[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Notices]
[Pages 70327-70329]
[FR Doc No: 2013-28092]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2005-0022]

T[Uuml]V S[Uuml]D Product Services GmbH: Request for Renewal of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor

ACTION: Notice.

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SUMMARY: This notice announces T[Uuml]V S[Uuml]D Product Services
GmbH's application containing a request for renewal of recognition as a
Nationally Recognized Testing Laboratory (NRTL) under 29 CFR 1910.7.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before December 10, 2013.

ADDRESSES: Submit comments by any of the following methods:
    1. Electronically: Submit comments and attachments electronically
at http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    2. Facsimile: If submissions, including attachments, are not longer
than 10 pages, commenters may fax them to the OSHA Docket Office at
(202) 693-1648.
    3. Regular or express mail, hand delivery, or messenger (courier)
service: Submit a copy of comments and any attachments to the OSHA
Docket Office, Docket No. OSHA-2005-0022, Technical Data Center, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-2625,
Washington, DC 20210;

telephone:<PHONE_NUMBER> (TDY number:<PHONE_NUMBER>). Note that
security procedures may result in significant delays in receiving
comments and other written materials by regular mail. Contact the OSHA
Docket Office for information about security procedures concerning
delivery of materials by express delivery, hand delivery, or messenger
service. The hours of operation for the OSHA Docket Office are 8:15
a.m.-4:45 p.m., e.t.
    4. Instructions: All submissions must include the Agency name and
the OSHA docket number (OSHA-2005-0022). OSHA will place all
submissions, including any personal information provided, in the public
docket without revision, and these submissions will be available online
at http://www.regulations.gov.
    5. Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.
Contact the OSHA Docket Office for assistance in locating docket
submissions.
    6. Extension of comment period: Submit requests for an extension of
the comment period on or before December 10, 2013 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW., Room N-3655, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: David W. Johnson, Director, Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW., Room N-3655, Washington, DC 20210, phone<PHONE_NUMBER>, or
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    OSHA recognition of an NRTL signifies that the organization meets
the requirements in Section 1910.7 of Title 29, Code of Federal
Regulations (29 CFR 1910.7). Recognition is an acknowledgment that the
organization can perform independent safety testing and certification
of the specific products covered within its scope of recognition and is
not a delegation or grant of government authority. As a result of
recognition, employers may use products properly approved by the NRTL
to meet OSHA standards that require testing and certification. OSHA
maintains an informational Web site for each NRTL that details its
scope of recognition available at http://www.osha.gov/dts/otpca/nrtl/index.html.
    The Agency processes applications by an NRTL for renewal of
recognition following requirements in Appendix A to 29 CFR 1910.7. OSHA
conducts renewals in accordance with the procedures in 29 CFR 1910.7,
App. II.C. In accordance with these procedures, NRTLs would submit a
renewal request to OSHA, not less than nine months or no more than one
year, before the expiration date of its current recognition. A renewal
request would include a request for renewal and any additional
information the NRTL wishes to submit to demonstrate its continued
compliance with the terms of its recognition and 29 CFR 1910.7. If OSHA
has not conducted an on-site assessment of the NRTL headquarters and
any key sites within the past 18 months, it will schedule the necessary
on-site assessments prior to the expiration date of the NRTL's
recognition. Upon review of the submitted material and, as necessary,
the successful completion of the on-site assessment, OSHA announces its
preliminary decision to grant or deny renewal in the Federal Register
and solicit comments from the public. OSHA then publishes a final
Federal Register notice responding to any comments and renewing the
NRTL's recognition for a period of five years, or denying the renewal
of recognition.
    T[Uuml]V S[Uuml]D Product Services GmbH (TUVPSG) initially received
OSHA recognition as a Nationally Recognized Testing Laboratory on July
20, 2001 (66 FR 38032), for a five-year period ending on July 20, 2006.
TUVPSG submitted a timely request for renewal, dated October 10, 2005
(see Exhibit 1), and retained its recognition pending OSHA's final
decision in this renewal process. The current address of the TUVPSG
facility recognized by OSHA and included as part of the renewal request
is T[Uuml]V S[Uuml]D Product Services GmbH, Ridlerstrasse 65, D-80339,
Munich, Germany.

II. Notice of Preliminary Findings

    OSHA is providing notice that TUVPSG is applying for renewal of its
current recognition as a NRTL. This renewal covers TUVPSG's existing
NRTL scope of recognition. TUVPSG submitted an acceptable application
for renewal of its recognition as an NRTL on October 10, 2005. OSHA
evaluated TUVPSG's application for renewal and preliminarily determined
that TUVPSG can continue to meet the requirements prescribed by 29 CFR
1910.7 for recognition. Accordingly, OSHA is making a determination
that it does not need to conduct an on-site review of TUVPSG's
facilities based on its evaluations of TUVPSG's application and all
other available information, including its most recent audit of
TUVPSG's facility conducted on April 26, 2013, in which the auditors
found TUVPSG to be in conformance with all applicable NRTL
requirements. This preliminary finding does not constitute an interim
or temporary approval of the application.
    OSHA welcomes public comment as to whether TUVPSG meets the
requirements of 29 CFR 1910.7 for renewal of their recognition as an
NRTL. Comments should consist of pertinent written documents and
exhibits. Commenters needing more time to comment must submit a request
in writing, stating the reasons for the request. OSHA must receive the
written request for an extension by the due date for comments. OSHA
will limit any extension to 30 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if it is not
adequately justified. To obtain or review copies of the publicly
available information in TUVPSG's application and other pertinent
documents (including exhibits), as well as all submitted comments,
contact the Docket Office, Room N-2625, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address; these
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2005-0022.
    The NRTL Program staff will review all comments to the docket
submitted in a timely manner and, after addressing the issues raised by
these comments, will recommend whether to grant TUVPSG's application
for renewal. The Assistant Secretary will make the final decision on
granting the application and, in making this decision, may undertake
other proceedings prescribed in Appendix A to 29 CFR 1910.7. OSHA will
publish a public notice of this final decision in the Federal Register.

III. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for

Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to Section
8(g)(2) of the Occupational Safety and Health Act of 1970 (29 U.S.C.
657(g)(2)), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on November 19, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-28092 FILED 11-22-13; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Notices]
[Page 71179-71180]
[DOCID:fr25no05-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8635; 34-52800, File No. 265-23]

Advisory Committee on Smaller Public Companies

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting of SEC Advisory Committee on Smaller Public
Companies.

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    The Securities and Exchange Commission Advisory Committee on
Smaller Public Companies is providing notice that it will hold a public
meeting on Wednesday, December 14, 2005, in Multi-Purpose Room L006 of
the Commission's headquarters, 100 F Street, NE., Washington, DC 20549,
beginning at 9 a.m. The meeting is expected to last until approximately
4 p.m. with a lunch break from approximately noon to 1 p.m. The meeting
will be audio webcast on the Commission's Web site at http://www.sec.gov
.

    The agenda for the meeting includes consideration of proposals of
the Advisory Committee's four subcommittees on possible recommendations
for changes to the current securities regulatory system for smaller
companies. The public is invited to submit written statements for the
meeting.

    Due Date: Written statements should be received on or before
December 7, 2005.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

     Use the Commission's Internet submission form (http://www.sec.gov/info/smallbus/acspc.shtml.
); or     Send an e-mail message to<EMAIL_ADDRESS>Please

include File Number 265-23 on the subject line; or

Paper Statements

     Send paper statements in triplicate to Jonathan G. Katz,
Committee Management Officer, Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-9303.

    All submissions should refer to File No. 265-23. This file number
should be included on the subject line if e-mail is used. To help us
process and review your statement more efficiently, please use only one
method. The Commission staff will post all statements on the Advisory
Committee's Web site (http://www.sec.gov./info/smallbus/acspc.shtml).

    Statements also will be available for public inspection and copying
in the Commission's Public Reference Room, 100 F Street, NE., Room
1580, Washington, DC 20549. All statements received will be posted
without change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Kevin M. O'Neill, Special Counsel, at
(202) 551-3260, Office of Small Business Policy, Division of
Corporation Finance, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: In accordance with Section 10(a) of the
Federal Advisory Committee Act, 5 U.S.C.-App. 1, Section 10(a), and the
regulations thereunder, Gerald J. Laporte, Designated Federal Officer
of the Committee, has ordered publication of this notice.

    Dated: November 18, 2005.
Jonathan G. Katz,
Committee Management Officer.
 [FR Doc. E5-6516 Filed 11-23-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Rules and Regulations]
[Pages 11130-11131]
[FR Doc No: 2021-02909]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0121; FRL-10017-02-Region 9]

Air Plan Approval; California; South Coast Air Quality Management
District; Ventura County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the South Coast Air Quality Management
District (SCAQMD) and the Ventura County Air Pollution Control District
(VCAPCD) portions of the California State Implementation Plan (SIP).
These revisions concern emissions of volatile organic compounds (VOCs)
from the use and application of industrial adhesives. We are approving
local rules that regulate these emission sources under the Clean Air
Act (CAA or the Act).

DATES: Effective on March 26, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2020-0121. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (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 through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information. If you need assistance
in a language other than English or if you are a person with
disabilities who needs a reasonable accommodation at no cost to you,
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On September 3, 2020 (85 FR 54952), the EPA proposed to approve the
following rules into the California SIP:

----------------------------------------------------------------------------------------------------------------
       Local agency          Rule No.           Rule title                 Adopted               Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD...................         1168  Adhesive and Sealant        October 6, 2017......  May 23, 2018.
                                         Applications.
VCAPCD...................        74.20  Adhesives and Sealants....  October 9, 2018......  January 31, 2019.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve these rules because we determined that they
comply with the relevant CAA requirements. Our proposed action and
associated TSDs contain more information on the rules and our
evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received eight comments. Each of the comments
were supportive of the proposed action.

III. EPA Action

    No comments were submitted that change our assessment of the rules
as described in our proposed action. Therefore, as authorized in
section 110(k)(3) of the Act, the EPA is fully approving these rules
into the California SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
SCAQMD and the VCAPCD rules described in the amendments to 40 CFR part
52 set forth below. The EPA has made, and will continue to make, these
documents available through www.regulations.gov and at the EPA Region
IX Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 3,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and

     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 26, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

Signing Statement

    This document of the Environmental Protection Agency was signed on
December 11, 2020, by John Busterud, Regional Administrator, Region IX,
pursuant to a consent decree entered on December 4, 2020 in Our
Childrens Earth Foundation v. Wheeler, 4:20-cv-00396-JSW (N.D. Cal.).
That document with the original signature and date is maintained by
EPA. For administrative purposes only, and in compliance with
requirements of the Office of the Federal Register, the undersigned EPA
Official re-signs the document for publication, as an official document
of the Environmental Protection Agency. This administrative process in
no way alters the legal effect of this document upon publication in the
Federal Register.

    Dated: December 11, 2020.
John Busterud,
Regional Administrator, Region IX.

    Signed in Berkeley on February 5, 2021 by:
Deborah Jordan,
Acting Regional Administrator, Region IX.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends Part 52, Chapter I, Title 40 of the Code of
Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(362)(i)(B)(3),
(c)(429)(i)(A)(7), (c)(518)(i)(C), and (c)(545) to read as follows:

Sec.  52.220   Identification of plan-in part.

* * * * *
    (c) * * *
    (362) * * *
    (i) * * *
    (B) * * *
    (3) Previously approved on December 21, 2009 in paragraph
(c)(362)(i)(B)(1) of this section and now deleted with replacement in
(c)(518)(i)(C)(1), Rule 1168, ``Adhesive and Sealant Applications,''
amended on January 7, 2005.
* * * * *
    (429) * * *
    (i) * * *
    (A) * * *
    (7) Previously approved on August 30, 2013 in paragraph
(c)(429)(i)(A)(1) of this section and now deleted with replacement in
(c)(545)(i)(A)(1), Rule 74.20, ``Adhesives and Sealants,'' revised on
September 11, 2012.
* * * * *
    (518) * * *
    (i) * * *
    (C) South Coast Air Quality Management District.
    (1) Rule 1168, ``Adhesive and Sealant Applications,'' amended on
October 6, 2017.
    (2) [Reserved]
* * * * *
    (545) New regulations for the following APCDs were submitted on
January 31, 2019 by the Governor's designee as an attachment to a
letter dated January 23, 2019.
    (i) Incorporation by reference.
    (A) Ventura County Air Pollution Control District.
    (1) Rule 74.20, ``Adhesives and Sealants,'' revised on October 9,
2018.
    (2) [Reserved]
    (B) [Reserved]
    (ii) [Reserved]

[FR Doc. 2021-02909 Filed 2-23-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Notices]
[Pages 19990-19991]
[FR Doc No: 2019-09272]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2017-0002-N-5]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA), this notice
announces that FRA is forwarding the Information Collection Request
(ICR)

abstracted below to the Office of Management and Budget (OMB) for
review and comment. The ICR describes the information collection and
its expected burden. On October 26, 2018, FRA published a notice
providing a 60-day period for public comment on the ICR.

DATES: Interested persons are invited to submit comments on or before
June 6, 2019.

ADDRESSES: Submit written comments on the ICR to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW, Washington, DC 20503, Attention: FRA Desk Officer.
Comments may also be sent via email to OMB at the following address:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Ms. Rachel Grice, Engineering
Psychologist, Office of Railroad Policy & Development, Human Factors
Division, Federal Railroad Administration, 1200 New Jersey Avenue SE,
Washington, DC 20590 (telephone:<PHONE_NUMBER>); or Ms. Kim Toone,
Information Collection Clearance Officer, Office of Administration,
Office of Information Technology, Federal Railroad Administration, 1200
New Jersey Avenue SE, Washington, DC 20590 (telephone:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On October 26, 2018, FRA
published a 60-day notice in the Federal Register soliciting comment on
the ICR for which it is now seeking OMB approval. See 83 FR 54173. FRA
received one comment in response to this notice from the Transportation
Trades Department, AFL-CIO (TTD). TTD questioned the scope of the study
due to the intent to survey locomotive engineers, while excluding
conductors, whom TTD contends are equally likely to suffer additional
fatigue due to commute time. TTD explained that, like engineers,
conductors are required to perform a number of safety-sensitive
functions on the job, which can be hampered by fatigue. Additionally,
TTD notes the hours of service statute and regulations do not
differentiate between the two occupations, providing identical fatigue
protections for all ``train employees.'' To address these concerns, FRA
revised the scope of the study to include conductors in addition to
locomotive engineers. The inclusion of conductors will enable FRA to
get the most complete results from this study on fatigue conditions.
    Before OMB decides whether to approve this proposed collection of
information, it must provide 30 days for public comment. Federal law
requires OMB to approve or disapprove paperwork packages between 30 and
60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5
CFR 1320.10(b); see also 60 FR 44978, 44983, Aug. 29, 1995. OMB
believes the 30-day notice informs the regulated community to file
relevant comments and affords the agency adequate time to digest public
comments before it renders a decision. 60 FR 44983, Aug. 29, 1995.
Therefore, respondents should submit their respective comments to OMB
within 30 days of publication to best ensure having their full effect.
    Comments are invited on the following ICR regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: The Impact of Commute Times on the Fatigue and Safety of
Locomotive Engineers and Conductors.
    OMB Control Number: 2130-NEW.
    Abstract: Time-on-task and time awake are two well-known factors
that contribute to fatigue. Time-on-task refers to the length of time a
person has been performing a task, whereas time awake refers to the
length of time since a person last slept. Both these factors can have a
detrimental effect on performance, with the risk of adverse safety
events (e.g., crashes) increasing as the length of time that a person
performs a task or remains awake increases. These factors also
influence each other; that is, the negative effects of increasing time-
on-task may become evident sooner if the person has also been awake for
a long time. Drivers with longer commutes experience greater time awake
and time-on-task than drivers with shorter commutes. A growing body of
evidence from a number of industries (e.g., medical, mining, long-haul
trucking) suggests that commuting time has a detrimental impact on
driving performance, particularly when combined with night-time shift
work. However, the extent to which these factors impact the fatigue and
safety of locomotive engineers and conductors remains unknown.
    Type of Request: New information collection.
    Affected Public: Railroad Workers.
    Form(s): FRA F 245.
    Respondent Universe: 69,000 total (31,000 locomotive engineers and
38,000 conductors).
    Frequency of Submission: Single submission per person.
    Reporting Burden: The estimated total annual burden is 3,450 hours
across the 10,350 locomotive engineers and conductors (estimating a 15%
response rate). Each respondent completes a single online questionnaire
and the questionnaire is estimated to take 20 minutes.
    Total Estimated Annual Responses: 10,350 responses.
    Total Estimated Annual Burden: 3,450 hours.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Chief Counsel.
[FR Doc. 2019-09272 Filed 5-6-19; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Page 16567]
[FR Doc No: 2013-06048]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration (FAA)

Notice of Opportunity for Public Comment on Non-Rule Making
Action To Change Land Use From Aeronautical to Non-Aeronautical at
Mobile Downtown Airport, Mobile, Alabama

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: Under the provisions of Title 49, U.S.C. Section 47153(c),
notice is being given that the FAA is considering a request from the
Mobile Airport Authority to waive the requirement that a 72.13 acre
parcel of surplus property, located on Mobile Downtown Airport, be used
for aeronautical purposes.

DATES: Comments must be received on or before April 15, 2013.

ADDRESSES: Comments on this notice may be mailed or delivered in
triplicate to the FAA at the following address: Jackson Airports
District Office, Attn: William Schuller, Program Manager, 100 West
Cross Street, Suite B, Jackson, MS 39208-2307.

    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Thomas Hughes, Director of Aviation, Mobile
Airport Authority at the following address: P.O. Box 88004, Mobile, AL
36608-0004.

FOR FURTHER INFORMATION CONTACT: William Schuller, Program Manager,
Jackson Airports District Office, 100 West Cross Street, Suite B,
Jackson, MS 39208-2307,<PHONE_NUMBER>. The application may be reviewed
in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing an update to the Mobile
Downtown Airport layout plan submitted by the Mobile Airport Authority.
The airport layout plan update, if approved, would change the land use
on 72.13 acres from aeronautical to non-aeronautical. The property will
then be leased for Commercial Development. The location of the land
relative to existing or anticipated aircraft noise contours greater
than 65ldn are not considered to be an issue. The proceeds from the
lease of this property will be used for airport purposes. The proposed
use of this property is compatible with airport operations.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the request,
notice and other documents germane to the request in person at the
Mobile Downtown Airport.

    Issued in Jackson, Mississippi, on March 7, 2013.
Rans D. Black,
Manager, Jackson Airports District Office, Southern Region.
[FR Doc. 2013-06048 Filed 3-14-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62884-62887]
[FR Doc No: 2011-26103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65473; File No. SR-BATS-2011-043]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Fees for Use of BATS Exchange, Inc.

October 3, 2011 .
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 30, 2011, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange.

The Exchange has designated the proposed rule change as one
establishing or changing a member due, fee, or other charge imposed by
the Exchange under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-
4(f)(2) thereunder,\4\ which renders the proposed rule change effective
upon filing with the Commission. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes amend the fee schedule applicable to Members
\5\ and non-members of the Exchange pursuant to BATS Rules 15.1(a) and
(c). While changes to the fee schedule pursuant to this proposal will
be effective upon filing, the changes will become operative on October
3, 2011.
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    \5\ A Member is any registered broker or dealer that has been
admitted to membership in the Exchange.
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    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to modify the ``Options Pricing'' section of
its fee schedule to: (i) Decrease the fees applicable to Customer \6\
orders that remove liquidity from the BATS options market (``BATS
Options''); (ii) eliminate a pricing structure that provides a Firm \7\
or Market Maker \8\ a reduced fee to remove liquidity if such Firm or
Market Maker satisfies certain volume thresholds; (iii) increase the
rebate applicable to Customer orders that add liquidity to BATS
Options; (iv) modify the rebates paid, subject to average daily volume
requirements, for orders that set either the national best bid (the
``NBB'') or the national best offer (the ``NBO''); and (v) modify a
program intended to incentivize sustained, aggressive quoting in
certain specified options series (the ``Quoting Incentive Program'' or
``QIP'').
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    \6\ As defined on the Exchange's fee schedule, a ``Customer''
order is any transaction identified by a Member for clearing in the
Customer range at the Options Clearing Corporation (``OCC'').
    \7\ As defined on the Exchange's fee schedule, a ``Firm'' order
is any transaction identified by a Member for clearing in the Firm
range at the OCC.
    \8\ As defined on the Exchange's fee schedule, a ``Market
Maker'' order is any transaction identified by a Member for clearing
in the Market Maker range at the OCC.
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(i) Decrease to Customer Liquidity Removal Fees
    The Exchange currently charges standard fees of $0.32 per contract
for Customer orders that remove liquidity from BATS Options. The
Exchange proposes to decrease this fee to $0.30 per contract, subject
to potential reduction for any Member with an ADV of 0.30% or more of
average TCV on BATS Options, as described below.
    The Exchange currently maintains a tiered pricing structure through
which Members can realize lower liquidity removal fees if such Members
have an average daily volume (``ADV'') \9\ equal to or greater than
0.30% of average total consolidated volume (``TCV'').\10\ For Members
reaching this volume threshold, the Exchange currently charges a fee of
$0.29 per contract for Customer orders. Thus, such Members currently
save $0.03 per contract as compared to the standard fee to remove
liquidity. While the Exchange proposes to maintain this $0.03 savings
per contract for Customer orders for Members that reach the volume
tier, due to the proposed decrease described above for standard
liquidity removal, the Exchange proposes to decrease liquidity removal
fees for Members that reach the volume tier by $0.02 per contract for
Customer orders. Accordingly, for Members reaching the volume
threshold, the Exchange will charge a fee of $0.27 per contract for
Customer orders.
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    \9\ As defined on the Exchange's fee schedule, ADV is average
daily volume calculated as the number of contracts added or removed,
combined, per day on a monthly basis. The fee schedule also provides
that routed contracts are not included in ADV calculation.
    \10\ As defined on the Exchange's fee schedule, TCV is total
consolidated volume calculated as the volume reported by all
exchanges to the consolidated transaction reporting plan for the
month for which the fees apply.
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(ii) Elimination of Liquidity Removal Discount for Firms and Market
Makers
    As explained above, the Exchange currently maintains a tiered
pricing structure through which Members can realize lower liquidity
removal fees if such Members have an ADV equal to or greater than 0.30%
of average TCV. For Members reaching this volume threshold, the
Exchange currently charges a fee of $0.39 per contract for Firm and
Market Maker orders, which is $0.03 less than the standard fee of $0.42
for such orders. The Exchange proposes to eliminate the reduced
liquidity removal fee for Firm and Market Maker orders of Members that
reach the volume threshold. Accordingly, the Exchange proposes to
charge a fee of $0.42 per contract for all Firm and Market Maker orders
that remove liquidity from BATS Options.
(iii) Increase to Customer Rebates to Add Liquidity
    The Exchange currently provides a rebate of $0.22 per contract for
Customer orders. The Exchange proposes to increase this rebate to $0.30
per contract. As is the case under the current pricing structure, the
removing Member's fee will be determined without regard to the capacity
of the adding party.
(iv) Modified Rebates for NBBO Setter Rebate Program
    The Exchange currently offers a rebate upon execution for all
orders that add liquidity that sets either the NBB or NBO (the ``NBBO
Setter Rebate''),\11\ subject to certain volume requirements. The NBBO
Setter Rebate currently offered by the Exchange to such Members is
$0.35 per contract for Members with an ADV equal to or greater than
0.30% of average TCV but less than 1% of average TCV and $0.45 per
contract for Members with an ADV equal to or greater than 1% of TCV.
The NBBO Setter Rebate is currently an exclusive rebate structure, in
that qualifying executions receive the applicable rebate irrespective
of any other condition. For instance, an execution that qualifies for
both the NBBO Setter Rebate and the Quoting Incentive Program (as
described below), would simply receive the NBBO Setter

Rebate and the Quoting Incentive Program would not alter the amount of
the rebate. The Exchange proposes to modify the NBBO Setter Rebate such
that it is additive, and thus, can be combined with other incentives
and structures offered by the Exchange. Specifically, the Exchange
proposes to provide an additional $0.06 per contract for executions
that qualify for the NBBO Setter Rebate by Members with an ADV equal to
or greater than 0.30% of average TCV but less than 1% of average TCV
and an additional $0.10 per contract for qualifying executions by
Members with an ADV equal to or greater than 1% of TCV. Accordingly, a
Member with an execution in an option that qualifies for both an NBBO
Setter Rebate and a QIP rebate (as described below) will receive the
applicable initial rebate of $0.22, $0.30, or $0.32 (depending on the
capacities of the party or parties to the trade), plus the proposed QIP
rebate of $0.05 per contract plus the applicable NBBO Setter Rebate of
either $0.06 per contract or $0.10 per contract. As such, whether the
NBBO Setter Rebate is an increase or decrease for any particular Member
or any particular transaction depends on a number of factors, including
the level of a Member's monthly trading activity on the Exchange,
whether such Member qualifies for the QIP in the applicable option, the
capacity of the orders sent by the Member and, in the case of Firms and
Market Makers, the capacity of the party against which such orders
execute.
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    \11\ An order that is entered at the most aggressive price both
on the BATS Options book and according to then current OPRA data
will be determined to have set the NBB or NBO for purposes of the
NBBO Setter Rebate without regard to whether a more aggressive order
is entered prior to the original order being executed.
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(v) Modification of Quoting Incentive Program (QIP)
    BATS Options currently offers a Quoting Incentive Program (QIP),
through which Members receive a rebate of $0.03 per contract, in
addition to any other liquidity rebate other than an NBBO Setter
Program liquidity rebate, for executions subject to the QIP. The QIP
currently applies only to executions in options overlying XLF, CSCO,
PFE, ORCL, and XRT. To qualify for the QIP a BATS Options Market Maker
must be at the NBB or NBO 70% of the time for series trading between
$0.03 and $5.00 for the front three (3) expiration months in that
underlying during the current trading month. A Member not registered as
a BATS Options Market Maker can also qualify for the QIP by quoting at
the NBB or NBO 80% of the time in the same series.
    The Exchange proposes two changes to the QIP. First, the Exchange
proposes to increase the rebate provided pursuant to the QIP from $0.03
per contract to $0.05 per contract. Second, the Exchange proposes to
expand the QIP from executions in options overlying specified
securities (XLF, CSCO, PFE, ORCL, and XRT) to all options traded on
BATS Options. All other aspects of the QIP currently in place will
remain the same, though the Exchange does propose changing the
description of the QIP on the Exchange's fee schedule because, as
described above, the Exchange proposes to permit QIP rebates to be
combined with NBBO Setter Rebates. Accordingly, a Member with an
execution in an option that qualifies for both the QIP and an NBBO
Setter Rebate will receive the applicable initial rebate of $0.22,
$0.30, or $0.32 (depending on the capacities of the party or parties to
the trade), plus the $0.05 per contract QIP rebate plus the applicable
NBBO Setter Rebate of either $0.06 per contract or $0.10 per contract.
    As is true under the current operation of the QIP, the Exchange
will determine whether a market maker qualifies for QIP rebates at the
end of each month by looking back at each Member's (including BATS
Options Market Makers) quoting statistics during that month. If at the
end of the month a Market Maker meets the 70% criteria or a Member that
is not registered as a BATS Options Market Maker meets the 80%
criteria, the Exchange will provide the additional rebate for all
executions subject to the QIP executed by that Market Maker or Member
during that month. The Exchange will provide Members with a report on a
daily basis with quoting statistics so such Members can determine
whether or not they are meeting the QIP criteria. The Exchange is not
proposing to impose any ADV requirements in order to qualify for the
QIP at this time.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\12\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\13\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The changes to Exchange execution fees and rebates proposed by this
filing are intended to attract order flow to the Exchange by continuing
to offer competitive pricing while also creating incentives to
providing aggressively priced displayed liquidity. The proposed changes
to Customer pricing, including the increase to the rebate provided for
Customer orders and decrease to the fee to take liquidity from the
Exchange are designed to incentivize firms to send additional Customer
orders to the Exchange. While certain Members that currently reach the
volume threshold and remove liquidity from the Exchange with Firm and
Market Maker orders will pay higher fees due to the proposal, the
increased revenue received by the Exchange will be used to fund
programs that the Exchange believes will attract additional liquidity,
including Customer liquidity, and thus improve the depth of liquidity
available on the Exchange. Accordingly, the Exchange believes that the
higher access fees for Firm and Market Maker orders will benefit
Members' results in trading on the Exchange to the extent the pricing
structure offered by the Exchange with respect to Customer orders, the
continued operation of the NBBO Setter Program, and the expansion to
the Quoting Incentive Program (QIP) incentivize liquidity providers to
provide more aggressively priced liquidity.
    Despite the increase in fees for Members that currently receive a
discount when removing liquidity with Firm or Market Maker orders, the
Exchange also believes that its proposed fee structure is fair and
equitable as the Exchange's standard fees generally still remain lower
than standard fees charged by other markets with similar fee
structures, such as NYSE Arca and Nasdaq.
    The Exchange believes that continuing to base its tiered fee
structure and NBBO Setter Program based on overall TCV, rather than a
static number of contracts irrespective of overall volume in the
options industry, is a fair and equitable approach to pricing. Volume-
based tiers such as the tiers in place on the Exchange have been widely
adopted in the equities markets, and are equitable and not unfairly
discriminatory because they are open to all members on an equal basis
and provide rebates that are reasonably related to the value to an
exchange's market quality associated with higher levels of market
activity, such as higher levels of liquidity

provision and introduction of higher volumes of orders into the price
and volume discovery process. Accordingly, the Exchange believes that
the proposal is not unfairly discriminatory because it is consistent
with the overall goals of enhancing market quality.
    Additionally, the Exchange believes that the proposed expansion of
the Quoting Incentive Program, which is similar to a fee structure in
place on at least one of the Exchange's competitors,\14\ will further
incentivize the provision of competitively priced, sustained liquidity
that will create tighter spreads, benefitting both Members and public
investors. The Exchange also believes that conditioning a Member's
ability to receive the QIP's additional rebate on reaching one of the
Exchange's quoting tiers is consistent with the Act for the reasons
described above with respect to volume-based tiers. The Exchange also
believes that providing a slightly lower threshold for meeting the QIP
to registered BATS Options Market Makers appropriately incentivizes
Members of BATS Options to register with the Exchange as Options Market
Makers. While the Exchange does wish to allow participation in the QIP
by all Members, the Exchange believes that registration by additional
Members as Market Makers will help to continue to increase the breadth
and depth of quotations available on the Exchange. The Exchange notes
that in addition to the fact that the QIP will be available to all
Members, the proposal is not unfairly discriminatory despite a slightly
higher quotation requirement for non-Market Makers due to the fact that
registration as a BATS Options Market Maker is equally available to all
Members.
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    \14\ See Securities Exchange Act Release No. 61869 (April 7,
2010), 75 FR 19449 (April 14, 2010) (SR-ISE-2010-25) (notice of
filing and immediate effectiveness of changes to fees and rebates
including adoption of specific rebates for market makers qualifying
for the Market Maker Plus program).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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

    No written comments were solicited or received.

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

    Pursuant to Section 19(b)(3)(A)(ii) of the Act \15\ and Rule 19b-
4(f)(2) thereunder,\16\ the Exchange has designated this proposal as
establishing or changing a due, fee, or other charge applicable to the
Exchange's Members and non-members, which renders the proposed rule
change effective upon filing.
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    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \16\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2011-043 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-BATS-2011-043. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing will also be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BATS-2011-043 and should be
submitted on or before November 1, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-26103 Filed 10-7-11; 8:45 am]
BILLING CODE 8011-01-P


Note to Docket EPA-HQ-OAR-2009-0837

At 10 a.m. on December 9, 2010, at 1310 L Street, Washington, D.C., EPA
representatives Ragan Tate (OGC), John Schakenbach (OAR), and Bob
Vollaro (OAR) met with Lauren Freeman of Hunton & Williams representing
the Utility Air Regulatory Group (UARG) and Lisa Jaeger of Bracewell &
Giuliani LLP representing Air Liquide in settlement discussions related
to the Petition for Review filed by UARG, and the Petition for Review
and Petition for Reconsideration filed by Air Liquide relating to
January 24, 2008 amendments to the Protocol Gas Verification Program and
Minimum Competency Requirements for Air Emission Testing provisions of
40 CFR Part 75.


                      EPA HCl Performance Specification
                          Stakeholder Kickoff Meeting
                            Conference Call Summary
                            Tuesday, May 17, 2011

1) Welcome  -  Introduction  -  Purpose
   EPA is gathering information from instrument and gas vendors, affected facilities, testers, and regulatory bodies with experience performing continuous measurements of HCl from stationary source emissions.  At a conference call Attendees (Attachment 1) provided stakeholder perspective on the current state of the science for CEM systems used to measure HCl in stationary source emission gases.

2) Technology discussion from the instrument vendor perspective
   Table 1 summarizes the current instruments from equipments vendors participating in the call.  Vendors are shown in alphabetical order. Additional comments from equipment vendors include descriptions of their systems and how they are used for field measurements.  A summary of these comments are provided below.
   Thermofisher
   Thermofisher offers a GFC system.  Water is removed as an interferent from the emissions gas using a permapure dryer system. GFC equipment is based on the standard simple rack mount design used for other Thermofisher CEMS equipment. The system has longer response time than their FTIR system approach to HCl monitoring.  That means the GFC has to be conditioned longer and calibrations are required more frequently.  The GFC is subject to more interference.

   Thermofisher is also gaining experience with FTIR HCl measurement. Lab and field evaluations are being conducted in waste incinerator, power utility and cement plant gas streams with up to 40% moisture. FTIR is more complicated and more expensive than the GFC system.  Thermofisher uses twice the standard deviation of the zero noise to determine detection limit. Hot, wet operation is a challenge at higher moisture levels.  The advantage of FTIR is the opportunity to perform multi-component analysis with one instrument.
   Sick-Maihak
   Sick-Maihak offers GFC, FTIR and TDLS bases HCl monitors.  All systems are run hot and wet. The Sick-Maihak GFC is a multi-component capable system.  Cross interferences are measured real time and used to process the data. The simplicity of the GFC makes this technology easier to operate in the field. Sick-Maihak has more field experience with the GFC and has tested this technology at cement production, waste combustion, and power generation sites.  The Sick-Maihak TDLS system can be used as extractive, cross stack or insitu with a probe.  TDLS are less susceptible to cross interference because of the narrow wavelength range generated by the laser. Less interference and a stronger optical source allows lower detection limits.

   Table 1 Summary of Conference Call Vendors and Technologies
                                    Vendor
                                Technology Base
                           Extractive or Cross Stack
                                  Wet or Dry
                             Lab Detection Limit
                                     (ppm)
                               Full Scale Range
                                     (ppm)
                                Averaging Time
                              Initial Calibration
                           Field Performance Checks
ABB
FTIR (1 - 2 wavenumber resolution)
Extractive
                                    Hot Wet
                                  0.1 to 0.2

HovaCal-Hot Wet at instrument detector
Checked at the analyzer/cell
Altech Environment
GFC - multicomponent

                   Permapure(R) water removal at the detector

HovaCal-Hot Wet at instrument detector
Checked at the analyzer
Altech Environment
FTIR

CEMTECK
CRDS
Extractive
                                      Wet
                                     0.2
0  -  3

CEMTECK
TDL
Cross Stack or extractive
                               Insitu or hot/wet
                                      0.2

Eco Chem analytics
GFC - multicomponent
Extractive
                                    Hot Wet
                                      0.1
0  -  10

HovaCal-Hot Wet at instrument detector
HCl Certified cylinder Gas
Gasmet
FTIR (8 wave number resolution)
Extractive

                                      0.1

HovaCal-Hot Wet at instrument detector
Can be checked at probe or analyzer
MKS Instruments
FTIR (0.5 wavenumber resolution)
Extractive
                                    Hot Wet
                                      0.1

                                     1 min

Sick-Maihak
FTIR (0.5 wavenumber resolution)
Multi Component
                                    Hot Wet
                                      0.1

Sick-Maihak
GFC
Multi
Component
                                    Hot Wet
                                      0.2

At the analyzer
Sick-Maihak
TDLS
Extractive and insitu
                                    Hot Wet
                                      0.1
0  -  5

Thermo fisher
FTIR (0.4 wavenumber resolution)
Extractive
                                    Hot Wet
                                      0.1
10  -  100's

HovaCal-Hot Wet at instrument detector
Can be checked at probe or analyzer
Thermo fisher
GFC
Extractive
                   Permapure(R) water removal at the detector
                                      0.2
5   -  5000
5 min
HovaCal-Hot Wet at instrument detector

FTIR  -  Fouier Transform Infrared
GFC  -  Gas Filter Correlation
TDLS  -  tunable diode laser spectroscopy.

   MKS instruments
   MKS instruments is currently testing a multi-component FTIR, extractive CEM that measures HCl in hot wet gas. The system has been operated up to 40% moisture.  FTIR is more expensive than a single component analyzer. Other components measured include hydrocarbons, NOx, SOx, HF, CO, and CO2. Challenges measuring HCl involve sampling rather than instrument analysis. MKS prefilter the gas stream.
   ABB
   ABB offers an FTIR CEM for HCl similar to those described by other vendors except their unit operates at a resolution of 1 to 2 wave numbers.
   Cemtech
   Cemtech offers a TDL and a laser based cavity ring down (CRDS) CEM unit for HCl monitoring.  The TDL technology offers a fiber coupled optical system which allows the optical system to be remotely located from the measurement location.  This technology can be multiplexed which allows the laser to be directed to multiple lines of sight or locations.  These systems are offered as cell based extractive or cross stack units.

   The CRDS unit that operates at reduced pressure to maintain stack emissions in the gas phase. No other sample conditioning is performed for this unit.  The gas is maintained at 50 C.  The sampling system uses a critical orifice through a filter sampling at 3 L/hour. The low pressure sampling and analysis system reduces or eliminates interference.  The probe and transfer line is fused silica lined and heated to 50 C to improve response time. The CRDS system can be used for multiple components by adding lasers or adding an optical bench that can be multiplexed with the system to measure at appropriate wavelengths for each component. The same probe, umbilical transport line and pumps are used for single or multiple analyte configurations.  Typical applications merge water measurement with HCl measurement. CRDS cell is maintained at a constant temperature and pressure.  The effective path length for this application is approximately 10 kilometers.  Therefore, the sample pressure can be reduced which keeps materials in the gas phase and narrows spectral lines thus reducing interference.  Cell sizes range from 5 to 10 inches consistent with small rack mountable CEMS.  Cemtech will perform its first field trial at a cement plant in July of 2011.  This system is currently operational at a waste water treatment facility and a waste incinerator.
   Gasmet Technologies
   Gasmet Technologies offers an FTIR HCl CEM system that has been installed in multiple locations in Europe including cement plants and waste incinerators.  The system measures multiple gases.  Less resolution is used to improve detection limits by reducing noise.

   Eco Chem Analytics

   Eco Chem Analytics has experience with a hot, wet, multi-component CEM system based on GFC technology.  Their GFC monitor measures eight (8) total gases including HCl, water and up to 6 other interfering compounds.  Units are installed in multiple U.S. facilities such as municipal waste water facilities and chemical facilities.

   Altech has experience with multi-component CEM system based on GFC technology. Installations include cement plants and municipal waste incinerators.

   Altech Environment

   Systems currently offers GFC multi-component system.  US installations include cement plants, and municipal waste incinerators.  Altech also has experience using FTIR to measure HCl through its support to European facilities.

3) Initial Calibration, System Checks

   Vendors perform calibration of new units at the factory. Vendors perform initial calibration using the HovaCal equipment or certified gas cylinders.    HovaCAL equipment is used (ABB, Altech Environment, Thermofisher) to generate various concentrations of HCl at temperatures as high as 375 F and up to 40% moisture.  HovaCal vaporizes an aqueous solution of the compound(s) of interest.  Instrument initial calibration is done during production.

   Some Gas Filter Correlation vendors (Thermofisher, Altech Environment) reduce or remove water interference by membrane (Permapure(R)) drying the gas stream. Residual water after membrane dryers can be measured by IR and appropriate corrections can be included if necessary. FTIR systems are initially calibrated using the HovaCAL and with certified gas cylinders (Thermofisher).

   Cross stack TDL (CemTech) is calibrated during manufacturing at the factory.  An internal gas cell is used to lock the laser and to calibrate or check calibration.  The laser light is redirected through the cell in line with the measurement path to perform a span and off peak zero check.  The frequency of span and off peak zero check is programmable.  In the field a span check is typically performed once every 24 hours.  The frequency of calibration checks of instrument performance are programmable using a constant pressure constant temperature cell in the optical measurement path.  This performance check acts as a matrix spike interference check on the instrument performance. Since the calibration is based on a ratio of the cell path length (typically multiple cm) and the measurement path length, the concentration in the cell is not as constrained as other methods and certified calibration gas can be used that is much higher concentration. Path length is measured independently and entered into system software allowing continuous concentration reporting. Temperature and pressure corrections need to be made to compensate for the difference between stack and reference cell conditions.

   Initial manufacturing setup for CRDS-TDL systems involves evaluation of the optical spectra for a new target gas and potential interfering gases.  A laser wavelength is selected from available TDLs that best match the sensitivity and lack of spectral interference found in the optical spectra review.  A wavelength specific to that laser is selected where there is no spectral overlap of any of the interfering gases including moisture with the target gas.  Once the new monitoring system is fabricated, it is evaluated using laboratory generated test gas that includes up to 50% moisture to demonstrate interference free measurement of the target gas.  The system is also tested with other common emission gases to ensure interference free operation.  The system is calibrated with known concentrations of calibration gas as part of the manufacturing process.

4) Field Calibration/Drift Checks and Dynamic Spike Performance Checks

   Field calibration checks are intended to verify the manufacturing calibration. Two types of field calibration checks and drift checks were discussed for FTIR and GFC. Some vendors reported checking instrument performance with hot wet gas at the instrument detector using HovaCal equipment.  Others report checking field performance using certified cylinder gas either through the probe or at the instrument detector.

   The HovaCAL hot wet instrument is more difficult to use in the field due to weight and complexity.  Performance checks done under hot wet conditions with the HovaCal equipment reduce conditioning and response time.  Vendor preference, in general, is to check instrument calibration and drift at the instrument cell/detector with the HovaCal and not to use the equipment on the stack to perform through the probe system checks.  Recalibration using the HovaCal to evaluate water vapor interference in the field is performed yearly (Eco Chem Analytics), typically when Relative Accuracy (RATA) is performed.

   Vendors and testers also use Certified HCl gas cylinders to recalibrate or check the instrument calibration in the field.  Through the probe system performance checks have been done using dry cylinder gases. For field calibration testers can flood the probe with cylinder gas at each concentration of interest.  Checking instrument performance with a certified (dry) HCl gas cylinder can take 20 minutes or more to stabilize through the probe. In Europe it is not common to check HCl field calibration through the probe.  Instead, European systems are challenged directly at the analyzer detector.  When TUV tested HCl monitors using the HovaCal hot wet calibration gas they found response times on the order of 3 minutes.  Gasmet does field performance checks at the analyzer and checks sample line integrity through the probe with NO or SO2 cylinder gas.

   Field performance checks of CRDS-TDL systems are performed through the probe using silica coated stainless steel lines from the cal gas supply to the probe.  Since this system samples at about 3 L/hour, and calibration checks take about 10 minutes, very little calibration gas is needed.   Gas can be run directly to the analyzer as a check of sample line integrity. Zero check of this system occurs every 10 seconds (6 times a minute) by turning off the laser and measuring background signal.

   Facilities needing to measure HCl at 3 ppm or lower, the calibration and linearity of the equipment become significant issues.   In the field, facilities check their equipment and vendor supplied spectra using the best quality gas standard they can find. The best spectra to use in the field are those that are generated on the equipment with known concentration of known quality gas standards.  These instrument specific reference spectra are important for low concentration measurements.  In addition to the target gas, spectra of interferents such as water and carbon dioxide are important.

5) What's the alternative to RATAs, are they necessary

   Dynamic spikes have been performed in numerous field tests (GFC and FTIR systems), and the most difficult challenge to this approach is measuring HCl in the presence of alkaline particulate (e.g., lime) as is found at cement plants.  Dynamic spikes less than 10% of the gas volume from the stack provide a robust challenge that evaluates the effect of both interfering gases and reactive particulate during HCl CEM field tests or monitoring programs.  This approach is consistent with PS-15.  Stakeholders did not know of a manufacturer or test facility that performed long term dynamic spiking to support continuous monitoring of HCl.  However, Eco Chem reports that the HovaCal can be programmed to produce a variety of concentrations in any sequence required.  Sources with both HCl and ammonia emissions pose a particular problem for performance checks because of the acid base reaction potential between these two gases.  Emissions Testing Inc. reports making measurements of HCl above 180 C to minimize this reaction.  However, the accumulated alkaline dust on the sample conditioning filter scrubs significant amounts of HCl from the gas stream.    Analyte spikes of at least 10% of the gas stream leave the sample relatively "undisturbed" resulting in a true check of the measurement performance.  While the standard version of the HovaCal can perform episodic dynamic spiking it is not an automated system and requires dedicated operator oversight to function properly. Eco Chem reports that a "process" version of the HovaCal can produce a daily dynamic spike without an operator continuously onsite.  However, current facility experience with through the probe dynamic spiking suggests it is difficult and time consuming on a periodic basis and not demonstrated for use on a continuous basis.  Regular dry gas spiking is performed and data exists but may not be related to instrument agreement with reference methods during (RATAs).

   Thermofisher reports plans to manufacture units that allow dynamic spiking and it is their intent to evaluate monitor performance over the next several months as they field test their instrument designs.  Thermofisher also plans to use SF6 as a tracer (for FTIR monitor tests) to evaluate dynamic spiking with a stable easily measured compound.

   From a facility standpoint, many current compliance systems (Altech, SICK, Eco Chem and TDL systems) use dry cylinder gas for performance and calibration spikes.  Typical measurement ranges for current compliance systems are between 0 and 25 ppm.  Current compliance levels are 25 ppm.

   The current cement rule poses a related challenge since it requires measuring a 30 day rolling average with a limit of 3 ppm.  Contemporary cement plants with in line raw mills the emissions are 10 times higher when the raw mill is off, which may translate to the need to measure 0.5 ppm for ~90% of the time to compensate for 10% of the time when the plan generates 15 ppm when the mill is off.  Since quantification limits are higher than the 0.1 to 0.2 ppm detection limit, demonstrating compliance may be a daunting task with today's measurement equipment.  The stakeholders will need an agreement on the relationship between the detection limit and the practical quantitation limit to determine if current measurement equipment can measure emissions present 90% of the time. As sampling systems age between maintenance intervals, the effective quantitation limits change.

6) Frequency of Performance checks

   Vendors or facilities conduct performance checks weekly in Great Britain.  Based on performance data, facilities can petition for less frequent checks if they demonstrate instrument stability for longer than a week.  The maximum time between checks is the maintained interval of the instrument, approximately 90 days.  European tests to evaluate monitor stability and calibration drift require field tests over a year period before reduced performance check schedules are approved.  The stability test requires two identical units evaluated over at least 2 performance or maintenance periods based on CEN requirements.

   In Europe, each country defines specific performance check frequency which can be stricter than the CEN standard.  Some European countries require more frequent performance check after the initial performance period, but none require daily checks.

7) Protocol Gases  -  Availability and Certification

Gas Vendors (Airgas and Linde) reported availability of HCl gas in cylinders at 10 ppm to 1% using FTIR.  Compressed gas under 1000 ppm is shippable in aluminum cylinders, however the vendors agreed nickel lined steel cylinders were preferable for stability.  The main issues with lower level certified standard preparation involve stability in cylinders and availability of NIST certified standards as a check on vendor certification analysis accuracy.  Vendors highly recommend using nickel lined cylinders. Some states that have HCl compliance requirements require nickel lined gas cylinders for HCl standards.  Vendors agreed that nickel lined or treated hardware (e.g., regulators) may be needed to spike HCl at concentrations below 10 ppm.  Moisture is also a key issue in the transport and stability of HCl.  Any moisture in the valve or regulator will bias results low due to reactions with the cylinder valve or regulator.  Gas vendors and testers added that keeping regulators on the cylinders once they are first put into service minimizes water contamination of the valve and regulator.

The analytical accuracy certified by the vendors for gasses from 10 ppm up to 1% is about 3%.  Below 10 ppm vendors are only willing to certify gas cylinders to  10% because the gas vendors do not have a traceable standard to compare to their measurements.  Vendors report NIST is currently capable of certifying gas to 2% accuracy.  Analysis is performed using (heated cell?) FTIR.  Airgas uses MKS equipment and vendor supplied library calibration curves to determine cylinder gas concentration.  The MKS spectra are traceable to HITRAN spectra.  For gasses at higher concentrations (i.e., from 1000 ppm to 1%) Airgas performs wet chemical analysis of HCl cylinder gas. Low concentration (1000 ppm) wet chemical analysis of HCl cylinder gas can be compared to FTIR results to verify FTIR determined concentrations.  Linde follows a similar process with a different IR vendor's equipment. They also compare the results from wet chemical analysis to the FTIR.

The challenge for gas vendors is NIST standard availability.  The request has been made through the process of upgrading the "Green Book" to encourage NIST to generate a certified gas standard for HCl.  The request for NIST support involves preparation of a NIST prime, or preferably a batch of NIST reference gas materials available for gas vendor purchase and use as a reference in the HCl gas certification process.  Without an NIST standard HCl gas there is no inter-comparison of vendor generated standard gases. Gas vendors believe NIST can generate a stable reference gas material no sooner than 18 months from the time they start. Frank
Guenther is the NIST contact for this activity.

Gas vendors report the ability to generate gas in cylinders at less than 10 ppm if a NIST standard was available to check the certified concentration.  The analytical uncertainty increases to 10% for standards prepared below 10 ppm because there is no (NIST) gas standard to check the bias of their results.  Certified standard gas cylinders in the range of 10 ppm to 1% are stable for 12 months. Vendor's best estimate of stability in the absence of a NIST low concentration HCl standard, for gas less than 10 ppm will be no better than 6 months.  Moisture contamination and inert transfer lines are a large component of HCl field cylinder stability.

Testers have generated low concentration HCl gas in the field by diluting high concentration gas standards.  Mass flow controller calibration, construction material and conditioning are contributors to the original standard gas uncertainty for dilution system generating low concentration HCl test gas.  However, the accuracy and precision a tester experiences is based on the combination of the uncertainty contributed by the calibration gas and the uncertainty contributed by the field dilution and delivery system.  Testers and facilities need to qualify both the detection limit and the linearity of their monitors.

Vendor(s) asked if the NIST reference standard development was limited to standards in the gas phase. Reference was made to the HOVACAL as a reference standard. Facility(s) responded they would prefer using a dry gas standard to keep the spiking process as simple as possible.

8) Other relevant performance specifications

State Performance Specifications (e.g., Pennsylvania) exist for waste to energy processes.  The Pennsylvania performance specification mirrors PS  -  2.  The concentration measured at these sources is well above 1 ppm. Typically facilities perform RATA tests using Method 26A.  Instruments well measuring dry gas streams.  Daily QA/QC and calibration is consistent but needs to be tracked regularly.  Early RATA tests failed the 20% agreement requirement and Pennsylvania agreed to accept an absolute  5 ppm agreement between Method 26A and the CEM.

According to Ralph Roberson at RMB consulting, the EGU facilities are concerned about the issue of RATA agreement because the mean difference divided by a small concentration results in a value that can be 100% of the target concentration. The issues here are similar to the issues encountered with Mercury CEMs.  The important technical issue for the Industry is performance evaluations where concentrations can be accurately measured by both the CEM and the reference method.

Jim Peeler at Emission Monitoring Inc. commented that for tests involving the cement industry area sources, Method 26 or 26A have not been allowed and testers must use Method 321.  The instrument (FTIR) is validated using known addition of spikes. Testers are hard pressed to get 2 ppm or lower spikes through the alkaline cement kiln dust caked onto the instrument inlet filter.  RATAs using a reference FTIR method to quality a FTIR CEM will not identify common interference issues.  Jim proposed automated analyte spikes as one way to demonstrate the performance of continuous HCl monitors.

According to Peeler, the states of Michigan and Maryland have approved dynamic spiking as an alternative to qualify HCl and SOx/NOx systems.

EPA Method 321 also has a provision for dynamic spiking as an integral part of the QC for FTIR measurements.

9) Other Issues to Address  -  Open Discussion

   The proposed EGU MACT rule sets the HCl standard at 1.4 ppm for existing sources.  Measurements will need to be qualified down to approximately 1 ppm.

   The gas vendors believe the path to an HCl NIST Reference Gas Material may occur sooner if NIST is willing to work with the Netherlands Measurement Institute NMi toward a memo of understanding regarding NMi HCl reference material.

10) Action Items

Schedule a conference call with Frank Guenther at NIST to discuss the need for an HCl reference gas standard.  Ray Merrill will talk with Bob Wright (EPA/ORD) to identify a small group of participants and schedule a conference call.

EPA has access to an early draft HCl PS written by Eli Lilly which we will review for relevance to development of an HCl Performance Specification.

EPA will review the status of dynamic spiking as an alternative to qualifying the performance in Method 7E.

EPA will prepare a summary of this conference call and distribute it to the stakeholders for review.

After receiving review comments EPA will schedule the next conference call to update stakeholders on the HCl performance specification and to open topics that need additional input or clarification.

         Table 1: Conference Call Attendees and Contact Information
Name
Affiliation
Interest
Email
Allan Rilling
ABB
Equip Vendor
<EMAIL_ADDRESS>Bob Davis
AirGas
Gas Vendor
<EMAIL_ADDRESS>Musa  Zada
Altech
Equip Vendor

Malik Hatar
Altech
Equip Vendor

Bob Vantuyl
Ash Grove Cement
Facility
bob.vantuyl@ashgrove
Andy Edwards
Ash Grove Cement
Facility

Deseri Haggard
Calportland
Facility

Ty Smith
Cemtech Environmental
Equip Vendor

Kieth Crab
Cemtech Environmental
Equip Vendor

Joe Aldina
Covanta Energy
Facility
<EMAIL_ADDRESS>Edul Chikhliwala
EcoChem Analytics
Equip Vendor
<EMAIL_ADDRESS>Laura Kinner
Emission Monitoring Inc.
Tester
<EMAIL_ADDRESS>Jim Peeler
Emission Monitoring Inc.
Tester
<EMAIL_ADDRESS>Ray Merrill
EPA/OAQPS/AQAD/MTG
Regulatory Agency
<EMAIL_ADDRESS>Jason Dewees
EPA/OAQPS/AQAD/MTG
Regulatory Agency
dewees.jason@ epa.gov
Robin Segall
EPA/OAQPS/AQAD/MTG
Regulatory Agency
segall.robin@@epa.gov
Barrett Parker
EPA/OAQPS/SPPD/MPG
Regulatory Agency
<EMAIL_ADDRESS>Rachael Agnew
EPA/OAQPS/SPPD/MPG
Regulatory Agency
<EMAIL_ADDRESS>Collin Boswell
EPA/OAQPS/SPPD/MPG
Regulatory Agency
boswell.collin @epa.gov
Gerri Garwood
EPA/OAQPS/SPPD/MPG
Regulatory Agency
<EMAIL_ADDRESS>Candace Sorrell
EPA/OAQPS/AQAD/MTG
Regulatory Agency
<EMAIL_ADDRESS>Luc Sevrette
Gasmet
Equip Vendor
<EMAIL_ADDRESS>Andre Hegre
Gas Technologies, Finland
Equip Vendor

Hector Ybanez,
Holcim Inc.
Facility
<EMAIL_ADDRESS>Matthew Rutledge
Lafarge
Facility

Mike Hayes
Linde Gas
Gas Vendor

Barbara Marshick
MKS Instruments
Equip Vendor
<EMAIL_ADDRESS>Fred Grunewald
MKS Instruments Inc.
Equip Vendor
<EMAIL_ADDRESS>Martin Spartz
Prism Analytical technology
Tester
<EMAIL_ADDRESS>Ralph Roberson
RMB Consulting
Facility-ECU
<EMAIL_ADDRESS>Dan Kietzer
Sick-Maihak
Equip Vendor
<EMAIL_ADDRESS>Kita Dieter
Thermofisher
Equip Vendor
<EMAIL_ADDRESS>Stephen Johnson
Thermofishter Inc.
Equip Vendor
<EMAIL_ADDRESS>James Willis
Titan America
Facility
<EMAIL_ADDRESS>Jeff Harrington
Tyco Environmental Systems
Equip Vendor

Gary Catchatory
Tyco Environmental Systems
Equip Vendor

Michael Corvese
Thermofisher
Equip Vendor
<EMAIL_ADDRESS>Frank Duckett
Thermofisher
Equip Vendor
<EMAIL_ADDRESS>Ashmud Patel
Ethyl Smith Automation

Henry Veger
CEM Specialties
Equip Vendor

Dave  Vigowax
Marantee Tile
Facility


MEMORANDUM

DATE:		7/30/15

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Madonna Narvaez, R10, AWT-150

SUBJECT:	Series of Conference calls held with R10 states to update status of CPP actions  --------------------------------------------------------------------------------

SUMMARY

      In June, 2015, the region held calls with our states on the Clean Power Plan. The first call was requested by Oregon DEQ. We then held calls with the rest of the states. Only the process and expected outreach for the final Carbon Power Plan rule were discussed. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES

6/23 EPA:	Kate Kelly, Madonna Narvaez, Debra Suzuki ODEQ: David Collier, Colin McConnaha

6/26 EPA:	Kate Kelly ADEC:	Denise Koch, Director, Air Quality Program

6/30 EPA:	Kate Kelly, Madonna Narvaez IDEQ:	Tiffany Floyd, Air Quality Director, Mary Anderson, Carl Brown

7/06 EPA:	Kate Kelly Washington Dept. of Ecology:	Stu Clark, Air Quality Program Director


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81617-81618]
[FR Doc No: 2010-32507]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0326]

Determination That TRANDATE (Labetalol Hydrochloride) Tablets,
300 Milligrams and 400 Milligrams, Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
TRANDATE (labetalol hydrochloride) tablets, 300 milligrams (mg) and 400
mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as the
ANDAs meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Deborah Livornese, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-0719.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness
(Sec.  314.162 (21 CFR 314.162)). Under Sec.  314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug. Under Sec.
314.161(a)(2), FDA must determine whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness whenever a listed drug
is voluntarily withdrawn from sale and ANDAs that refer to the listed
drug have been approved. Section 314.161(d) provides that if FDA
determines that a listed drug was withdrawn from sale for reasons of
safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
    TRANDATE (labetalol hydrochloride) tablets, 300 mg and 400 mg, are
the subject of NDA 18-716, held by Prometheus Laboratories, Inc., and
initially approved on August 1, 1984. TRANDATE is indicated for the
management of hypertension. TRANDATE (labetalol hydrochloride) tablets,
300 mg and 400 mg, are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book. TRANDATE (labetalol
hydrochloride) tablets, 400 mg, have never been marketed. In previous
instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21,
1996), the Agency has determined that, for purposes of Sec. Sec.
314.161 and 314.162, never marketing an approved drug product is
equivalent to withdrawing the drug from sale.
    JRRapoza Associates, Inc., submitted a citizen petition dated June
16, 2010 (Docket No. FDA-2010-P-0326), under 21 CFR 10.30, requesting
that the Agency determine whether TRANDATE (labetalol hydrochloride)
tablets, 300 mg, were withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 400 mg
strength, on our own initiative, we have also determined whether that
strength was withdrawn for safety or effectiveness reasons.
    After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec.  314.161 that

TRANDATE (labetalol hydrochloride) tablets, 300 mg and 400 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that TRANDATE
(labetalol hydrochloride) tablets, 300 mg and 400 mg, were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events and have found no information that would
indicate that this product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400 mg, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to the TRANDATE products listed in this
document. Additional ANDAs that refer to these products may also be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32507 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P