[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15833-15834]
[FR Doc No: 2012-6388]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66564; File No. SR-OPRA-2012-02]

Options Price Reporting Authority; Notice of Filing and Immediate
Effectiveness of Proposed Amendment to the Plan for Reporting of
Consolidated Options Last Sale Reports and Quotation Information To
Amend OPRA's Fee Schedule

 March 9, 2012.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given that
on March 8, 2012, the Options Price Reporting Authority (``OPRA'')
submitted to the Securities and Exchange Commission (``Commission'') an
amendment to the Plan for Reporting of Consolidated Options Last Sale
Reports and Quotation Information (``OPRA Plan'').\3\ The proposed
amendment would revise OPRA's Nonprofessional Subscriber Fee and Usage-
based Vendor Fee and adopt a new Enterprise Rate Nonprofessional
Subscriber Fee. The Commission is publishing this notice to solicit
comments from interested persons on the proposed OPRA Plan amendment.
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    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The OPRA Plan is a national market system plan approved by
the Commission pursuant to Section 11A of the Act and Rule 608
thereunder (formerly Rule 11Aa3-2). See Securities Exchange Act
Release No. 17638 (March 18, 1981), 22 SE.C. Docket 484 (March 31,
1981). The full text of the OPRA Plan is available at http://www.opradata.com.
    The OPRA Plan provides for the collection and dissemination of
last sale and quotation information on options that are traded on
the participant exchanges. The nine participants to the OPRA Plan
are BATS Exchange, Inc., Chicago Board Options Exchange,
Incorporated, C2 Options Exchange, Incorporated, International
Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX,
Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
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I. Description and Purpose of the Plan Amendment

    The purpose of the amendment is to make a set of changes in OPRA's
Fee Schedule as follows: OPRA's Nonprofessional Subscriber Fee would be
increased from $1.00 per Nonprofessional Subscriber \4\ per month to
$1.25 per Nonprofessional Subscriber per month. The cap on OPRA's
Usage-based Vendor Fees for receipt of OPRA data by Nonprofessional
Subscribers would be increased commensurately to $1.25 per
Nonprofessional Subscriber per month.\5\ OPRA would also establish

a new monthly ``Enterprise Rate Nonprofessional Subscriber Fee'' that
would cap each Vendor's combined obligation for Nonprofessional
Subscriber Fees and Usage-based Vendor Fees for Nonprofessional
Subscribers at $375,000 per month.
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    \4\ OPRA defines a ``Subscriber,'' in general, as an entity or
person that receives OPRA data but does not redistribute it to third
parties, and defines a ``Nonprofessional Subscriber'' as a
Subscriber who is a ``Nonprofessional.'' OPRA's definition of the
term ``Nonprofessional'' is stated in its forms of ``Electronic
Subscriber Agreement'' and ``Hardcopy Subscriber Agreement.'' These
forms are available on OPRA's Web site, www.opradata.com.
    \5\ OPRA's Fee Schedule provides that a Vendor may determine the
fee that it pays with respect to its distribution of current OPRA
data to a Nonprofessional Subscriber in one of two ways: either the
Vendor may pay OPRA's flat monthly Nonprofessional Subscriber Fee
(currently $1.00/month, proposed in this filing to be increased to
$1.25/month), or the Vendor may count the Nonprofessional
Subscriber's queries for OPRA data and pay Usage-based Vendor Fees
based on the actual usage of OPRA data by the Nonprofessional
Subscriber, subject to a cap that OPRA has always set at the amount
of the Nonprofessional Subscriber Fee. Many Vendors prefer to pay
the flat Nonprofessional Subscriber Fee, even though their aggregate
fees on the basis of Usage-based Vendor Fees might be lower and
could not be greater, due to the administrative simplicity of doing
so and the fact that the cost on a per Subscriber basis of doing so
is very small.
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    OPRA's Nonprofessional Subscriber Fee and Usage-based Vendor Fees
were established at their current levels effective on January 1,
2000.\6\ OPRA has not increased these fees since then in large part
because of the simplicity of having the Nonprofessional Subscriber Fee
and the cap on Usage-based Vendor Fees for receipt of OPRA data by a
Nonprofessional Subscriber each set at $1.00. However, the effect over
a period of twelve years has been to increase the ratio of OPRA's
Professional Device Fee as compared to the Nonprofessional Subscriber
Fee. (For the year 2000, OPRA's weighted average Professional Device
Fee was approximately $12.55 per device; it is now $25.00/device.\7\)
OPRA believes that increasing its Nonprofessional Subscriber Fee will
restore an appropriate balance between its revenues derived from
Professional Subscriber Device-based Fees on the one hand and
Nonprofessional Subscriber Fees and Usage-based Vendor Fees for
Nonprofessional Subscribers on the other hand.
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    \6\ See File No. SR-OPRA-99-02; Release No. 34-42152 (November
17, 1999). In File No. SR-OPRA-99-02, OPRA reduced the
Nonprofessional Subscriber Fee from $2.50 per Nonprofessional
Subscriber to the current $1.00 per Nonprofessional Subscriber.
    \7\ In the year 2000, OPRA had a sliding scale for its
Professional Subscriber Fees, with different rates based on whether
a Professional Subscriber was a Member of one or more of the
Exchanges that were parties to the OPRA Plan and on the Professional
Subscriber's number of devices; OPRA's Professional Subscriber Fees
ranged from $10.50/device for an Exchange Member with 750 or more
devices to $27.00/device for a non-Member with nine or fewer
devices. Over the course of several years, OPRA made incremental
changes in its Professional Subscriber Fees to eliminate all
distinctions in these fees based on a Professional Subscriber's
status as a member or nonmember of an exchange that is a party to
the OPRA Plan or on the Subscriber's total number of OPRA-enabled
devices. See File No. SR-OPRA-2004-01; Release No. 34-49382
(February 25, 2004).
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    In response to input from the Vendor community, OPRA is proposing
to introduce an ``Enterprise Rate Nonprofessional Subscriber Fee.'' The
Enterprise Rate Nonprofessional Subscriber Fee would limit the maximum
aggregate amount of Nonprofessional Subscriber Fees and Usage-based
Vendor Fees with respect to Nonprofessional Subscribers that any Vendor
would be required to pay with respect to its Nonprofessional
Subscribers. The proposed Enterprise Rate Nonprofessional Subscriber
Fee is $375,000 per month.
    OPRA anticipates that these proposed changes in its fees will
result in an increase in its revenues of approximately $1,700,000 on an
annual basis at current usage rates.\8\ OPRA believes that this
increase will restore the relationship of its fees for Nonprofessional
Subscribers to its fees for Professional Subscribers and represent an
appropriate contribution to covering the overall costs of OPRA and its
member exchanges to which these fees may properly be applied.
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    \8\ This projection is approximate for several reasons, among
them that the fee increase may cause some Vendors to review their
lists of Nonprofessional Subscribers for inactive accounts and may
cause some Vendors to begin paying Usage-based Vendor fees rather
than Nonprofessional Subscriber Fees.
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    The text of the proposed amendment to the OPRA Plan is available at
OPRA, the Commission's Public Reference Room, http://opradata.com, and
on the Commission's Web site at www.sec.gov.

II. Implementation of the OPRA Plan Amendment

    OPRA designated this amendment as qualified to be put into effect
upon filing with the Commission in accordance with clause (i) of
paragraph (b)(3) of Rule 608 under the Act.\9\ OPRA intends to
implement the amendment on May 1, 2012.
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    \9\ 17 CFR 242.608(b)(3)(i).
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    The Commission may summarily abrogate the amendment within sixty
days of its filing and require refiling and approval of the amendment
by Commission order pursuant to Rule 608(b)(2) under the Act \10\ if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or the
maintenance of fair and orderly markets, to remove impediments to, and
perfect the mechanisms of, a national market system, or otherwise in
furtherance of the purposes of the Act.
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    \10\ 17 CFR 242.608(b)(2).
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III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed OPRA
Plan amendment 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-OPRA-2012-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OPRA-2012-02. 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 plan amendment that are
filed with the Commission, and all written communications relating to
the proposed plan amendment 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 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of OPRA.
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-OPRA-2012-02
and should be submitted on or before April 6, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(29).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-6388 Filed 3-15-12; 8:45 am]
BILLING CODE 8011-01-P


Placeholder for information claimed as Confidential Business Information
(CBI)

Information regarding processing categories and labor burden and cost
estimates claimed as CBI received in a letter from Micron Technology,
Inc. on December 2, 2009.  This information is being maintained in a
separate confidential portion of the docket.

For more information please contact Kirsten Cappel by phone at (202)
343-9556 or by email at<EMAIL_ADDRESS>


[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24040-24041]
[FR Doc No: 2011-10337]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1969-DR; Docket ID FEMA-2011-0001]

North Carolina; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of North Carolina (FEMA-1969-DR), dated April
19, 2011, and related determinations.

DATES: Effective Date: April 19, 2011.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 19, 2011, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of North Carolina resulting from severe storms, tornadoes, and
flooding on April 16, 2011, is of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of North Carolina.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for debris removal and
emergency protective measures (Categories A and B), including direct
Federal assistance, under the Public Assistance program and
Individual Assistance in the designated areas, and Hazard Mitigation
throughout the State. Consistent with the requirement that Federal
assistance is supplemental, any Federal funds provided under the
Stafford Act for Public Assistance, Hazard Mitigation, and Other
Needs Assistance will be limited to 75 percent of the total eligible
costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Michael Bolch, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of North Carolina have been
designated as adversely affected by this major disaster:

    Bertie, Bladen, Cumberland, Halifax, Harnett, Johnston, Lee,
Onslow, Wake, and Wilson for Individual Assistance.
    Bertie, Bladen, Craven, Cumberland, Currituck, Greene, Halifax,
Harnett, Hertford, Hoke, Johnston, Lee, Onslow, Pitt, Robeson,
Sampson, Wake, and Wilson Counties for debris removal and emergency
protective measures (Categories A and B), including direct Federal
assistance, under the Public Assistance program.

    All counties within the State of North Carolina are eligible to
apply for assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-10337 Filed 4-28-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Page 56683]
[FR Doc No: 2020-20163]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee (ARAC); Renewal

AGENCY: Federal Aviation Administration (FAA), Transportation (DOT).

ACTION: Notice of renewal.

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SUMMARY: The FAA announces the charter renewal of the Aviation
Rulemaking Advisory Committee (ARAC), a Federal Advisory Committee that
works with industry and the public to improve the development of the
FAA's regulations. This charter renewal will take effect on September
14, 2020, and will expire after 2 years unless otherwise renewed.

FOR FURTHER INFORMATION CONTACT: Thuy H. Cooper, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to section 14(a)(2)(A) of the
Federal Advisory Committee Act (Pub. L. 92-463), the FAA is giving
notice of the charter renewal for the ARAC. The ARAC was established to
provide advice and recommendations to FAA on regulatory matters. The
ARAC is composed of representatives from member organizations and
associations that represent the various aviation industry segments. The
diversity of the Committee ensures the requisite range of views and
expertise necessary to discharge its responsibilities. See the ARAC
website for details on pending tasks at http://www.faa.gov/regulations_policies/rulemaking/committees/documents/.

    Issued in Washington, DC, on September 9, 2020.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2020-20163 Filed 9-11-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Page 68493]
[FR Doc No: 2021-25963]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2020-0635; FRL 9323-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Primary Copper Smelters (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Primary Copper
Smelters (EPA ICR No. 1850.09, OMB Control No. 2060-0476), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently-approved through November 30,
2021. Public comments were previously requested, via the Federal
Register on February 8, 2021 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before January 3,
2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2020-0635, online using www.regulations.gov (our preferred method),
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov or in person at the EPA Docket Center, WJC
West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The telephone number for the Docket Center is<PHONE_NUMBER>. For
additional information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Primary Copper Smelters (40 CFR part 63,
subpart QQQ) were proposed on April 20, 1998; promulgated on June 6,
2002; and most-recently amended on November 19, 2020. These regulations
apply to each existing and new copper concentrate dryer, smelting
furnace, slag cleaning vessel, copper converter department, and the
entire group of fugitive emission sources located at a primary copper
smelter facility that is a major source of hazardous air pollutant
(HAP) emissions. Major sources of HAP emissions are sites that emit, or
have the potential to emit, any single HAP at a rate of 9.07 megagrams
(10 tons) or more per year or any combination of HAPs at a rate of
22.68 megagrams (25 tons) or more per year. New facilities include
those that commenced either construction or reconstruction after the
date of proposal. This information is being collected to assure
compliance with 40 CFR part 63, subpart QQQ.
    Form Numbers: None.
    Respondents/affected entities: Primary copper smelters.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart QQQ).
    Estimated number of respondents: 2 (total).
    Frequency of response: Semiannually.
    Total estimated burden: 6,380 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $761,000 (per year), which includes $5,480 in
annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is an overall decrease in burden
from the most-recently approved ICR. This increase is not due to any
program changes, but is due to a decrease in the estimated number of
sources subject to the NESHAP. The Agency has identified, through
recent rulemaking efforts, that one of three primary copper smelters
located in the United States is no longer a major source of HAP.
Therefore, approximately two respondents will be subject to these
standards over the three-year period covered by this ICR.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-25963 Filed 12-1-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 21, 2007 (Volume 72, Number 183)]
[Notices]
[Page 54019-54020]
[DOCID:fr21se07-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-96-000]

Babcock & Brown Holdings Inc.; Notice of Filing

September 17, 2007.
    Take notice that on September 12, 2007, Babcock & Brown Holdings
Inc., (BBH) pursuant to Rule 207 of the Commission's Rules of Practice
and Procedure, tendered for filing a petition for a declaratory order
in which it asks the Commission to find that a subsidiary of BBH,
TransBay Cable LLC, has not yet commenced commercial operations, is not
currently a public utility under the Public Utility holding Company Act
of 2005 (PUHCA 2005), and will not become a public utility for purposes
of PUHCA 2005 until such time as it commences providing transmission
services.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern Time on October 12, 2007.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-18657 Filed 9-20-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Pages 14593-14594]
[FR Doc No: 2014-05649]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2014-0024]

Reports, Forms, and Recordkeeping Requirements

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

ACTION: Request for public comment on an extension of a currently
approved collection.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before May 13, 2014.

ADDRESSES: Comments must refer to the docket notice numbers cited at
the beginning of this notice and be submitted to Docket Management,
1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590 by any of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590.
     Hand Delivery/Courier: 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Supplementary
Information section of this document. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://Docket
Info.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to the street address listed above. The internet
access to the docket will be at http://www.regulations.gov. Follow the
online instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for

collection of information may be obtained at no charge from Deborah
Mazyck, NHTSA, 1200 New Jersey Ave. SE., Room W43-443, NVS-131,
Washington, DC 20590. Ms. Mazyck's telephone number is<PHONE_NUMBER>.
Please identify the relevant collection of information by referring to
its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i.) Whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii.) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii.) How to enhance the quality, utility, and clarity of the
information to be collected and;
    (iv.) How to minimize the burden of the collection of information
on those who are to respond, including the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g. permitting
electronic submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: Automobile Parts Content Labeling for 49 CFR Part 583.
    OMB Control Number: 2127-0573.
    Form Number: The collection of this information uses no standard
form.
    Affected Public: Vehicle manufacturers.
    Requested Expiration Date of Approval: Three years from approval
date.
    Abstract: 49 CFR part 583 establishes requirements for the
disclosure of information relating to the countries of origin of the
equipment of new passenger motor vehicles. This information will be
used by NHTSA to determine whether manufacturers are complying with the
American Automobile Labeling Act (49 U.S.C. 32304). The American
Automobile Labeling Act requires all new passenger motor vehicles
(including passenger cars, certain small buses, all light trucks and
multipurpose passenger vehicles with a gross vehicle weight rating of
8,500 pounds or less), to bear labels providing information about
domestic and foreign content of their equipment. The labels, which are
affixed to new passenger motor vehicles, serve as an aid to potential
purchasers in the selection of new passenger motor vehicles by
providing them with information about the value of the U.S./Canadian
and foreign parts of each vehicle, the countries of origin of the
engine and transmission, and the site of the vehicle's final assembly.
    Estimated Annual Burden: NHTSA anticipates approximately 21 vehicle
manufacturers will be affected by these reporting requirements. NHTSA
does not believe that any of these 21 manufacturers are a small
business (i.e., one that employs less than 500 persons) since each
manufacturer employs more than 500 persons. Manufacturers of new
passenger motor vehicles, including passenger cars, certain small
buses, and light trucks with a gross vehicle weight rating of 8,500
pounds or less, must file a report annually.
    NHTSA estimates that the vehicle manufacturers will incur a total
reporting annual hour burden and cost burden of 52,962 hours and
$2,439,108, respectively. The amount includes annual burden hours
incurred by multi-stage manufacturers and motor vehicle equipment
suppliers.
    Number of Respondents: 21.
    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 estimate 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.

David M. Hines,
Director, Office of Crash Avoidance Standards.
[FR Doc. 2014-05649 Filed 3-13-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 203 (Friday, October 19, 2012)]
[Notices]
[Pages 64335-64336]
[FR Doc No: 2012-25793]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL--9743-2]

Notification of a Public Teleconference of the Science Advisory
Board; Perchlorate Advisory Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces two public teleconferences of the
SAB Perchlorate Advisory Panel to discuss its revised draft report
concerning EPA's draft white paper Life Stage Considerations and
Interpretation of Recent Epidemiological Evidence to Develop a Maximum
Contaminant Level Goal (MCLG) for Perchlorate.

DATES: The public teleconferences will be held on Wednesday December 5,
2012 and Friday December 7, 2012. The teleconferences will be held from
2:00 p.m. to 5:00 p.m. (Eastern Standard Time) on both days.

ADDRESSES: The teleconference will be conducted by telephone only.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning the meeting may contact Mr. Thomas
Carpenter, Designated Federal Officer (DFO), EPA Science Advisory Board
(1400R), U.S. Environmental Protection Agency, 1300 Pennsylvania Avenue
NW., Washington, DC 20460; via telephone/voice mail

(202) 564-4885; fax<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>General information concerning the SAB can be
found on the SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Background: Pursuant to the Federal Advisory Committee Act (FACA),
as amended, 5 U.S.C., App., notice is hereby given that the SAB
Perchlorate Advisory Panel will hold a public teleconferences to
discuss its draft report regarding EPA's draft white paper Life Stage
Considerations and Interpretation of Recent Epidemiological Evidence to
Develop a Maximum Contaminant Level Goal (MCLG) for Perchlorate. The
SAB was established pursuant to 42 U.S.C. 4365 to provide independent
scientific and technical advice to the Administrator on the technical
basis for Agency positions and regulations. The SAB is a Federal
Advisory Committee chartered under FACA. The SAB will comply with the
provisions of FACA and all appropriate SAB Staff Office procedural
policies.
    The SAB Perchlorate Advisory Panel held a public meeting on July
18-19, 2012 to discuss the EPA white paper and a public teleconference
on September 25, 2012 to discuss its initial draft (9/5/21012) report.
The purpose of these public teleconferences is for the Panel to discuss
its revised draft report on this advisory activity. Additional
background on this SAB advisory activity is provided on the SAB Web
site at: http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/Perchlorate%20MCLG%20Approaches?OpenDocument.''
    Availability of Meeting Materials: A meeting agenda, draft report,
and other materials for the teleconferences will be posted on the SAB
Web site at www.epa.gov/sab.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to EPA.
Members of the public can submit relevant comments pertaining to the
group conducting this advisory activity, EPA's charge, or meeting
materials. Input from the public to the SAB will have the most impact
if it consists of comments that provide specific scientific or
technical information or analysis for the SAB to consider. Members of
the public wishing to provide comment should contact the Designated
Federal Officer for the relevant advisory committee directly.
    Oral Statements: In general, individuals or groups requesting an
oral presentation at a public teleconference will be limited to three
minutes per speaker. To be placed on the public speaker list for the
December 5, 2012 meeting, interested parties should notify Mr. Thomas
Carpenter, DFO, by email no later than November 28, 2012.
    Written Statements: Written statements for these teleconferences
should be received in the SAB Staff Office by the same deadlines given
above for requesting oral comments. Written statements should be
supplied to the DFO via email (acceptable file format: Adobe Acrobat
PDF, MS Word, WordPerfect, MS PowerPoint, or Rich Text files in IBM-PC/
Windows 98/2000/XP format). It is the SAB Staff Office general policy
to post written comments on the web page for the advisory meeting or
teleconference. Submitters are requested to provide an unsigned version
of each document because the SAB Staff Office does not publish
documents with signatures on its Web sites. Members of the public
should be aware that their personal contact information, if included in
any written comments, may be posted to the SAB Web site. Copyrighted
material will not be posted without explicit permission of the
copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Carpenter at the
phone number or email address noted above, preferably at least ten days
prior to the meeting, to give EPA as much time as possible to process
your request.

    Dated: October 11, 2012.
Vanessa T. Vu,
Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2012-25793 Filed 10-18-12; 8:45 am]
BILLING CODE 6560-50-P


------

			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on August 23, 2004

NOTICE OF ACTION TAKEN -- DOCKETS OST-2002-13061

                                     OST-2002-13011

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applications of     FRONTIER AIRLINES, INC.  filed  6/11/2004 for:

XX  Renewal of exemption authority for two years under 49 U.S.C. 40109
to provide the following service:

Docket OST-2002-13061:

Scheduled foreign air transportation of persons, property, and mail
between the terminal point Denver, Colorado, and the terminal point
Cancun, Mexico.

Docket OST-2002-13011:

Scheduled foreign air transportation of persons, property, and mail
between (1) the terminal point Denver, Colorado, and the terminal point
San Jose del Cabo, Mexico; and (2) the terminal point

Denver, Colorado, and the terminal point Mazatlan, Mexico..  Frontier
requested that the authority be

renewed through August 23, 2006.

Applicant rep:   Edward P. Faberman<PHONE_NUMBER>    DOT Analyst:
Linda L. LundellThuy H. Cooper<PHONE_NUMBER>5423

D I S P O S I T I O N

XX  Granted renewal of exemption authority for two years (subject to
conditions, see below)

XX  Dismissed request for longer-term authority (see remarks, below)

The above action was effective when taken:   : August 23, 2004 through
through August 23, 2006.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX   The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:     		XX  Holder’s
certificates of public convenience and necessity

		XX  Standard Exemption Conditions (attached)

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

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.

Remarks:  In its application, Frontier requested that the subject
authority be renewed through August 23, 2006.  Consistent with our
standard practice for this type of application, we renewed Frontier’s
authority for two years and dismissed its request for longer-term
authority.

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

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted or dismissed, we denied all requests in the
referenced Dockets.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action
set forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.aspU.S. Carrier Exemption
Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

   On _________, 7/23/03, the Department approved the carrier’s
request to convert its Denver-Mazatlan services from year-round to
seasonal.  All other services are offered on a year-round basis.


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Proposed Rules]
[Pages 71294-71299]
[FR Doc No: 2011-29463]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 158 and 161

[EPA-HQ-OPP-2010-0427; FRL-8886-1]
RIN 2070-AJ26

Prions; Proposed Amendment To Clarify Product Performance Data
for Products With Prion-Related Claims and Availability of Draft Test
Guidelines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental proposed rule.

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

SUMMARY: As a supplement to the proposed rule to declare a prion (i.e.,
proteinaceous infectious particle) a ``pest'' under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its
regulations to expressly include prion within the regulatory definition
of pest, EPA is now proposing to amend its product performance data
requirements to clarify that efficacy data are required for all
products with prion-related claims. The existing product performance
data requirements already require efficacy data to be submitted when
the ``pesticide product bears a claim to control pest microorganisms
that pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment. * * *''
Since this general requirement applies to products with prion-related
claims, EPA is proposing to amend the regulation to specifically
identify that efficacy data are required for products with prion-
related claims. In addition, EPA is announcing the availability for
public review and comment of draft test guidelines concerning the
generation of product performance data for prion-related products.

DATES: Comments must be received on or before January 17, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0427, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S.

Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0427. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you apply for or
own pesticide registrations. Potentially affected entities may include,
but are not limited to:
     Producers of pesticide products (NAICS code 32532).
     Producers of antimicrobial pesticides (NAICS code 32561).
     Veterinary testing laboratories (NAICS code 541940).
     Medical pathology laboratories (NAICS code 621511).
     Taxidermists, independent (NAICS code 711510).
     Surgeons (NAICS code 621111).
     Dental surgeons (NAICS code 621210).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What is a Prion?

    Prions (``proteinaceous infectious particles'') may occur in the
central nervous system tissues of animals as an abnormal
(``misfolded''), infectious form of prion protein. Prion protein in its
normal form, or conformation, can be designated PrP\c\ (``cellular''
isoform) while abnormal conformations of prion proteins are generally
called prions. Different types of prions are commonly designated by the
type of diseases they produce, such as PrP\Sc\ (prions associated with
scrapie) and PrP\BSE\ (prions associated with bovine spongiform
encephalopathy--mad cow disease).
    In the disease process, prions (such as PrP\sc\) recruit normal
prion proteins (PrP\c\) and convert them into prions (e.g., another
copy of PrP\Sc\). This recruitment and conversion process results in
the progressive accumulation of disease-producing prions. When this
process takes place in the brain, it causes disease that slowly
progresses from neuronal dysfunction and degeneration to death. These
neurodegenerative prion diseases are known collectively as
transmissible spongiform encephalopathies (TSE). TSE's include scrapie
disease in sheep,

bovine spongiform encephalopathy (BSE) in cattle, chronic wasting
disease (CWD) in deer and elk, kuru and variant Creutzfeld-Jakob
Disease (vCJD) in humans, and similar diseases in other animals. EPA
and other agencies are concerned that animal-related prions may spread
to other animals (e.g., scrapie to sheep, CWD to cervids) or to humans
(e.g., BSE), and that human-related prions may be passed to other
humans (e.g., kuru or CJD). These diseases are always fatal in humans
and animals alike, and there are no known treatments or cures.

B. Regulatory History of Products With Prion-Related Claims

    On September 10, 2003, EPA determined that a prion should be
considered to be a ``pest'' under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.) and that products
intended to inactivate prions (i.e., ``prion products'') should be
regulated under FIFRA (Ref. 1).
    On January 26, 2011 (76 FR 4602) (FRL-8850-4), to eliminate any
confusion about the status of prion-related products under FIFRA, EPA
issued a proposed rule that, when finalized, would declare a prion a
``pest'' under FIFRA, and amend EPA's regulations to expressly include
prion within the regulatory definition of pest. EPA currently considers
a prion to be a pest under FIFRA; in addition, a product intended to
reduce the infectivity of any prion on inanimate surfaces (i.e., a
``prion-related product'') is considered to be a pesticide and
regulated as such. Subject to some exceptions, any pesticide product
must be registered or exempted under FIFRA sections 3, 24(c), or 18
before the product may be distributed or sold in the United States.

C. Data Requirements for Pesticides

    First promulgated in 1984, EPA's pesticide data requirements
outline the kinds of data and related information typically needed to
register a pesticide. Since there is much variety in pesticide
chemistry, exposure, and hazard, the requirements are designed to be
flexible. Test notes to the data requirements tables explain the
conditions under which data are typically needed. Essentially, the data
requirements identify the questions that the applicant will need to
answer regarding a pesticide product before the Agency can register it.
    At this time, the data requirements for conventional, biochemical,
and microbial pesticides are codified in 40 CFR part 158, and data
requirements for antimicrobial pesticides are codified in 40 CFR part
161. In addition, part 158 contains general provisions concerning data
for the pesticides covered by the regulation (subpart A), instructions
on how to use the data tables in the regulation (subpart B), and a
series of data tables that identify data requirements tailored to
specific kinds of pesticides, i.e., conventional pesticides (subparts
D-O), biochemical pesticides (subpart U), microbial pesticides (subpart
V), and several reserved subparts as placeholders for future tailoring
of the data requirements that is underway to facilitate the utility of
the data tables for pesticide registrants.
    On October 26, 2007, EPA revised the structure of part 158 and the
data requirements for conventional pesticides (72 FR 60934) (FRL-8106-
5), and biochemical pesticides and microbial pesticides (72 FR 60988)
(FRL-8109-8). In conjunction with those revisions, EPA also transferred
intact the original 1984 pesticide data requirements that had been in
part 158 into a new part 161, entitled ``Data Requirements for
Antimicrobial Pesticides'' (72 FR 60251, October 24, 2007) (FRL-8116-
2). In essence, part 161 is intended to be transitional by preserving
the existing data requirements applicable to antimicrobial pesticides
until a new final regulation that tailors the data requirements for
antimicrobial pesticides is promulgated. On October 8, 2008 (73 FR
59382), EPA proposed to establish data requirements specific to
antimicrobial pesticide chemicals in 40 CFR part 158, subpart W and to
remove part 161.

D. Test Guidelines Used To Develop Data for Submission to EPA

    EPA's Office of Chemical Safety and Pollution Prevention (OCSPP)
has issued a series of harmonized test guidelines for use in the
testing of pesticides and toxic substances, and the development of test
data for submission to the Agency. The OCSPP harmonized test guidelines
are documents that specify methods that EPA recommends be used to
generate data that are submitted to EPA to support the registration of
a pesticide under FIFRA (7 U.S.C. 136 et seq.), setting of a tolerance
or tolerance exemption for pesticide residues under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a), or the
decision making process for an industrial chemical under the Toxic
Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.).
    The OCSPP harmonized test guidelines are developed by EPA
scientists and non-EPA individuals with a particular interest or
expertise in the subject matter covered, including representatives from
the scientific community, industry, non-profit organizations, and other
governments. Some of these guidelines harmonize EPA's test methods with
guidelines established by the Organization for Economic Cooperation and
Development (OECD), an international organization whose membership
includes most industrialized nations which maintain comprehensive
testing methods for pesticides and industrial chemicals. When
necessary, significant scientific issues are presented for external
peer review to the FIFRA Scientific Advisory Panel (SAP) or to another
group of scientific experts for that particular topic.
    The OCSPP harmonized test guidelines serve as a compendium of
accepted scientific methodologies and protocols for conducting the
studies routinely used for generating data on pesticides and industrial
chemicals regulated under FIFRA, FFDCA, and TSCA, and may also be
useful for voluntary testing purposes.
    Under FIFRA and FFDCA, studies conducted according to the OCSPP
test guidelines or another approved protocol may be used in satisfying
FIFRA data requirements in 40 CFR part 158 and 40 CFR part 161, Data-
Call-In's issued pursuant to FIFRA section 3(c)(2)(B), as needed to
satisfy data requirements appropriate for specific pesticide
registration applications, or for satisfying data requirements to
demonstrate the safety of a tolerance or tolerance exemption under
FFDCA section 408.
    As a guidance document, the test guidelines are not binding on
either EPA or any outside parties. At places in the guidance, the
Agency uses the word ``should.'' In the guidance, use of ``should''
with regard to an action means that the action is recommended rather
than mandatory. The procedures contained in the test guidelines are
recommended for generating the data that are the subject of the test
guideline, but EPA recognizes that departures may be appropriate in
specific situations. EPA will consider alternatives to the
recommendations described in the test guidelines on a case-by-case
basis, after assessing whether the alternative will provide the data
necessary to inform the regulatory decision that must be made.
    The OCSPP harmonized test guidelines can be accessed online at
http://epa.gov/ocspp/pubs/frs/home/testmeth.htm. Please note that
although

collectively referred to as the ``OCSPP Test Guidelines,'' the
individual guidelines issued before April 22, 2010, use ``OPPTS'' in
the titles. On April 22, 2010, the office name changed from ``Office of
Prevention, Pesticides, and Toxic Substances'' or ``OPPTS'' to ``Office
of Chemical Safety and Pollution Prevention'' and ``OCSPP.''

III. Proposed Data Requirement

A. What is the agency's authority for taking this action?

    This action is issued under the authority of sections 2 through 34
of FIFRA (7 U.S.C. 136-136y). In particular, the proposed rule is
issued pursuant to FIFRA section 25(a) (7 U.S.C. 136w(a)).

B. What action is the agency taking?

    EPA is proposing to amend its pesticide data requirement
regulations to clarify that efficacy data are required to support the
registration of all end-use products that are intended to be used on
inanimate items and/or environmental surfaces, and which bear label
claims to reduce the infectivity of prions. Specifically, EPA proposes
to amend the data requirements for product performance testing that are
currently found in 40 CFR 158.400 and 40 CFR 161.640 by inserting an
entry in the data tables to more clearly specify that efficacy data are
required for prion-related products.
    Currently, EPA's regulations at 40 CFR 158.400(e)(1) and
161.640(b)(1) require efficacy data to be submitted when the
``pesticide product bears a claim to control pest microorganisms that
pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment. * * *''
Because a prion-related product would bear a claim to reduce the
infectivity of prions (that poses a threat to human health), an
applicant or registrant would be required by existing regulations to
submit valid data that demonstrate that its prion-related product is
effective. As such, this amendment simply provides more specificity for
those who are considering whether to register a product for use on
inanimate items and/or environmental surfaces and make claims that the
product will reduce the infectivity of prions.
    As indicated in Unit II.C., EPA issued a proposed rule in 2008 (73
FR 59382, October 8, 2008) that proposed to codify the data
requirements for antimicrobial pesticide chemicals in 40 CFR part 158,
subpart W. That 2008 proposed rule also proposed the following:
     To remove the existing data requirements for antimicrobial
pesticide chemicals that currently appear in 40 CFR part 161 (see 73 FR
at 59446).
     To amend the table in 40 CFR 158.400(d) by removing the
category ``Efficacy of antimicrobial agents'' and all of the entries
under that category (see 73 FR at 59431).
     To create a new provision and table to address product
performance data for antimicrobial agents in 40 CFR 158.2220 (see 73 FR
at 59432).
    EPA is therefore also presenting an alternate proposal to amend the
table that proposed to consolidate the product performance data
requirements for antimicrobials in proposed 40 CFR 158.2220 to include
an entry in the proposed data table at 40 CFR 158.2220(c) to specify
that efficacy data are required for prion-related products.
    In summary, EPA is proposing to more clearly specify that efficacy
data are required for prion-related products by either:
     Inserting a new entry in the data tables that are
currently found in 40 CFR 158.400 and 40 CFR 161.640.
     If the 2008 proposal concerning proposed 40 CFR 158.2220
has been finalized, by inserting a new entry in the data table that was
proposed to be included in 40 CFR 158.2220.

IV. Draft Test Guidelines

    EPA is also announcing the availability of draft test guidelines
for public review and comment that the Agency intends to include in the
OCSPP harmonized test guidelines described in Unit II.D., as part of
the 810 Series of Product Performance Test Guidelines. Specifically,
the draft guidelines address product performance tests for products
with prion-related claims and are identified as ``Product Performance
Test Guidelines; OCSPP 810.2700: Products with Prion-Related Claims''
(Ref. 2). The guidelines for products with prion-related claims are
designed to provide the data and information needed to assess the
efficacy of antimicrobial pesticides intended to be used on inanimate
items and/or environmental surfaces, and which bear label claims to
reduce the infectivity of prions.
    On March 31 and April 1, 2009, EPA presented its draft test
guidelines to the FIFRA SAP for peer review (Ref. 3), along with a
``white paper'' summarizing the most relevant scientific studies and
publications related to the issue of whether a prion is a pest in
support of the separate proposed rule on that issue. The SAP provided
comments on the draft guidance document on June 29, 2009 (Ref. 4). EPA
has considered the SAP's recommendations and incorporated changes, as
appropriate (Ref. 5). In addition, the draft test guidelines underwent
interagency review in 2010.
    With this document, EPA is providing an opportunity for public
review and comment on the revised draft test guidelines.

V. FIFRA Review Requirements

    In accordance with FIFRA sections 25(a), 25(d), and 21(b), the
Agency submitted a draft of this proposed rule to the Committee on
Agriculture in the House of Representatives, the Committee on
Agriculture, Nutrition, and Forestry in the United States Senate, the
Secretary of Agriculture, the FIFRA Scientific Advisory Panel (SAP),
and the Secretary of Health and Human Services. The SAP and the
Secretaries of Agriculture and Health and Human Services waived review
of this proposed rule.

VI. Statutory and Executive Order Reviews

    This action only proposes to amend an existing regulation to
include more specificity regarding an existing efficacy data
requirement for products intending to make prion-related claims. It
does not otherwise propose to amend or impose any other requirements.
The proposed rule will not otherwise involve any significant policy or
legal issues, and will not impact existing costs. As such, the Office
of Management and Budget (OMB) has determined that this is not a
``significant regulatory action'' under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993) and this
action is therefore not subject to review under Executive Orders 12866
and 13563, entitled Improving Regulation and Regulatory Review (76 FR
3821, January 21, 2011).
    Nor does it impose or change any information collection burden that
requires additional review by OMB under the provisions of the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). The information collection
activities contained in the regulation are already approved under
information collection instruments related to: (1) The submission of
data to EPA in to establish a tolerance or an exemption from the
requirement to have a tolerance currently approved under 2070-0024 (EPA
ICR No. 0276); (2) the activities associated with the application for a
new or amended registration of a pesticide currently approved under OMB
Control No. 2070-0060 (EPA ICR

No. 0277); (3) the activities associated with the application for an
experimental use permit currently approved under OMB Control No. 2070-
0040 (EPA ICR No. 0276); and (4) activities associated with the
generation of data in response to a Data-Call-In currently approved
under OMB Control No. 2070-0174 (EPA ICR No. 2288). An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for certain EPA regulations in
40 CFR are listed in 40 CFR part 9 and in the Federal Register, as
appropriate.
    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed
rule does not have a significant adverse economic impact on a
substantial number of small entities. The proposed amendment does not
change existing impacts. In general, EPA strives to minimize potential
adverse impacts on small entities when developing regulations to
achieve the environmental and human health protection goals of the
statute and the Agency. EPA solicits comments specifically about
potential small business impacts.
    State, local, and tribal governments are rarely pesticide
applicants or registrants, so this proposed rule is not expected to
affect these governments. Accordingly, pursuant to Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), EPA has
determined that this action is not subject to the requirements in
sections 202 and 205 because it does not contain a Federal mandate that
may result in expenditures of $100 million or more for State, local,
and tribal governments, in the aggregate, or for the private sector in
any 1 year. In addition, this action does not significantly or uniquely
affect small governments or impose a significant intergovernmental
mandate, as described in sections 203 and 204 of UMRA. For the same
reasons, EPA has determined that this proposed rule does not have
``federalism implications'' as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999), because it would
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in the Order. Thus, Executive Order 13132 does not apply
to this proposed rule. Nor does it have ``tribal implications'' as
specified in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 22951, November 9,
2000). EPA is not aware of any tribal governments which are pesticide
registrants. Thus, Executive Order 13175 does not apply to this action.
    Since this action is not economically significant under Executive
Order 12866, it is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), and Executive Order 13211, entitled
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001).
    This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act (NTTAA)
(15 U.S.C. 272 note).
    This action does not have an adverse impact on the environmental
and health conditions in low-income and minority communities.
Therefore, this action does not involve special consideration of
environmental justice related issues as specified in Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).

VII. References

    As indicated under ADDRESSES, a docket has been established for
this rulemaking under docket ID number EPA-HQ-OPP-2010-0427. The
following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical contact listed under FOR FURTHER INFORMATION CONTACT.

1. U.S. Environmental Protection Agency. 2004. Considerations of
Prions as a Pest under FIFRA. Memorandum to the Record from Susan B.
Hazen, Principal Deputy Assistant Administrator, Office of
Prevention, Pesticides, and Toxic Substances. April 29, 2004.
2. U.S. Environmental Protection Agency. 2010. Product Performance
Test Guidelines, Series 810, Draft OCSPP No. 810.2700, entitled
``Products with Prion Related Claims.'' Draft dated November 12,
2010.
3. U.S. Environmental Protection Agency. 2009. Product Performance
Test Guidelines, Series 810, Draft OCSPP No. 810.2400, entitled
``Products with Prion Related Claims.'' Draft dated February 23,
2009.
4. U.S. Environmental Protection Agency. 2009. Transmittal of
Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held
March 31-April 1, 2009 on ``Scientific Issues Associated with
Designating a Prion as a `Pest' under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test
Methods.'' Memorandum from Myrta R. Christian, Designated Federal
Official, FIFRA Scientific Advisory Panel, Office of Science
Coordination and Policy, to Debbie Edwards, Ph.D., Director, Office
of Pesticide Programs. June 29, 2009. See http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html.
5. U.S. Environmental Protection Agency. 2010. EPA Responses to
Comments by the FIFRA Scientific Advisory Panel Concerning
``Scientific Information Concerning the Issue of Whether Prions Are
a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).'' February 17, 2010.

List of Subjects in 40 CFR Parts 158 and 161

    Environmental protection, Administrative practice and procedures,
Agricultural commodities, Chemical testing, Pesticides and pests,
Reporting and recordkeeping requirements, Test guidelines.

    Dated: October 31, 2011.
Lisa P. Jackson,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 158--[AMENDED]

    1. The authority citation for part 158 continues to read as
follows:

    Authority:  7 U.S.C. 136-136y, 21 U.S.C. 346a.

    2. In Sec.  158.400(d), amend the table under the category
``Efficacy of antimicrobial agents'' by adding a new entry at the end
of the category to read as follows:

Sec.  158.400  Product performance data requirements table.

* * * * *
    (d) * * *

                                                                          Table--Product Performance Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use pattern                                                    Test substance to
                                                  -----------------------------------------------------------------------------------------------------------         support
                                                        Terrestrial             Aquatic             Greenhouse                                               ------------------------  Test note
         Guideline No.          Data  requirement ------------------------------------------------------------------               Residential                                            No.
                                                     Food     Non-food                           Food     Non-food    Forestry       outdoor        Indoor        MP          EP
                                                     crop       crop       Food     Non-food     crop       crop
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents

                                                                                * * * * * * *
810.2700......................  Products with           NR          NR        NR          NR        NR          NR          NR               NR           R          NR          EP   ..........
                                 prion-related
                                 claims.

                                                                                * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    3. As proposed at 73 FR 59432, October 8, 2008, Sec.  158.2220(c)
is further amended by adding a new entry at the end of the table to
read as follows:

Sec.  158.2220  Product performance.

* * * * *
    (c) * * *

                           Table--Antimicrobial Product Performance Data Requirements
----------------------------------------------------------------------------------------------------------------
         Guideline No.            Data requirement          All use patterns               Test substance
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
810.2700.......................  Products with       R............................  EP.
                                  prion-related
                                  claims.
----------------------------------------------------------------------------------------------------------------

PART 161--[AMENDED]

    4. The authority citation for part 161 is revised to read as
follows:

    Authority: 7 U.S.C. 136-136y, 21 U.S.C. 346a

    5. In Sec.  161.640(a), amend the table under the category
``Efficacy of antimicrobial agents'' by adding a new entry at the end
of the category to read as follows:

Sec.  161.640  Product performance data requirements table.

    (a) * * *

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                General use patterns                                                 Test substance
                                             ------------------------------------------------------------------------------------------------------------------------------------
                                                   Terrestrial              Aquatic             Greenhouse                                                                           Guideline
    Kind of data  required        (b) Notes  -------------------------------------------------------------------                Domestic                  Data to      Data to     reference No.
                                                Food      Non-food                           Food     Non-food     Forestry     outdoor       Indoor     support MP   support EP
                                                crop        crop       Food     Non-food     crop       crop
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of anti-microbial agent

                                                                                * * * * * * *
Products with prion-related     ............  ........  ...........  .......  ...........  .......  ...........  ...........  ...........  R..........  ...........  EP *.......  810.2700
 claims.

                                                                                * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-29463 Filed 11-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Notices]
[Pages 15110-15111]
[FR Doc No: 2013-05228]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Engine Bird Ingestion
Requirements--New Task

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of new task assignment for the Aviation Rulemaking
Advisory Committee (ARAC).

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

SUMMARY: The FAA assigned ARAC a new task to review and assess the
adequacy of certain portions of the existing engine bird ingestion
requirements. This notice is to inform the public of this ARAC
activity.

FOR FURTHER INFORMATION CONTACT: Alan Strom, Rulemaking and Policy
Branch, ANE-111, Engine and Propeller Directorate, FAA, 12 New England
Executive Park, Burlington, Massachusetts, 01803, telephone (781) 238-
7143, facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA established ARAC to provide advice and recommendations to
the FAA Administrator on the FAA's rulemaking activities with respect
to aviation-related issues. This includes obtaining advice and
recommendations on the FAA's commitments to harmonize FAA Regulations
with its partners in Europe and Canada.
    Amendment 33-20, adopted September 5, 2000, revised the bird
ingestion type certification standards for aircraft turbine engines to
better address the actual bird threat encountered in service. These
requirements were adopted, in part, as a response to National
Transportation Safety Board (NTSB) safety recommendation A-76-64. The
NTSB recommended increasing

the level of bird ingestion capability for aircraft engines. Amendment
33-23, adopted October 17, 2007, added requirements to address larger
flocking birds, mass greater then 1.15 kg (2.5 pounds), since existing
engine certification requirements did not specifically address the
threat that these size birds, or their growing population, present to
airplane operational safety. Medium bird ingestion criteria for small
engines were established consistent with corresponding criteria for
medium and large engines, which is freedom from multiengine power loss
events at a rate of 1E-8 per aircraft cycle. The objective of the ARAC
task is to evaluate whether the requirements for small and medium bird
core ingestion and the large flocking bird requirements for engines
with 1.35m\2\-2.5m\2\ inlet areas should be revised.

The Task

    Review and assess the standards and advisory material for bird
ingestion requirements as follows:
    1. Evaluate the core ingestion element of small and medium bird
requirements to determine if the intended safety objective of the
current rule is adequate. Consider the threat from large flocking bird
species in this assessment. Identify any deficiencies in the current
rule, and provide the FAA with recommendations for changes as
appropriate.
    2. Evaluate large flocking bird requirements, to determine the need
for new large flocking bird requirements, or advisory material, or
both, for Class D engines (1.35m\2\-2.5m\2\ inlet areas). Identify any
deficiencies of the current rule, and provide the FAA with
recommendations for changes as appropriate.
    3. Review and consider the following related National
Transportation Safety Board (NTSB) safety recommendations when
evaluating items 1 and 2 above:
    a. ``A-10-64: Modify the 14 Code of Federal Regulations Sec.
33.76(c) small and medium flocking bird certification test standard to
require that the test be conducted using the lowest expected fan speed,
instead of 100-percent fan speed, for the minimum climb rate.''
    b. ``A-10-65: During the bird-ingestion rulemaking database (BRDB)
working group`s reevaluation of the current engine bird-ingestion
certification regulations, specifically reevaluate the 14 Code of
Federal Regulations Sec.  33.76(d) large flocking bird certification
test standards to determine whether they should: (1) Apply to engines
with an inlet area of less than 3,875 square inches and (2) Include a
requirement for engine core ingestion. If the BRDB working group`s
reevaluation determines that such requirements are needed, incorporate
them into 14 CFR Sec.  33.76(d) and require that newly certificated
engines be designed and tested to these requirements.''
    4. Define an industry led process for periodic update and review of
engine bird ingestion data, such that industry and the authorities can
maintain an awareness of the bird threat experienced in service.
    Tasks 1 through 4 above should consider the Aerospace Industries
Association engine bird ingestion database recently updated in
coordination with FAA and the European Aviation Safety Agency. That
database update was in response to the US Air Flight 1549 Hudson River
accident in January 2009 and related NTSB safety recommendations.
    The final ARAC report should include a summary of the overall work
scope, conclusions and rationale for all recommendations related to the
above tasks.
    Schedule: Required completion is no later than March 31, 2015.

ARAC Acceptance of Task

    ARAC accepted the task and will establish the Engine Harmonization
Working Group (EHWG), under the Transport Airplane and Engine
Subcommittee (TAE). The working group will serve as staff to ARAC and
assist ARAC in the analysis of the assigned tasks. ARAC must review and
approve the working group's recommendations. If ARAC accepts the
working group's recommendations, it will forward them to the FAA.

Working Group Activity

    The EHWG must comply with the procedures adopted by ARAC. As part
of the procedures, the working group must:
    1. Recommend a work plan for completion of the task, including the
rationale supporting such a plan for consideration by the subcommittee.
    2. Conduct a review and analysis of the assigned tasks.
    3. Draft the recommendation report based on the review and analysis
of the tasks and any other related materials or documents.
    4. Present the recommendation at a subcommittee meeting.
    5. Provide a status report at each meeting of the ARAC.

Participation in the Working Group

    The EHWG will be composed of technical experts having an interest
in the assigned task. A working group member need not be a
representative or a member of ARAC. If you have expertise in the
subject matter and wish to become a member of the working group, write
to the person listed under the caption FOR FURTHER INFORMATION CONTACT
expressing that desire. Describe your interest in the task and state
the expertise you would bring to the working group. We must receive all
requests by April 5, 2013. The Subcommittee Chair, the FAA
Representative, and the Working Group Co-Chairs will review the
requests and advise you whether or not your request is approved.
    If you are chosen for membership on the working group, you must
represent your aviation community segment and actively participate in
the working group by attending all meetings, and providing written
comments when requested to do so. You must devote the resources
necessary to support the working group in meeting any assigned
deadlines. You must keep your management chain and those you may
represent advised of working group activities and decisions to ensure
that the proposed technical solutions do not conflict with the position
of those you represent when the proposed recommendations are presented
to the Subcommittee and ARAC for approval.
    Once the working group has begun deliberations, members will not be
added or substituted without the approval of the Subcommittee Chair,
FAA Representatives, including the Designated Federal Officer, and the
working group.
    The Secretary of Transportation determined that the formation and
use of ARAC is necessary and in the public interest in connection with
the performance of duties imposed on the FAA by law.
    ARAC meetings are open to the public. Meetings of the EHWG will not
be open to the public, except to the extent individuals with an
interest and expertise are selected to participate. The FAA will make
no public announcement of working group meetings.

    Issued in Washington, DC, on March 1, 2013.
Lirio Liu,
Designated Federal Officer, Aviation Rulemaking Advisory Committee.
[FR Doc. 2013-05228 Filed 3-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72248-72249]
[FR Doc No: 2021-27521]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0548]

Data Standards for Drug and Biological Product Submissions
Containing Real-World Data; Draft Guidance for Industry; Availability;
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability entitled
``Data Standards for Drug and Biological Product Submissions Containing
Real-World Data; Draft Guidance for Industry'' that appeared in the
Federal Register on October 22, 2021. The Agency is taking this action
in response

to requests for an extension to allow interested persons additional
time to submit comments.

DATES: FDA is extending the comment period on the ``Data Standards for
Drug and Biological Product Submissions Containing Real-World Data;
Draft Guidance for Industry'' published October 22, 2021 (86 FR 58672).
Submit either electronic or written comments by February 4, 2022 to
ensure that the Agency considers your comment on this draft guidance
before it begins work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0548 for ``Data Standards for Drug and Biological Product
Submissions Containing Real-World Data; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-
796-2500, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 22, 2021, FDA published a notice
of availability with a 60-day comment period to provide comments on the
draft guidance entitled ``Data Standards for Drug and Biological
Product Submissions Containing Real-World Data: Draft Guidance for
Industry.'' FDA has received requests to extend the comment period to
allow sufficient time to develop and submit meaningful comments. FDA
has considered the requests and is extending the comment period for 45
days, until February 4, 2022. The Agency believes that a 45-day
extension allows adequate time for interested persons to submit
comments.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27521 Filed 12-20-21; 8:45 am]
BILLING CODE 4164-01-P