[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29065-29068]
[FR Doc No: 2017-13391]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AD17-12-000; PL03-3-000; AD03-7-000; ER17-795-000; ER17-
795-001; RP16-1299-000; RP16-1299-001; RP16-1299-002; ER17-386-001;
ER17-386-002]

Supplemental Notice of Technical Conference

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Developments in Natural Gas Index        AD17-12-000
 Liquidity and Transparency.
Price Discovery in Natural Gas and       PL03-3-000
 Electric Markets.
Natural Gas Price Formation............  AD03-7-000
ISO New England Inc....................  ER17-795-000
                                         ER17-795-001

Kinetica Energy Express, LLC...........  RP16-1299-000
                                         RP16-1299-001
                                         RP16-1299-002
New York Independent System Operator,    ER17-386-001
 Inc.                                    ER17-386-002
------------------------------------------------------------------------

Supplemental Notice of Technical Conference

    As announced in the Notices issued May 10, 2017,\1\ and June 13,
2017,\2\ Federal Energy Regulatory Commission (Commission) staff will
hold a technical conference on Thursday, June 29, 2017 from 9:00 a.m.
to 5:30 p.m. to discuss the state of liquidity and transparency in the
physical natural gas markets. A revised agenda and list of panel
participants for this conference are attached. The conference is free
of charge and open to the public. Commission members may participate in
the conference.
---------------------------------------------------------------------------

    \1\ Developments in Natural Gas Index Liquidity and
Transparency, Docket No. AD17-12-000 (May 10, 2017) (Notice of
Technical Conference) (https://elibrary.ferc.gov/IDMWS/common/opennat.asp?fileID=14586688).
    \2\ Developments in Natural Gas Index Liquidity and
Transparency, Docket No. AD17-12-000 (June 13, 2017) (Supplemental
Notice of Technical Conference) (https://elibrary.ferc.gov/IDMWS/common/opennat.asp?fileID=14613488).
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    This Supplemental Notice contains the following changes to the
previously-issued technical conference agenda: (1) Edward Fortunato,
Managing Director of Analytics for Constellation Energy, Exelon
Corporation is not participating as a panelist on Panels 1 and 2 of the
technical conference and; (2) Gregg Bradley, Supervisor of Market
Compliance for the Internal Market Monitor, ISO New England Inc. will
be a panelist on Panel 2 of the technical conference. Christopher
Hamlen, Regulatory Counsel, ISO-NE, is not participating as a panelist.
    In addition, please take note that the Commission will accept post
technical conference comments up to 30 days after the technical
conference. Please file any comments with the Commission by July 31,
2017.
    If they have not already done so, those who plan to attend the
technical conference are strongly encouraged to complete the
registration form located at: https://www.ferc.gov/whats-new/registration/06-29-17-form.asp. The dress code for the conference will
be business casual.
    The technical conference will be transcribed. Transcripts will be
available from Ace Reporting Company and may be purchased online at
www.acefederal.com, or by phone at<PHONE_NUMBER>. In addition, there
will be a free webcast of the conference. The webcast will allow
persons to listen, but not participate, and will be accessible at
www.ferc.gov Calendar of Events. The Capitol Connection provides
technical support for the webcast and offers the option of listening to
the technical conference via phone-bridge for a fee; visit
www.CapitolConnection.org or call<PHONE_NUMBER> with any webcast
questions.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about the technical conference, please
contact:

Sarah McKinley (Logistics), Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Eric Primosch (Technical), Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Omar Bustami (Legal), Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: June 21, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[GRAPHIC] [TIFF OMITTED] TN27JN17.000

Docket No. AD17-12-000
June 29, 2017
Agenda
    The purpose of the staff-led Technical Conference on Developments
in Natural Gas Index Liquidity and Transparency is to solicit feedback
and develop a record regarding index robustness and to discuss what, if
anything, the industry and/or the Commission could do to increase
transparency and support greater robustness in natural gas price
formation. The technical conference will examine: (1) The current state
of natural gas index liquidity and voluntary reporting to index
developers; (2) the use of natural gas indices over time; and (3)
possible actions that the industry and/or the Commission could take to
increase transparency and support greater robustness in natural gas
price formation.

9:00 a.m.-9:15 a.m. Welcome and Opening Remarks
9:15 a.m.-9:45 a.m. Natural Gas Index Presentation (Commission Staff)

    Staff will present an overview of natural gas transactions using
FERC Form No. 552 data. The presentation will review trends in next-day
and next-month transactions, the number of companies that report to
index developers, and the volume of fixed-priced transactions that
contribute to natural gas indices. Staff will also present an overview
of natural gas indices referenced in jurisdictional tariffs.

9:45 a.m.-12:00 p.m. Panel 1: Robustness and Liquidity of Natural Gas
Indices

    Most price indices are supplied as a commercial service by
publishers of daily, weekly, or monthly newsletters. Price indices play
a pivotal role in natural gas market price formation, and are commonly
referenced in physical and financial transactions. This panel will
examine the robustness and liquidity of natural gas indices, the degree
of industry reliance on index-based contracts rather than fixed-price
contracts, the decline in fixed-price reporting to index developers,
and whether natural gas indices accurately reflect market conditions.
    Panelists are encouraged to respond to the following:
    1. Describe the current trends in natural gas fixed-price and
physical basis trading that you believe positively or negatively impact
price formation in the natural gas market, detailing any observable
shifts in liquidity. Are there differences in market fundamentals,
procedures, or policies which disproportionately impact either overall
or regional liquidity?
    2. How have the volume and quality of next-day and next-month
fixed-price and physical basis transaction reporting changed? In
addition, describe any changes in other information used to form
natural gas indices. Are there market, regulatory, or other factors
that discourage reporting? If so, are there ways to incent reporting?
    3. For indices published by index developers and referenced in FERC
jurisdictional tariffs, the Commission requires index developers to
comply with five standards: (1) Code of conduct and confidentiality;
(2) completeness; (3) data verification, error correction, and
monitoring; (4) verifiability; and (5) availability and
accessibility.\3\ How have index developers' methodologies and
practices changed since these standards were developed? Are the
standards established in 2003 still relevant and sufficient to allow
for healthy and robust natural gas price formation in today's
environment?
---------------------------------------------------------------------------

    \3\ Policy Statement on Natural Gas and Electric Price Indices,
104 FERC ] 61,121, at P 33 (2003).
---------------------------------------------------------------------------

    4. Is there a need for additional transparency regarding natural
gas index price assessments and the level of liquidity underlying each
natural gas index published by index developers? Should common minimum
liquidity thresholds be defined? If so, who should define them, and
what should be the mechanism for accomplishing this? For example,
should index developers provide information about which indices are
illiquid? What kind of coordination would be necessary, and what kind
of information would be shared, and with whom, when a given natural gas
price index is deemed illiquid?
Panelists
 Mark Callahan, Editorial Director of Platts North America, S&P
Global
 J.C. Kneale, Vice President of North American Natural Gas,
Power & NGL Markets, InterContinental Exchange
 Euan Craik, Chief Executive Officer, Argus Media
 Tom Haywood, Editor of Natural Gas Week, Energy Intelligence
 Dexter Steis, Executive Publisher, Natural Gas Intelligence
 Vince Kaminski, Professor in Practice of Energy, Rice
University
 Orlando Alvarez, President and CEO, BP Energy Company

12:00 p.m.-1:00 p.m. Break
1:00 p.m.-3:30 p.m. Panel 2: Role of Natural Gas Indices in Price
Formation

    Natural gas indices are used by industry for a variety of purposes,
such as settling bilateral contracts of varying terms, basis swap
futures, index swap futures, swing swap futures, and calendar and basis
spreads. Natural gas indices also are used in FERC jurisdictional
interstate natural gas pipeline and wholesale electric transmission
tariffs for various purposes. For example, indices are used in many
interstate natural gas pipeline tariffs to settle imbalances or
determine penalties. In addition, State Commissions use indices as
benchmarks in reviewing the prudence of natural gas purchases by local
distribution companies. Finally, some Regional Transmission
Organizations and Independent System Operators (RTOs/ISOs) rely on
natural gas indices to develop reference levels for market power
mitigation. Given the prevalence of indices in the natural gas and
electric industries, indices must be robust and have the confidence of
market participants for such markets to function properly and
efficiently.
    Panelists are encouraged to respond to the following:
    1. Describe current industry uses of physical natural gas price
indices. Are natural gas price indices sufficiently reflecting the
locational value of natural gas to permit decision-making by those with
an interest in the value of natural gas such as: End users, producers,
marketers, and other buyers and sellers?
    2. Are there improvements that should be made to increase the
likelihood that natural gas indices will reflect the market value at
particular locations? For example, could index publishers provide
increased transparency when there are insufficient transactions to
formulate an index price? What additional information could signal that
market activity is sufficiently robust to create accurate prices?
    3. For RTOs/ISOs that rely on natural gas indices to develop
reference levels for market power mitigation, do you have concerns
about the robustness or liquidity of the natural gas indices used in
your tariffs? If so, please explain why.
    4. Recognizing that the use of natural gas indices in FERC
jurisdictional tariffs is different from their use in commercial
transactions, the Commission established liquidity thresholds for
indices referenced in jurisdictional tariffs.\4\ Do these thresholds
accurately capture minimum liquidity thresholds over an appropriate
time period? Should the liquidity of indices referenced in FERC
jurisdictional tariffs be reassessed periodically, and if so, who
should assess it, and what should be the mechanism for accomplishing
this? What kind of coordination would be necessary, and what kind of
information should be shared and with whom, should a given index be
deemed illiquid?
---------------------------------------------------------------------------

    \4\ Price Discovery in Natural Gas and Electric Markets, 109
FERC ] 61,184 at P60 (2004).
---------------------------------------------------------------------------

Panelists:
 Paul Greenwood, Vice President of the Americas, Africa, and
Asia Pacific New Markets for ExxonMobil, Natural Gas Supply Association
Representative
 Pallas LeeVanSchaik, External Market Monitor, Potomac
Economics
 Guillermo Bautista Alderete, Director of Market Analysis and
Forecasting, California ISO
 Gregg Bradley, Supervisor of Market Compliance for the
Internal Market Monitor, ISO New England Inc.
 George Wayne, Director of Account Services for the Western
Pipelines, Kinder Morgan
 Corey Grindal, Senior Vice President of Gas Supply, Cheniere
Energy
 David Louw, Division Director of Risk Management and
Compliance, Macquarie Energy
 Donnie Sharp, Senior Natural Gas Supply Coordinator for
Huntsville Utilities, American Public Gas Association Representative
 Lee Bennett, Manager, Pricing and Business Analysis for
Transcanada, Interstate Natural Gas Association of America
Representative
 Susan Bergles, Assistant General Counsel, American Gas
Association

3:30 p.m.-3:45 p.m. Break
3:45 p.m.-5:25 p.m. Panel 3: Options To Increase Transparency and
Liquidity of Natural Gas Indices

    Should action be taken to foster more meaningful, reliable, and
transparent price information in natural gas markets? What changes may
be necessary to incent voluntary price reporting and improve the
accuracy, reliability, and transparency of natural gas price indices?
Discuss the degree to which the level of voluntary reporting and other
developments within the commercial service model of natural gas index
development impact the robustness of natural gas indices.
    Panelists are encouraged to respond to the following:
    1. Is there a need to develop industry wide liquidity thresholds?
While the Commission maintains certain liquidity thresholds for indices
referenced in jurisdictional tariffs, should standards be developed
that would apply to other uses of natural gas indices? If so, how can
such standards be developed and by whom? Can this be addressed through
voluntary consensus or through other regulatory processes? Are there
legal, commercial, or technical impediments to doing so?
    2. Should the Commission take steps to provide greater natural gas
price transparency and market information, promote index developer
competition, and enhance confidence in natural gas price formation
through increased transparency and accessibility of natural gas index
information? For example, should the Commission consider exercising its
authority under section 23(a)(1) through (3) of the Natural Gas Act to
require market participants to report price forming transactions to
index developers?
    3. Is index data sufficiently available and transparent? Does the
commercial service model negatively or positively impact price
formation? What actions, policies, or trends have impacted price
discovery? Is there additional information market participants need to
ensure robust natural gas price formation? Who should provide that
information? How would that information be shared?
Panelists:
 Greg Leonard, Vice President, Cornerstone Research
 Orlando Alvarez, President and CEO, BP Energy Company
 Mark Callahan, Editorial Director for Platts North America,
S&P Global
 J.C. Kneale, Vice President of North American Natural Gas,
Power & NGL Markets, InterContinental Exchange
 Vince Kaminski, Professor in Practice of Energy, Rice
University
 Curtis Moffatt, Deputy General Counsel and Vice President,
Kinder Morgan
 Joe Bowring, President, Monitoring Analytics
 Corey Grindal, Senior Vice President of Gas Supply, Cheniere
Energy
 Tom Haywood, Editor of Natural Gas Week, Energy Intelligence
 Drew Fossum, Senior Vice President and General Counsel,
Tenaska Inc.
 Joan Dreskin, Vice President and General Counsel, Interstate
Natural Gas Association of America

5:25 p.m.-5:30 p.m. Closing Remarks

[FR Doc. 2017-13391 Filed 6-26-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Notices]
[Page 32102]
[FR Doc No: 2021-12656]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-629, OMB Control No. 3235-0719]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Exchange Act Rules 13n-1--13n-12; Form SDR

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rules 13n-1 through 13n-12
(17 CFR 240.13n-1 through 240.13n-12) and Form SDR (``Rules''), under
the Securities Exchange Act of 1934 (15 U.S.C. 78m(n)(3) et seq.). The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Under the Rules, security-based swap data repositories (``SDRs'')
are required to register with the Commission by filing a completed Form
SDR (the filing of a completed Form SDR also constitutes an application
for registration as a securities information processor (``SIP'')). SDRs
are also required to abide by certain minimum standards set out in the
Rules, including a requirement to update Form SDR, abide by certain
duties and core principles, maintain data in accordance with the rules,
keep systems in accordance with the Rules, keep records, provide
reports to the Commission, maintain the privacy of security-based swaps
(``SBSs'') data, make certain disclosures, and designate a Chief
Compliance Officer. In addition, there are a number of collections of
information contained in the Rules. The information collected pursuant
to the Rules is necessary to carry out the mandates of the Dodd-Frank
Act and help ensure an orderly and transparent market for SBSs.
    Assuming a maximum of ten SDRs, the Commission estimates that the
total reporting burden for all of the Rules and Form SDR for all
respondents is 463,493 hours initially, with a total annual burden
thereafter of 270,511.70 hours totaling approximately 1,275,028 hours.
This equates to approximately 425,009.29 hours per year when annualized
over three years. In addition, the Commission estimates that the total
cost for all of the Rules and Form SDR for all respondents is
approximately $103,364,700 initially, with a total annual cost
thereafter of $65,227,720 totaling approximately $299,047,860. This
equates to $99,682,619.90 per year when annualized over three years. A
detailed break-down of the estimated burdens and costs is provided in
the supporting statement.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: June 10, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-12656 Filed 6-15-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34677-34678]
[FR Doc No: 2015-14884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1566]

Naming of Drug Products Containing Salt Drug Substances; Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Naming of Drug
Products Containing Salt Drug Substances'' which replaces the draft
guidance of the same title that published on December 26, 2013. This
guidance describes the United States Pharmacopeia's (USP's) ``Monograph
Naming Policy for Salt Drug Substances in Drug Products and Compounded
Preparations,'' which became official on May 1, 2013, and how the
Center for Drug Evaluation and Research (CDER) is implementing it.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mamta Gautam-Basak, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Naming of Drug Products Containing Salt Drug Substances''
that replaces the draft of the same title that published on December
26, 2013 (78 FR 78366). This guidance is being published to explain how
CDER is implementing the USP's policy entitled ``Monograph Naming
Policy for Salt Drug Substances in Drug Products and Compounded
Preparations.'' It is a naming and labeling policy applicable to drug
products that contain an active ingredient that is a salt. The policy
stipulates that USP will use the name of the active moiety, instead of
the name of the salt, when creating a drug product monograph title and
the strength will be expressed in terms of the active moiety. The
policy allows for exceptions under specified circumstances. CDER is now
applying this policy to new prescription drug products under
development under section 505 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 355).
    The USP Salt Policy became official on May 1, 2013, and USP is now
applying it to all new drug product monographs for products that
contain an active ingredient that is a salt. It affects the development
of new drug products because a USP monograph title for a new drug
product, in most instances, serves as the nonproprietary or
``established'' name of the related drug product (section 502(e)(3) of
the FD&C Act) (21 U.S.C. 352(e)). If a drug product's label or labeling
contains a name that is inconsistent with the applicable monograph
title, it risks being misbranded (section 502(e)(1)(A)(i) of the FD&C
Act).
    This guidance describes the USP policy and discusses how CDER and
industry can implement the policy. Following the policy will help
reduce medication errors caused by a mismatch between the established
name and strength on the label of drug products that contain a salt. In
addition, we anticipate that this policy will help health care
practitioners calculate equivalent doses when changing from one dosage
form to another, even if the products contain active ingredients that
are different salts, because the strengths and names will both be based
on the active moiety.
    In the Federal Register of December 26, 2013 (78 FR 78366), this
guidance was published as a draft guidance. We have carefully reviewed
and considered the comments that were received on the draft guidance
and have made changes for clarification.
    This guidance is being issued consistent with FDA's good guidance
practices regulation 21 CFR 10.115. This guidance represents CDER's
current

thinking on drug product naming nomenclature for new drugs that contain
a salt as the active ingredient. It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance includes information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information referenced in this guidance that are related
to the burden for the submission of investigational new drug
applications are covered under 21 CFR 312 and have been approved under
OMB control number 0910-0014. The collections of information referenced
in this guidance that are related to the burden for the submission of
new drug applications that are covered under 21 CFR 314 have been
approved under OMB control number 0910-0001. The submission of
prescription drug product labeling under 21 CFR 201.56 and 201.57 is
approved under OMB control number 0910-0572.
    The guidance also references 21 CFR 201.10 ``Drugs; Statement of
Ingredients.'' In the Federal Register of December 18, 2014 (79 FR
75506), FDA published its proposed rule on the electronic distribution
of prescribing information for human prescription drugs, including
biological products. In Section VII, ``Paperwork Reduction Act of
1995,'' FDA estimated the burden to design, test, and produce the label
for a drug product's immediate container and outer container or
package, as set forth in 21 CFR part 201, including Sec. Sec.  201.10,
201.100(b), and other sections in subpart A and subpart B.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14884 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P


documents that are transmitted via a telecommunications network,
excluding hard copy facsimile.

  Addressing State/Local agencies as “respondents” is consistent
with EPA’s interpretation of the definition of respondent in the
Paperwork Reduction Act (PRA).

  Ibid.

  Ibid.

  Title XVII of Pub. L. 105 277.

  Bureau of Labor Statistics; “Table 4. Employment Cost Index for
total compensation, for civilian workers, by occupational and
industry;” Employment Cost Index, Historical Listing, Continuous
Occupational and Industry Series, September 1975 – March 2011; April
29, 2011.  Available online at:   HYPERLINK
"http://www.bls.gov/web/eci/ecicois.pdf"
http://www.bls.gov/web/eci/ecicois.pdf , last accessed on June 8, 2011.
Civilian Workers, All Workers, March 2008=107.6 and March 2011=114.0.

  Bureau of Labor Statistics, "Table 7. Employment Cost Index for total
compensation, for State and local government workers, by occupational
and industry," Employment Cost Index, Historical Listing, Continuous
Occupational and Industry Series, September 1975 – March 2011; April
29, 2011.  Available online at:   HYPERLINK
"http://www.bls.gov/web/eci/ecicois.pdf"
http://www.bls.gov/web/eci/ecicois.pdf , last accessed on June 8, 2011.
State and Local Government Workers, All Workers, March 2008=108.9 and
March 2011=116.6.

  Bureau of Labor Statistics, Table Containing History of CPI-U U.S. All
Items Indexes and Annual Percent Changes From 1913 to Present, May 13,
2011.  Available online at:    HYPERLINK
"ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt"
ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt , last accessed on
June 8, 2011.  All items, March 2008=213.528 and April 2011=224.906.

  U.S. Postal Service; “First-Class Mail Prices.”  Available online
at:    HYPERLINK
"http://www.usps.com/prices/first-class-mail-prices.htm"
http://www.usps.com/prices/first-class-mail-prices.htm , last accessed
on June 8, 2011.

  U.S. Postal Service; “Extra Services Prices.”  Available online
at:    HYPERLINK "http://www.usps.com/prices/extra-services-prices.htm"
http://www.usps.com/prices/extra-services-prices.htm , last accessed on
June 8, 2011.

  Standard business envelope cost based on current market price, as of
March 7, 2011 (i.e., box of 500 standard business envelopes with gummed
closure at $8.99).

  U.S. Postal Service; “First-Class Mail Prices.”  Available online
at:    HYPERLINK
"http://www.usps.com/prices/first-class-mail-prices.htm"
http://www.usps.com/prices/first-class-mail-prices.htm , last accessed
on June 8, 2011.

  Standard business envelope cost based on current market price, as of
March 7, 2011 (i.e., box of 500 standard business envelopes with gummed
closure at $8.99).

  Bureau of Labor Statistics, Table Containing History of CPI-U U.S. All
Items Indexes and Annual Percent Changes From 1913 to Present, May 13,
2011.  Available online at:    HYPERLINK
"ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt"
ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt , last accessed on
June 8, 2011.  All items, March 2008=213.528 and April 2011=224.906.

  U.S. Postal Service; “First-Class Mail Prices.”  Available online
at:    HYPERLINK
"http://www.usps.com/prices/first-class-mail-prices.htm"
http://www.usps.com/prices/first-class-mail-prices.htm , last accessed
on June 8, 2011.

  U.S. Postal Service; “Extra Services Prices.”  Available online
at:    HYPERLINK "http://www.usps.com/prices/extra-services-prices.htm"
http://www.usps.com/prices/extra-services-prices.htm , last accessed on
June 8, 2011.

  Catalog envelope cost based on current market price, as of March 7,
2011 (i.e., box of 100 6” x 9” brown kraft catalog envelopes with
gummed closure at $8.79).

  US Office of Personnel Management, “Base Hourly Rate,” 2011
General Schedule (Base), January 2011.  Available online at:
HYPERLINK "http://opm.gov/oca/11tables/indexgs.asp"
http://opm.gov/oca/11tables/indexgs.asp , last accessed on June 8, 2011.

  Based on EPA’s Capital Planning and Investment Control (CPIC) for
CDX.  Data current as of May 26, 2011.

  Based on data current as of May 26, 2011.

  Addressing State/Local agencies as “respondents” is consistent
with EPA’s interpretation of the definition of respondent in the
Paperwork Reduction Act (PRA).

  Ibid.

  Ibid.

  This assumption was taken from Cross-Media Electronic Reporting and
Records Rule (CROMERRR) Cost Benefit Analysis, Final, dated November 17,
2004.

  This assumption was taken from Cross-Media Electronic Reporting and
Records Rule (CROMERRR) Cost Benefit Analysis, Final, dated November 17,
2004.

  Ibid.

  This assumption was taken from Section <IP_ADDRESS> (page 29) of
Cross-Media Electronic Reporting and Records Rule (CROMERRR) Cost
Benefit Analysis, Final, dated November 17, 2004.

  Ibid.

  Refer to Section 6(d) for additional clarification on the types of
respondents examined in this ICR.

  “Existing electronic document receiving system” means an
electronic document receiving system that is being used to receive
electronic documents in lieu of paper to satisfy requirements under an
authorized program on October 13, 2005 or the system, if not in use, has
been substantially developed on or before that date as evidenced by the
establishment of system services or specifications by contract or other
binding agreement (40 CFR 3.3).  Pursuant to 40 CFR 3.1000(a)(3),
States/Locals with an existing electronic document receiving system for
an authorized program must submit an application to revise or modify
such authorized program in compliance with 40 CFR 3.1000(a)(1) no later
than January 13, 2010.

  “New electronic document receiving system” refers to an electronic
document receiving system that was not being used to receive electronic
documents in lieu of paper to satisfy requirements under an authorized
program on October 13, 2005 or the system, if not in use, that had not
been substantially developed on or before that date.  Pursuant to 40 CFR
3.1000(a)(2), States/Locals with new electronic document receiving
systems must receive EPA approval of revisions or modifications to the
authorized program before the program may receive electronic documents
in lieu of paper documents to satisfy program requirements.

  U.S. Census Bureau, “Number of Firms, Number of Establishments,
Employment, and Annual Payroll by Enterprise Employment Size for the
United States and States, Totals:  2008,” February 15, 2011.
Available online at:  http://www.census.gov/econ/susb/, last accessed on
February 23, 2011.  These are the latest Statistics of U.S. Businesses
(SUSB) annual data.

  Bureau of Labor Statistics; Quarterly Census of Employment and Wages;
Number of Employees (US Total, All Industries, All Establishment Sizes);
2009 (Annual).  Available online at:    HYPERLINK
"http://data.bls.gov/pdq/querytool.jsp?survey=en"
http://data.bls.gov/pdq/querytool.jsp?survey=en , last accessed on April
27, 2011.

 PAGE

 PAGE  36

 PAGE  38

Table 4 (continued)

Reasons for Change in Respondent Burden Hours from EPA ICR Number
2002.04 to EPA ICR Number 2002.05 a

 PAGE  37

 PAGE  48

A-  PAGE   \* MERGEFORMAT  2

B-  PAGE   \* MERGEFORMAT  10

 PAGE

C-  PAGE   \* MERGEFORMAT  6

C-  PAGE   \* MERGEFORMAT  1

C-  PAGE   \* MERGEFORMAT  8

Attachment C-1 (continued)

Number of Existing and New State/Local Electronic Document

Receiving Systems, by State Environmental Program

(also referred to as the “Master Table”)

C-  PAGE   \* MERGEFORMAT  16

C-  PAGE   \* MERGEFORMAT  11

C-  PAGE   \* MERGEFORMAT  13

C-  PAGE   \* MERGEFORMAT  15

Attachment C-5 (continued)

Number of Establishments (Facilities) by Employment Size, 2008

C-  PAGE   \* MERGEFORMAT  17

Attachment C-6 (continued)

Application of Methodology to Existing Receiving Systems

C-  PAGE   \* MERGEFORMAT  18


[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Rules and Regulations]
[Pages 46875-46877]
[FR Doc No: 2019-19099]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

Docket No. FAA-2019-0403; Product Identifier 2019-NM-012-AD; Amendment
39-19723; AD 2019-17-03]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus SAS Model A320-214 and -271N airplanes and Model A321-
211 and -231 airplanes. This AD was prompted by a test of a new wall
partition for a certain cabin attendant seat model that revealed the
backrest was permanently deformed and did not allow the seat pan to
return to a full-up position; investigation results identified that a
heat treatment had not been applied on certain backframes. This AD
requires modifying the affected cabin attendant seats, as specified in
a European Aviation Safety Agency (EASA) AD, which is incorporated by
reference. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective October 11, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 11,
2019.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0403.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0403; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus SAS
Model A320-214 and -271N airplanes and Model A321-211 and -231
airplanes. The NPRM published in the Federal Register on June 5, 2019
(84 FR 26027). The NPRM was prompted by a test of a new wall partition
for a certain cabin attendant seat model that revealed the backrest was
permanently deformed and did not allow the seat pan to return to a
full-up position; investigation results identified that a heat
treatment had not been applied on certain backframes. The NPRM proposed
to require modifying the affected cabin attendant seats.
    The FAA is issuing this AD to address a seat pan that does not
return to a full-up position, which, if not corrected, could reduce the
escape path through the adjacent exit door in case of evacuation,
possibly resulting in injury to passengers or flightcrew.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0005, dated January 14, 2019
(``EASA AD 2019-0005'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A320-214 and -271N airplanes and
Model A321-211 and -231 airplanes. The MCAI states:

    During a test of a new wall partition for cabin attendant seat
model 2428, the backrest was found permanently deformed and did not
allow the seat pan to return to a full-up position. Investigation
results identified that a heat treatment had not been applied on
certain backframes, which could lead to permanent deformation of the
seat backrest.
    This condition, if not corrected, could reduce the escape path
through the adjacent exit door in case of evacuation, possibly
resulting in injury to aeroplane occupants.
    To address this potential unsafe condition, Airbus issued the
applicable SB [service bulletin], which refers to Goodrich SB,
providing instructions to modify affected parts by replacing the
backframe, and to add a placard after modification.
    For the reasons described above, this [EASA] AD requires
modification of the affected parts.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0403.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0005 describes procedures for modifying the affected
cabin attendant seats (which includes an inspection to determine the
part number and serial number of the cabin attendant seat) by replacing
the backrest and adding a placard. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 19 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 462 work-hours x $85 per hour =                N/A  Up to $39,270.............  Up to $746,130.
 $39,270.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for reporting.

    The FAA estimates that it would take about 1 work-hour per product
to comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, the FAA estimates the
cost of reporting the modification results on U.S. operators to be $85
per product.
    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the additional actions specified
in this AD.
    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in our cost estimate.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2019-17-03 Airbus SAS: Amendment 39-19723; Docket No. FAA-2019-0403;
Product Identifier 2019-NM-012-AD.

(a) Effective Date

    This AD is effective October 11, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A320-214 and -271N airplanes
and Model A321-211 and -231 airplanes, certificated in any category,
as identified in European Aviation Safety Agency (EASA) AD 2019-
0005, dated January 14, 2019 (``EASA AD 2019-0005'').

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by a test of a new wall partition for a
certain cabin attendant seat model that revealed the backrest was
permanently deformed and did not allow the seat pan to return to a
full-up position; investigation results identified that a heat

treatment had not been applied on certain backframes. The FAA is
issuing this AD to address this condition, which, if not corrected,
could reduce the escape path through the adjacent exit door in case
of evacuation, possibly resulting in injury to passengers or
flightcrew.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2019-0005.

(h) Exceptions to EASA AD 2019-0005

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0005 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0005 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j) of this AD. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0005 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.
    (4) Paperwork Reduction Act Burden Statement: A federal agency
may not conduct or sponsor, and a person is not required to respond
to, nor shall a person be subject to a penalty for failure to comply
with a collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 1
hour per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW, Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(j) Related Information

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Aviation Safety Agency (EASA) AD 2019-0005, dated
January 14, 2019.
    (ii) [Reserved]
    (3) For EASA AD 2019-0005, contact the EASA, at Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this EASA AD at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. EASA AD
2019-0005 may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0403.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on August 22, 2019.
Suzanne Masterson,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-19099 Filed 9-5-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67466-67467]
[FR Doc No: 2011-28223]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the National Mammography Quality Assurance Advisory
Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organization interested in participating in the selection of
nonvoting industry representatives to serve on the National Mammography
Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices
and Radiological Health notify FDA in writing. A nominee may either be
self-nominated or nominated by an organization to serve as a nonvoting
industry representative. Nominations will be accepted for current
vacancies effective with this notice.

DATES: Any industry organizations interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by December
1, 2011, for the vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by December 1, 2011.

ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5234, Silver Spring, MD 20993, (301) 796-
5960, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The Mammography Quality Standards Reauthorization Act of 2004 (Pub.
L. 108-365) requires the addition of at least two industry
representatives with expertise in mammography equipment to the NMQAAC.
The Agency is requesting nominations for nonvoting industry
representatives on the NMQAAC.

I. NMQAAC

    Advise FDA on: (1) Developing appropriate quality standards and
regulations for mammography facilities; (2) developing appropriate
standards and regulations for bodies accrediting mammography facilities
under this program; (3) developing regulations with respect to
sanctions; (4) developing procedures for monitoring compliance with
standards; (5) establishing a mechanism to investigate consumer
complaints; (6) reporting new developments concerning breast imaging
which should be considered in the oversight of mammography facilities;
(7) determining whether there exists a shortage of mammography
facilities in rural and health professional shortage areas and
determining the effects of personnel on access to the services of such
facilities in such areas; (8) determining whether there will exist a
sufficient number of medical physicists after October 1, 1999; and (9)
determining the costs and benefits of compliance with these
requirements.

II. Qualifications

    Persons nominated for membership as an industry representative on
the NMQAAC must meet the following criteria: (1) Demonstrate expertise
in mammography equipment and (2) be able to discuss equipment
specifications and quality control procedures affecting mammography
equipment. The industry representative must be able to represent the
industry perspective on issues and actions before the advisory
committee, serve as liaison between the committee and interested
industry parties, and facilitate dialogue with the advisory committee
on mammography equipment issues.

III. Selection Procedure

    Any industry organization interested in participating in the
selection of appropriate nonvoting members to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select candidates, within 60 days after the receipt of
the FDA letter, to serve as nonvoting members to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting candidates. However, if no
individual is selected within the 60 days, the Commissioner of Food and
Drugs will select the nonvoting members to represent industry
interests.

IV. Application Procedure

    Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
    FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees and, therefore,
encourages nominations for appropriately qualified candidates from
these groups. Specifically, in this document, nominations for nonvoting
representatives of industry interests are encouraged from the
mammography manufacturing industry.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 26, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-28223 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Notices]
[Pages 47693-47697]
[FR Doc No: 2012-19564]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No FMCSA-2011-0097]

Pilot Program on NAFTA Trucking Provisions

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

ACTION: Notice; request for public comment.

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

SUMMARY: FMCSA announces and requests public comment on data and
information concerning the Pre-Authorization Safety Audit (PASA) for
GCC Transportes SA de CV (GCC) which applied to participate in the
Agency's long-haul pilot program to test and demonstrate the ability of
Mexico-domiciled motor carriers to operate safely in the United States
beyond the municipalities on the international border or the commercial
zones of such municipalities. This action is required by the ``U.S.
Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq
Accountability Appropriations Act, 2007'' and all subsequent
appropriations.

DATES: Comments must be received on or before August 20, 2012.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2011-0097 by any one of the following
methods: Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, (M-30), U.S. Department
of Transportation (DOT), 1200 New Jersey Avenue SE., West Building,
Ground Floor, Room 12-140, Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., ET, Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
All submissions must include the Agency name and docket number for this
notice. See the ``Public Participation'' heading below for instructions
on submitting comments and additional information.

    Note that all comments received, including any personal information
provided, will be posted without change to http://www.regulations.gov.
Please see the ``Privacy Act'' heading below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
Room W12-140 on the ground floor of the DOT Headquarters Building at
1200 New Jersey Avenue SE., Washington, DC, 20590, between 9 a.m. and 5
p.m., ET, Monday through Friday, except Federal holidays.
    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
Privacy Act System of Records Notice for the DOT Federal Docket
Management System published in the Federal Register on January 17, 2008
(73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.
    Public Participation: The http://www.regulations.gov Web site is
generally available 24 hours each day, 365 days each year. You can get
electronic submission and retrieval help and guidelines under the
``help'' section of the http://www.regulations.gov Web site. Comments
received after the comment closing date will be included in the docket,
and will be considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Marcelo Perez, FMCSA, North American
Borders Division, 1200 New Jersey Avenue SE., Washington, DC 20590-
0001. Telephone<PHONE_NUMBER> Ext. 228; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On May 25, 2007, the President signed into law the U.S. Troop
Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability
Appropriations Act, 2007 (the Act), (Pub. L. 110-28, 121 Stat. 112,
183, May 25, 2007). Section 6901 of the Act requires that certain
actions be taken by the Department of Transportation (the Department)
as a condition of obligating or expending appropriated funds to grant
authority to Mexico-domiciled motor carriers to operate beyond the
municipalities in the United States on the United States-Mexico
international border or the commercial zones of such municipalities
(border commercial zones).
    On July 8, 2011, FMCSA announced in the Federal Register [76 FR
40420] its intent to proceed with the initiation of a U.S.-Mexico
cross-border long-haul trucking pilot program to test and demonstrate
the ability of Mexico-domiciled motor carriers to operate safely in the
United States beyond the border commercial zones as detailed in the
Agency's April 13, 2011, Federal Register notice [76 FR 20807]. The
pilot program is a part of FMCSA's implementation of the North American
Free Trade Agreement (NAFTA) cross-border long-haul trucking provisions
in compliance with section 6901(b)(2)(B) of the Act. FMCSA reviewed,
assessed, and evaluated the required safety measures as noted in the
July 8, 2011, notice and considered all comments received on or before
May 13, 2011, in response to the April 13, 2011, notice. Additionally,
to the extent practicable, FMCSA considered comments received after May
13, 2011.
    In accordance with section 6901(b)(2)(B)(i) of the Act, FMCSA is
required to publish in the Federal Register, and provide sufficient
opportunity for public notice and comment comprehensive data and
information on the PASAs conducted of motor carriers domiciled in
Mexico that are granted authority to operate beyond the border
commercial zones. This notice serves to fulfill this requirement.
    FMCSA is publishing for public comment the data and information
relating to one PASA that was completed on February 10, 2012. FMCSA
announces that the Mexico-domiciled motor carrier in Table 1
successfully completed the PASA. Notice of this completion was also
published in the FMCSA Register.
    Tables 2, 3 and 4 all titled (``Successful Pre-Authorization Safety
Audit (PASA) Information'') set out additional information on the
carrier(s) noted in Table 1. A narrative description of each column in
the tables is provided as follows:
    A. Row Number in the Appendix for the Specific Carrier: The row
number for each line in the tables.
    B. Name of Carrier: The legal name of the Mexico-domiciled motor
carrier that applied for authority to operate in the United States
(U.S.) beyond the border commercial zones and was considered for
participation in the long-haul pilot program.
    C. U.S. DOT Number: The identification number assigned to the
Mexico-domiciled motor carrier and required to be displayed on each
side of the motor carrier's power units. If granted provisional
operating authority, the Mexico-domiciled motor carrier will be
required to add the suffix ``X'' to the ending of its assigned U.S. DOT
Number for those vehicles approved to participate in the pilot program.
    D. FMCSA Register Number: The number assigned to the Mexico-
domiciled motor carrier's operating authority as found in the FMCSA
Register.
    E. PASA Initiated: The date the PASA was initiated.
    F. PASA Completed: The date the PASA was completed.
    G. PASA Results: The results upon completion of the PASA. The PASA
receives a quality assurance review before approval. The quality
assurance process involves a dual review by the FMCSA Division Office
supervisor of the auditor assigned to conduct the PASA and by the FMCSA
Service Center New Entrant Specialist designated for the specific FMCSA
Division Office. This dual review ensures the successfully completed
PASA was conducted in accordance with FMCSA policy, procedures and
guidance. Upon approval, the PASA results are uploaded into the FMCSA's
Motor Carrier Management Information System (MCMIS). The PASA
information and results are then recorded in the Mexico-domiciled motor
carrier's safety performance record in MCMIS.
    H. FMCSA Register: The date FMCSA published notice of a
successfully completed PASA in the FMCSA Register. The FMCSA Register
notice advises interested parties that the application has been
preliminarily granted and that protests to the application must be
filed within 10 days of the publication date. Protests are filed with
FMCSA Headquarters in Washington, DC. The notice in the FMCSA Register
lists the following information:
    a. Current registration number (e.g., MX-123456);
    b. Date the notice was published in the FMCSA Register;
    c. The applicant's name and address; and
    d. Representative or contact information for the applicant.
    The FMCSA Register may be accessed through FMCSA's Licensing and
Insurance public Web site at http://li-public.fmcsa.dot.gov/, and
selecting FMCSA Register in the drop down menu.
    I. U.S. Drivers: The total number of the motor carrier's drivers
approved for long-haul transportation in the United States beyond the
border commercial zones.
    J. U.S. Vehicles: The total number of the motor carrier's power
units approved for long-haul transportation in

the United States beyond the border commercial zones.
    K. Passed Verification of 5 Elements (Yes/No): A Mexico-domiciled
motor carrier will not be granted provisional operating authority if
FMCSA cannot verify all of the following five mandatory elements. FMCSA
must:
    a. Verify a controlled substances and alcohol testing program
consistent with 49 CFR part 40.
    b. Verify a system of compliance with hours-of-service rules of 49
CFR part 395, including recordkeeping and retention;
    c. Verify the ability to obtain financial responsibility as
required by 49 CFR part 387, including the ability to obtain insurance
in the United States;
    d. Verify records of periodic vehicle inspections; and
    e. Verify the qualifications of each driver the carrier intends to
use under such authority, as required by 49 CFR parts 383 and 391,
including confirming the validity of each driver's Licencia Federal de
Conductor and English language proficiency.
    L. If No, Which Element Failed: If FMCSA cannot verify one or more
of the five mandatory elements outlined in 49 CFR part 365, Appendix A,
Section III, this column will specify which mandatory element(s) cannot
be verified.
    Please note that for items L through P below, during the PASA,
after verifying the five mandatory elements discussed in item K above,
FMCSA will gather information by reviewing a motor carrier's compliance
with ``acute and critical'' regulations of the Federal Motor Carrier
Safety Regulations (FMCSRs) and Hazardous Materials Regulations (HMRs).
Acute regulations are those where noncompliance is so severe as to
require immediate corrective actions by a motor carrier regardless of
the overall basic safety management controls of the motor carrier.
Critical regulations are those where noncompliance relates to
management and/or operational controls. These regulations are
indicative of breakdowns in a carrier's management controls. A list of
acute and critical regulations is included in 49 CFR part 385, Appendix
B, Section VII.
    Parts of the FMCSRs and HMRs having similar characteristics are
combined together into six regulatory areas called ``factors.'' The
regulatory factors are intended to evaluate the adequacy of a carrier's
management controls.
    M. Passed Phase 1, Factor 1: A ``yes'' in this column indicates the
carrier has successfully met Factor 1 (listed in part 365, Subpart E,
Appendix A, Section IV(f)). Factor 1 includes the General Requirements
outlined in parts 387 (Minimum Levels of Financial Responsibility for
Motor Carriers) and 390 (Federal Motor Carrier Safety Regulations--
General).
    N. Passed Phase 1, Factor 2: A ``yes'' in this column indicates the
carrier has successfully met Factor 2, which includes the Driver
Requirements outlined in parts 382 (Controlled Substances and Alcohol
Use and Testing), 383 (Commercial Driver's License Standards;
Requirements and Penalties) and 391 (Qualifications of Drivers and
Longer Combination Vehicle (LCV) Driver Instructors).
    O. Passed Phase 1, Factor 3: A ``yes'' in this column indicates the
carrier has successfully met Factor 3, which includes the Operational
Requirements outlined in parts 392 (Driving of Commercial Motor
Vehicles) and 395 (Hours of Service of Drivers).
    P. Passed Phase 1, Factor 4: A ``yes'' in this column indicates the
carrier has successfully met Factor 4, which includes the Vehicle
Requirements outlined in parts 393 (Parts and Accessories Necessary for
Safe Operation) and 396 (Inspection, Repair and Maintenance) and
vehicle inspection and out-of-service data for the last 12 months.
    Q. Passed Phase 1, Factor 5: A ``yes'' in this column indicates the
carrier has successfully met Factor 5, which includes the hazardous
material requirements outlined in parts 171 (General Information,
Regulations, and Definitions), 177 (Carriage by Public Highway), 180
(Continuing Qualification and Maintenance of Packagings) and 397
(Transportation of Hazardous Materials; Driving and Parking Rules).
    R. Passed Phase 1, Factor 6: A ``yes'' in this column indicates the
carrier has successfully met Factor 6, which includes Accident History.
This factor is the recordable accident rate during the past 12 months.
A recordable ``accident'' is defined in 49 CFR 390.5, and means an
accident involving a commercial motor vehicle operating on a public
road in interstate or intrastate commerce which results in a fatality;
a bodily injury to a person who, as a result of the injury, immediately
received medical treatment away from the scene of the accident; or one
or more motor vehicles incurring disabling damage as a result of the
accident requiring the motor vehicle to be transported away from the
scene by a tow truck or other motor vehicle.
    S. Number U.S. Vehicles Inspected: The total number of vehicles
(power units) the motor carrier is approved to operate in the United
States beyond the border commercial zones that received a vehicle
inspection during the PASA. During a PASA, FMCSA inspected all power
units to be used by the motor carrier in the pilot program and applied
a current Commercial Vehicle Safety Alliance (CVSA) inspection decal,
if the inspection is passed successfully. This number reflects the
vehicles that were inspected, irrespective of whether the vehicle
received a CVSA inspection at the time of the PASA decal as a result of
a passed inspection.
    T. Number U.S. Vehicles Issued CVSA Decal: The total number of
inspected vehicles (power units) the motor carrier is approved to
operate in the United States beyond the border commercial zones that
received a CVSA inspection decal as a result of an inspection during
the PASA.
    U. Controlled Substances Collection: Refers to the applicability
and/or country of origin of the controlled substance and alcohol
collection facility that will be used by a motor carrier that has
successfully completed the PASA.
    a. ``US'' means the controlled substance and alcohol collection
facility is based in the United States.
    b. ``MX'' means the controlled substance and alcohol collection
facility is based in Mexico.
    c. ``Non-CDL'' means that during the PASA, FMCSA verified that the
motor carrier is not utilizing commercial motor vehicles subject to the
commercial driver's license requirements as defined in 49 CFR 383.5
(Definition of Commercial Motor Vehicle). Any motor carrier that does
not operate commercial motor vehicles as defined in Sec.  383.5 is not
subject to DOT controlled substance and alcohol testing requirements.
    V. Name of Controlled Substances and Alcohol Collection Facility:
Shows the name and location of the controlled substances and alcohol
collection facility that will be used by a Mexico-domiciled motor
carrier who has successfully completed the PASA.

                                 Table 1
------------------------------------------------------------------------
 Row number in Tables 2, 3 and
 4 of the Appendix to today's      Name of carrier         USDOT No.
            notice
------------------------------------------------------------------------
1.............................  GCC Transportes SA de            650155
                                 CV.
------------------------------------------------------------------------

                                          Table 2--Successful Pre-Authorization Safety Audit (PASA) Information
                                                                [See also Tables 3 and 4]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Column C--    Column D--    Column E--    Column F--                      Column H--    Column I--    Column J--
  Column A--row    Column B--Name of  U.S. DOT No.      FMCSA         PASA          PASA       Column G--PASA       FMCSA     U.S. drivers      U.S.
       No.              carrier                     register No.    initiated     completed        results        register                    vehicles
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...............  GCC Transportes SA       650155    MX-7001100       12/8/11       3/14/12   Pass............      7/27/12             9            13
                   de CV.
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                          Table 3--Successful Pre-Authorization Safety Audit (PASA) Information
                                                                [See also Tables 2 and 4]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Column K--
                                   Column C--    Column D--       Passed      Column L--if    Column M--      Column N--      Column O--     Column P--
 Column A--row   Column B--name   U.S. DOT No.      FMCSA      verification     no, which   passed phase 1  passed phase 1   passed phase   passed phase
      No.          of carrier                   register No.   of 5 elements     element       factor 1        factor 2       1 factor 3     1 factor 4
                                                                 (yes/no)        failed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............  GCC Transportes        650155     MX-701100   Yes...........            N   Pass..........  Pass..........  Pass.........  Pass.
                 SA de CV.
--------------------------------------------------------------------------------------------------------------------------------------------------------

                              Table 4--Successful Pre-Authorization Safety Audit (PASA) Information as of September 9, 2011
                                                                [See also Tables 2 and 3]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Column T--                    Column V-- name
                                                                                Column S--    number U.S.    Column U--      of controlled
 Column A--row   Column B--name    Column C--    Column D--    Column Q--     Column R--     number U.S.    vehicles      controlled     substances and
      No.          of carrier     U.S. DOT No.      FMCSA     passed phase  passed phase I    vehicles     issued CVSA     substance         alcohol
                                                register No.   I factor 5      factor 6       inspected       decal       collection       collection
                                                                                facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............  GCC Transportes        650155     MX-701100           N/A   Pass..........           13            13   U.S...........  RI-Tech Drug
                 SA de CV.                                                                                Testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Agency acknowledges that through the PASA process it determined
that GCC has affiliations with additional companies. An attachment to
the PASA provides information regarding these affiliations. During the
carrier vetting and PASA process, FMCSA reviewed its records related to
the affiliates, and confirmed that the companies are in good standing.
    In an effort to provide as much information as possible for review,
the application and PASA results for this carrier are posted at the
Agency's Web site for the pilot program at http://www.fmcsa.dot.gov/intl-programs/trucking/Trucking-Program.aspx. For carriers that
participated in the Agency's demonstration project that ended in 2009,
copies of the previous PASA and compliance review, if conducted, are
also posted. All documents were redacted so that personal information
regarding the drivers is not released. Sensitive business information,
such as the carrier's tax identification number, is also redacted. In
response to previous comments received regarding the PASA notice
process, FMCSA also posted copies of the vehicle inspections conducted
during the PASA in the PASA document.
    A list of the carrier's vehicles approved by FMCSA for use in the
pilot program is also available at the above referenced Web site.
    FMCSA notes that the drivers proposed by the carrier for
participation in the pilot program were tested for English language
proficiency during the PASA and were found to be proficient. However,
two of the proposed drivers have been recently cited for violations of
49 CFR 392.11(b)(2) during transportation in the border commercial
zone. FMCSA brought this issue to GCC's attention, and GCC advised
FMCSA that it sent the drivers to additional training to improve their
English language proficiency.
    The Agency also notes that GCC has been cited for violations of the
FMCSRs during the last 24 months and the company is above the Agency's
intervention threshold in the Driver Fitness basic within the Agency's
Safety Measurement System. This Driver Fitness score generally results
from citations for drivers failing to adequately communicate in
English. As noted above FMCSA has determined that each of the drivers
designated to participate in the Pilot Program is able to read and
speak the English language sufficiently to comply with our regulation.
In addition GCC has advised FMCSA that it is providing additional
training to their drivers to improve their English language
proficiency. Therefore, while the SMS score above the intervention
threshold is a concern that will be monitored, under these
circumstances, we do not believe it constitutes an indication that the
carrier is not willing or able to comply with our regulations and the
requirements of the Pilot Program. The majority of the remaining cited
violations relate to vehicle maintenance issues. Further, FMCSA
reviewed the violations cited, and determined that the only violation
on a vehicle proposed for the pilot program was due to low air in a
tire and this defect was remedied.
    Lastly, FMCSA is aware that companies affiliated with GCC have had
SMS alerts. However, the Agency has confirmed that GCC Transportes was
not established to evade or conceal a negative safety performance
history by

those companies. The Agency monitors the safety of the affiliated
carriers through SMS and will take action on those carriers, as
appropriate.
    To date, no carriers have failed the PASA. The Act only requires
publication of data for carriers receiving operating authority, as
failure to successfully complete the PASA precludes the carrier from
being granted authority to participate in the long-haul pilot program.
FMCSA will publish this information to show motor carriers that failed
to meet U.S. safety standards.

Request for Comments

    In accordance with the Act, FMCSA requests public comment from all
interested persons on the PASA information presented in this notice.
All comments received before the close of business on the comment
closing date indicated at the beginning of this notice will be
considered and will be available for examination in the docket at the
location listed under the ADDRESSES section of this notice. Comments
received after the comment closing date will be filed in the public
docket and will be considered to the extent practicable. In addition to
late comments, the FMCSA will also continue to file, in the public
docket, relevant information that becomes available after the comment
closing date. Interested persons should continue to examine the public
docket for new material.
    FMCSA notes that under its regulations, preliminary grants of
authority, pending the carrier's showing of compliance with insurance
and process agent requirements and the resolution of any protests, are
publically noticed through publication in the FMCSA Register. Any
protests of such grants must be filed within 10 days of publication of
notice in the FMCSA Register.

Larry W. Minor,
Associate Administrator, Office of Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2012-19564 Filed 8-8-12; 8:45 am]
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