[Federal Register Volume 78, Number 47 (Monday, March 11, 2013)]
[Notices]
[Pages 15371-15373]
[FR Doc No: 2013-05562]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0962]

Drug Development for Chronic Fatigue Syndrome and Myalgic
Encephalomyelitis; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), Center for Drug Evaluation
and Research, is announcing a public workshop to discuss how best to
facilitate and expedite the development of safe and effective drug
therapies to treat signs and symptoms related to chronic fatigue
syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined
that CFS and ME are serious conditions for which there are no approved
drug treatments. On April 25, 2013, as part of FDA's Patient-Focused
Drug Development initiative, patients will provide feedback on disease
impact on quality of life and individual experience with current
treatment regimens. On April 26, 2013, there will be discussions with
academic and Government experts, patient advocates, patients, and
clinicians on how to identify sound, quantitative outcome measures that
can be used in clinical trials to determine whether disease symptoms
improve with specific drug interventions.
    Date and Time: The public workshop will be held on April 25, 2013,
from 1 p.m. to 5 p.m., and on April 26, 2013, from 8:30 a.m. to 5 p.m.

    Location: The public workshop will be held at the Bethesda
Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814,<PHONE_NUMBER>, Fax:
301-897-0192.
    Contact Persons:
    Mary Gross, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3519<EMAIL_ADDRESS>    Randi Clark, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-4287<EMAIL_ADDRESS>or
    Sara Eggers, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-4904<EMAIL_ADDRESS>    Registration and Requests to Participate in Panel Discussions: If
you wish to attend the public workshop or participate in a panel
discussion, you must register by submitting an electronic or written
request by 5 p.m. on April 8, 2013. Submit electronic requests to
http://mecfsmeeting.eventbrite.com. Submit written requests to Mary
Gross, Randi Clark, or Sara Eggers (see Contact Persons). You must
provide your name and business, organization, or personal affiliation
as applies (e.g., industry, government, patient). Patients who are
interested in presenting comments as part of the initial panel
discussions may indicate which topic(s) they wish to address (see
section II of this document).
    The public workshop is free and seating will be on a first-come,
first-served basis. We recommend that you register early because
seating is limited. FDA may limit both the number of participants from
individual organizations and the total number of attendees, based on
space limitations. Registrants will receive confirmation once they have
been accepted to attend the meeting. For those who cannot attend in
person, a live Webcast of the meeting will be located at http://mecfsmeeting.eventbrite.com. For information about joining the meeting
via Webcast, please go to  http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm.
    FDA will post an agenda of the public workshop and other background
material 5 days before the workshop at http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm.
    You may submit questions about the public workshop to<EMAIL_ADDRESS>prior to the April 25 and 26 workshop dates.
    If you need special accommodations because of a disability, contact
Mary Gross, Randi Clark, or Sara Eggers (see Contact Persons) at least
7 days in advance.
    Comments: Submit either electronic or written comments by April 8,
2013, to receive consideration. Submit electronic comments to
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov. Electronic or written comments will be accepted
after the meeting until August 2, 2013.
    FDA will also hold an open public comment period on April 25 to
give the public an opportunity to comment on topics that may not have
been addressed in the discussion of topics 1 and 2 (see section II of
this document). Workshop participants should register to participate in
the open public comment period by April 8, 2013, and will be asked to
provide a brief summary of their comments.

SUPPLEMENTARY INFORMATION

I. Background

    The Food and Drug Administration, Center for Drug Evaluation and
Research, is announcing a scientific workshop to discuss how best to
facilitate and expedite the development of safe and effective drug
therapies to treat signs and symptoms related to CFS and ME. FDA has
determined that CFS and ME are serious conditions for which there are
no approved drug treatments. On April 25, 2013, patients will give
feedback on disease impact on quality of life and their experiences
with current treatment regimens. On April 26, 2013, there will be
discussions with academic and Government experts, patient advocates,
patients, and clinicians on how to identify sound, quantitative outcome
measures to determine whether disease symptoms improve with specific
interventions. For purposes of this workshop, the terms ``CFS'' and
``ME'' have been used interchangeably in describing the conditions.
These terms are used as a frame of reference only. The terms are
intended to be inclusive and make no judgment on the cause of different
symptom complexes. Drug development focuses on quantitative measures of
benefit (e.g., symptom improvement) in either the entire population or
in a defined subset, not on the name of the disease. In some cases,
evaluating symptoms individually may be the optimal approach, while in
others, evaluating a constellation of symptoms may be better.

II. Purpose and Scope of the Public Workshop

    FDA has selected CFS and ME to be the focus for a workshop under
the Patient-Focused Drug Development initiative, an effort that
involves obtaining a better understanding of patients' perspectives on
the severity of the disease and assessment of currently available
treatment options. Patient-Focused Drug Development is being conducted
to fulfill FDA performance commitments made as part of the
authorization of the Prescription Drug User Fee Act under Title I of
the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
The full set of performance commitments is available on the FDA Web
site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    On Day 1 of the workshop (April 25, 2013) FDA will gather patients'
perspectives on CFS and ME as part of the Patient-Focused Drug
Development initiative. Day 1 will focus on two main topics: (1)
Disease symptoms and daily impacts that matter most to patients; and
(2) Patients' perspectives on current approaches to treating CFS and
ME. Discussion questions for topics 1 and 2 are as follows:

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients

    1. What are the most significant symptoms that you experience
resulting from your condition? (Examples may include prolonged
exhaustion, confusion, muscle pain, heat or cold intolerance.)
    2. What are the most negative impacts on your daily life that
result from your condition and its symptoms? (Examples may include
difficulty with specific activities, such as sleeping through the
night.)
    a. How does the condition affect your daily life on the best days
and worst days?
    b. What changes have you had to make in your life because of your
condition?

Topic 2: Patients' Perspectives on Current Approaches To Treating CFS
and ME

    1. What treatments are you currently using to help treat your
condition or its symptoms? (Examples may include FDA-approved
medicines, over-the-counter products, and other therapies, including
non-drug therapies such as activity limitations.)
    a. What specific symptoms do your treatments address?
    b. How has your treatment regimen changed over time and why?
    2. How well does your current treatment regimen treat the most
significant symptoms of your disease?
    a. Have these treatments improved your daily life (for example,
improving your ability to do specific activities)? Please explain.
    b. How well have these treatments worked for you as your condition
has changed over time?
    c. What are the most significant downsides of these treatments (for
example, specific side effects)?
    For each of these topics, a brief initial patient panel discussion
will begin the dialogue, followed by a facilitated discussion inviting
comments from other patient participants. FDA has not yet identified
the panel participants. As part of the meeting registration, patients
who are interested in presenting comments as part of the initial panel
discussions may indicate which topic(s) they wish to address and will
be asked to provide a brief summary of responses to the questions
listed below. FDA will confirm with patients who have been identified
to provide comments as part of the opening panel discussion in advance
of the workshop.
    FDA will try to accommodate all participants who wish to speak on
Day 1, either through the panel discussions, audience participation, or
the open public comment period; however, the duration of comments may
be limited by time constraints. Those who are unable to attend the
meeting in person, but who would like to provide their perspective on
the discussion questions for topics 1 and 2 are invited to submit
electronic or written comments to the Division of Docket Management
(see Comments).
    Day 2 of the workshop (April 26, 2013), will include a scientific
discussion on how best to facilitate and expedite the development of
safe and effective drug therapies for signs and symptoms related to CFS
and ME. Presentations and panel discussions will include the following:
     Lessons learned from previous studies;
     The role of drug repurposing;
     Pathways to expediting drug therapies;
     Appropriate clinical trial design in CFS and ME;
     Outcome measures to assess efficacy; and
     Potential valid endpoint measurements of symptom
improvement.

III. Transcripts

    Please be advised that a transcript of the workshop will be
available for review at the Division of Dockets Management (see
Comments) and on the Internet at http://www.regulations.gov. The
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.

    Dated: March 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05562 Filed 3-8-13; 8:45 am]
BILLING CODE 4160-01-P


PROTOCOL FOR EARLY ACTION COMPACTS DESIGNED TO ACHIEVE AND MAINTAIN THE 8 HOUR OZONE STANDARD Purpose of Compact Early voluntary 8 hour air quality plans can be developed through a Compact between Local, State and the Environmental Protection Agency ( EPA) officials for areas that are in attainment ( including no monitored violations) of the 1 hour ozone standard but approach or monitor exceedances of the 8 hour standard. These early action plans will include all necessary elements of a comprehensive air quality plan, but will be tailored to local needs and driven by local decisions. The Early Action Compact is designed to develop and implement control strategies, account for growth, and achieve and maintain the 8 hour ozone standard. This approach will offer a more expeditious time line for achieving emission reductions than the EPA's expected 8 hour implementation rulemaking, while providing " fail safe" provisions for the area to revert to the traditional State Implementation Plan ( SIP) process if specific milestones are not met. Early Action Compacts should complement any existing Ozone Flex Agreements.

The principles of the tri party Early Action Compact to be executed by Local, State and the EPA officials are: ° Early planning, implementation, and emission reductions leading to expeditious attainment and maintenance of the 8 hour ozone standard; ° Local control of the measures to be employed, with broad based public input; ° State support to ensure technical integrity of the early action plan; ° Formal incorporation of the early action plan into the SIP; ° Deferral of the effective date of nonattainment designation and related requirements so long as all Compact terms and milestones are met; and ° Safeguards to return areas to traditional SIP requirements should Compact terms and/ or milestones be unfulfilled, with appropriate credit given for emission reduction measures implemented.

Compact Requirements The Compact will address the following components:

A. Milestones and Reporting

In order to facilitate self evaluation and communication with the EPA, TNRCC and stakeholders, the Early Action Compact must include clearly measurable milestones for the development and implementation of the plan. Local areas will assess and report their progress against milestones in a regular, public process, at least every six months. Milestones will include, at a minimum:  Completion of emissions inventories and modeling;  Adoption of control strategies that demonstrate attainment;  Completion and adoption of the early action SIP revision;  Attainment not later than December 31, 2007;  Post attainment demonstration and plan updates as outlined in Section E;

In the absence of achieving milestones, including attaining the 8 hour ozone standard on or before December 31, 2007, the area will be deemed in violation of the Compact and will be subject to the full planning requirements under applicable Clean Air Act ( CAA) standard SIP processes including requirements defined as part of the EPA's 8 hour implementation rulemaking. Such an area will be subject to the same requirements and deadlines which would have been effective under the CAA and the EPA's 8 hour designation rulemaking had it not participated in this program, with no preferential delays or exemptions from the EPA. However, the area will receive appropriate credit in the standard SIP process for all emission reductions from measures implemented in this program.

If the area has had the effective date of its nonattainment designation deferred and the area does not reach attainment of the standard by December 31, 2007, then the nonattainment designation will be effective immediately. If the EPA's implementation schedule also requires SIP's from areas on or before December 31, 2007, then a SIP revision demonstrating attainment by the new attainment date will be due for the nonattainment area no later than December 31, 2008. The EPA will offer areas no extensions or delays of the applicable attainment date.

B. Emissions Inventory

Modeling emissions inventories using the most current tools available will be completed for at least one recent episode in order to support the early action plan. Emission inventories must include:  1999 or later episode reflective of a typical ozone season exceedance that meets the EPA episode selection guidance to ensure that representative meteorological regimes are considered;  MOBILE6 data with link based Travel Demand Model ( TDM) mobile data in urban areas;  NONROAD model data adjusted for local equipment populations and usage rates;  Area source databased when possible on local survey data.

Further episode inventories will also be developed over time to fully represent the variety of situations that typically contribute to ozone production in the area and to include the most recent developments.

Emission inventories will be compared and analyzed for trends in emission sources over time. This will improve an area's understanding of the trends in emissions in their community and will aid in verification of the accuracy of the inventories.

C. Modeling

Emission inventories will be used to develop SIP quality modeling episodes that perform within the EPA's accepted margin of accuracy, including a base case and future case on or before December 31, 2007. Therefore, inventories must sufficiently account for projected future growth in ozone precursor emissions, particularly from stationary, non road, and on road mobile sources.

Local area must carefully document modeling approach, and work will be supported and reviewed by the State and concurrently reviewed by the EPA.

Quantifiable emission reduction measures will be integrated into the future case to produce one or more control cases. These control cases will be used to indicate the relative effectiveness of different measures and aid in selecting appropriate measures.

Prior to plan implementation the control strategies should be determined based on model results from a control case episode that shows achievement of the 8 hour ozone standard on or before December 31, 2007 through implementation of the control strategies.

Communities will continue to develop other episodes as necessary to fully represent the variety of situations that typically contribute to ozone production in the area and to support the plan with the most current information and tools. Other episodes may also indicate necessary revisions to ensure that sufficient emission reduction measures are selected and implemented to continue to achieve target ozone concentration levels.

D. Control Strategies

After all adopted Federal and State or Tribal controls that have been or will be implemented by the attainment date of December 31, 2007 are accounted for in the modeling, the local area will adopt additional local controls, as necessary, to demonstrate attainment of the 8 hour standard by December 31, 2007. As an initial matter, by June 16, 2003, the local area will identify and describe the local control measures that will be considered during the local planning process. The June 16, 2003 deadline for describing the control measures under consideration must be met to maintain eligibility in the program. While failure to list a measure at this stage would not preclude its adoption later, it is important to develop a reasonably complete initial list of measures. This will provide the public with clear information on the measures under consideration, will help ensure that interested parties are fully aware of the level of effort and local commitment that is necessary, and will demonstrate that the local area is making progress toward meeting the critical March 31, 2004 deadline for adoption of local measures. The resulting local plan must be completed and submitted to the State or Tribal leader by March 31, 2004 for inclusion in the State implementation plan. The local plan shall include measures that are specific, quantified, and permanent, and that if approved by EPA, will be Federally enforceable SIP revisions. The March 31, 2004 submission also will include specific implementation dates for the adopted local controls, as well as detailed documentation and reporting processes.

Controls will be implemented as soon as practicable, but not later than December 31, 2005.

Controls will be designed and implemented by the community with full stakeholder participation.

All control measures will be incorporated by the state into the State Implementation Plan and submitted to the EPA for review and approval. In the event that areas wish to add or substitute measures after SIP submittal, plan modifications will be treated as SIP revisions and facilitated by the state.

E. Maintenance for Growth

The plan must include a component to address emissions growth at least 5 years beyond December 31, 2007, ensuring that the area will remain in attainment of the 8 hour standard during that period. This future attainment maintenance analysis may employ one or more of the following or any other appropriate techniques necessary to make such a demonstration:  Modeling analysis showing ozone levels below the 8 hour standard in 2012;  An annual review of growth ( especially mobile and stationary source) to ensure control measures and growth assumptions are adequate;  Identification and quantification of federal, state, and/ or local measures indicating sufficient reductions to offset growth estimates.

The plan must also detail a continuing planning process that includes modeling updates and modeling assumption verification ( particularly growth assumptions). Modeling updates and planning processes must consider and evaluate:  all relevant actual new point sources;  impacts from potential new source growth; and  future transportation patterns and their impact on air quality in a manner that is consistent with the most current adopted Long Term Transportation Plan and most current trend and projections of local motor vehicle emissions.

If the review of growth demonstrates that adopted control measures are inadequate to address growth in emissions, additional measures will be added to the plan. Local planning processes should prepare for this possibility.

F. Public Involvement

Public involvement will be conducted in all stages of the planning and implementation process.

Public education programs will be used to raise awareness regarding issues, opportunities for involvement in the planning process, implementation of control strategies, and any other issues important to the area.

Interested stakeholders will be involved in the planning process as early as possible. Planning meetings will be open to the public, with posted meeting times and locations. Plan drafts will be publicly available, and the drafting process will have sufficient opportunities for comment from all interested stakeholders.

Public comment on the proposed final plan will follow the normal SIP revision process as implemented by the State.

Semi annual reports detailing, at a minimum, progress toward milestones, will be publicly presented and publicly available.

Local, State and the EPA Commitments Local Areas Local areas hold primary responsibility for the development and implementation of the plan, as well as for maintaining communication with all parties, including: ° Drawing up the Compact, which embodies the requirements described in Sections A F, including a time line for milestones. ° Completing and signing by all parties of the Early Action Compact no later than December 31, 2002. ° By June 16, 2003, the local area will identify and describe the local control measures that will be considered during the local planning process. ° By March 31, 2004, the local area will submit their early action plan to the State/ EPA to permit adequate time for adoption as part of the SIP no later than December 31, 2004. ° Notifying parties as soon as possible of issues and developments, which may impact performance and progress toward milestones. ° Notifying parties as soon as possible if Compact milestones will be missed or have been missed. ° Notifying parties as soon as possible if Compact modification/ termination is to be requested.

State The state will assist in the drafting of the Early Action Compact and will provide support to areas throughout the planning and implementation process, including: ° Technical assistance in the development of emission inventories, modeling process, trend analysis and quantification and comparison of control measures; ° Necessary information on all Federal and State adopted emission reduction measures which affect the area; ° Critical third party review of emissions inventory, modeling, and self evaluation work; ° Technical and strategic assistance, as appropriate, in the selection and implementation of control strategies; ° Technical and planning assistance in developing and implementing processes to address the impact of emissions growth beyond the attainment date; ° Maintenance of monitors and reporting and analysis of monitoring data; ° Support for public education efforts; ° Coordinate communication between local areas and the EPA to facilitate continuing the EPA review of local work; ° Expeditious review of the locally developed plan, and if deemed adequate, propose modification of the SIP to adopt the early action plan; ° Adoption of control measures into the SIP as expeditiously as possible. The final complete SIP revision must be completed, adopted, and submitted by the state to the EPA by 2004. EPA The EPA will recognize the local area's and State's commitment to voluntarily adopt an early, substantive, enforceable and scientifically based attainment plan with early implementation of control measures by becoming a party to the Early Action Compact developed in conformance with this protocol. ° The EPA will provide technical assistance to the state and local area in the development of the early action plan. ° The EPA will move quickly to review and approve completed plans by no later than nine months after submission of the SIP revision by the state. ° When the EPA's 8 hour implementation guidelines call for designations, the EPA will defer the effective date of nonattainment designation and related requirements for participating areas that fail to meet the 8 hour ozone standard as long as all terms and milestones of the compact are being met, including submission of the early action SIP revision by 2004. ° Provided that the monitors in the area reflect attainment by December 31, 2007, the EPA will move expeditiously to designate the area as attainment and impose no additional requirements. ° If at any time the area does not meet all the terms of this Compact, including meeting agreed upon milestones, then it will forfeit its participation and its designation ( or redesignation if necessary) will become effective according to the EPA's 8 hour ozone implementation guidelines. The EPA will offer such an area no delays, exemptions or other favorable treatment because of its previous participation in this program. ° If the area violates the standard as of December 31, 2007, and the area has had the effective date of its nonattainment designation deferred, the area's nonattainment designation will become effective. The state will then submit a revised attainment demonstration SIP revision according to the CAA and the EPA's 8 hour implementation rule, unless the 8 hour implementation schedule requires SIP's from 8 hour nonattainment areas before December 31, 2008. In that event, a revised attainment demonstration SIP revision for the participating area will be due as soon as possible but no later than December 31, 2008. In no event will the EPA extend the attainment date for the area beyond that required by the CAA and/ or the EPA's 8 hour implementation rule. ° No area will be allowed to renew their Early Action Compact after December 31, 2007, or initiate a new compact if it has previously forfeited its participation.


[Federal Register Volume 84, Number 201 (Thursday, October 17, 2019)]
[Notices]
[Pages 55576-55577]
[FR Doc No: 2019-22690]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]

Prescription Drug User Fee Act Waivers, Reductions, and Refunds
for Drug and Biological Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Prescription Drug User Fee Act Waivers, Reductions, and Refunds for
Drug and Biological Products.'' This guidance provides recommendations
to applicants planning to request a waiver or reduction in user fees.
This guidance finalizes the draft guidance for industry of the same
title issued in June 2018.

DATES: The announcement of the guidance is published in the Federal
Register on October 17, 2019.

ADDRESSES: You may submit submit either electronic or written comments
on Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0108 for ``Prescription Drug User Fee Act Waivers,
Reductions, and Refunds for Drug and Biological Products.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting

of comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Keith Verrett, Division of User Fee
Management and Budget Formulation, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., Rm. 2179, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Prescription Drug User Fee Act Waivers, Reductions, and
Refunds for Drug and Biological Products.'' This guidance provides
recommendations to applicants regarding requests for waivers,
reductions, or refunds of user fees assessed under sections 735 and 736
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g
and 379h). This guidance describes the types of waivers, reductions,
and refunds permitted under the user fee provisions of the FD&C Act and
the procedures for submitting requests for waivers, reductions,
refunds, as well as requests for reconsiderations or appeals. The
guidance also provides additional clarification on certain issues such
as user fee exemptions for orphan drugs and FDA's current thinking on
considerations relevant to eligibility for user fee waivers,
reductions, and refunds under the applicable statutory provisions.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Prescription Drug User Fee Act Waivers,
Reductions, and Refunds for Drug and Biological Products.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
    This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information of this guidance has been approved under OMB
control number 0910-0693. The collection of information associated with
Form FDA 3397 has been approved under OMB control number 0910-0297. The
collections of information associated with new drug applications or
biologics license applications have been approved under OMB control
numbers 0910-0001 and 0910-0338, respectively. See section X of the
guidance document.

III. Electronic Access

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

    Dated: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22690 Filed 10-16-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Proposed Rules]
[Pages 68481-68484]
[FR Doc No: 2015-28277]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2012-0434; FRL-9936-61-Region 6]

Approval and Promulgation of State Implementation Plans,
Louisiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the State Implementation Plan (SIP) for Louisiana.
These rule revisions are the 2007 General Revisions, and 2008-2010

Miscellaneous Rule Revisions to the SIP that were submitted by the
State of Louisiana. The overall intended outcome is to make the
approved Louisiana SIP consistent with current Federal and State
requirements. This action is in accordance with the federal Clean Air
Act (the Act).

DATES: Comments must be received on or before December 7, 2015.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2012-0434, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     Email: Alan Shar at<EMAIL_ADDRESS>     Mail or delivery: Air Planning Section Chief (6PD-L),
Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas,
Texas 75202-2733.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2012-0434. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit
electronically any information through www.regulations.gov or email
that you consider to be CBI or other information whose disclosure is
restricted by statute. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters and any form of encryption, and be free
of any defects or viruses. Multimedia submissions (audio, video, etc.)
must be accompanied by a written comment. The written comment is
considered the official comment and should include discussion of all
points you wish to make. The EPA will generally not consider comments
or comment contents located outside of the primary submission (i.e. on
the web, cloud, or other file sharing system). For additional
information on submitting comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar (6PD-L), telephone (214)
665-6691, email<EMAIL_ADDRESS>To inspect the hard copy materials,
please contact Alan Shar.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Background

    On July 5, 2011 (76 FR 38977) EPA finalized approval of general
rule revisions to the Louisiana SIP which covered the years of 1996-
2006.
    We are now proposing to approve two revisions to the Louisiana SIP
submitted to EPA by the Louisiana Department of Environmental Quality
(LDEQ). The first submittal is the 2007 general revisions submitted to
EPA with a letter dated August 14, 2009. The second submittal is the
2008-2010 miscellaneous rules revisions submitted to EPA with a letter
dated August 29, 2013.

Evaluation

    The 2008-2010 miscellaneous rules revisions apply to Louisiana
Administrative Code (LAC) 33: III, Chapters 7 and 13. The 2007 general
revisions apply to LAC 33: III, Chapters 1, 2, 5, 6, 9, 11, 13, 15, 21,
22, 23, and 25. The Louisiana rule revisions submittals, their
corresponding Chapters, and our actions are shown in Table 1 below.

                         Table 1--Submittals, Their Corresponding Chapters, and Actions
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                                                         Revisions to LAC 33:III
              Submittals                 Calendar year    Chapters acting upon       Chapters not acting upon
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Miscellaneous rules...................       2008-2010  7, 13...................  ..............................
General revisions.....................            2007  1, 9, 11, 13, 14, 21,     2, 5, 6, and 15.
                                                         22, 23, and 25.
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    Certain provisions of the 2007 general revisions are not being
acted upon here because they were withdrawn or we plan to act on them
separately in the future. In a letter dated October 2, 2015 LDEQ
withdrew its revisions to Chapter 15 from our review. The October 2,
2015 withdrawal letter is available in this docket. The EPA plans to
act on SIP revisions to Chapters 2, 5, and 6 separately in the future.
    There is no increase in the amount of emissions or number of
sources affected as a result of ministerial or administrative rules
revisions throughout this notice; therefore, section 110(l) of the Act
has been complied with.
    In 2006, EPA revised the National Ambient Air Quality Standards
(NAAQS) for particulate matter. The LDEQ adopted revisions to NAAQS for
particulate matter in LAC 33:III, Chapter 7. This revision will update
the Louisiana air quality regulations to include the revised NAAQS for
particulate matter. The revision is consistent with the NAAQS for
PM2.5 and PM10 standards of 40 CFR 50. See 71 FR
61144 (October 17, 2006), and http://www3.epa.gov/ttn/naaqs/criteria.html (URL dated October 5, 2015). We propose their approval
into the SIP.
    Currently, the LAC 33:III Chapter 13 Abrasive Blasting is not in
the EPA-approved SIP. The 2007 general revisions submittal establishes
the standards of performance for abrasive blasting operations and
includes provisions concerning requirement to control emissions through
either enclosure or establishment of best management practices,
maintenance of control equipment, recordkeeping requirements, and
prohibited materials and methods that cannot be used in abrasive
blasting activities requirements. The LDEQ later in its

2008-2010 miscellaneous rules submittal revised this rule by
incorporating an updated version of the American Society for Testing
and Materials (ASTM) Test Method in Sec.  1327 for taking samples when
determining the weight percent of fines in abrasive materials.
Incorporating a specific ASTM Test Method in Sec.  1327 will provide
for consistency in the rule and facilitate compliance determinations.
Revisions to LAC 33:III Chapter 13 will result in enhancing the SIP,
and reducing particulate matter emissions from abrasive blasting
operations. We propose their approval into the SIP.
    Revisions to LAC 33:III Chapter 1 General Provisions concern Sec.
111 Definitions. The revisions defines the term SPOC or the Single
Point of Contact. The revision is ministerial or administrative in
nature. We propose its approval into the SIP.
    Revisions to LAC 33:III Chapter 9 General Regulations on Control of
Emissions and Emission Standards concern Sec.  918 Recordkeeping and
Annual Reporting and Sec.  919 Emission Inventory which require data
for emission reports be collected annually, include air pollutants that
a NAAQS has been issued for, and the owner or operator submit reports
to the Office Environmental Assessment. The revisions are ministerial
or administrative in nature. We propose their approval into the SIP.
    Revisions to LAC 33:III Chapter 11 Control of Emissions of Smoke
concern reporting of opacity exceedances and exemptions. The revisions
now require that reports be submitted to the SPOC instead of the Office
of Environmental Compliance, Emergency and Radiological Services
Division. The revisions are ministerial or administrative in nature. We
propose their approval into the SIP.
    Revisions to LAC 33:III Chapter 14 Conformity concern Sec.  1410
Criteria for Determining Conformity of General Federal Actions and
Sec.  1434 Consultation that designate the secretary of Department of
Environmental Quality or a designee and assistant secretary of the
Office of Planning and Programming or a designee participate in the
conformity consultation process. The revisions are ministerial or
administrative in nature. We propose their approval into the SIP.
    Revisions to LAC 33:III Chapter 21 Control of Emission of Organic
Compounds concern Sec. Sec.  2103, 2108, 2113, 2116, 2122, 2123, 2132,
2153, and 2159. See Part B of the TSD for more information. The
revisions throughout this Chapter are ministerial and administrative in
nature. We propose their approval into the SIP.
    Revision to LAC 33:III Chapter 22 Control of Emissions of Nitrogen
Oxides concerns Sec.  2201 removing the term ``Air Permits Division.''
This revision is ministerial or administrative in nature. We propose
its approval into the SIP.
    Revisions to LAC 33:III Chapter 23 Control of Emissions for
Specific Industries concern Sec. Sec.  2301 and 2303 deleting the terms
``Air Quality Assessment Division;'' and Sec.  2307 deleting ``the
Office of Environmental Compliance, Emergency and Radiological Services
Division'' when submitting the required reports and plans. The revision
are ministerial or administrative in nature. We propose their approval
into the SIP.
    Revisions to LAC 33:III Chapter 25, Subchapter B--Biomedical Waste
Incineration Rules concern Sec.  2511 Standards of Performance for
Biomedical Waste; Subchapter C-Refuse Incinerators Sec.  2521 Refuse
Incinerators; and Subchapter D-Crematories Sec.  2531 Standards of
Performance for Crematories. On July 5, 2011 (76 FR 38977) EPA approved
the existing provisions of LAC 33:III Chapter 25 into the SIP. The
revisions reflect the updated names of offices or departmental
organizations that reports or test results should be submitted to for
review and approval. The revisions are ministerial or administrative in
nature. We propose their approval into the SIP.
    Certain provisions of the Louisiana SIP are affected by EPA's June
12, 2015 National SIP Call (80 FR 33967). Those provisions are
identified as Sec. Sec.  1107(A), 1507(A)(1), 1507(B)(1),
2153(B)(1)(i), 2201(C)(8), 2307(C)(1), and 2307(C)(2). Finally, our
proposed approval of amendments to LAC 33:III, Chapters 11, 21, 22, and
23 should not, in any way, be construed as explicitly or implicitly
voiding or minimizing any concerns or inadequacies identified in EPA's
National SIP Call of June 12, 2015 (80 FR 33967) with respect to the
above referenced provisions. We continue to expect that issues raised
within the context of the EPA's National SIP Call to be addressed in a
timely fashion. See section 110(k)(5) of the Act.

Proposed Action

    We are proposing to approve rule revisions to LAC 33:III, Chapter
1, Sec.  111; Chapter 7, Sec. Sec.  701, 703, and 711; Chapter 9,
Sec. Sec.  918, and 919; Chapter 13, Sec. Sec.  1323, 1325, 1327, 1329,
1331, and 1333; Chapter 14, Sec. Sec.  1410, and 1434; Chapter 21,
Sec. Sec.  2103, 2108, 2113, 2116, 2121, 2122, 2123, 2132, 2153, and
2159; Chapter 22, Sec.  2201; Chapter 23, Sec. Sec.  2301, 2302, and
2307; and Chapter 25, Sec. Sec.  2511, 2521, and 2531.
    We are proposing to approve these revisions in accordance with
sections 110, and 129 of the Act.

Incorporation by Reference

    In this action, we are proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with the requirements of 1 CFR 51.5, we are proposing to incorporate by
reference revisions to the Louisiana regulations as described in the
Proposed Action section above. We have made, and will continue to make,
these documents generally available electronically through
www.regulations.gov and/or in hard copy at the EPA Region 6 office.

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. If a portion of the plan revision meets
all the applicable requirements of this chapter and Federal
regulations, the Administrator may approve the plan revision in part.
42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions,
EPA's role is to approve state choices that meet the criteria of the
Act, and to disapprove state choices that do not meet the criteria of
the Act. Accordingly, this proposed action approves state law as
meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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;
     Does not provide 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); and
     Is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the proposed
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).

List of Subjects in 40 CFR Part 52

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

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

    Dated: October 27, 2015.
Samuel Coleman,
Acting Regional Administrator, Region 6.
[FR Doc. 2015-28277 Filed 11-4-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 2, 2008 (Volume 73, Number 86)]
[Rules and Regulations]
[Page 24164-24168]
[DOCID:fr02my08-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29043; Directorate Identifier 2007-NM-177-AD;
Amendment 39-15494; AD 2008-09-13]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Boeing Model 737-300, -400, and -500 series airplanes. This AD requires
revising the FAA-approved maintenance inspection program to include
inspections that will give no less than the required damage tolerance
rating for each structural significant item (SSI), doing repetitive
inspections to detect cracks of all SSIs, and repairing cracked
structure. This AD results from a report of incidents involving fatigue
cracking in transport category airplanes that are approaching or have
exceeded their design service objective. We are issuing this AD to
maintain the continued structural integrity of the entire fleet of
Model 737-300, -400, and -500 series airplanes.

DATES: This AD is effective June 6, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 6,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind, Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness

directive (AD) that would apply to all Boeing Model 737-300, -400, and
-500 series airplanes. That NPRM was published in the Federal Register
on August 24, 2007 (72 FR 48597). That NPRM proposed to require
revising the FAA-approved maintenance inspection program to include
inspections that will give no less than the required damage tolerance
rating for each structural significant item (SSI), doing repetitive
inspections to detect cracks of all SSIs, and repairing cracked
structure.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the four commenters.

Requests To Allow Alternative Inspections for Previously Repaired/
Altered Structure

    Boeing, Southwest Airlines, and United Airlines request that the
NPRM be revised to include a provision for alternative inspections when
a repair area prohibits operators from doing the inspections specified
in paragraph (h) of the NPRM. The commenters request that the initial
alternative inspection be done within 12 months after the repair is
discovered during the initial inspection required by paragraph (h). Two
of the commenters point out that there is a similar provision in
paragraph (e) of AD 98-11-04 R1, amendment 39-10984 (64 FR 987, January
7, 1999). The commenters state that including such a provision will
assist operators.
    We agree. We have added a new paragraph (i) to this AD (and
reidentified subsequent paragraphs) that provides alternative
inspections to those in paragraph (h) of this AD.

Request To Allow Compliance With the Repair Assessment Program (RAP)

    Southwest and United request that the RAP be considered an
alternative method of compliance (AMOC) for the supplemental structural
inspection document (SSID) inspections of any repaired or modified SSI
specified in paragraph (h) of the NPRM. United States that the FAA
approved the RAP as an AMOC for those areas of the fuselage covered by
repairs for Models 737-100, -200, and -200C series airplanes. Southwest
states that multiple requirements for an individual repaired or
modified area will create confusion, and that eventually the alternate
inspection procedures will either be duplicated or only approved for
one program.
    We partially agree. We agree with the commenters that some of the
inspection areas subject to the requirements of this AD also may be
included in the RAP. The owner/operator of an affected airplane or
Boeing, on behalf of the owner/operator, will need to perform an
evaluation of each of these areas of the airplane to determine if the
actions performed in accordance with the RAP meet the requirements of
the SSID inspection program. Our understanding is that Boeing is
looking into this evaluation; however, we have not received any data
supporting a request for an AMOC. Once the evaluation has been
completed, the owner/operator or Boeing may submit the data to
substantiate that those actions performed in accordance with the RAP
would provide an acceptable level of safety, under the provisions of
paragraph (l) of this AD. We have made no change to the AD in this
regard.

Request To Delegate Approval of Structure Affected by Winglet
Modifications

    Southwest requests that the NPRM be revised to allow an Authorized
Representative (AR) for the Boeing Commercial Airplanes Delegation
Option Authorization Organization to approve AMOCs for modified or
altered structure such as winglets. Without such a provision, Southwest
states that operators of airplanes on which winglets have been
installed in accordance with a supplemental type certificate (STC) will
need to seek AMOCs directly from the FAA. Southwest believes that such
a provision would reduce the workload for operators and the FAA.
    We do not agree. At this time, we cannot authorize Boeing ARs to
approve repair data or AMOCs for non-Boeing type design products such
as STCs for which Boeing does not have access to the design data. We
have made no change to the AD in this regard.

Request To Approve NPRM as a Method of Compliance With Aging Airplane
Safety Final Rule (AASFR)

    Southwest and United request that the NPRM be approved as a method
of compliance for the AASFR for the relevant SSIs.
    We partially agree. We agree with the commenters that compliance
with this AD would be an acceptable means of compliance with the AASFR
for the baseline structure of Model 737-300, -400, and -500 series
airplanes. The Costs of Compliance section of the NPRM included such a
statement, which is restated in this final rule. In addition, the
Supplemental Inspections section of the AASFR states, ``The FAA will
accept a SSID program for the baseline structure of an airplane
developed by the OEM and approved by the FAA. If a SSID does not
consider repairs, alterations, and modifications (RAMs), as required by
this rule, the FAA would not accept it as a means to comply with this
portion of the rule.'' Therefore, we find that no change to the final
rule is necessary.

Request To Allow Zonal and Surveillance Inspections

    British Airways requests that zonal and surveillance inspections be
considered acceptable for the general visual inspection specified in
Boeing Document D6-82669, ``Supplemental Structural Inspection Document
Models 737-300/400/500 Airplanes,'' Original Release, dated May 2007
(hereafter ``the SSID'') (referred to in the NPRM as the appropriate
source of service information for the proposed actions).
    We do not agree. Each operator's maintenance inspection program
defines inspection terminology. That maintenance inspection program
might be defined by different revisions of the Maintenance Steering
Group (MSG) procedures or other procedures accepted by the operator's
Certificate Management Office. Because inspection definitions have
changed over time, each operator must confirm that the maintenance
inspections procedures (e.g., surveillance or general visual
inspections) it performs are equivalent to those specified in section
5.0 of the SSID to take damage tolerance rating (DTR) credit for the
SSID program. In addition, while zonal inspection programs include
general visual inspections of an area, including the structure in that
area, the zonal program might not include the same general visual
inspection required by the SSID such as the specific structural detail,
the frequency to do the inspection, and the requirement to do the
inspection in the direction specified. Therefore, we have made no
change to the AD in this regard.

Request To Extend Compliance Time of Reporting Requirement

    Southwest and United also request that the compliance time for the
reporting requirement in Section 6.0, ``SSI Discrepancy Reporting,'' of
the SSID be revised from 5 to 30 days. The commenters state that 5 days
is insufficient time for reviewing documentation from various
maintenance bases.
    We do not agree. In developing an appropriate compliance time for
this action, we considered the urgency associated with cracks involving
an SSI or related structure in close vicinity to the SSI as well as the
recommendations

of the manufacturer. In consideration of these items, we have
determined that a 5-day compliance time for reporting discrepant
inspection findings will enable the manufacturer to obtain better
insight into the nature, cause, and extent of the cracking, and
eventually to develop a final action to address the unsafe condition.
However, according to the provisions of paragraph (l) of this AD, we
might approve requests to adjust the compliance time if the request
includes data that prove that the new compliance time would provide an
acceptable level of safety.

Request To Identify Differences Between the AD and the SSID

    British Airways requests that all differences between the AD and
the SSID be identified. British Airways states that such differences
were identified in other SSID ADs.
    We partially agree. We agree with the commenter to identify
differences between the AD and the SSID and did so in the Differences
Between the Proposed AD and Service Information section of the NPRM.
However, we find that no change to the final rule is necessary, since
that section of the NPRM does not reappear in the final rule.

Request To Clarify a Certain Section of the Preamble of the NPRM

    Boeing requests that the Issuance of Advisory Circular (AC) section
in the preamble of the NPRM be clarified. Boeing states that AC No. 91-
56, ``Supplemental Structural Inspection Program for Large Transport
Category Airplanes,'' dated May 6, 2001, applies to airplanes certified
under the fail-safe and fatigue requirements of Civil Air Regulations
(CAR) 4b or part 25 of the Federal Aviation Regulations (14 CFR part
25), not damage tolerance structural requirements as stated in the
Issuance of AC section of the NPRM.
    We agree with Boeing that the identified section could be
clarified. However, no change has been made to the final rule since the
identified sections of the NPRM do not reappear in the final rule.

Explanation of Change to Reported Incidents

    We have revised the AD to specify that this AD results from a
report of incidents involving fatigue cracking only.

Explanation of Change to Costs of Compliance

    The requirements for the baseline structure of Model 737-300, -400,
and -500 series airplanes are currently described in 14 CFR
121.1109(c)(1) and 129.109(b)(1), not in 14 CFR 121.370(a) and 129.16
as indicated in the third paragraph of the Cost of Compliance section
of the NPRM. Therefore, we have revised the Costs of Compliance section
of the AD accordingly.

Explanation of Editorial Changes

    We have revised references to the title of Boeing Document D6-82669
from ``Supplemental Structural Inspection Document,'' to ``Supplemental
Structural Inspection Document Models 737-300/400/500 Airplanes'' in
this AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    There are about 1,961 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this AD.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
            Action                Work hours    Average  labor        Cost         registered       Fleet cost
                                                rate  per hour                      airplanes
----------------------------------------------------------------------------------------------------------------
Revision of maintenance        1,200 per                   $80  $96,000 per                 599  $2,496,000.
 inspection program.            operator (26                     operator.
                                U.S.
                                operators).
Inspections..................  600 per                      80  $48,000, per                599  $28,752,000 per
                                airplane.                        airplane, per                    inspection
                                                                 inspection                       cycle.
                                                                 cycle.
----------------------------------------------------------------------------------------------------------------

    The number of inspection work hours, as indicated above, is
presented as if the accomplishment of the actions in this AD are to be
conducted as ``stand alone'' actions. However, in actual practice,
these actions for the most part will be done coincidentally or in
combination with normally scheduled airplane inspections and other
maintenance program tasks. Therefore, the actual number of necessary
additional inspection work hours will be minimal in many instances.
Additionally, any costs associated with special airplane scheduling
will be minimal.
    Further, compliance with this AD will be a means of compliance with
the AASFR for the baseline structure of Model 737-300, -400, and -500
series airplanes. The AASFR requires certain operators to incorporate
damage tolerance inspections into their maintenance inspection
programs. These requirements are described in 14 CFR 121.1109(c)(1) and
129.109(b)(1). Accomplishment of the actions required by this AD will
meet the requirements of these CFR sections for the baseline structure.
The costs for accomplishing the inspection portion of this AD were
accounted for in the regulatory evaluation of the AASFR final rule.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and

responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-09-13 Boeing: Amendment 39-15494. Docket No. FAA-2007-29043;
Directorate Identifier 2007-NM-177-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective June 6, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Boeing Model 737-300, -400, and -500
series airplanes, certificated in any category.

Unsafe Condition

    (d) This AD results from a report of incidents involving fatigue
cracking in transport category airplanes that are approaching or
have exceeded their design service objective. We are issuing this AD
to maintain the continued structural integrity of the entire fleet
of Model 737-300, -400, and -500 series airplanes.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Service Information

    (f) The term ``the SSID,'' as used in this AD, means Boeing
Document D6-82669, ``Supplemental Structural Inspection Document
Models 737-300/400/500 Airplanes,'' Original Release, dated May
2007.

Revision of the FAA-Approved Maintenance Inspection Program

    (g) Before the accumulation of 66,000 total flight cycles, or
within 12 months after the effective date of this AD, whichever
occurs later, incorporate a revision into the FAA-approved
maintenance inspection program that provides no less than the
required damage tolerance rating (DTR) for each structural
significant item (SSI) listed in the SSID. (The required DTR value
for each SSI is listed in the SSID.) The revision to the maintenance
inspection program must include and must be implemented in
accordance with the procedures in Section 5.0, ``Damage Tolerance
Rating (DTR) System Application,'' and Section 6.0, ``SSI
Discrepancy Reporting'' of the SSID. Under the provisions of the
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.), the Office
of Management and Budget (OMB) has approved the information
collection requirements contained in this AD and has assigned OMB
Control Number 2120-0056.

Initial and Repetitive Inspections

    (h) Except as provided by paragraph (i) of this AD: Before the
accumulation of 66,000 total flight cycles, or within 4,000 flight
cycles measured from 12 months after the effective date of this AD,
whichever occurs later, do the applicable initial inspections to
detect cracks of all SSIs, in accordance with the SSID. Repeat the
applicable inspections thereafter at the intervals specified in
Section 3.0, ``Implementation'' of the SSID.
    (i) For any SSI that has been repaired or altered before the
effective date of this AD such that the repair or design change
affects your ability to accomplish the actions required by paragraph
(h) of this AD: You must request FAA approval of an alternative
method of compliance (AMOC) in accordance with section 39.17 of the
Federal Aviation Regulations (14 CFR 39.17), at the initial
compliance time specified in paragraph (h) of the AD; or do the
actions specified in paragraphs (i)(1) and (i)(2) of this AD, at the
times specified in those paragraphs, as an approved means of
compliance with the requirements of paragraph (h) of this AD.
    (1) At the initial compliance time specified in paragraph (h) of
the AD, identify each repair or design change to that SSI.
    (2) Within 12 months after the identification of a repair or
design change required by paragraph (i)(1) of this AD, assess the
damage tolerance characteristics of each SSI affected by each repair
or design change to determine the effectiveness of the applicable
SSID inspection for that SSI and if not effective, incorporate a
revision into the FAA-approved maintenance inspection program to
include a damage-tolerance based alternative inspection program for
each affected SSI. Thereafter, inspect the affected structure in
accordance with the alternative inspection program. The inspection
method and compliance times (i.e., threshold and repeat intervals)
of the alternative inspection program must be approved in accordance
with the procedures specified in paragraph (l) of this AD.

Repair

    (j) If any cracked structure is found during any inspection
required by paragraph (h) or (i) of this AD, before further flight,
repair the cracked structure using a method approved in accordance
with the procedures specified in paragraph (l) of this AD.

Inspection Program for Transferred Airplanes

    (k) Before any airplane that is subject to this AD and that has
exceeded the applicable compliance times specified in paragraph (h)
of this AD can be added to an air carrier's operations
specifications, a program for the accomplishment of the inspections
required by this AD must be established in accordance with paragraph
(k)(1) or (k)(2) of this AD, as applicable.
    (1) For airplanes that have been inspected in accordance with
this AD: The inspection of each SSI must be done by the new operator
in accordance with the previous operator's schedule and inspection
method, or the new operator's schedule and inspection method, at
whichever time would result in the earlier accomplishment for that
SSI inspection. The compliance time for accomplishment of this
inspection must be measured from the last inspection accomplished by
the previous operator. After each inspection has been done once,
each subsequent inspection must be performed in accordance with the
new operator's schedule and inspection method.
    (2) For airplanes that have not been inspected in accordance
with this AD: The inspection of each SSI required by this AD must be
done either before adding the airplane to the air carrier's
operations specification, or in accordance with a schedule and an
inspection method approved by the Manager, Seattle Aircraft
Certification Office (ACO), FAA. After each inspection has been done
once, each subsequent inspection must be done in accordance with the
new operator's schedule.

Alternative Methods of Compliance (AMOCs)

    (l)(1) The Manager, Seattle ACO, has the authority to approve
AMOCs for this AD, if requested in accordance with the procedures
found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to

be approved, the repair approval must specifically refer to this AD.

Material Incorporated by Reference

    (m) You must use Boeing Document D6-82669, ``Supplemental
Structural Inspection Document Models 737-300/400/500 Airplanes,''
Original Release, dated May 2007, to do the actions required by this
AD, unless the AD specifies otherwise.
    (1) The document contains the following errors:
    (i) Pages 8.0.3 and 8.0.4 of Section 8.0, as specified in the
List of Effective Pages, do not exist.
    (ii) There are two sets of pages (four pages total) with the
same page numbers in Section 11.3 (i.e., pages E.30.1 and E.30.2).
The first set of page numbers (i.e., DTR Check Form for Item E-30
and the following blank page) is correct. The second set of page
numbers (i.e., DTR Check Form for Item E-31 and the following blank
page) is incorrect. Those pages should be identified as page numbers
31.1 and 31.2, as specified in the List of Effective Pages.
    (iii) None of the pages are dated. The issue date for those
pages is May 2007, as specified in the Revision Highlights section.
    (2) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (4) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 8, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-9316 Filed 5-1-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]
[Page 3117-3119]
[DOCID:fr16ja09-144]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59217; File No. SR-NYSE-2008-138]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change by New York Stock Exchange LLC To Memorialize an Interpretation
of the Listed Company Manual Concerning Shareholder Approval
Requirements and To Describe a Certain Application of its Audit
Committee Rule

January 8, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Exchange Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is
hereby given that,

on December 22, 2008, New York Stock Exchange LLC (the ``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission the
proposed rule change as described in Items I, II and III below, which
items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule changes from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to memorialize an interpretation of the
Listed Company Manual. The text of the proposed rule change is
available on the Exchange's Web site (http://www.nyse.com), at the
Exchange's Office of the Secretary and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    On September 7, 2008 the Secretary of the Treasury of the United
States and the Director of the FHFA jointly announced that on September
6, 2008, pursuant to authority previously granted by Congress, FNM and
FRE were placed into conservatorship with the FHFA, and Treasury
entered into a Senior Preferred Stock Purchase Agreement with each
company providing for, among other things, the issuance by each company
to Treasury of senior preferred stock, and common stock warrants
representing an ownership stake of 79.9% in each company.\4\
---------------------------------------------------------------------------

    \4\ The Commission notes that the terms ``FHFA,'' ``FNM,'' and
``FRE'' refer to the Federal Housing Finance Agency, Fannie Mae, and
Freddie Mac, respectively.
---------------------------------------------------------------------------

    The issuance of a security convertible into common stock equal to
or in excess of 20% of the then outstanding common stock of a listed
company generally requires shareholder approval under Section 312.03 of
the NYSE Listed Company Manual. The NYSE has for many years taken the
position that a listed company which is a debtor-in-possession under
the U.S. bankruptcy laws satisfies the stockholder approval that might
otherwise be required in connection with an issuance of common stock or
a security convertible into common stock by obtaining bankruptcy court
approval of the issuance of such stock. Such an interpretation is the
only practical approach given that in such a circumstance the court,
not the stockholders, has the authority to authorize or refuse to
authorize the issuance of the security. Consequently, this rule filing
codifies the Exchange's longstanding position that a listed company
which is a debtor-in-possession satisfies any applicable stockholder
approval requirement under Section 312.03 by obtaining bankruptcy court
approval of the proposed issuance.
    The FHFA has specified that ``the powers of the stockholders [of
FNM and FRE] are suspended until the conservatorship is
terminated.''\5\ Based on this, the NYSE has concluded that for
purposes of its rules requiring stockholder approval of the issuance of
securities, i.e., Sections 312.03 and 303A.08 of the Listed Company
Manual, it is appropriate to treat FNM and FRE while they are in
conservatorship in the same manner as if they were each a debtor-in-
possession under the bankruptcy law. Accordingly, the NYSE takes the
position that the requirement of Section 312.03 has been satisfied in
connection with the issuance to the Department of the Treasury (the
``Treasury'') by each of FNM and FRE of the warrants exercisable for
common stock.
---------------------------------------------------------------------------

    \5\ See Questions and Answers of Conservatorship, available on
the Web site of the FHFA. (http://www.ofheo.gov/media/pdf/
FHFACONSERVQA.pdf) Note that FHFA in the same paragraph stated that
``Stockholders will continue to retain all rights in the stock's
financial worth; as such worth is determined by the market.''
---------------------------------------------------------------------------

    Following the establishment of the conservatorship, the independent
directors serving on the audit committees of the boards of directors of
each of the companies left the board. Each of FNM and FRE are currently
engaged in obtaining replacement directors and arranging the
appropriate delegation from FHFA to the boards and the audit committees
to allow the audit committees to function. In keeping with its normal
procedures under the provisions of Listed Company Manual Section
303A.06, NYSE is allowing the companies an appropriate period of time
in which to fill the vacancies on the audit committee. The NYSE was
informed that in connection with the quarterly financial reports on
Form 10-Q which were filed in November for the companies' third
quarter, each company arranged for its staff and independent auditor to
make a presentation regarding the quarterly report to appropriate
departments of the FHFA that was intended to replicate the kind of
review that an audit committee would normally conduct with respect to a
company's quarterly financials. The NYSE believes that this action is
appropriate in light of the fact that neither company had an audit
committee that was able to conduct that review. The Exchange notes that
this filing does not seek to interpret Rule 10A-3 under the Sarbanes-
Oxley Act. Rather, the Exchange is simply describing its application of
the requirements of Section 303A.06 of the Manual to FNM and FRE during
the period that they do not have independent audit committees.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \6\ of the Exchange Act in general and furthers the
objectives of Section 6(b)(5) of the Exchange Act \7\ in particular in
that it is designed to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. The Exchange believes its proposed interpretations of
Sections 312.03 and 303A.06 are reasonable in light of the policies
underlying those rules and constitute a suitable application of its
rules to this unique and unprecedented situation. In particular, the
Exchange notes that (i) it is in the public interest that the issuance
of securities to the Treasury should not be subject to shareholder
approval in light of the scale of Treasury's provision of capital to
the two companies and (ii) the oversight of the companies' financial
reporting by FHFA provides a reasonable level of protection to
investors while the companies are repopulating their independent audit
committees required by Section 303A.06.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).

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

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act.

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

    Written comments were neither solicited nor received.

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

    The proposed rule change is effective upon filing pursuant to
Section 19(b)(3)(A) of the Exchange Act \8\ and paragraph (f)(1) of
Rule 19b-4 thereunder \9\ as constituting a stated policy, practice, or
interpretation with respect to the meaning, administration, or
enforcement of an existing Exchange rule. At any time within 60 days of
the filing of the proposed rule change, the Commission may summarily
abrogate 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 Exchange Act.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(f)(1).
    \9\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

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 Exchange 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-NYSE-2008-138 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-NYSE-2008-138. 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 inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of the filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2008-138 and should be submitted on or before February 6, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-881 Filed 1-15-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 110 (Tuesday, June 9, 2015)]
[Notices]
[Page 32557]
[FR Doc No: 2015-14023]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-152-000.
    Applicants: American Transmission Company LLC.
    Description: Application for Authority to Acquire Transmission
Facilities of American Transmission Company LLC.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5199.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: EC15-153-000.
    Applicants: PowerOne Corporation, ResCom Energy LLC.
    Description: Application under Section 203 of ResCom Energy LLC, et
al.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5204.
    Comments Due: 5 p.m. ET 6/23/15.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2437-002.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company Notice of Non-Material
Change in Status.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5200.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER10-2740-008; ER10-2742-006.
    Applicants: Rocky Road Power, LLC, Tilton Energy LLC.
    Description: Notice of Change in Status of Rocky Road Power, LLC,
et al.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5193.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER15-1364-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing per 35: 2015-06-03_SA 768 Compliance
ATC-UPPCo Bill of Sales to be effective N/A.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5034.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1366-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing per 35: 2015-06-03_SA 2761
Compliance ATC-UPPCo CFA to be effective N/A.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5039.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1368-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing per 35: 2015-06-03_SA 2762
Compliance ATC-UPPCo PCA to be effective N/A.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5043.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1408-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing per 35: 2015-06-03_SA 2768
Compliance ATC-City of Plymouth CFA to be effective N/A.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5065.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1842-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Withdrawal per 35.15: Notice of Cancellation
FTSA with M-S-R to be effective 6/1/2015.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5006.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1843-000.
    Applicants: NextEra Energy, Inc.
    Description: Petition for Waiver of Affiliate Pricing Rules of
NextEra Energy, Inc. under ER15-1843.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5201.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER15-1844-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Original WMPA Service Agreement 4159; Queue AA1-131 to be effective 5/
26/2015.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5048.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1845-000.
    Applicants: New York Independent System Operator, Inc.,
Consolidated Edison Company of New York, Inc.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): O&R
Con Ed-Ramapo Interconnection Agreement (SA 2216) to be effective 6/4/
2015.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5089.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1846-000.
    Applicants: New York Independent System Operator, Inc.,
Consolidated Edison Company of New York, Inc.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): SA
2217 O&R Con Ed-Sugarloaf interconnection agreement to be effective 6/
4/2015.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5091.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1847-000.
    Applicants: Tucson Electric Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): Re-
collation Filing to be effective 6/3/2015.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5128.
    Comments Due: 5 p.m. ET 6/24/15.

    Docket Numbers: ER15-1848-000.
    Applicants: RTO Energy Trading, LLC.
    Description: Tariff Withdrawal per 35.15: Notice of Cancellation of
Market-Based Rate Tariff to be effective 6/30/2015.
    Filed Date: 6/3/15.
    Accession Number: 20150603-5131.
    Comments Due: 5 p.m. ET 6/24/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-14023 Filed 6-8-15; 8:45 am]
 BILLING CODE 6717-01-P