prohibits the States or their political
subdivisions from requiring a motor carrier to display either in or on
a CMV any form of identification other than a form required by the
Secretary of Transportation. However, Sec.  14506(b)(2) provides that:

    Notwithstanding [Sec.  14506(a)], a State may continue to
require display of credentials that are required--(2) under the
International Fuel Tax Agreement * * * or under an applicable State
law if, on October 1, 2006, the State has a form of highway use
taxation not subject to collection through the International Fuel
Tax Agreement;

(emphasis added).

FMCSA Decision

    To qualify for the statutory exception at 49 U.S.C. 14506(b)(2),
the credentials (in this case a decal) required by New York City's CMV
tax must be part of a highway use tax that was in effect prior to
October 1, 2006. Because the tax has been in effect since 1960, the
only question before the Agency is whether it is a highway use tax
within the meaning of the statutory exception.
    In enacting Sec.  14506(b)(2), Congress did not define a highway
use tax. Nor is there any other statutory or regulatory definition of
highway use tax applicable to this statutory provision. In the absence
of controlling authority, the Agency looks to common usage of the term.
In the broadest sense, a highway use tax could mean any type of tax to
support highways or any kind of tax on highway business, vehicles, or
commerce, or any combination of these. E.M. Cope, Trends in Highway
Taxation in the United States, 49 American Highways 8, 9 (Oct. 1970).
Perhaps a better focused definition is any ``lev[y] that appl[ies] to
motor vehicles because of their highway use.'' Id.
    In the absence of statutory or regulatory guidance, the Agency
examines the plain language of New York City's CMV Tax. By definition,
the tax is levied for use of a CMV on the public highways or streets of
the city. See Sec.  11-801 (definitions of ``commercial motor vehicle''
and ``use''). Section 11-802(b) offers alternative interpretations of
the tax, both of which characterize it as one based on use of highways:

    To the extent that the tax as imposed by subdivision a of this
section may be invalid solely because it is based on the use in the
city of the motor vehicles, the tax shall also be deemed to be based
on the privilege of using the public highways or streets of the city
by such motor vehicle.

Accordingly, on its face, the CMV Tax is for use of the public
highways.
    Proceeds from highway use taxes are often dedicated, at least in
part, to a special fund for highway infrastructure; however the DOF's
petition does not state how revenue from the CMV Tax is used.
Nonetheless, a highway use tax may be levied without demonstrating that
the revenues are earmarked for highway infrastructure. See, e.g., Mid-
States Freight Lines, Inc. v. Bates, 200 Misc. 885, 890 (N.Y. Sup.
Ct.), aff'd, 279 A.D. 451 (3d Dep't.), aff'd, 304 N.Y. 700

(1952). Stated otherwise, a highway use tax need not necessarily be
dedicated to highway purposes. As a result, the DOF's failure to
demonstrate a connection between the CMV Tax and highway funding is not
dispositive.
    FMCSA concludes, therefore, that New York City's CMV Tax is a
highway use tax within the meaning of 49 U.S.C. 14506(b)(2).
    In consideration of the above, FMCSA grants the DOF's petition for
reconsideration and reverses its decision preempting New York City's
credential display requirement. Today's decision is limited to the new
arguments the DOF raised in its petition for reconsideration claiming
exception from preemption under Sec.  14506(b)(2). Under this analysis,
New York City's credential display requirement in Sec.  11-809 is not
preempted and New York City may resume enforcement.
    This decision does not affect the Agency's previous determination
preempting the credential display requirements in New Jersey and Cook
County, Illinois.

    Issued on: February 29, 2012.
Anne S. Ferro,
Administrator, Federal Motor Carrier Safety Administration.
[FR Doc. 2012-5319 Filed 3-5-12; 8:45 am]
BILLING CODE; P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

July 7, 2011

MEMORANDUM

SUBJECT:	Meeting with Ford on June 28, 2011

FROM:	Don Kopinski

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on June 28, 2011 between Ford and EPA staff.  The following people attended:

      Ford:  Ken McAlinden, Alyssa Werthman, Satish Atluri, Bob Thomas                     EPA: Tony Fernandez, Chuck Moulis, Chris Nevers, Bob Peavyhouse, Don Kopinski

The discussion focused on analytically-derived CO2.  Ford staff's presentation of their revised derivation of a best-fit curve for analytically derived CO2 is attached.

Attachment


[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3793]
[DOCID:fr22ja08-114]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on October 29, 2007, vol. 72, no. 208, page
61200. The respondents to this information collection will be CFR part
135 and part 121 operators. The FAA will use the information to ensure
compliance and adherence to the regulations.

DATES: Please submit comments by February 21, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Part 119--Certification: Air Carrier and Commercial
Operators.
    Type of Request: Extension without change of a currently approved
collection.
    OMB Control Number: 2120-0593.
    Forms(s): FAA Form 8400-6.
    Affected Public: An estimated 2,445 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 5 hours per
response.
    Estimated Annual Burden Hours: An estimated 8869.5 hours annually.
    Abstract: The respondents to this information collection will be
CFR part 135 and Part 121 operators. The FAA will use the information
to ensure compliance and adherence to the regulations.
    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 Nathan Lesser, Desk Officer, Department
of Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on January 14, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 08-212 Filed 1-18-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62185-62187]
[FR Doc No: 2016-21487]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78745; File No. SR-BatsEDGX-2016-48]

Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Delay the Implementation of the Options Regulatory Fee

September 1, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 22, 2016, Bats EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') 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 Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is

publishing this notice to solicit comments on the proposed rule change
from interested persons.

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to delay implementation of recently
enacted amendments to the fee schedule applicable to Members \5\ and
non-Members of the Exchange pursuant to EDGX Rules 15.1(a) and (c) to
adopt an Options Regulatory Fee (``ORF'').
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
    \5\ A member is defined as ``any registered broker or dealer
that has been admitted to membership in the Exchange.'' See Exchange
Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 Exchange 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 these 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange recently submitted a proposed rule change to modify
the fee schedule applicable to the Exchange's options platform (``EDGX
Options'') to adopt an ORF in the amount of $0.0002 per contract
side.\6\ The Exchange proposed to assess the per-contract ORF to each
Member and non-Member for all options transactions cleared by OCC in
the ``customer'' range, regardless of the exchange on which the
transaction occurs. In order to provide market participants additional
time to assess the impact of the ORF on their transactions and order
execution scenarios, the Exchange is delaying the implementation date
of the fee until February 1, 2017.\7\
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    \6\ See Securities Exchange Release No. 78452 (August 1, 2016),
81 FR 51951 (August 5, 2016) (SR-BatsEDGX-2016-33).
    \7\ The Exchange noted in its proposal and included text in its
fee schedule that it may only increase or decrease the ORF semi-
annually, and any such fee change will be effective on the first
business day of February or August. Id. See also the Exchange's fee
schedule available at http://batstrading.com/support/fee_schedule/edgx/ (dated August 5, 2016). The Exchange initially filed the
proposed fee change on August 11, 2016 (SR-BatsEDGX-2016-43). On
August 19, 2016, the Exchange withdrew SR-BatsEDGX-2016-43 and
submitted SR-BatsEDGX-2016-47. On August 22, 2016, the Exchange
withdrew SR-BatsEDGX-2016-47 and submitted this filing.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\8\ The
Exchange also believes that its proposal furthers the objectives of
Section 6(b)(5) of the Act \9\ in that it is designed to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest. The Exchange believes
delaying the implementation of ORF will provide market participants
additional time to assess the impact of the ORF on their transactions
and order execution scenarios, and that implementation of the fee on
February 1, 2017 will benefit investors and the public interest.\10\
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    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ The Exchange notes that other exchanges have delayed the
implementation of fees that were previously published by the
Commission. See Securities Exchange Act Release Nos. 72605 (July 14,
2014), 79 FR 42066 (July 18, 2014) (SR-Phlx-2014-44); 67068 (May 29,
2012), 77 FR 33256 (June 5, 2012) (SR-Nasdaq-2012-064); 66287
(February 1, 2012), 77 FR 6161 (February 7, 2012) (SR-FINRA-2012-
008); and 57183 (January 22, 2008), 73 FR 5249 (January 29, 2008)
(SR-Nasdaq-2008-007).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The ORF is not intended to have
any impact on competition. Rather, it is designed to enable the
Exchange to recover a material portion of the Exchange's cost related
to its regulatory activities. Therefore, the Exchange does not believe
delaying the implantation of ORF till February 1, 2017 will have any
impact on competition.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4
thereunder.\12\ At any time within 60 days of the filing of the
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.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 No. SR-BatsEDGX-2016-48 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 No. SR-BatsEDGX-2016-48. 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, 100 F Street NE., Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. 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 No. SR-BatsEDGX-2016-48, and should be submitted on or before
September 29, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-21487 Filed 9-7-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55435-55438]
[FR Doc No: 2022-19491]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]

Revocation of Two 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.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Becton, Dickinson and Company (BD) for the BD
SARS-CoV-2/Flu for BD MAX System, and Talis Biomedical Corporation
(Talis) for the Talis One COVID-19 Test System. FDA revoked these
Authorizations 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 Authorization for the BD SARS-CoV-2/Flu for BD MAX System is
revoked as of August 1, 2022. The Authorization for the Talis One
COVID-19 Test System is revoked as of August 23, 2022.

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 February 10,
2021, FDA issued an EUA to BD for the BD SARS-CoV-2/Flu 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
April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the
FD&C Act. On November 5, 2021, FDA issued an EUA to Talis for the Talis
One COVID-19 Test System, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on March 22, 2022 (87 FR 16196), 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

    In a request received by FDA on July 26, 2022, BD requested
withdrawal of, and effective August 1, 2022, FDA revoked, the
Authorization for the BD SARS-CoV-2/Flu for BD MAX System. Because BD
notified FDA that BD has discontinued the sale of the BD SARS-CoV-2/Flu
for BD MAX System and requested FDA to withdraw the authorization of
the BD SARS-CoV-2/Flu for BD MAX System, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
    In a request received by FDA on August 12, 2022, Talis requested
revocation of, and on August 23, 2022, FDA revoked, the Authorization
for the Talis One COVID-19 Test System. Because Talis notified FDA that
Talis has not commercially distributed the authorized product in the
United States and requested FDA revoke the authorization of the Talis
One COVID-19 Test System, 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 EUA of BD for the BD SARS-CoV-2/Flu for BD MAX System
and of Talis for the Talis One COVID-19 Test System. 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] TN09SE22.044

[GRAPHIC] [TIFF OMITTED] TN09SE22.045

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19491 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32476-32479]
[DOCID:fr08jn10-103]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0250]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements for premarket
approval of medical devices.

DATES:  Submit either electronic or written comments on the collection
of information by August 9, 2010.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Approval of Medical Devices--21 CFR Part 814 /Food and Drug
Administration Modernization Act of 1997 (FDAMA) Sections 201, 202,
205, 208, and 209 (OMB Control Number 0910-0231)--Extension

    Section 515 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360e) sets forth the requirements for premarket approval of
certain class III medical devices. Class III devices are either pre-
amendments devices that have been classified into class III, or post-
amendments devices which are not substantially equivalent to a pre-
amendments device, or transitional devices. Class III devices are
devices such as implants, life sustaining or life supporting devices,
and/or devices which otherwise present a potentially unreasonable risk
of illness or injury, and/or are of substantial importance in
preventing impairment of human health. Most premarket approval
applications (PMAs) are for post-amendments class III devices.
    Under section 515 of the act, an application must contain certain
specific information, including full reports of all information
concerning investigations showing whether the device is reasonably safe
and effective. The application should also include a statement of
components, ingredients, and properties of the principles of operation
for such a device. In addition, the application should also include a
full description of the methods used in, and the facilities and
controls used for the manufacture and processing of the device and
labeling specimens. The implementing regulations, contained in part 814
(21 CFR part 814), further specifies the contents of a PMA for a class
III medical device and the criteria FDA sets forth in approving,
denying, or withdrawing approval of a PMA as well as supplements to
PMAs. The purpose of this regulation is to establish an efficient and
thorough procedure for FDA's review of PMAs and supplements to PMAs for
certain class III (premarket approval) medical devices. The regulations
under part 814 facilitate the approval of PMAs and supplements to PMAs
for devices that have been shown to be reasonably safe and effective
and otherwise meet the statutory criteria for approval. The regulations
also ensure the disapproval of PMAs and supplements to PMAs for devices
that have not been shown to be reasonably safe and effective and that
do not otherwise meet the statutory criteria for approval. FDAMA
(Public Law 105-115) was enacted on November 21, 1997, to implement
revisions to the act by streamlining the process of bringing safe and
effective drugs, medical devices, and other therapies to the U.S.
market. Several provisions of this act affect the PMA process, such as
section 515(d)(6) of the act. This section provided that PMA
supplements were required for all device changes that affect safety and
effectiveness of a device unless such changes are modifications to
manufacturing procedures or method of manufacture. This type of
manufacturing change now requires a 30-day notice, or where FDA finds
such notice inadequate, a 135-day PMA supplement.
    To make the PMA process more efficient, in the past several years
FDA has done the following: (1) Made changes to the PMA program based
on comments received, (2) complied with changes to the program mandated
by FDAMA and the Medical Device User Fee Modernization Act, and (3)
worked toward completion of its PMA reinvention efforts.
    Respondents to this information collection are persons filing a PMA
application or a PMA supplement with FDA for approval of certain class
III medical devices. Part 814 defines a person as any individual,
partnership, corporation, association, scientific or academic
establishment, government agency or organizational unit, or other legal
entity. These respondents include entities meeting the definition of
manufacturers such as manufacturers of commercial medical devices in
distribution prior to May 28, 1976 (the enactment date of the Medical
Device Amendments). In addition, hospitals that reuse single use
devices (SUDs) are also included in the definition of manufacturers. It
is expected that FDA will receive one PMA application from hospitals
that remanufacture SUDs annually. This figure has been included in
table 1 of this document, as part of the reporting burden in Sec.
814.20.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
            21 CFR Section/  FDAMA Section                 Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.15(b)                                                               8                     1                  8                  2                 16
--------------------------------------------------------------------------------------------------------------------------------------------------------

814.20                                                                 36                     1                 36                668             24,048
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.37(a) through (c) and (e)                                          36                     1                 36                167              6,012
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(a)                                                             670                     1                670                 60             40,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(d)                                                              68                     1                 68                  6                408
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(f)                                                             505                     1                505                 16              8,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.82(a)(9)                                                           18                     1                 18                135              2,430
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.84(b)                                                             648                     1                648                 10              6,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 201 (FDAMA) Agreement Meeting                                   3                     1                  3                 50                150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 202 (FDAMA) Expedited Review Request                            5                     1                  5                 10                 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 205 (FDAMA) Effectiveness Meeting                               5                     1                  5                 50                250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 208 (FDAMA) Classification Panel Meetings                      20                     1                 20                 30                600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 209 (FDAMA) 100-day meeting                                    28                     1                 28                 10                280
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals                                                              2,050                    13              2,050              1,214             89,004
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.82(a)(5) and (a)(6)                                               698                     1                698                 17             11,866
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The industry-wide burden estimate for PMAs is based on an FDA
actual average fiscal year (FY) annual rate of receipt of 36 PMA
original applications, 532 PMA supplements, and 505 30-day notices
using FY 2005 through 2009 data. The burden data for PMAs is based on
data provided by manufacturers by device type and cost element in an
earlier study. The specific burden elements for which FDA has data are
as follows:
     Clinical investigations--67 percent of total burden
estimate;
     Submission of additional data or information to FDA during
a PMA review--12 percent;
     Additional device development cost (e.g., testing)--10
percent; and
     PMA and PMA supplement preparation and submissions, and
development of manufacturing and controls data--11 percent.

Reporting Burden

    The reporting burden can be broken out by certain sections of the
PMA regulation as follows:
     Sec.  814.15--Research Conducted Outside the United States
    Approximately 20 percent of the clinical studies submitted in
support of a PMA application are conducted outside the United States.
Each study should be performed in accordance with the ``Declaration of
Helsinki'' or the laws and regulations of the country in which the
study was conducted. If the study was conducted in accordance with the
laws of the country, the PMA applicant is required to explain to FDA in
detail the differences between the laws of the country and the
``Declaration of Helsinki.'' Based on the number of PMAs received that
contained studies from overseas, FDA estimates that the burden estimate
necessary to meet this requirement is 20 hours.
     Application in Sec.  814.20(a) through (c) and (e)
    The majority of the 24,048 hourly burden estimate is due in part to
this requirement. Included in this requirement are the conduct of
laboratory and clinical trials as well as the analysis, review, and
physical preparation of the PMA application. FDA estimates that 36
manufacturers, including hospital re-manufacturers of SUDs, will be
affected by these requirements which are based on the actual average of
FDA receipt of new PMA applications in FY 2005 through 2009. FDA's
estimate of the hours per response (668) was derived through FDA's
experience and consultation with industry and trade associations. In
addition, FDA also based its estimate on the results of an earlier
study which accounts for the bulk of the hourly burden for this
requirement, which is identified by manufacturers.
     Sec.  814.37--PMA Amendments and Resubmitted PMAs
    As part of the review process, FDA often requests PMA applicant to
submit

additional information regarding the device necessary for FDA to file
the PMA or to complete its review and make a final decision. The PMA
applicant may, also on their own initiative, submit additional
information to FDA during the review process. These amendments contain
information ranging from additional test results, re-analysis of the
original data set to revised device labeling. Almost all PMAs received
by the Agency have amendments submitted during the review process. FDA
estimates that 6,012 burden hours are necessary to satisfy this
requirement.
     PMA Supplements in Sec.  814.39(a)
    FDA believes that the amendments mandated by FDAMA for Sec.
814.39(f), permitting the submission of the 30-day notices in lieu of
regular PMA supplements, will result in an approximate 20 percent
reduction in the total number of hours as compared to regular PMA
supplements. As a result, FDA estimates that 40,200 hours of burden are
needed to complete the requirements for regular PMA supplements.
     Special PMA Supplements--Changes Being Affected in Sec.
814.39(d)
    These types of supplements are intended to enhance the safety of
the device or the safe use of the device. The number of PMA supplements
received that fit this category averaged 68 per year based on the
numbers received from FY 2005 through FY 2009. Because of the minimal
data required to be included in this type of supplement, FDA estimates
that the burden hours necessary to satisfy this requirement are 408
hours.
     30-Day Notice in Sec.  814.39(f)
    Under section 515(d) of the act, modifications to manufacturing
procedures or methods of manufacture that affect the safety and
effectiveness of a device subject to an approved PMA do not require
submission of a PMA supplement under Sec.  814.39(a) and are eligible
to be the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The manufacturer may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice, that it is not adequate. FDA estimates the
burden to satisfy this requirement is 8,080 hours.
     Post-Approval Requirements in Sec.  814.82(a)(9)
    Post-approval requirements concern approved PMAs that were not
reclassified and require a periodic report. After approval, all PMAs
require a submission of an annual report. On average, approximately
half of the submitted PMAs (18), require associated post-approval
studies, i.e., followup of patients used in clinical trials to support
the PMA or additional preclinical information, that is labor-intensive
to compile and complete; the remaining PMAs require minimal
information. Based on experience and consultation with industry, FDA
has estimated that preparation of reports and information required by
this section requires 2,430 hours.
     Reports in Sec.  814.84(b)
    Post-approval requirements described in Sec.  814.82(a)(7) require
submission of an annual report for each approved PMA. FDA estimates
that respondents will average about 10 hours in preparing their reports
to meet this requirement. This estimate is based on FDA's experience
and consultation with industry. Thus, FDA estimates that the periodic
reporting burden required by this section will take 6,480 hours.

Statutory Reporting Burden Estimate (FDAMA)

    The total statutory reporting burden under the requirements of
sections 201, 202, 205, 208, and 209 of FDAMA is estimated to be 1,230
hours. This burden estimate was based on actual real and estimated FDA
data tracked from FY 2005 through FY 2009, and an estimate was also
derived to forecast future expectations with regard to this statutory
data.

Recordkeeping in Sec.  814.82(a)(5) and (a)(6)

    The recordkeeping burden under this section requires the
maintenance of records, used to trace patients and the organization and
the indexing of records into identifiable files to ensure the device's
continued safety and effectiveness. These records are required only of
those manufacturers who have an approved PMA and who had original
clinical research in support of that PMA. For a typical year's
submissions, 70 percent of the PMAs are eventually approved with 90
percent of these having original clinical trial data. Therefore,
approximately 25 PMAs a year would be subject to these requirements.
Also, because the requirements apply to all active PMAs, all holders of
an active PMA application must maintain these records.
    PMAs have been required since 1976, and there are 698 active PMAs
that could be subject to these requirements, based on actual FDA data.
Each study has approximately 200 subjects, and at an average of 5
minutes per subject, there is a total burden per study of 1,000
minutes, or 17 hours. The aggregate burden for all 698 holders of
approved original PMAs, therefore, is 11,866 hours.
    The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the current good manufacturing
practices for medical devices regulation (part 820) may be relevant to
a PMA review and may be submitted as part of an application. In
individual instances, records may be required as conditions of approval
to ensure the device's continuing safety and effectiveness.

    Dated: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13763 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S


CONSIDERATION OF 1994 AND 1995 PROPOSALS ON ALTERNATIVE OPERATING
SCENARIOS AND ADVANCE NSR WITH ASSOCIATED COMMENT SUMMARIES

Overview

During the process of creating our proposal on Flexible Air Permitting,
EPA considered certain comments received from industry, environmental
groups, and regulatory agencies on our 1994 and 1995 proposals to revise
parts 70 and 71.  This document summarizes the changes that were
proposed in 1994 and 1995 with respect to the concepts and definitions
of “alternative operating scenarios” (AOSs) and “advance NSR”
and the comments they generated.  While the positions in these two
proposals were not finalized, the comments received in response to them
together with other relevant Agency experiences, including insights
gained from the development and evaluation of several State pilot
permits, were useful as EPA developed its positions contained in the
proposal for Flexible Air Permitting.  The summary below is intended to
reflect the extent to which EPA considered these comments in determining
our proposed approaches.

Proposed Changes to Parts 70 and 71: 1994 and 1995

In August 1994, EPA proposed to allow use of the concept of AOSs to
provide advance approval to construct and operate new or modified units
subject to NSR and section 112(g) (referred to as “advance NSR”).
The concept of advance NSR put forward at that time was that the
permitting authority would decide the applicable NSR requirements before
an anticipated project or class of projects was constructed or modified,
and then include that project’s requirements in the part 70 permit for
the facility.  As a result, the project would be “pre-approved” by
the permitting authority.  This pre-approval would avoid the need for a
separate NSR permit and a part 70 permit revision prior to the project
being constructed or operated.  The NSR permit would be unnecessary
because preconstruction review and approval had already occurred for the
anticipated project or class of projects, and the NSR permit terms were
already established (in the part 70 permit).  A part 70 permit revision
would be unnecessary since the part 70 permit already contained the NSR
construction and operation requirements for the project.

A second proposed change addressed the requirement in §70.6(a)(9) that
a source keep a contemporaneous record of all changes among AOSs in an
on-site log.  The proposed revisions to part 70 would allow a source to
use an on-site log of changes among operating scenarios when each of
those scenarios had monitoring that met two conditions.  First, under
the 1994 proposal, each scenario must be monitored in a way that yielded
objective, contemporaneous measurement and recordation of the relevant
emissions or parameters.  Second, each scenario must have a sufficiently
different means of measurement that the contemporaneous record revealed
the scenario under which the source was operating when the record was
made.  In any other case, the facility would be required, for each week
during which one or more changes to a different operating scenario was
made, to copy the on-site log of changes for that week and mail it to
the permitting authority.  These proposed provisions were intended to
assured that either the scenarios were monitored in a way that
inherently revealed the scenario in effect at all times, or the
permittee reported changes among scenarios within a sufficient period of
time to avoid any significant possibility of after-the-fact tampering.

The 1994 proposal to treat advance NSR as an AOS under part 70 did not
propose to materially alter the underlying NSR State implementation plan
(SIP) requirements.  The extent to which advance NSR approval would be
available, or indeed, whether it would be available at all, would be
governed by each State minor NSR program.  The 1994 proposal did not
address the extent to which advance NSR would be available in State NSR
programs.  It simply provided that, where advance NSR was available, the
AOS provisions of §70.6(a)(9) would offer a mechanism for implementing
it through part 70 permits.  A permitting authority considering
implementing advance NSR under the 1994 proposal would be required to
consider the extent to which its NSR rules allowed the use of approaches
which forecast specific NSR requirements in advance.  Advance NSR, as
proposed, would demand an ability to predict the construction and
operational details of the future project or class of projects with
enough certainty to allow the permitting authority to fix relevant NSR
requirements in the part 70 permit, including compliance monitoring
terms.  A permitting authority would also have to consider whether
including advance NSR as an AOS in a part 70 permit would satisfy its
own procedures for drafting, providing for review of, and issuing NSR
permits for the changes which were being preapproved.

	In 1995 EPA further clarified its proposed positions on advance NSR by
proposing to add definitions of “advance NSR” and “alternate
operating scenario” to §70.2,  and also explained that in EPA’s
view, a change subject to an advance approval scenario would not be a
change under section 502(b)(10) of the Clean Air Act (the Act).
Rather, EPA proposed in 1995 that it would constitute a switch to an AOS
under §70.6(a)(9).  As the preamble noted, this interpretation would
have two advantages.  First, it would allow the use of advance NSR for
title I modifications and avoid the limitation that changes under
section 502(b)(10) cannot be title I modifications.  Second, the
seven-day advance notification under section 502(b)(10) which attaches
to each change made under that section would not apply to changes under
the advance NSR approval.  Consequently, where the NSR program would
allow for advance approval, and the permitting authority could approve
an AOS containing advance approval, the part 70 permit could allow a
source to make the approved change without a part 70 revision.

The definition EPA proposed for “advance NSR” in §70.2 was as
follows:

Advance NSR means terms or conditions in a part 70 permit setting forth
requirements applicable to new units or modifications under applicable
major or minor NSR programs or regulations implementing section 112(g)
of the Act, so that such changes may be operated without having to
obtain a part 70 permit revision.

A revised definition of AOS was also proposed, as follows:

Alternative operating scenarios means terms or conditions in a part 70
permit which assure compliance with different modes of operation for
which a different applicable requirement applies and for which the
source is designed to accommodate.

      What follows is a summary of the comments made from industry,
regulatory agencies, and environmental groups on the changes proposed in
1994 and 1995.  In addition to soliciting general comments regarding the
proposals, there were also specific areas about which the Agency was
interested in receiving comments.  First, EPA solicited comments on the
availability of the advance NSR option subject to certain additional
constraints, as well as the appropriateness of the use of advance NSR
for nonattainment area NSR under part D of title I of the Act, PSD under
part C, minor NSR under section 110(a)(2)(C), and modifications of HAP
sources under section 112.  Second, the Agency was interested in
permitting authorities’ experiences with monitoring alternative
scenarios.  In their experience, has tampering with compliance reports
been a problem?  Would the proposed revisions effectively address any
such problem?  Third, the Agency invited comments on the appropriate
interval for reporting.  Fourth, EPA solicited comments on the
definitions for “advance NSR” and “alternative operating
scenario.”

Summary of Comments on “  SEQ CHAPTER \h \r 1 advance NSR” concept

A large number of industry commenters supported advance NSR.  On the
whole the commenters felt advance NSR approval would provide flexibility
and would be useful particularly with permits with emissions caps.
There was one regulatory agency that favored the advance NSR concept and
one that opposed it.  The commenter that opposed the concept felt that
adding another set of construction permits to the already complicated
part 70 permit process would simply slow down the process.

In relation to the specific areas where the Agency had solicited
comments, there were a number regarding the extension of advance NSR
approval if the associated NSR permit’s time limit expires before the
operating permit’s term is up.  Four industry comments supported the
extension, stating that extending NSR approval is needed if advance NSR
is to provide real benefits in operation flexibility.  One suggested
method for extension would be to include in the permit a provision to
allow the source to submit a notification exercising the extension
option without any other requirement for a response from the permitting
authority.  Another suggestion was for EPA to specifically provide that
States can grant advance NSR approval for whatever period they deem
appropriate.  Two regulatory agencies opposed extending the NSR permit
timeline, questioning whether it would save time and stating that
additional constraints should not be placed on the NSR process already
in place.

	Several industry commenters were in support of advance NSR for the
specific programs mentioned above, while other industry commenters were
not as explicit in identifying the programs named by EPA for which they
believed advance NSR to be appropriate.  Two regulatory agencies
provided comment on the appropriateness of advance NSR approval for the
specific programs mentioned above.  One regulatory agency stated that
for major NSR (part D and PSD), the existing programs already
incorporate the needed flexibility – a source could get a PSD approval
with the operating permit if it will start the project within
18 months.  However, the commenter indicated that any longer lead time
should necessitate a new technology review and a new public comment
period.  The commenter also stated that minor NSR and HAP sources should
be handled by existing programs and notification requirements.  The
second regulatory agency stated it did not support advance NSR approval
for major or minor NSR because changes of this magnitude should be
addressed at the time that a company is committing to them, not just
anticipating them.  Otherwise, this commenter stated, other changes that
have occurred in the interim which might impact the decision cannot be
considered appropriately.

Summary of Comments on “advance NSR” definition

	Many commenters (consisting of all three groups) suggested alterations
to the proposed definition for clarification.  One industry
commenter noted that the proposed definition uses the term “new
units,” which is not defined, and does not mention reconstructed
sources, although it does address the other two possibilities
(newly-constructed sources and modifications).

	An environmental group believed that “advance NSR” needed to be
clarified to express the limited scope of the concept.  Specifically,
the words “one or more specifically identified” should be added
before the phrase “new units.”  One regulatory agency believed that
“advance NSR” did not adequately encompass the flexibility of the
States to make decisions on the alternative scenarios (e.g., decide that
a construction permit is still needed, allow review of plans for a
proposed change before construction is initiated).  The commenter
suggested “permit provisions to accommodate future new and modified
units” as a better description than “advance NSR.”

	Two of the industrial commenters were concerned about possible
confusion between the terms “advance NSR” and “PALs.”  They
suggested that the Agency should clarify that the requirement under
advance NSR to provide information about the applicable terms and
conditions of anticipated changes does not apply to NSR PALs, and that
EPA should state in the rule that to the extent a facility has
pre-approval under a PAL permit to implement generic changes, advance
specification of the terms and conditions that apply to those changes is
not required.

	Two commenters (one industry and one environmental group) specifically
supported adding a definition of “advance NSR” to promote greater
certainty in implementing emissions caps under section 502(b)(10) of the
Act.

Summary of Comments on Alternative Operating Scenarios tc "	6.4.1
Alternative Operating Scenarios - General " \l 3

	The comments on AOSs came from industry.  Four of these commenters
generally supported the concept of AOSs as a potential means of
obtaining operational flexibility, but expressed concern that the
proposed restrictions on AOSs would unnecessarily complicate their use
or make them unworkable. One of these commenters and two other industry
commenters stated that it should be clarified that AOSs are only
appropriate when there are alternative emissions standards that would
apply to the alternative scenarios.

	Five other industry commenters indicated that AOSs as proposed would
not prove useful because it is impossible to accurately predict future
operating conditions over the life of the permit.  Two of these
commenters provided examples of the extremely rapid and radical shift in
operations that characterize their industry.  These commenters suggested
a more innovative approach to AOSs, for example to characterize as AOSs
a specific number of wholesale technology changes and a specific number
of equipment upgrades.  Under this suggested approach, the permit could
allow for these activities to be undertaken without triggering any
permit revisions as long as the source remained within the emissions cap
and did not increase HAP emissions in conjunction with the changes in
excess of de minimis levels.  The commenters noted that the permit need
only contain general language indicating that AOSs are available only
for VOC emissions and only where the certain prerequisites are
satisfied, such as (1) VOC emissions from the change must not exceed
the plantsite emissions cap, (2) the change must meet certain RACT and
other SIP requirements specified in the permit, and (3) the change must
not trigger any new applicable requirement.

	Several comments were received from industry on the proposal to allow
permitting authorities to add AOSs that were not requested by the source
to part 70 permits.  Eight commenters opposed the proposal, while three
commenters were in agreement with it.

	The eight opposing commenters raised several concerns.  Many commenters
indicated that such scenarios would add unnecessary detail to the
permits, limiting the inherent flexibility that would otherwise be
available.  Some felt that it was an intrusion on business privacy and
that the permitting authorities could not know enough about each
individual source’s operations to properly create an alternative
scenario.  A third concern was that all the additional scenarios may bog
down the permitting process or result in an unrealistic portrayal of
emissions, inflating the fees charged to sources.  Two commenters
believed that EPA misread the provisions of the Act in proposing that
permitting authorities be authorized to add AOSs to permits.

 	Three commenters agreed with the proposal, although two of them
suggested two guiding principles to define the limitations of the
permitting authorities’ discretion:

	1.  An AOS is only necessary to the extent that changes in a source’s
mode of operation implicate either (1) a new applicable requirement or
(2) different measures for demonstrating compliance with applicable
requirements.  In particular, there is no need for extraneous process
operation detail in a permit unrelated to demonstrating compliance.

	2.  An AOS should contain only the detail necessary for demonstrating
compliance with applicable requirements.  In particular, the level of
detail should be governed by the underlying applicable requirement.  For
example, if the applicable requirement establishes an emissions limit,
such as a VOC emissions limit for a degreaser, and specifies compliance
by mass balance, the scenario need only include the RACT emissions limit
along with the mass balance formula.  No other process details would be
necessary or appropriate.

Summary of Comments on Reporting Requirements for Alternative Operating
Scenarios

	The majority of commenters opposed the proposed revisions to
§70.6(a)(9)(i), generally characterizing the proposed new AOS reporting
requirements as unnecessary and burdensome, and stating that the burden
would not be justified by the very small environmental benefit that
would result.  Several commenters, both regulatory agencies and
industry, stated that the proposed reporting would make AOSs less
useful, and several regulatory agencies indicated that permitting
authorities do not have the resources to review weekly reports.  One
industry commenter felt that once the permit is given, the source should
only be required to notify the agency of any exceedances of the
scenarios.  Another stated that the source should be allowed to operate
under one all-encompassing operating scenario, rendering the reporting
moot.  One industry commenter felt that information would be available
to foreign competitors about U.S. sources’ production processes.
Another industry commenter also stated that the requirements were not
feasible for smaller sources that may not have the resources to generate
and submit weekly reports.  Several industry commenters also noted that
in most cases AOSs are unlikely to be so different that a different
means of measurement would be used, although the recorded range of
values may well vary among alternative scenarios.

	Some suggested alternatives were offered, including quarterly reports,
annual logs, onsite logs, semi-annual reporting, or determination of
requirements on a case-by-case basis and included as a permit condition.
 Several of the commenters favored reporting along with the regular
semi-annual monitoring reports that are already required under the Act.

	One regulatory agency and one industry commenter supported the proposed
notice requirement for AOSs, although the industry commenter requested
that EPA clarify that only a “one-time” notice is required to be
submitted the week following a change to an AOS and that no notice is
required for weeks in which no change among operating scenarios is made.

Summary of Comments on “Alternative Operating Scenario” definition
SEQ CHAPTER \h \r 1

	Two industry commenters and one regulatory agency supported the
proposed definition and did not suggest changes.  Eleven industry
commenters suggested changes to the wording of the definition of
alternative operating scenarios for clarity and efficacy.  One of the
elements that several commenters focused on was “designed to
accommodate.”  The commenters stated that the term was not previously
defined in part 70 (although it is a term of art in the NSR program),
and varying interpretations of the term could lead to substantial
confusion and possibly limit the range of operating scenarios available
under the permit.  The suggestions were to delete the phrase completely
or for EPA to define the phrase such that AOSs could include both those
that are feasible under the source’s design as well as those that are
reviewed and included in its title V operating permit.

	Additional specific changes were suggested by industry commenters:

Clarify the definition to make it clear that the purpose of AOSs is
simply to record applicable requirements that apply to sources or
activities that have variable operations (or future effective
requirements).

Delete “. . . for which a different applicable requirement applies and
. . .” to simplify the definition and to avoid any confusion in
situations such as a change in service for a storage tank that causes
the emissions unit to no longer be subject to a regulation.

Do not specify that alternative operating scenarios are always subject
to “a different applicable requirement” because sometimes the same
applicable requirement may apply to multiple scenarios.

Delete reference to terms and conditions that “assure compliance”
with different modes of operation for which a different applicable
requirement exists, since it implies monitoring/enhanced monitoring.

Redefine AOSs so that the term refers to permit authorizations that
“may” be requested at a source’s option and is not implied that it
must be requested.

Specifically mention the new definition of “advance NSR.”

Clarify that AOSs “may include those reviewed in accordance with an
advance NSR condition included in the part 70 permit” in order to
expand possible NSR actions.

August 27, 2007

 PAGE

 PAGE   7


[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)]
[Notices]
[Pages 10562-10563]
[FR Doc No: 2015-03965]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74342; File No. SR-NASDAQ-2015-014]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Postpone Implementation of Changes to Rules 4751(h) and 4754(b)
Relating to the Closing Process

 February 20, 2015.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 11, 2015, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
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\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to postpone implementation of changes to
Rules 4751(h) and 4754(b) relating to the closing process.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.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 Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    NASDAQ is proposing to delay implementation of changes to Rules
4751(h) and 4754(b) relating to the closing process, which are
effective but not yet implemented. On December 16, 2014, the Exchange
filed an immediately effective filing \3\ to amend the processing of
the Closing Cross under Rule 4754(b) to adopt a ``Lockdown Period,''
the point at which NASDAQ will close the order book for participation
in the Closing Cross. The Exchange also amended Rule 4751(h) to
harmonize the processing of Market Hours Day orders \4\ and Good-til-
market close orders \5\ upon initiation of the Lockdown Period.
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    \3\ Securities Exchange Act Release No. 73943 (December 24,
2014), 80 FR 69 (January 2, 2015) (SR-NASDAQ-2014-123).
    \4\ See Rule 4751(h)(6).
    \5\ See Rule 4751(h)(8).
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    The Exchange had originally anticipated implementing the changes in
mid-February 2015, after the expiration of the 30 day operative delay
provided by Rule 19b-4(f)(6)(iii) under the Act.\6\ The Exchange,
however, has experienced unanticipated delay in the development of the
changes to its systems, which has made the original implementation date
unachievable. The Exchange believes it will be able to implement the
changes on April 13, 2015, and is providing notice of the delay and new
implementation date.
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    \6\ 17 CFR 240.19b-4(f)(6)(iii).
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2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of section 6 of the Act, in general, and with section
6(b)(5) of the Act, in particular, because it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest; and is not designed to
permit unfair discrimination between customers,

issuers, brokers, or dealers. The Exchange believes that the changes
NASDAQ is making to Rules 4751(h) and 4754(b) promote consistency and
transparency in the process for handling orders in the closing process.
Delaying implementation of the changes for brief period so that NASDAQ
may implement the changes to its systems necessary to ensure that the
Lockdown Period and processing of Market Hours Day and Good-til-market
close orders are handled in the Closing Cross operate as planned
promotes fair and orderly markets, the protection of investors and the
public interest.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\7\ The Exchange
believes that the proposal is irrelevant to competition because it is
not driven by, and will have no impact on, competition. Specifically,
the proposal is representative of the Exchange's efforts to harmonize
and simplify the processing of orders during the closing process.
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    \7\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A)(iii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so the Exchange may
provide immediate notice of its intent to delay implementation of the
closing process due to unanticipated system development issues. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will allow the Exchange to provide immediate notice of this
delay. Therefore, the Commission hereby waives the 30-day operative
delay and designates the proposed rule change to be operative upon
filing with the Commission.\12\
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    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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-NASDAQ-2015-014 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2015-014. 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, 100 F Street NE.,
Washington, DC 20549, 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 office of the Exchange. 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-NASDAQ-2015-014 and should
be submitted on or before March 19, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-03965 Filed 2-25-15; 8:45 am]
BILLING CODE 8011-01-P