[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Notices]
[Pages 24190-24191]
[FR Doc No: 2012-9650]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-124-000]

East Cheyenne Gas Storage, LLC; Notice of Amendment

    Take notice that on April 6, 2012, East Cheyenne Gas Storage, LLC
(East Cheyenne), 10901 W. Toller Drive, Suite 200, Littleton, Colorado,
80127, filed in the captioned docket an application under sections 7(b)
and 7(c) of the Natural Gas Act (NGA), for an order amending the
certificate of public convenience and necessity issued by the
Commission in Docket No. CP10-34-000, as amended in Docket No. CP11-40-
000. Specifically, East Cheyenne requests authorization to make certain
changes to its certificated gas storage project, which relate primarily
to the design and number of wells (injection/withdrawal and water
disposal wells) to be used in the initial project development and the
pipeline and other facilities necessary to service such wells, and to
abandon two existing injection/withdrawal wells. East Cheyenne also
requests authorization to increase the certificated cushion gas
capacity of the West Peetz field, from 5.706 billion cubic feet (Bcf)
to 10.822 Bcf, all as more fully set forth in the application which is
on file with the Commission and opens to public inspection. The filing
may also be viewed on the web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For

assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
William A. Lang, President, East Cheyenne Gas Storage, LLC, 10370
Richmond Avenue, Suite 510, Houston, Texas 77042, by Telephone: (713)
403-6460 or Facsimile:<PHONE_NUMBER>.
    East Cheyenne requests that the Commission grant the requested
authorizations and related approvals prior to July 9, 2012. By issuing
an order by this date, the Commission will facilitate East Cheyenne's
efficient and timely development of storage capacity at its East
Cheyenne Gas Storage Project. East Cheyenne states that it does not
propose any change in the working gas capacity, injection rates or
withdrawal rates authorized by the Commission in the original
certificate order, as amended, in this Application.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: May 4, 2012.

    Dated: April 13, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-9650 Filed 4-20-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Page 61807]
[FR Doc No: 2015-26073]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 6474-002, 7982-003]

Peer Electric, LLC; KC Pittsfield LLC; Notice of Transfer of
Exemptions

    By letter filed September 21, 2015, Peer Electric, LLC (Peer)
informed the Commission that the exemption from licensing for the
Eastman Brook Project, FERC No. 6474, originally issued September 7,
1982,\1\ has been transferred to KC Pittsfield LLC. Also, the Celley
Mill Project, FERC No. 7982, originally issued September 24, 1984,\2\
has been transferred to KC Pittsfield LLC. The projects are located on
Eastman Brook in Grafton County, New Hampshire. The transfer of
exemptions do not require Commission approval.
---------------------------------------------------------------------------

    \1\ 20 FERC ] 62,426, Notice of Exemption From Licensing (1982).
    \2\ 28 FERC ] 62,429, Order Granting Exemption From Licensing of
a Small Hydroelectric Project of 5 Megawatts or Less (1984).
---------------------------------------------------------------------------

    2. KC Pittsfield LLC is now the exemptee of the Eastman Brook
Project, FERC No. 6474 and the Celley Mill Project, FERC No. 7982. All
correspondence should be forwarded to: Kelly W. Sackheim, KC Pittsfield
LLC, c/o Landry Associates Certified Public Accountants, PA, 6 Chenell
Drive 280, Concord, New Hampshire 03301.

    Dated: October 6, 2015.
Kimberly D. Bose,
Secretary.
 [FR Doc. 2015-26073 Filed 10-13-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 71081-71083]
[FR Doc No: 2023-22625]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[DOT-NHTSA-2023-0037]

Emergency Medical Services Education Agenda 2050: Request for
Information

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

ACTION: Notice of Request for Information (RFI).

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SUMMARY: This notice announces a RFI. The NHTSA Office of Emergency
Medical Services (EMS) is seeking comments from all sources (public,
private, government, academic, professional, public interest groups,
and other interested parties) on the planned re-envisioning of the 2000
EMS Education Agenda for the Future: A Systems Approach. The purpose of
this document is to solicit comments on EMS Education Agenda 2050, and
request responses to specific questions provided in this document. This
is neither a request for proposals nor an invitation for bids.

DATES: It is requested that comments on this announcement be submitted
by October 31, 2023.

FOR FURTHER INFORMATION CONTACT: Clary Mole, EMS Specialist, National
Highway Traffic Safety Administration, U.S. Department of
Transportation is available by phone at<PHONE_NUMBER> or by email at
[email protected].

SUPPLEMENTARY INFORMATION: In 2012, the National EMS Advisory Council
(NEMSAC) convened a national roundtable meeting on the EMS Education
Agenda for the Future: A Systems Approach. In a 2014 report on these
proceedings, NEMSAC advised that stakeholders at the State and local
level had just begun to experience the full impact of the evolution
toward a national integrated system of education for EMS personnel.
While stakeholders were reticent to move forward with a new education
agenda, they did provide feedback about themes that should be
considered in the future publication. From the feedback collected at
the meeting, NEMSAC developed recommendations to be used in the
eventual re-envision of the agenda for EMS. These recommendations are
summarized below:
     Educational content should retain the flexibility accorded
by the National EMS Education standards, but programs should use
nationally recognized evidence-based guidelines to drive local
curriculum development.
     The National EMS Information System data, evidence-based
research, and practice analyses should be sourced in developing
evidence-based guidelines and curriculum.
     Mobile Integrated Healthcare has received considerable
attention from the EMS Community. This and other alternative community-
based healthcare delivery models (of the future) should evoke an
expanded foundational knowledge and critical thinking capabilities that
will poise future EMS practitioners to be able to evolve with the
changing healthcare system or rapidly adjust to emerging healthcare
crises.
     EMS educators should begin a career in academia with
expertise in adult learning, educational theory, curriculum
development, and competency evaluation but also possess experiential
knowledge in evidence-based care.
    In the 10 years since NEMSAC's roundtable meeting, the national EMS
education system continued to evolve--especially during the COVID-19
pandemic. In late 2021, the Federal Interagency Committee on EMS
(FICEMS) began sponsoring listening sessions to inform a consensus-
driven, national report entitled, FICEMS: EMS and 911 COVID-19 Response
White Paper. This publication cited challenges and solutions collected
during stakeholder listening sessions for the EMS education system.
Among the challenges, EMS education stakeholders cited scarcity (in
some cases deficits) in resources for education, rigidity of curriculum
delivery modalities, the increased employer demands on students, and
inconsistent or delayed responses to the needs of the national EMS
education system as major contributors that led to the breakdown in the
EMS workforce pipeline.
    Prior to the COVID-19 pandemic, NHTSA published EMS Agenda 2050: A
People-centered Vision for the Future of EMS (Agenda 2050). This
collaborative project set a vision for a people-centered EMS systems
that serves every individual in every community across the Nation.
Later this year, NHTSA and its partners will begin a new project to
develop EMS Education Agenda 2050. This project will not replace but
build upon the achievements of the 2000 EMS Education Agenda for the
Future: A Systems Approach to lead a national conversation around the
future vision for EMS Education and EMS as a profession.

I. Background

    NHTSA, in partnership with Health Resources and Services
Administration,

published EMS Education Agenda for the Future: A Systems Approach
(Education Agenda) in 2000. This document was founded on the broad
national EMS education system concepts introduced in the EMS Agenda for
the Future (1996). The Education Agenda described a consensus vision of
an EMS education system with a high degree of structure, coordination,
and interdependence. It proposed a less prescriptive system that
offered educators flexibility in creating a student-centered learning
environment and a process for accommodating future advancements in
technology and medicine. The proposed system maximized efficiency,
consistency in instructional quality, and entry level graduate
competency by prescribing a high degree of structure, coordination, and
interdependence. To achieve this vision, the education system of the
future centered on five integrated primary components:

 National EMS Core Content
 National EMS Scope of Practice Model
 National EMS Education Standards
 National EMS Education Program Accreditation
 National EMS Certification

    After the Education Agenda was published, stakeholders began
implementing their respective integrated system components. Almost 25
years later, the national EMS education system has successfully evolved
into one that exemplifies both consistency and flexibility. System
interdependencies have helped to avoid duplication of effort in
curriculum and education program development, evaluating the minimum
competencies of graduates, certification and licensing processes, and
facilitation of practitioner reciprocity.
    In 2020, the EMS education system interdependencies modernized by
the Education Agenda were tested. Challenges presented by the COVID-19
pandemic forced a variety of adaptations. Traditional education
programs reported a lag in students' capabilities of achieving the
programmatic competencies requirements for graduation. The lag was
attributed to a variety of causes including a focus on pandemic
response activities over training and education, employer demands on
working students, and the rigidity of in-person, classroom-based
education delivery models. After the majority of programs adjusted to
the challenges, lags in graduation were cured, and students achieved
programmatic competencies at rates similar to those pre-pandemic.
    The response to the pandemic did not impact education programs
only. The impact to EMS agency daily operations was felt as well.
During the COVID pandemic, agencies experienced increases in EMS
activation and response rates which created additional stressors for
student EMS practitioners already working in a high stress job
environment but also enrolled in an EMS education program. These
stressors were a major contributor to a migration of practitioners away
from the EMS workforce. Agencies and organizational stakeholders
asserted that it could be education program graduation requirements
causing breakdown in the workforce pipeline; however, there were no
observed decreases in graduation or certification testing rates. These
observations prompt two questions: If graduation and certification
testing rates have remained unchanged, why have agencies reported
recruitment and retention issues? If graduates are not entering the EMS
workforce, where are they finding jobs?
    With agencies experiencing increased demand and a deficiency in
qualified EMS practitioners to respond to it, service delivery models
had to evolve. To bridge the gap in community-based care resources,
community paramedicine and mobile integrated healthcare (CP-MIH)
service delivery models increased in prevalence, and improvised
training programs were used to close new job-specific competency gaps
among existing EMS practitioners and individuals in training.
    Other themes brought to the forefront during the pandemic include
addressing healthcare disparities; the use of EMS data as a tool for
surveillance and nationwide quality of care improvements; and a greater
value to having an EMS workforce that is not only equitable, inclusive,
and accessible, but as diverse as the community it serves. These
themes, evolving service delivery models, and the subsequent evolution
of competencies needed by practitioners suggest that it is time for
NHTSA to gather our partners to begin a new conversation about the
future of EMS Education and EMS as a profession in the United States.

II. Questions Regarding EMS Education Agenda 2050

    Responses to the following questions are requested to help plan the
revision of the Education Agenda. Please be as specific as possible and
as appropriate please provide references.
    1. What are the most critical issues facing EMS education system
that should be addressed in the revision of the EMS Education Agenda?
Please provide specific examples.
    2. What progress has been made in implementing the EMS Education
Agenda since 2000?
    3. How have you used EMS Education Agenda? Please provide specific
examples.
    4. As an EMS Stakeholder, how might a revised EMS Education Agenda
be most useful to you?
    5. What significant changes have occurred in the EMS education
system at the national, Federal, State, and local levels since 2000?
    6. What significant changes will impact the EMS education system in
the next 25 years?
    7. How might the revised EMS Education Agenda contribute to
enhanced EMS for children?
    8. How might the revised EMS Education Agenda support and/or
promote data-driven and evidence-based improvements in EMS education
systems and EMS practitioner practice?
    9. How could the revised EMS Education Agenda enhance collaboration
among EMS systems, health care providers and facilities, public safety
answering points, public health, public safety, emergency management,
insurers, and others?
    10. How could the revised EMS Education Agenda be used to promote
community sustainability and resilience?
    11. How could the revised EMS Education Agenda contribute to
improved coordination for disaster response, recovery, preparedness,
and mitigation?
    12. How could the revised EMS Education Agenda enhance the exchange
of evidence-based practices between national, Federal (and military),
State, and local levels?
    13. How could the revised EMS Education Agenda support the seamless
and unimpeded transfer of military EMS personnel to roles as civilian
EMS providers?
    14. How could the revised EMS Education Agenda support interstate
credentialing of EMS personnel?
    15. How could the revised EMS Education Agenda support improved
patient outcomes in rural and frontier communities?
    16. How could the revised EMS Education Agenda lead to improved EMS
systems in tribal communities?
    17. How could the revised EMS Education Agenda promote a culture of
safety among EMS personnel, agencies, and organizations?
    18. Are there additional EMS attributes that should be included in
the revised EMS Education Agenda? If so,

please provide an explanation for why these additional EMS attributes
should be included.
    19. Are there EMS attributes in the 2000 EMS Education Agenda that
should be eliminated from the revised edition? If so, please provide an
explanation for why these EMS attributes should be eliminated.
    20. What are your suggestions for the process that should be used
in revising the EMS Education Agenda?
    21. What specific agencies/organizations/entities are essential to
involve, in a revision of the EMS Education Agenda?
    22. Do you have any additional comments regarding the revision of
the EMS Education Agenda?

(Authority: 23 U.S.C. 403(b)(1)(A)(iv); 49 CFR 1.95; 501.8)

    Issued in Washington, DC.
Nanda Narayanan Srinivasan,
Associate Administrator, Research and Program Development.
[FR Doc. 2023-22625 Filed 10-12-23; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27541-27542]
[FR Doc No: E9-13586]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0254; FRL-8413-2]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register
pesticide products containing new active ingredients not included in
any currently registered products pursuant to the provisions of section
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.

DATES: Comments must be received on or before July 10, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0254, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0254. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Marshall Swindell, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection

Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

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

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing active ingredients not included in any previously registered
products pursuant to the provision of section 3(c)(4) of FIFRA. Notice
of receipt of these applications does not imply a decision by the
Agency on the applications.
     File Symbol: 52484-G. Applicant: The Lubrizol Corporation, 29400
Lakeland Blvd., Wickliffe, OH 44092-2298, submitted by Keller and
Heckman, LLC, 1001 G St., NW., Washington, DC 20001. Product Name:
Contram ST-1. Active Ingredient: N,N,'-methylenebismorpholine at 98.5%.
Proposal classification/Use: Materials preservative used to suppress
the growth of bacteria in metalworking fluids, cutting, cooling, and
lubricating fluid concentrates.
     File Symbol: 85808-R. Applicant: Schulke and Mayr GmBH, Robert-
Koch Str. 2, 22851 Norderstedt, Germany, submitted by Technology
Sciences Group Inc., 1150 18\th\ St., NW., Suite 1000, Washington, DC
20036. Product Name: Stabicide 71.  Active Ingredient: N,N'-
methylenebis (5-methyloxazolidin) 99%. Proposal classification/Use:
Materials preservative used to suppress the growth of bacteria in
metalworking fluids, drilling muds, and fuels.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: May 26, 2009.
 Joan Harrigan Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.

[FR Doc. E9-13586 Filed 6-9-09; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Page 13429]
[FR Doc No: 2016-05588]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77320; File No. SR-NASDAQ-2016-002]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change to List and Trade Shares of the First Trust
Municipal High Income ETF

March 8, 2016.
    On January 6, 2016, The NASDAQ Stock Market LLC (``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
list and trade shares of the First Trust Municipal High Income ETF
under Nasdaq Rule 5735. The proposed rule change was published for
comment in the Federal Register on January 27, 2016.\3\ The Commission
has not received any comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76944 (Jan. 21,
2016), 81 FR 4712.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is March 12, 2016. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
April 26, 2016, as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NASDAQ-2016-002)
---------------------------------------------------------------------------

    \5\ Id.
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-05588 Filed 3-11-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8874-8881]
[FR Doc No: 2015-03420]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1459]

Memorandum of Understanding Addressing Certain Distributions of
Compounded Human Drug Products Between the States and the Food and Drug
Administration; New Proposed Draft; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability for public comment of a draft standard
memorandum of understanding (MOU) entitled ``Memorandum of
Understanding Addressing Certain Distributions of Compounded Human Drug
Products Between the State of [insert State] and the U.S. Food and Drug
Administration.'' The draft standard MOU describes the responsibilities
of the State that chooses to sign the MOU in investigating and
responding to complaints related to compounded human drug products
distributed outside the State and in addressing the interstate
distribution of inordinate amounts of compounded human drug products.
    FDA is also announcing the withdrawal of an earlier draft standard
MOU entitled ``Memorandum of Understanding on Interstate Distribution
of Compounded Drug Products,'' which was issued in January 1999. The
January 1999 draft standard MOU is superseded by the new draft standard
MOU.

DATES: FDA is withdrawing its draft standard MOU that published on
January 21, 1999 (64 FR 3301), as of February 19, 2015. Submit either
electronic or written comments on the new draft standard MOU by June
19, 2015. Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 by June 19, 2015 (see the ``Paperwork
Reduction Act of 1995'' section of this document).

ADDRESSES: Submit written requests for single copies of the MOU to
Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Suite 5100, Silver
Spring, MD 20993-0002. Send one self-addressed label to assist that
office in processing your request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the new draft standard MOU.
    Submit electronic comments on the new draft standard MOU or on the
collection of information to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Edisa Gozun, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Suite 5100, Silver Spring, MD 20993-0002,
301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 353a) describes the conditions that must be satisfied
for drug products compounded by a licensed pharmacist or licensed
physician to be exempt from the following sections of the FD&C Act: (1)
Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP) requirements), (2) section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications or abbreviated new
drug applications).
    One of the conditions to qualify for the exemptions listed in
section 503A of the FD&C Act is that (1) the drug product is compounded
in a State that has entered into an MOU with FDA that addresses the
distribution of inordinate amounts of compounded drug products
interstate and provides for appropriate investigation by a State agency
of complaints relating to compounded drug products distributed outside
such State; or (2) if the drug product is compounded in a State that
has not entered into such an MOU, the licensed pharmacist, pharmacy, or
physician does not distribute, or cause to be distributed, compounded
drug products out of the State in which they are compounded in
quantities that exceed 5 percent of the total prescription orders
dispensed or distributed by such pharmacy or physician (see section
503A(b)(3)(B)(i) and (b)(3)(B)(ii) of the FD&C Act).
    Section 503A(b)(3)(B) of the FD&C Act directs FDA to develop, in
consultation with the National Association of Boards of Pharmacy
(NABP), a standard MOU for use by the States in complying with section
503A(b)(3)(B)(i).

II. Previous Efforts To Develop a Standard MOU

    In the Federal Register of January 21, 1999 (64 FR 3301), FDA
announced the availability for public comment of a draft standard MOU,
developed in consultation with NABP (1999 draft

standard MOU). Over 6,000 commenters submitted comments on the 1999
draft standard MOU. Because of litigation over the constitutionality of
the advertising, promotion, and solicitation provisions in section
503A,\1\ the draft standard MOU was never completed. In 2013, section
503A of the FD&C Act was amended by the Drug Quality and Security Act
(DQSA) (Pub. L. 113-54) to remove the advertising, promotion, and
solicitation provisions that were held unconstitutional, and FDA is
implementing section 503A, including the provisions on the MOU. By this
notice, FDA is withdrawing the 1999 draft standard MOU, and the new
draft standard MOU made available today supersedes that draft standard
MOU.
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    \1\ The conditions of section 503A of the FD&C Act originally
included restrictions on the advertising or promotion of the
compounding of any particular drug, class of drug, or type of drug
and the solicitation of prescriptions for compounded drugs. These
provisions were challenged in court and held unconstitutional by the
U.S. Supreme Court in 2002. See Thompson v. Western States Med.
Ctr., 535 U.S. 357 (2002).
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III. New 503A Guidance

    Immediately after the enactment of the DQSA, in December 2013, the
Agency published a draft guidance on section 503A of the FD&C Act
entitled ``Pharmacy Compounding of Human Drug Products Under Section
503A of the Federal Food, Drug, and Cosmetic Act'' (2013 draft 503A
guidance) (see 78 FR 72901 (December 4, 2013) announcing the
availability of the draft guidance). That draft guidance described
FDA's proposed policy with regard to specific provisions of section
503A of the FD&C Act that require rulemaking or other action by FDA,
such as the MOU provisions. Thirty-one commenters on the 2013 draft
503A guidance offered FDA their views on the MOU provisions of section
503A. FDA considered these comments in developing the new draft
standard MOU. The final 503A guidance, published July 2, 2014 (see 79
FR 37742 announcing the availability of the final 503A guidance),
states that FDA does not intend to enforce the 5 percent limit on
distribution of compounded drug products out of the State in which they
are compounded until after FDA has finalized an MOU and made it
available to the States for their consideration and signature. After
considering any comments on the new draft standard MOU submitted to
this docket, FDA intends to finalize the standard MOU and make it
available for signature by individual States. FDA will determine at the
time of publication of the final MOU how long it will allow States to
consider whether to sign the MOU before FDA begins to enforce the 5
percent limit in those States that have not signed an MOU.

IV. New Draft Standard MOU

    FDA has now developed a new draft standard MOU on which it is
soliciting public comment. FDA has consulted with NABP in developing
this new draft standard MOU. FDA also considered the comments submitted
in 1999 on the previous draft standard MOU, as well as comments on the
MOU provisions it received in connection with the published 2013 draft
503A guidance. Key provisions of the new draft standard MOU are
summarized and discussed in this section of the document and, where
appropriate, compared to the provisions in the 1999 draft standard MOU.

A. Investigation of Complaints

    The new draft standard MOU provides that States that enter into the
MOU will agree to:
     Investigate complaints relating to human drug products
compounded in the State and distributed outside the State, including
complaints about adverse drug experiences or certain product quality
issues to, among other things, determine whether there is a potential
public health risk or safety concern, and confirm that any risk or
safety concern is adequately contained;
     As appropriate, take action to ensure that the relevant
compounding pharmacy, pharmacist, or physician determines the root
cause of the problem and eliminates any public health risk identified
in relation to the complaint;
     Notify FDA within 72 hours of any complaints relating to a
compounded human drug product distributed outside the State involving a
potential public health risk or immediate safety concern, such as a
report of a serious adverse drug experience or serious product quality
issue, the State's initial assessment of the validity of the complaint,
and any actions the State has taken or plans to take to address such
complaints;
     Provide FDA with certain information about the complaint,
including the following:
    [cir] Name and contact information of the complainant;
    [cir] name and address of the pharmacist/pharmacy/physician that is
the subject of the complaint;
    [cir] a description of the complaint, including a description of
any compounded drug product that is the subject of the complaint;
    [cir] the State's initial assessment of the validity of the
complaint relating to a compounded human drug product distributed
outside the State; and
    [cir] a description and date of any actions the State has taken to
address the complaint; and
     Maintain records of the complaints it receives, the
investigation of each complaint, and any response to or action taken as
a result of a complaint, beginning when the State receives notice of
the complaint. The draft standard MOU says that the State agrees to
maintain these records for at least 3 years, beginning on the date of
final action or the date of a decision that the complaint requires no
action.
    The new draft standard MOU, as compared to the 1999 draft standard
MOU, clarifies that the types of complaints of compounded human drug
products that should be investigated include any adverse drug
experience (not just serious adverse drug experiences, which were
identified as an example of the types of complaints to be investigated
in the 1999 draft standard MOU) and product quality issues that, if
left uncorrected, could lead to potential public health risks or safety
concerns. Even nonserious adverse drug experiences and product quality
issues can be indicative of problems at a compounding facility that
could result in product quality defects leading to serious adverse drug
experiences if not corrected. For example, inflammation around the site
of an injection can indicate product contamination from inadequate
sterile practices at the compounding pharmacy. If the pharmacy has
inadequate sterile practices, other more serious contamination could
result in serious adverse events.
    FDA is clarifying that the complaints that States agree to
investigate under the MOU are only those complaints that are made about
compounded human drug products distributed outside the State. In
contrast to the 1999 draft standard MOU, the new draft standard MOU
does not contain a provision that would require the States entering
into the MOU with FDA to agree to investigate alleged violations of the
FD&C Act. Upon further reflection, FDA has tentatively concluded that
it would be more appropriate for FDA to determine whether a particular
action is a violation of Federal law. Of course, if any State
identifies a potential violation of Federal law, it is encouraged to
report it to FDA.
    Furthermore, the new draft standard MOU does not include specific
directions to the States relating to how to conduct their investigation
of

complaints. Rather, as recommended by comments previously submitted on
the 1999 draft standard MOU, the details of such investigations are
left to the States' discretion.
    States signing the new standard MOU would agree to notify FDA about
certain complaints and provide FDA with certain information about the
complaint so FDA could investigate the complaint itself, or take other
appropriate action.\2\
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    \2\ FDA is currently considering whether to propose regulations
or issue guidance documents to further its implementation of section
503A(b)(3)(B) of the FD&C Act. Notice of any such action will be
provided in the Federal Register.
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B. Inordinate Amounts

    The new draft standard MOU provides that States that enter into the
MOU will agree to:
     Review compounding records during inspections of
compounding pharmacies to identify whether the compounding pharmacy, or
the compounding pharmacist or physician, is distributing inordinate
amounts of compounded human drug products interstate;
     Notify FDA if the State identifies any pharmacy,
pharmacist, or physician within its jurisdiction that has distributed
inordinate amounts of compounded human drug products interstate;
     Take action regarding any pharmacy, pharmacist, or
physician that distributes inordinate amounts of compounded human drug
products interstate; and
     Provide FDA with certain information, including the
following:
    [cir] The name and address of the pharmacy/pharmacist/physician;
    [cir] a description of the evidence indicating that the pharmacy/
pharmacist/physician has distributed inordinate amounts of compounded
human drug products interstate, including a description of any
compounded drug product that was distributed in inordinate amounts; and
    [cir] a description and date of any actions the State has taken to
address the distribution of inordinate amounts of compounded human drug
product interstate.
    In the new draft standard MOU, a pharmacist, pharmacy, or physician
is considered to have distributed an inordinate amount of compounded
human drug products interstate if the number of units of compounded
human drug products distributed interstate during any calendar month is
equal to or greater than 30 percent of the number of units of
compounded and non-compounded drug products distributed or dispensed
both intrastate and interstate by such pharmacist, pharmacy, or
physician during that calendar month. FDA does not intend to include in
the consideration of inordinate amounts those prescriptions dispensed
to a patient (or patient's agent), where the patient (or patient's
agent) to whom the drug is dispensed carries the drug across State
lines after it has been dispensed to the patient (or the patient's
agent) at the facility in which the drug was compounded.\3\ This
concept would be called the 30 percent limit.
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    \3\ Drugs that a patient takes across state lines in this manner
are distributed interstate. However, for reasons explained in this
notice, FDA's draft standard MOU does not count them toward the
limit on distributing inordinate amounts of compounded drug products
interstate.
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    The 1999 draft standard MOU defined ``inordinate amounts'' as the
number of compounded prescriptions dispensed or distributed interstate
annually by a pharmacy or physician that is equal to or greater than 20
percent of the total number of prescriptions dispensed or distributed
(including both intrastate and interstate) by such pharmacy or
physician; or the number of compounded prescriptions dispensed or
distributed interstate annually by a pharmacy or physician that is less
than 20 percent of the total number of prescriptions dispensed or
distributed (including both intrastate and interstate) by such pharmacy
or physician, but prescriptions for one or more individual compounded
drug products (including various strengths of the same active
ingredient) dispensed or distributed interstate constitute more than 5
percent of the total number of prescriptions dispensed or distributed.
The 1999 draft standard MOU also included an exclusion from
calculations to determine inordinate amounts for ``local'' interstate
distribution to patients within 50 miles of the compounding pharmacy,
and for interstate distribution in response to a public health
emergency or catastrophic event.
    Many comments on the 1999 draft standard MOU opposed the percentage
limits it contained, and some comments on the 2013 draft 503A guidance
opposed any definition of inordinate amounts that would significantly
restrict interstate distributions under section 503A of the FD&C Act.
Other comments suggested not defining ``inordinate amounts,'' leaving
the definition up to the States, or defining the term as ``the amount
that would be considered conventional manufacturing.'' FDA is proposing
the 30 percent limit as the definition of ``inordinate amounts'' for
the following reasons.
    Section 503A of the FD&C Act reflects Congress' recognition that
human drug compounding may be appropriate when it is based on receiving
a valid prescription or notation for an identified individual patient.
However, drug products compounded under this section of the FD&C Act
are not required to demonstrate that they are safe or effective, bear
adequate directions for use, or conform to CGMP. Congress, therefore,
imposed strict limits on the distribution of drug products compounded
under this section to protect the public health and the integrity of
the drug approval process.
    In particular, Congress did not intend for compounders operating
under these statutory provisions to grow into conventional
manufacturing operations making unapproved drugs, operating a
substantial proportion of their business interstate. Although other
provisions of the FD&C Act apply to state-licensed pharmacies and
physicians that may qualify for the exemptions under section 503A of
the FD&C Act (e.g., the adulteration provisions for making drugs under
insanitary conditions), and although FDA may take action in appropriate
cases against compounders that violate these provisions or that operate
outside of the conditions in section 503A, Congress recognized that
these compounders are primarily overseen by the States. If a
substantial proportion of a compounder's drugs are distributed outside
a State's borders, adequate regulation of those drugs poses significant
challenges to State regulators. States face logistical, regulatory, and
financial challenges inspecting compounders located outside of their
jurisdiction. In addition, particularly if a compounder distributes
drugs to multiple States, it can be very difficult to gather the
scattered information about possible adverse events associated with
those drugs, connect them to the compounder, and undertake coordinated
action to address a potentially serious public health problem.
    Therefore, as a baseline measure, section 503A(b)(3)(B) of the FD&C
Act limits the distribution of compounded human drug products outside
of the State in which they are compounded under section 503A(a) to 5
percent of the total prescription orders dispensed or distributed by a
licensed pharmacist, pharmacy, or physician. It then directs FDA, in
consultation with NABP, to develop a standard MOU that addresses the
distribution of inordinate amounts of compounded human drug products
interstate and provides for appropriate

investigation by a State agency of complaints relating to compounded
human drug products distributed outside such State. Implementation of
this provision requires FDA to determine whether a limit higher than 5
percent would be appropriate, provided the States make certain
agreements: A State agrees to appropriately investigate complaints
relating to compounded human drug products distributed out of the State
and agrees to address the distribution of amounts that would be
inordinate.
    FDA tentatively concludes that if a State agrees to meet the
conditions set forth in this MOU, distribution interstate up to the 30
percent limit would not be inordinate. This conclusion is based on
FDA's expectation that States signing the MOU would appropriately
investigate complaints about compounded human drug products distributed
out of State, and address compounders distributing an inordinate amount
of compounded drug products out of the state in which they are
compounded. FDA's current view is that its proposed limit would
appropriately balance the benefits of access to compounded human drug
products with the need to protect the public health and the drug
approval system. We do not believe that an additional limit is
necessary for the distribution of an individual compounded drug product
such as that contained in the 1999 draft standard MOU.
    In developing the new draft standard MOU, we considered that
patients can now obtain compounded human drug products from outsourcing
facilities,\4\ which are not subject to volume restrictions on
interstate distribution. This could mitigate the access concerns noted
in some comments FDA received on the definition of ``inordinate
amounts'' in the 1999 draft standard MOU, and in more recent comments
expressing concerns about access if ``inordinate amounts'' is defined
restrictively or the 5 percent limit is enforced.
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    \4\ The DQSA adds new section 503B to the FD&C Act (21 U.S.C.
353b). Under section 503B(b) of the FD&C Act, a compounder may elect
to become an outsourcing facility by registering with FDA. Products
compounded in a registered outsourcing facility can qualify for
exemptions from the FDA approval requirements in section 505 of the
FD&C Act and the requirement to label products with adequate
directions for use under section 502(f)(1) of the FD&C Act if the
requirements in section 503B are met. Outsourcing facilities will be
inspected by FDA and must comply with other provisions of the FD&C
Act, such as CGMP requirements.
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    It is appropriate to provide a bright line test for when
compounding pharmacies located in States that sign the MOU cross the
line to conventional manufacturing that should be subject to all of the
requirements of the FD&C Act, including the new drug approval and CGMP
requirements. Congress provided such a bright line test, the 5 percent
limit, for compounders located in States that do not sign the MOU.
    Some commenters in response to the 1999 draft MOU and the 2013
draft 503A guidance were concerned with limitations on interstate
distribution of compounded human drug products to contiguous States. In
the 1999 draft MOU, the calculation of ``inordinate amounts'' excluded
compounded human drug products that were distributed interstate but
within 50 miles of the pharmacy or physician's office. After
considering the provision in the 1999 draft MOU and the comments, FDA
believes that the 30 percent limit on inordinate amounts provided in
this new draft standard MOU is high enough that special calculations to
address interstate distribution between contiguous States or over short
distances are not needed. Moreover, the new draft standard MOU includes
consideration of inordinate amounts of prescriptions dispensed to a
patient (or patient's agent), if the patient (or patient's agent) to
whom the drug is dispensed carries the drug across State lines after it
has been dispensed to the patient (or patient's agent) at the facility
in which the drug was compounded. We also do not intend to count as
part of the 5 percent limit on distribution out of the State
prescriptions dispensed to a patient (or patient's agent), if the
patient (or patient's agent) to whom the drug is dispensed carries the
drug across State lines after it has been dispensed to the patient (or
patient's agent) at the facility in which the drug was compounded. We
believe this treatment of these transactions where there are direct
relationships among the patient, the prescriber, and the pharmacist or
physician compounding the drug is consistent with section 503A of the
FD&C Act.
    Finally, the new draft standard MOU does not exclude from the
calculation of ``inordinate amounts'' interstate distributions in
response to a public health emergency or catastrophic event. We believe
the 30 percent limit affords adequate opportunity for interstate
distributions and note that outsourcing facilities may be able to
compound drugs in an emergency and drugs on FDA's drug shortage list,
further mitigating access concerns.

C. Definitions

    The Appendix to the new draft standard MOU defines key terms used
in the MOU, including ``adverse drug experience,'' ``serious adverse
drug experience,'' ``product quality issue,'' ``serious product quality
issue,'' and ``distribution.'' The definitions of ``adverse drug
experience,'' ``serious adverse drug experience,'' ``product quality
issue,'' and ``serious product quality issue'' are taken from relevant
sections of FDA's regulations (see 21 CFR 310.305 and 314.81). For
purposes of the new draft standard MOU, a ``distribution'' occurs when
a compounded human drug product leaves the facility in which the drug
was compounded. Distribution includes delivery or shipment to a
physician's office, hospital, or other health care setting for
administration and dispensing to an agent of a patient or to a patient
for his or her own use. However, the definition notes that, to qualify
for the exemptions under section 503A of the FD&C Act, a compounder
must obtain a prescription for an individually identified patient
(section 503A(a)), and the draft standard MOU would not alter this
condition. Interstate distributions of compounded drug products would
count toward the 30 percent limit whether or not the compounded drug
products satisfied the prescription condition, or other conditions, in
section 503A of the FD&C Act.
    Some comments on the 2013 draft 503A guidance state that provisions
in the standard MOU relating to drug distribution should not apply to
dispensed drugs. Although the comments do not share a single definition
of dispensing, or offer a detailed definition, they generally take the
position that a drug is dispensed when it is provided pursuant to a
prescription or doctor's order, and that dispensing is not a form of
distribution. We have not adopted this approach, and propose a
definition of distribution that we believe is consistent with the text
and purpose of section 503A of the FD&C Act. Under our draft standard
MOU, a distribution occurs when a compounded drug leaves the facility
where it was made, regardless of whether the drug is also deemed to be
dispensed.
    Section 503A(b)(3)(B) of the FD&C Act directs FDA to include
provisions in the MOU regarding the distribution of compounded drugs.
The section does not define distribution to exclude dispensing, which
Congress has done elsewhere when that was its intention.\5\

Our proposed definition implements the purpose of section 503A(b)(3)(B)
of the FD&C Act, which is to limit and regulate compounded drugs that
are sent out of the state in which they are made.\6\ Our definition is
also consistent with the ordinary meaning of distribute; it is natural
to say that an entity compounding under section 503A of the FD&C Act
distributes the drugs it makes to patients and health care providers,
just as the manufacturers of other regulated articles are said to
distribute their products to their customers. The definition proposed
by comments, on the other hand, would write an exclusion for dispensing
into the statute where Congress did not. It would also mean that drug
products compounded under section 503A of the FD&C Act are excluded
from the MOU and the 5 percent limit, because, in order to qualify for
the exemptions under section 503A, a compounder must obtain a valid
prescription order for an individually identified patient. For the
reasons stated previously in section IV.B of this document, we believe
this would achieve the opposite of what Congress intended.
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    \5\ In different contexts, where it would further a regulatory
purpose, Congress and the Agency have specifically defined
distribute to exclude dispensing. See, for example, section 581(5)
of the FD&C Act, which applies to Title II of the DQSA, and 21 CFR
208.3, which applies to 21 CFR part 208 of our regulations. Section
503A of the FD&C Act does not contain a similar definition, or
specific direction to exclude dispensing from the meaning of
distribution. We also note that these definitions were adopted for
provisions that focus on conventionally manufactured drug products,
which assign different obligations to dispensers than to
wholesalers, packagers, or other intermediaries in light of the
different role that dispensers play with respect to product labeling
and the drug distribution chain. In contrast, section 503A of the
FD&C Act focuses on compounded drugs, and the reasons for defining
distribution to exclude dispensing in Title II of the DQSA or part
208 do not apply.
    \6\ See discussion of the purposes of section 503A of the FD&C
Act in section IV.B, supra.
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    In support of their alternative approach, commenters note that in
section 503A(b)(3)(B)(ii) of the FD&C Act, Congress directed FDA to
calculate the quantity of ``prescription orders dispensed and
distributed'' when the Agency applies the 5 percent limit to
compounders in states that do not sign the MOU. This language, however,
supports FDA's proposed approach, because it makes clear that Congress
understood the word distribute in this section to refer to filling
prescription orders; otherwise it would not have directed the Agency to
count the number of prescription orders that pharmacists and
prescribers ``distributed.'' Nor is there anything to suggest that
Congress understood distributed and dispensed to be mutually exclusive
categories rather than overlapping categories. Given the statutory text
and purpose, we believe that Congress referred to drugs dispensed or
distributed in section 503A(b)(3)(B) of the FD&C Act to make clear that
the Agency must not limit its calculation of total prescription orders
to compounded drugs that the pharmacy or prescriber makes, but also
include any other prescription orders, such as conventionally
manufactured drugs, for which the pharmacist or prescriber serves
solely as the dispenser.

V. Other Issues

A. Development of a Standard MOU

    A number of commenters on both the 1999 draft MOU and on the 2013
draft 503A guidance suggested that FDA specifically negotiate MOUs with
individual States, rather than develop a standard MOU. Section 503A of
the FD&C Act requires the Agency to develop a standard MOU for use by
the States. Furthermore, it would be impractical to develop an
individualized MOU with every State, and creating individualized MOUs
would create a patchwork of regulation of interstate distribution from
compounders seeking to qualify for the exemptions under section 503A of
the FD&C Act. This would be confusing to the health care community, as
well as regulators.

B. Exemptions From the Interstate Distribution Provisions

    Some comments on the 2013 draft 503A guidance requested that we
consider exempting certain drug products or types of compounding
entities from the limits in the MOU and the 5 percent limit. For
example, some comments recommended that we exempt nonsterile products
or home infusion pharmacies.
    Congress did not exempt any particular drug products or compounding
entities from the 5 percent limit. Furthermore, FDA believes that the 5
percent limit and the MOU limit on inordinate amount provisions are
important to distinguish pharmacy compounding from conventional
manufacturing in the guise of compounding, and to protect consumers and
the integrity of the drug approval process. American consumers rely on
the FDA drug approval process to ensure that medications have been
evaluated for safety and effectiveness before they are marketed in the
United States. Drugs made by compounders, including those made at human
drug compounding outsourcing facilities, are not FDA-approved. This
means that they have not undergone premarket review of safety,
effectiveness, or manufacturing quality. Therefore, when an FDA-
approved drug is commercially available, FDA recommends that
practitioners prescribe the FDA-approved drug rather than a compounded
drug unless the prescribing practitioner has determined that a
compounded product is necessary for the particular patient and would
provide a significant difference for the patient as compared to the
FDA-approved commercially available drug product.
    In section 503A of the FD&C Act, Congress enacted several
conditions to differentiate compounders from manufacturers and provided
that only if they meet those conditions can they qualify for the
exemptions from the drug approval requirements in section 505 of the
FD&C Act. One of those conditions relates to limitations on the
interstate distribution of compounded human drug products, and FDA
intends to enforce those provisions to differentiate compounding that
qualifies for the exemptions from conventional manufacturing in the
guise of compounding that does not, and will apply the conditions to
all types of drugs and all categories of compounding.

C. Information Sharing Between States and FDA

    Several commenters on the 1999 draft MOU proposed that signatories
to the MOU would agree to share information on a variety of subjects.
The new draft standard MOU provides that States will agree to notify
FDA of any complaint relating to a compounded human drug product
distributed outside the State involving a potential public health risk
or immediate safety concern, such as a report of a serious adverse drug
experience or serious product quality issue, and provide information
about those events and issues. The new draft standard MOU also provides
that States will notify FDA if they identify a pharmacist, pharmacy, or
physician within their jurisdiction that has distributed inordinate
amounts of compounded human drug products interstate. In addition, FDA
regularly posts on its compounding Web site information about
enforcement and other actions related to compounders that violate the
FD&C Act, and it is obligated to share certain information with States
under section 105 of the DQSA.

D. Enforcement of the 5 Percent Limit on Distribution of Compounded
Drug Products Out of the State in Which They Are Compounded

    In the 2013 draft 503A guidance, FDA stated that it does not intend
to enforce the 5 percent limit on distribution of compounded drug
products outside of the State in which they are compounded until 90
days after FDA has finalized a standard MOU and made it available to
the States for their consideration and signature. Most commenters on
the 2013 draft 503A guidance said this period was too short, but did
not recommend a specific alternative. A few commenters recommended a
different timeframe, one recommending 120 days and another recommending
365 days. The 1997 Senate Committee Report for the Food and Drug
Administration Modernization Act suggests that a 180-day period for
States to decide whether to sign might be appropriate.\7\ The Agency
proposes a 180-day period after the final standard MOU is made
available for signature before FDA will enforce the 5 percent limit in
States that have not signed the MOU, and invites public comment on
whether this is the appropriate timeframe. FDA will announce at the
time it publishes the final standard MOU and makes it available for
signature when it intends to begin enforcing the 5 percent limit in
States that do not sign.
---------------------------------------------------------------------------

    \7\ ``[U]ntil the State . . . enters into a memorandum of
understanding (MOU) with the Secretary or 180 days after the
development of the standard MOU, whichever comes first, the [section
503A] exemption shall not apply if inordinate quantities of
compounded products are distributed outside of the State in which
the compounding pharmacy or physician is located.'' (U.S. Senate
Committee Report, see note 2.)
---------------------------------------------------------------------------

VI. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)), requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Section 503A of the FD&C Act describes, among other things, the
circumstances under which certain human drug products compounded by a
licensed pharmacist or licensed physician are exempt from certain
sections of the FD&C Act. One of the conditions to qualify for the
exemptions listed in section 503A of the FD&C Act is that: (1) The
human drug product is compounded in a State that has entered into an
MOU with FDA that addresses the distribution of inordinate amounts of
compounded human drug products interstate and provides for appropriate
investigation by a State agency of complaints relating to compounded
human drug products distributed outside such a State; or (2) if the
human drug product is compounded in a State that has not entered into
such an MOU, the licensed pharmacist, pharmacy, or physician does not
distribute, or cause to be distributed, compounded human drug products
out of the State in which they are compounded, more than 5 percent of
the total prescription orders dispensed or distributed by such pharmacy
or physician (see section 503A(b)(3)(B)(i) and (b)(3)(B)(ii).
    Section 503A(b)(3) directs FDA, in consultation with the NABP, to
develop a standard MOU for use by states in complying with the
provisions concerning the interstate distribution of inordinate amounts
of compounded human drug products interstate and appropriate
investigation by a State agency of complaints relating to compounded
human drug products distributed outside such State.
    The new draft standard MOU contains the information collections
that must be approved by OMB under the PRA. These information
collections are described in this section of the document. For purposes
of this analysis, FDA assumes that 25 States will sign the standard MOU
with FDA.
    Under section III.a. of the new draft standard MOU, the State will
notify FDA by email at<EMAIL_ADDRESS>within 72 hours of
receiving any complaint relating to a compounded human drug product
distributed outside the State involving a potential public health risk
or immediate safety concern, such as a report of a serious adverse drug
experience or serious product quality issue. The notification will
include the following information: (1) The name and contact information
of the complainant, in the case of a complaint; (2) the name and
address of the pharmacist, pharmacy, and/or physician that is the
subject of the complaint; (3) a description of the complaint, including
a description of any compounded drug product that is the subject of the
complaint; (4) the State's initial assessment of the validity of the
complaint relating to a compounded human drug product distributed
outside the State; and (5) a description and date of any actions the
State has taken to address the complaint. In addition, the States will
maintain records of the complaints they receive, the investigation of
each complaint, and any response to or action taken as a result of a
complaint, beginning when the State receives notice of the complaint.
The States will maintain these records for at least 3 years, beginning
on the date of final action or the date of a decision that the
complaint requires no action.
    Based on our knowledge of State regulation of compounding practices
and related complaints, we estimate that annually a total of
approximately 25 States (``no. of respondents'' in table 1, row 1) will
notify FDA within 72 hours of receiving any complaint relating to a
compounded human drug product distributed outside the State involving a
potential public health risk or immediate safety concern. We estimate
that each State will notify FDA annually of approximately 3 complaints
it receives (``no. of responses per respondent'' in table 1, row 1),
for a total of 75 notifications of complaints sent to FDA (``total
annual responses'' in table 1, row 1). We estimate that preparing and
submitting this information to us as described in the MOU will take
approximately 0.5 hours per response (``average burden per response''
in table 1, row 1), for a total of 37.5 hours (``total hours'' in table
1, row 1).
    We also estimate that a total of approximately 25 States (``no. of
recordkeepers'' in table 2) will prepare and maintain records for 3
years of the complaints they receive, investigations of complaints, and
on any State action

taken or replies to complaints. We estimate that each State will
receive approximately 3 complaints annually and will prepare and
maintain approximately 5 records per each complaint the State receives,
for a total of 15 records per State (``no. of records per
recordkeeper'' in table 2), and a total of 375 records annually across
all States (``total annual records'' in table 2). We further estimate
that preparing and maintaining these records will take approximately 1
hour per record (``average burden per recordkeeping (in hours)'' in
table 2), for a total of 375 hours (``total hours'' in table 2).
    Under section III.a. of the new draft standard MOU, investigations
performed by the State under this MOU will ensure that (1) the root
cause of the problem that is the subject of the complaint is
determined, (2) any risk or safety concern associated with the
compounded human drug product is adequately contained (i.e., there is
no ongoing risk to the public), and (3) sufficient corrective action
has been taken to eliminate any future public health risk.
    Under section III.b of the new draft standard MOU, the States will
notify FDA by email at<EMAIL_ADDRESS>within 7 days of
determining that a pharmacist, pharmacy, or physician within their
jurisdiction has distributed inordinate amounts of compounded human
drug products interstate, as described in the MOU. The notification
should include the following information: (1) The name and address of
the pharmacist/pharmacy/physician; (2) a description of the evidence
indicating that the pharmacist/pharmacy/physician has distributed
inordinate amounts of compounded human drug products interstate,
including a description of any compounded drug product that was
distributed in inordinate amounts; and (3) a description and date of
any actions the State has taken to address the distribution of
inordinate amounts of compounded human drug products interstate.
    We estimate that annually a total of approximately 25 States (``no.
of respondents'' in table 1, row 2) will notify FDA of their
determination that a pharmacist, pharmacy, or physician has distributed
inordinate amounts of compounded human drug products interstate. We
estimate that each State will notify FDA annually of approximately 2
determinations it makes (``no. of responses per respondent'' in table
1, row 2), for a total of 50 determinations (``total annual responses''
in table 1, row 2). We estimate that preparing and submitting this
information to FDA as described in the MOU will take approximately 0.5
hours per response (``average burden per response'' in table 1, row 2),
for a total of 25 hours (``total hours'' in table 1, row 2).
    Under section V of the current draft standard MOU, a State may
designate a new liaison to the MOU by notifying FDA's administrative
liaison in writing. If a State's liaison becomes unavailable to fulfill
its functions under the MOU, the State will name a new liaison within 2
weeks and notify FDA.
    We estimate that annually a total of approximately 13 States (``no.
of respondents'' in table 1, row 3) will notify FDA of a new liaison to
the MOU. We estimate that each State will submit to FDA annually
approximately 1 notification of a new liaison (``no. of responses per
respondent'' in table 1, row 3), for a total of 13 notifications of a
new liaison (``total annual responses'' in table 1, row 3). We estimate
that preparing and submitting each notification as described in the MOU
will take approximately 0.2 hours per response (``average burden per
response'' in table 1, row 3), for a total of 2.6 hours (``total
hours'' in table 1, row 3).
    Under section VI of the new draft standard MOU, a State may
terminate its participation in the MOU by submitting to FDA a 30-day
notice of termination.
    We estimate that annually a total of approximately 1 State (``no.
of respondents'' in table 1, row 4) will notify FDA that it intends to
terminate its participation in the MOU. We estimate that this State
will submit to FDA annually approximately 1 notification of termination
(``no. of responses per respondent'' in table 1, row 4), for a total of
1 notification (``total annual responses'' in table 1, row 4). We
estimate that preparing and submitting the notification as described in
the MOU will take approximately 0.2 hours per notification (``average
burden per response'' in table 1, row 4), for a total of 0.2 hours
(``total hours'' in table 1, row 4).
    Under section VI of the new draft standard MOU, if a State does not
adhere to the provisions of the MOU, FDA may post a 30-day notice of
termination on its Web site. As a result of this action by FDA, the
State will notify all pharmacists, pharmacies, and physicians within
the State of the termination and advise them that compounded human drug
products may be distributed (or caused to be distributed) out of the
State only in quantities that do not exceed 5 percent of the total
prescription orders dispensed or distributed by the pharmacist,
pharmacy, or physician.
    We estimate that annually a total of approximately 1 State (``no.
of respondents'' in table 3) will submit 1 notification of termination
as described in the MOU (``no. of disclosures per respondent'' in table
3) to the pharmacists, pharmacies, and physicians in its State for a
total of 1 notification of termination (``total annual disclosures'' in
table 3). We estimate that preparing and submitting each notification
will take approximately 1 hour per notification (``average burden per
disclosure (in hours)'' in table 3), for a total of 1 hour (``total
hours'' in table 3).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number o
Compounding MOU between FDA and     Number of     responses per   Total annual   Average burden    Total hours
             States                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
State notifies FDA of                        25               3              75             0.5             37.5
 compounding complaints it
 receives......................
State notifies FDA of the                    25               2              50             0.5             25
 distribution of inordinate
 amounts of compounded drug
 products......................
State notifies FDA of a new                  13               1              13             0.2              2.6
 liaison to the MOU............
State notifies FDA of its                     1               1               1             0.2              0.2
 intent to terminate
 participation in the MOU......
                                --------------------------------------------------------------------------------
    Total......................              64               7             139             N/A             65.3
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
Compounding MOU between FDA and     Number of       Number of     Total annual         per
             States               recordkeepers    records per       records      recordkeeping    Total Hours
                                                  recordkeeper                     (in Hours)
----------------------------------------------------------------------------------------------------------------
State recordkeeping for 3 years              25              15             375               1            375
 of compounding complaints.....
                                --------------------------------------------------------------------------------
    Total......................              25              15             375               1            375
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
 Compounding MOU between FDA and     Number of      disclosures    Total annual   per disclosure    Total hours
             States                 respondents   per respondent    disclosures      (in Hours)
----------------------------------------------------------------------------------------------------------------
State notification to                          1               1               1               1               1
 pharmacists, pharmacies, and
 physicians that its
 participation in the MOU has
 been terminated by FDA.........
                                 -------------------------------------------------------------------------------
    Total.......................               1               1               1               1               1
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

VII. Request for Comments

    FDA invites comments from interested persons on the new draft
standard MOU that would establish an agreement between the signatory
States and FDA regarding the appropriate investigation by such States
of complaints relating to compounded human drug products distributed
outside the State, and the distribution of inordinate amounts of
compounded human drug products interstate. The Agency is providing a
120-day comment period.
    After considering any comments on the new draft standard MOU
submitted to this docket, FDA intends to finalize the standard MOU and
make it available for signature by individual States. FDA will
determine at the time of publication of the final MOU how long it will
allow States to consider whether to sign the MOU before FDA begins to
enforce the 5 percent limit in those States that have not signed an
MOU.
    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set 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.

VIII. Electronic Access

    Persons with access to the Internet may obtain the draft standard
MOU at http://www.regulations.gov.

    Dated: February 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03420 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Proposed Rules]
[Page 17373]
[FR Doc No: 2011-7222]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0169; FRL-9286-9]

Approval and Promulgation of Implementation Plans; Nevada;
Determination of Attainment for the Clark County 8-Hour Ozone
Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to determine that the Clark County (Nevada) 8-
hour ozone nonattainment area has attained the 1997 8-hour ozone
national ambient air quality standards (NAAQS). This proposed
determination is based upon complete, quality-assured, and certified
ambient air monitoring data that show the area has monitored attainment
of the 1997 8-hour ozone NAAQS for the 2007 to 2009 monitoring period.
Preliminary air quality monitoring data available for 2010 are
consistent with continued attainment. Based on this proposed
determination, the requirement for the State of Nevada to submit an
attainment demonstration and associated reasonably available control
measures (RACM), a reasonable further progress (RFP) plan, contingency
measures, and other planning requirements related to attainment of the
1997 8-hour ozone NAAQS for the Clark County ozone nonattainment area
would be suspended for as long as the nonattainment area continues to
meet the 1997 8-hour ozone NAAQS. This action is being taken under the
Clean Air Act (CAA).

DATES: Written comments must be received on or before April 28, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0169, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R09-OAR-2011-0169,'' Lisa Hanf, Chief, Air Planning
Office, Air Division, U.S. Environmental Protection Agency, Region IX,
75 Hawthorne Street (Air-2), San Francisco, California 94105.
    5. Hand Delivery or Courier: At the previously-listed EPA Region IX
address. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: John Kelly,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
direct final action, of the same title, which is located in the Rules
section of this Federal Register. EPA is approving the attainment
determination and related suspension of attainment planning-related SIP
submittal requirements as a direct final rule without prior proposal
because EPA views this as a noncontroversial action and anticipates no
adverse comments. A detailed rationale for the determination and
suspension of attainment-related SIP submittal requirements is set
forth in the preamble to the direct final rule. If EPA receives no
adverse comments, EPA will not take further action on this proposed
rule.
    If EPA receives adverse comments, EPA will withdraw the direct
final rule and it will not take effect. EPA will address all public
comments in a subsequent final rule based on this proposed rule. EPA
will not institute a second comment period on this action. Any parties
interested in commenting on this action should do so at this time.
Please note that if we receive adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

    Dated: March 15, 2011.
Jared Blumenfeld,
Regional Administrator, EPA Region IX.
[FR Doc. 2011-7222 Filed 3-28-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57589-57590]
[DOCID:fr03oc05-91]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL05-145-000]

Emergency Petition and Complaint of the District of Columbia
Public Service Commission; Notice of Proposed Restricted Service List

September 23, 2005.
    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure provides that, to
eliminate unnecessary expenses or improve administrative efficiency,
the Secretary may establish a restricted service list for a particular
proceeding.\1\ A restricted service list contains the names of persons
who, in the judgment of the decisional authority establishing the list,
are active participants with respect to the phase or issue in the
proceeding for which the restricted service list is established.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2010(d) (2005).
---------------------------------------------------------------------------

    Any person on the current official service list for the above-
captioned proceedings may request inclusion on the restricted service
list, or may request that a restricted service list not be established,
by filing a motion stating the reason for the request within 15 days of
the date of this notice.
    The Commission strongly encourages electronic filings. The motions
described above may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site under the eFiling link at http://www.ferc.gov. If a person cannot

file a motion electronically, an original and 14 copies of any such
motions must be filed with Magalie R. Salas, Secretary of the
Commission, at 888 First Street, NE., Washington, DC, 20426. All
motions, electronic or paper, must be served on each person whose name
appears on the current official service list in the above-docketed
proceeding. If no such motions are filed, the restricted service list
will be effective at the end of the 15-day

period. Otherwise, a further notice will be issued ruling on any motion
or motions filed within the 15-day period.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5367 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: February 3, 2010 (Volume 75, Number 22)]
[Rules and Regulations]
[Page 5536-5537]
[DOCID:fr03fe10-15]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 192 and 195

[Docket No. PHMSA-2007-27954; Amdt. Nos. 192-112 and 195-93]
RIN 2137-AE28

Pipeline Safety: Control Room Management/Human Factors,
Correction

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Final rule; correction.

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

SUMMARY: PHMSA is correcting a Final Rule that appeared in the Federal
Register on December 3, 2009. That final rule amended the Federal
Pipeline Safety Regulations to address human factors and other aspects
of control room management for pipelines where controllers use
supervisory control and data acquisition (SCADA) systems, but contained
errors regarding certain dates, both in the preamble and the
amendments. This document corrects those errors.

DATES: Effective Date: February 3, 2010. Applicability Date: This
correction is applicable beginning February 1, 2010.

FOR FURTHER INFORMATION CONTACT: For technical information contact
Byron Coy at<PHONE_NUMBER> or by e-mail at<EMAIL_ADDRESS>For
legal information contact Benjamin Fred at<PHONE_NUMBER> or by e-mail
at<EMAIL_ADDRESS>All materials in the docket may be accessed
electronically at http://www.regulations.gov. General information about
PHMSA may be found at http://phmsa.dot.gov.

SUPPLEMENTARY INFORMATION: On December 3, 2009, PHMSA published a final
rule in the Federal Register (74 FR 63310) entitled ``Pipeline Safety:
Control Room Management/Human Factors.'' This final rule contained
several errors regarding certain compliance dates. The final rule
became effective on February 1, 2010, and the corrected dates detailed
in this final rule correction are applicable as of February 1, 2010.
    On page 63311 of the preamble to the December 3 rule, in the first
column in the DATES section, the compliance date is corrected to read
``Compliance Date: An operator must develop control room management
procedures by August 1, 2011, and implement the procedures by February
1, 2013.''

0
Therefore, in accordance with the reasons stated in the preamble, PHMSA

amends 49 CFR part 192 by making the following correcting amendments:

PART 192--TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE:
MINIMUM FEDERAL SAFETY STANDARDS

0
1. The authority citation for part 192 continues to read as follows:

    Authority:  49 U.S.C. 5103, 60102, 60104, 60108, 60109, 60110,
60113, and 60118; and 49 CFR 1.53.

Sec.  192.631  [Amended]

0
2. In paragraph (a)(2), in the second sentence, remove the phrase
``implement the procedures no later than February 1, 2012'' and add the
phrase ``implement the procedures no later than February 1, 2013'' in
its place.

Sec.  195.446  [Amended]

0
3. In paragraph (a), in the last sentence, remove the phrase
``implement the procedures no later than February 1, 2012'', and add
the phrase ``implement the procedures no later than February 1, 2013''
in its place.

    Issued in Washington, DC, on January 28, 2010.
Cynthia L. Quarterman,
Administrator.
[FR Doc. 2010-2190 Filed 2-2-10; 8:45 am]
BILLING CODE 4910-60-P