[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Proposed Rules]
[Pages 1590-1592]
[FR Doc No: 2016-00166]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-4010; Airspace Docket No. 15-ASO-11]

Proposed Establishment of Class D and Class E Airspace, and
Proposed Amendment of Class E Airspace; Lake City, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class D airspace and Class E
surface area airspace at Lake City, FL, providing the controlled
airspace required for the Air Traffic Control Tower at Lake City
Gateway Airport. This action also would amend existing Class E airspace
by recognizing the airport's name change. Controlled airspace is
necessary for the safety and management of instrument flight rules
(IFR) operations at the airport.

DATES: Comments must be received on or before February 29, 2016.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg. Ground Floor Rm. W12-140, Washington, DC 20590-0001; Telephone:
1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2015-4010; Airspace Docket No. 15-ASO-11, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.
    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. For further information, you can contact the
Airspace Policy and Regulations Group, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.9Z at NARA, call<PHONE_NUMBER>, or go to
http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would establish Class D and Class E airspace, and amend
Class E airspace at Lake City Gateway Airport, Lake City, FL.

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.

    Communications should identify both docket numbers (FAA Docket No.
FAA-2015-4010; Airspace Docket No. 15-ASO-11) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2015-4010; Airspace Docket No. 15-ASO-11.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace
Designations and Reporting Points, dated August 6, 2015, and effective
September 15, 2015. FAA Order 7400.9Z is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.9Z lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class D airspace and Class E
surface area airspace, and amend Class E airspace extending upward from
700 feet above the surface at Lake City Gateway Airport, Lake City, FL,
providing the controlled airspace required to support the Air Traffic
Control Tower. Class D airspace extending upward from the surface up to
and including 2,500 feet would be established within a 4.2 mile radius
of the airport. Class E surface area airspace would be established
within a 4.2 mile radius of the airport. Controlled airspace is
necessary for IFR operations. The airport name under existing Class E
airspace would be changed from Lake City Municipal Airport to Lake City
Gateway Airport.
    Class D and Class E airspace designations are published in
Paragraphs 5000, 6002, and 6005, respectively of FAA Order 7400.9Z,
dated August 6, 2015, and effective September 15, 2015, which is
incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore; (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, paragraph 5.6.5a, ``Environmental
Impacts: Policies and Procedures'' prior to any FAA final regulatory
action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9Z, Airspace Designations and Reporting
Points, dated August 6, 2015, effective September 15, 2015, is amended
as follows:

Paragraph 5000 Class D Airspace.
* * * * *

ASO FL D Lake City, FL [New]

Lake City Gateway Airport, FL
    (Lat. 30[deg]10'56'' N., long. 82[deg]34'37'' W.)
    That airspace extending upward from the surface to and including
2,500 feet within a 4.2-mile radius of Lake City Gateway Airport.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6002 Class E Surface Area Airspace.

* * * * *

ASO FL E2 Lake City, FL [New]

Lake City Gateway Airport, FL
    (Lat. 30[deg]10'56'' N., long. 82[deg]34'37'' W.)
    Within a 4.2-mile radius of Lake City Gateway Airport. This
Class E airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be continuously published in the
Airport/Facility Directory.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO FL E5 Lake City, FL [Amended]

Lake City Gateway Airport, FL
    (Lat. 30[deg]10'56'' N., long. 82[deg]34'37'' W.)
    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Lake City Gateway Airport.

    Issued in College Park, Georgia, on December 18, 2015.
Ryan W. Almasy,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2016-00166 Filed 1-12-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76463-76464]
[FR Doc No: 2011-31336]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65861; File No. SR-ISE-2011-77]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Network and Gateway Fees

December 1, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that, on November 17, 2011, the International Securities
Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the
Securities and Exchange Commission (the ``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its network and gateway fees. The
text of the proposed rule change is available on the Exchange's Web
site (http://www.ise.com), at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to amend the Exchange's
network and gateway fees.
Network Fees
    The Exchange recently transitioned to new data centers. The
Exchange's primary data center is at Equinix, while Telx serves as the
back-up data center. At its old data center, ISE offered a number of
connectivity options, including two Dedicated Line Connections and an
Ethernet/Managed Service Provider connection with multiple Megabit
connection options. At the new data centers, however, the Exchange only
offers two Ethernet connection options, a one Gigabit (GB) connection
at a cost of $500 per month and a ten GB connection at a cost of $4,000
per month. As a result, the Exchange proposes to remove from its
Schedule of Fees the other existing Ethernet/Managed Service Provider
Megabit connection options \3\ as well as the two Dedicated Line
Connection options \4\ as these are no longer available at the new data
centers. With the unavailability of Dedicated Line Connections, the
Exchange also no longer provides the Order Routing Service \5\ and
proposes to remove this fee from its Schedule of Fees. Additionally, at
the new data centers, members are no longer able to connect to the
Exchange via third-party managed service providers. The Exchange,
therefore, proposes to remove reference to Managed Service Provider
from its Schedule of fees also.
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    \3\ The Ethernet/Managed Service Provider connection costs are
identified on the Exchange's Schedule of Fees as follows: $100 per
month for 1--10 Megabits (MB); $250 per month for 11--100 MBs; $500
per month for 101 MBs--1 Gigabit (GB); and $4,000 per month for
10GBs.
    \4\ The Dedicated Line Connection costs are identified on the
Exchange's Schedule of Fees as follows: for a T-1 and smaller
connections, $300 per line per month; for T-3 connections, $1,500
per line per month.
    \5\ The Order Routing Service is identified on the Exchange's
Schedule of Fees as follows: $100 per line per month.
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    Finally, in addition to ISE, the new data centers house a number of
firms, some of whom are ISE members and others that are not. Non-ISE
members at Equinix and Telx include software vendors who have developed
a front end application that provides its customers a connection to
ISE. These customers are members of ISE and instead of connecting to
ISE directly choose to connect to the Exchange through these software
vendors. To allow these and other prospective non-ISE members to cross-
connect their servers to ISE servers, we propose to offer the same
connectivity options that we currently offer to ISE members.
Gateway Fees
    Up until the transition to the new data centers, members were able
to lease ``gateway'' equipment, i.e., Routers, Switches and Servers,
through ISE in order to establish a connection to the Exchange. As
noted on the Exchange's Schedule of Fees, the cost of leasing this
equipment was 4.75% of ISE's equipment costs. The Exchange also charged
a one-time fee of $500 to members who wanted the Exchange to install,
move, add, change or remove any such equipment. The Exchange no longer
leases any such equipment and proposes to remove these fees from its
Schedule of Fees.
    The Exchange has designated this proposal to be operative on
December 1, 2011.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\6\ in general, and with
Section 6(b)(4) of the Act,\7\ in particular, in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among Exchange members and other

persons using its facilities. In particular, the proposed rule change
will provide greater transparency into the connectivity options
available to market participants. The proposed rule change treats
similarly situated market participants in the same manner by assessing
the same fees to all market participants, whether or not they are a
member of the Exchange, based on their connectivity needs. The Exchange
notes that the one GB and the ten GB connectivity options are similar
to those currently in place at other exchanges. For example, NASDAQ OMX
PHLX, Inc. (``PHLX'') currently offers a one GB and a ten GB network
connection option to market participants that connect to that
exchange.\8\
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
    \8\ See PHLX Fee Schedule at http://www.nasdaqtrader.com/content/marketregulation/membership/phlx/feesched.pdf.
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\ At any time within 60 days of the filing
of such proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2011-77 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2011-77. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2011-77 and should be
submitted on or before December 28, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31336 Filed 12-6-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5816-5817]
[FR Doc No: 2013-01638]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0082]

Guidance for Industry on Clinical Pharmacogenomics: Premarket
Evaluation in Early-Phase Clinical Studies and Recommendations for
Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Clinical
Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies
and Recommendations for Labeling.'' This guidance is intended to assist
the pharmaceutical industry and other investigators engaged in new drug
development in evaluating how variations in the human genome,
specifically DNA sequence variants, could affect a drug's
pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The
guidance provides recommendations on when and how genomic principles
should be considered and applied in early-phase clinical studies to
address questions arising during drug development and regulatory
review.

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

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Issam Zineh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3178, Silver Spring, MD 20993-0002, 301-
796-4756; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled
``Clinical Pharmacogenomics: Premarket

Evaluation in Early-Phase Clinical Studies and Recommendations for
Labeling.'' This guidance should help sponsors, researchers, and other
interested persons engaged in new drug development in evaluating how
variations in the human genome, specifically DNA sequence variants,
could affect a drug's pharmacokinetics, pharmacodynamics, efficacy, or
safety. The guidance provides recommendations on when and how genomic
principles should be considered and applied in early-phase clinical
studies to address questions arising during drug development and
regulatory review. The guidance does not address trial design or
statistical analysis considerations for later-phase randomized
controlled clinical trials that are intended to draw definitive
conclusions about treatment effects in a genomic subgroup or
codevelopment of a drug and in vitro diagnostic. Rather, the
considerations here are more relevant for exploratory and observational
studies intended to generate genomic hypotheses that may then be tested
in confirmatory trials.
    Drug development is commonly described in ``phases'' (21 CFR
312.21). The first two phases provide initial information about safety
and efficacy, and ideally examine a broad range of doses, so that the
larger, later adequate, and well-controlled trials (phase 3) that are
needed to support marketing approval can be efficiently designed.
Across the drug development continuum, genomic data may be used for
several purposes, including: (1) Identifying the basis for PK outliers
and intersubject variability in clinical response; (2) ruling out the
role of polymorphic pathways as clinically significant contributors to
variable PK, PD, efficacy, or safety; (3) estimating the magnitude of
potential drug-drug interactions; (4) investigating the molecular or
mechanistic basis for lack of efficacy or occurrence of adverse
reactions; and (5) designing clinical trials to test for greater
effects in specific subgroups (i.e., use in study enrichment
strategies).
    On February 18, 2011 (76 FR 9583), FDA issued a draft of this
guidance to solicit comments from the public. After carefully reviewing
received comments and in light of increased regulatory experience and
the evolution of the science, FDA has revised the guidance. In addition
to making clarifying changes, FDA added content to describe when
pharmacogenomics (PGx) studies are warranted, including circumstances
when full sample ascertainment is expected to evaluate a specific
hypothesis. In addition, a number of topics were further elaborated,
including targeted sample collection, sample retention, genotyping
approaches, pooled analyses, dedicated prospective PGx studies, genetic
substudies, and safety PGx.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on conducting pharmacogenomic studies in
early-phase clinical studies. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information have been approved under OMB
control numbers 0910-0014 and 0910-0572.

III. Comments

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

IV. Electronic Access

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

    Dated: January 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01638 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33497-33503]
[FR Doc No: 2017-15203]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0407]

Pilot Project Program Under the Drug Supply Chain Security Act;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
its intent to establish a pilot project program under the Drug Supply
Chain Security Act (the DSCSA Pilot Project Program) to assist in
development of the electronic, interoperable system that will identify
and trace certain prescription drugs as these are distributed within
the United States. Under this program, FDA will work with stakeholders
to establish one or more pilot projects to explore and evaluate methods
to enhance the safety and security of the pharmaceutical distribution
supply chain. Participation in the DSCSA Pilot Project Program will be
voluntary and will be open to pharmaceutical distribution supply chain
members. FDA will be particularly interested in participation
reflecting the diversity of the supply chain, including large and small
entities from all industry sectors. This notice describes the proposed
DSCSA Pilot Project Program, including proposed instructions for
submitting a request to participate. FDA is soliciting comments on the
proposed collection of information associated with establishment of the
DSCSA Pilot Project Program before submitting the proposed collection
to the Office of Management and Budget (OMB) for approval. FDA does not
intend to begin the proposed DSCSA Pilot Project Program or accept
requests to participate in the program until OMB has approved the
proposed collection of information.

DATES: Submit written or electronic comments on this pilot project
program by September 18, 2017.

ADDRESSES:  You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-0407 for ``Pilot Project Program under the Drug Supply Chain
Security Act; Request for Comments.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 50, Rm. 4285, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system by November
27, 2023, that will identify and trace certain prescription drugs as
they are distributed within the United States. Section 202 of the DSCSA
added the new sections 581 and 582 to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360eee and 360eee-1,
respectively). Under section 582(j) of the FD&C Act, FDA is required to
establish one or more pilot projects, in coordination with authorized
manufacturers, repackagers, wholesale distributors, and dispensers, to
explore and evaluate methods to enhance the safety and security of the
pharmaceutical distribution supply chain.
    FDA will be establishing the DSCSA Pilot Project Program to
implement section 582(j) of the FD&C Act. This program will assist the
development of the interoperable electronic system to be established by
2023. The new system has the potential to reduce diversion of drugs
distributed domestically as well as help reduce the influx of
counterfeit drugs from foreign sources. The program will be designed to
explore issues related to utilizing the product identifier for product
tracing, improving the technical capabilities of the supply chain,
identifying the system attributes that are necessary to implement the
requirements established under the DSCSA, and any other issues
identified by FDA (see section 582(j)(2)(B) of the FD&C Act).
Particular program goals include assessing the ability of supply chain
members to: Satisfy the requirements of section 582 of the FD&C Act;
identify, manage, and prevent the distribution of suspect and
illegitimate products as defined in section 581(21) and 581(8) of the
FD&C Act, respectively; and demonstrate the electronic, interoperable
exchange of product tracing information across the pharmaceutical
distribution supply chain, in addition to identifying the system
attributes needed to implement the requirements of section 582,
particularly the requirement to utilize a product identifier for
product tracing and verification purposes. FDA plans to coordinate with
stakeholders who reflect the diversity of the pharmaceutical
distribution supply chain, including large and small entities from all
industry sectors. The pilot project is designed to allow industry to
identify and evaluate the most efficient systems for their unique
operational systems.

II. The Proposed DSCSA Pilot Project Program

    FDA will be seeking pilot project participants from the
pharmaceutical distribution supply chain (authorized manufacturers,
repackagers, wholesale distributors, and dispensers) and other
stakeholders. FDA expects that participants will propose the design and
execution of their pilot project in their submission to FDA; however,
FDA intends to meet with all pilot project participants to ensure that
the learnings from the pilot project(s) will be complementary in
informing the direction of the development of the electronic,
interoperable system that will go into effect in 2023. FDA encourages
supply chain members to focus their proposed pilot project(s) on the
DSCSA requirements related to the interoperable, electronic tracing of
products at the package level. Specifically, the pilot project(s)
should focus on the requirements for package-level tracing and
verification that go into effect in 2023. Such pilot projects will be
more useful than pilot projects dedicated to lot-level tracing. If
there are adequate pilot project submissions, FDA may establish more
than one pilot project to accomplish the goals of the DSCSA Pilot
Project Program.

A. Products Eligible for Proposed Pilot Projects

    Proposed pilot projects may include any prescription drug that is a
``product'' within the meaning of section 581(13) of the FD&C Act. At
its discretion, FDA may also consider proposed pilot projects involving
product types outside the scope of section 581(13) of the FD&C Act
(e.g., over-the-counter medicines) that could further the objectives of
the DSCSA Pilot Project Program. Each package and homogenous case of
product that is part of a pilot project should bear a ``product
identifier'' as described in sections 581(14) and 582(a)(9) of the FD&C
Act.

B. Potential Issues To Examine and Evaluation Methods To Use in
Proposed Pilot Projects

    On April 5 and 6, 2016, FDA held a public workshop entitled
``Proposed Pilot Project(s) under the Drug Supply Chain Security Act
(DSCSA).'' This public workshop provided a forum for members of the
pharmaceutical distribution supply chain to discuss the design
objectives of pilot projects established by FDA under section 582(j) of
the FD&C Act. Based on the information gathered at that workshop and
from the comments submitted to the public docket for the workshop
(Docket No. FDA-2016-N-0407), FDA has identified several potential
issues to examine, and evaluation methods to use, in pilot projects
established under the DSCSA Pilot Project Program. These potential
issues and evaluation methods are summarized in table 1. This table is
intended only to assist in the design of potential pilot projects; it
does not represent FDA's views or policies regarding the issues
described in the table. For ease of reference, the potential issues to
examine and evaluation methods have been grouped by focus areas for the
pilot projects.

  Table 1--Potential Issues To Examine and Evaluation Methods To Use in
                         Proposed Pilot Projects
------------------------------------------------------------------------
                               Potential issues to  Potential evaluation
  Pilot project focus area           examine               methods
------------------------------------------------------------------------
Product Identifier..........   Processes     Impacts of
                               related to the        different
                               requirement for       representations of
                               manufacturers to      the product
                               affix or imprint a    identifier on
                               product identifier    systems or
                               to each package and   processes.
                               homogenous case of   --Number of errors.
                               product intended to  --Time to process.
                               be introduced in a   --Time to reconcile
                               transaction into      these differences.
                               commerce.
                               Methods
                               used to issue and
                               manage serial
                               numbers (e.g.,
                               including a
                               contract
                               manufacturer's role
                               if applicable or
                               how a repackager
                               associates its
                               product identifier
                               with the product
                               identifier assigned
                               by the original
                               manufacturer).
                               Different
                               representations for
                               the product
                               identifier (e.g.,
                               different formats
                               of NDC or serial
                               number).
Barcode Quality.............   Readability   Barcode
                               of barcode printed    read error rates.
                               or affixed           --Number of items
                               including impact of   unnecessarily
                               environmental and     quarantined or held
                               human factors.        up.
                               Application  --Time and resource
                               of linear and 2D      impacts.
                               barcodes on product.

                               Distinguishing
                               which barcode to
                               read/use and when.
Interoperability............   Process and   For both
                               technical             decentralized and
                               challenges due to     centralized models,
                               variety of            time implications.
                               solutions expected   --To investigate
                               (e.g., type of        suspect and
                               database used and     illegitimate
                               system architecture   products.
                               for exchanging       --For notifications
                               information among     required within the
                               trading partners).    statutory
                               Maintaining   timelines.
                               the integrity of     --Related to scaling
                               information           up from pilot to
                               contained in the      full production.
                               barcode of            Product
                               serialized product    tracing information
                               throughout the        (across multiple
                               distribution supply   partners).
                               chain (e.g., a       --Capability to
                               trading partner       retrieve the
                               goes out of           information.
                               business or one      --Accuracy of the
                               acquires another      information (within
                               business).            and between
                               Different     systems).
                               methods for
                               exchanging
                               information (e.g.,
                               the use of
                               Electronic Data
                               Interchange,
                               Electronic Product
                               Code Information
                               Services, and other
                               solutions
                               separately).
                                                     Security
                                                     and access.
                                                    --Evaluate and
                                                     document access
                                                     levels for trading
                                                     partners.
Data/Database/System Issues.   Data          System
                               quality from          Performance and
                               beginning to end of   Effectiveness.
                               the product          --Time to access and
                               lifecycle and vice    use product tracing
                               versa.                information, once
                               System        that data is
                               performance when      received into a
                               full or partially     system.
                               loaded with data.
                               Data format  --Quality of product
                               or processes for      tracing
                               data transfer.        information.
                              --Use of technical    --Number of breaches
                               standards for         to system.
                               defining data        --Number of attempts
                               attributes to         to breach the
                               enable                system that were
                               interoperable         prevented or
                               transfers.            minimized.
                              --Methods to handle
                               the ``master data''
                               (product-specific
                               data) and
                               transaction data
                               separately to
                               minimize ``master
                               data'' redundancy.
                               Integration   Data and
                               into individual/      product flow.
                               company data         --Number of
                               systems.              unsuccessful
                               Control and   attempts to access
                               access to data by     data and
                               trading partners,     operational
                               FDA or other          impacts.
                               Federal or State     --Number of system
                               officials (data       interactions within
                               governance).          one, and amongst
                               Ability of    multiple, trading
                               the system to         partners.
                               record product       --Time and resource
                               status (e.g., to      changes on
                               indicate expired,     operations when
                               illegitimate, in      data and product
                               error, quarantined)   not moving at same
                               at all packaging      time (e.g., product
                               levels.               arrives before data
                                                     arrives).
                                                    --Time for location/
                                                     ownership/status
                                                     changes to be
                                                     reflected in the
                                                     system.
                                                    --Time of product
                                                     flow delays and
                                                     associated costs
                                                     due to system or
                                                     data problems.
Aggregation/Disaggregation..   Multiple      Number of
                               levels of adoption    system and product
                               of inference, by      interactions within
                               different trading     one, and amongst
                               partners..            multiple, trading
                              --Impact of            partners.
                               inference gaps,       Time
                               changes or errors     required to conduct
                               in data,              aggregate/
                               particularly          disaggregate
                               downstream when       operations and
                               searching or          transactions.
                               examining the data;
                               how can errors be
                               corrected.
                                                     Accuracy of
                                                     aggregation data
                                                     (measure error
                                                     counts).
                                                     Time to
                                                     gather aggregation/
                                                     disaggregation data
                                                     for investigations
                                                     and notifications.
                                                     Time to
                                                     resolve errors in
                                                     data.
Verification/Notification...   Process for   Response
                               investigation of      times: Current vs.
                               suspect or            future process.
                               illegitimate          Time needed
                               product, including    to obtain product
                               any communication     tracing information
                               or coordination.      to respond to a
                              --Making and           request for
                               responding to         verification.
                               verification          Time needed
                               requests.             to make, respond
                              --Making,              to, or terminate a
                               responding, and       notification.
                               terminating           Time to
                               notifications.        gather product
                              --Responding to        tracing information
                               requests for          to support an
                               information.          investigation for a
                              --Testing boundaries   suspect or
                               of the system.        illegitimate
                                                     product, or a
                                                     recall.

                                                     Percentage
                                                     of items that are
                                                     successfully
                                                     verified vs. those
                                                     that were targeted
                                                     for verification.
                                                     Number of
                                                     connections/queries
                                                     needed to gather
                                                     product tracing
                                                     information in
                                                     response to a
                                                     verification or
                                                     notification
                                                     request.
Exception Handling/Errors/     Identify      Percent
 Inconsistencies.              `honest errors'       errors detected:
                               (e.g., over/under     compare exceptions
                               shipments, clerical   introduced vs.
                               errors or             exceptions
                               aggregation errors).  detected.
                               Correcting   --Identify the first
                               `honest errors'.      step in the process
                                                     where error
                                                     detected.
                                                     Number of
                                                     new or changed
                                                     processes needed to
                                                     accomplish DSCSA
                                                     goals.
                                                    --Time and resource
                                                     impacts.
                                                     `Honest
                                                     Errors'.
                                                    --Number of items
                                                     unnecessarily
                                                     quarantined and
                                                     held up.
                                                    --Time required to
                                                     detect and correct
                                                     errors.
                                                    --Impact on trading
                                                     partners to correct
                                                     errors.
                                                     Barcode
                                                     read error rates.
                                                    --Number of items
                                                     unnecessarily
                                                     quarantined or held-
                                                     up.
                                                    --Time and resource
                                                     impacts.
Special Scenarios...........   Situations    Error rates
                               when data and         for special
                               product do not move   processes.
                               together.            --Number of items
                               Situations    unnecessarily
                               when serialized       quarantined or held-
                               product are sold      up.
                               and distributed      --Time and resource
                               along with non-       impacts.
                               serialized product.
                                                     Accuracy of
                                                     linkage between
                                                     original
                                                     manufacturer
                                                     product identifier
                                                     and repackager-
                                                     issued product
                                                     identifier.
------------------------------------------------------------------------

    FDA also received input from the workshop participants and in the
comments submitted to the public docket on factors that the Agency
should take into consideration when establishing pilot projects. These
factors described in the comments include the extent to which the pilot
projects:
     Represent the mix of products and levels of packaging in
the supply chain.
     Include a diverse set of supply chain stakeholders (types
and sizes) and transaction types.
     Use adaptive design to make the pilot projects more
efficient.
     Target known weaknesses in the supply chain.
     Can be completed in time to provide useful information for
trading partners.
     Evaluate human factors that could present implementation
challenges.
     Simulate illegitimate products/transactions to test a
process or system.
     Document costs to implement, use, and maintain piloted
solutions.
    Although the Agency intends to take these factors into
consideration when establishing pilot projects, FDA also recognizes
that a single pilot project is unlikely to satisfy every factor.
Accordingly, FDA may establish a pilot project based on a request to
participate in the program that does not satisfy one or more of the
factors listed in this document.

C. Proposed Instructions for Submitting a Request To Participate in the
Proposed DSCSA Pilot Project Program

    Once the DSCSA Pilot Project Program is established, volunteers
interested in participating in the DSCSA Pilot Project Program will be
able to submit a request to participate by email to a designated FDA
email address for the program. For a group of entities that partner to
participate in a pilot project, only one submission and one point-of-
contact for the proposed pilot project should be provided in the
request to participate. Requests to participate may also consider other
ideas for a pilot project that are not included in this notice.

D. Proposed Content of the Submission for a Request To Participate in
the Proposed DSCSA Pilot Project Program

    The following information should be included in the request:
     Contact information for the submitter or point of contact,
if different from the submitter (name, mailing address, phone number,
email address).
     Names of all partnering entities that would participate in
such pilot project (name of company and name of company
representative).
     Type(s) of each partnering entity participating in the
pilot project (partnering entities include authorized trading partners
or other supply chain stakeholders).
     Number of employees for each partnering entity that would
participate in such pilot project.
     Proposed start and finish dates of the pilot project.
     Commitment to start the pilot project within 4 months of
receiving a letter of acceptance from FDA.
     Product(s) that will be used in the pilot project.
     Location(s) where pilot project will be performed
(facility address).
     Description of the proposed pilot project, including, but
not limited to, the goals, objectives, processes that will be studied,
and evaluation methods.

E. Initiation and Duration of Proposed Pilot Projects

    The selected participants should be ready to start their pilot
project within 4 months of receiving a letter of acceptance from FDA
into the program. The duration of a pilot project should not exceed 6
months. FDA may consider a pilot project with a later start date or
longer duration depending on the proposed goal(s) and objective(s).
Each pilot project is expected to be completed within the proposed
duration time period. This time period does not include an additional
30-days for completion of a final report (see section G. Proposed
Reports).

F. Participation in Proposed Pilot Projects

    Prior to launching a pilot project, FDA will hold a design strategy
meeting with the selected pilot participant(s) to review the goal(s)
and objective(s) for the pilot project and discuss the plans and other
pertinent details. The participant(s) will be responsible for
conducting their pilot project. A group of entities (members of the
pharmaceutical distribution supply chain and other stakeholders,
including trade associations) that partner to conduct a pilot project
may be considered a single participant for purposes of the DSCSA Pilot
Project Program. The partners in any pilot project that is selected
into the program will be responsible for the funding and resources
necessary to conduct the pilot project, and for determining each
partner's role and responsibility in their pilot project. Pilot project
participants will also be expected to submit reports on the progress of
their pilot projects to FDA (see section G. Proposed Reports).
Participants should evaluate their pilot project using the evaluation
methods they identified during the pilot project design process.

G. Proposed Reports

    Each pilot project is expected to be completed within the proposed
duration time period, and participants will be expected to report
progress to FDA while the pilot project is being conducted, in addition
to a final report within 30 days of completing the pilot project. These
reports will provide insight into the systems and process needed to
comply with certain DSCSA requirements for enhance drug distribution
security.
1. Progress Report(s)
    Each pilot project program participant is expected to provide
reports on the progress of their pilot project to FDA. The progress
reports are intended to capture the ongoing work during the pilot
project, including but not limited to, current status or results,
changes, challenges, and/or lessons learned. FDA will work with
participants to develop an appropriate schedule for the submission of
progress reports based on the design and duration of the pilot project.
Because the duration of a pilot project should not exceed 6 months, the
frequency of progress reports will vary based on the length of the
individual pilot project. Pilot projects of relatively shorter duration
may result in shorter time intervals between progress reports. For
example, FDA may ask for monthly progress reports for a 6-month pilot
project, however for a one-month pilot project, FDA may ask for weekly
progress reports.
2. Final Report
    Within 30 business days of completing a pilot project, each
participant is expected to provide a final report to FDA that captures
the description, objectives, methods, evaluation, costs and key
findings and lessons learned from the project. Timely completion of
pilot project and the final report will support FDA's DSCSA
implementation, including the statutory requirements under section
582(j) to consider information from pilot projects in the development
of guidances for unit-level tracing and standards for the interoperable
data exchange in section 582(h)(3) and (4) of the FD&C Act. FDA may
also request that the participants meet with the Agency upon the
completion of their pilot project or the final report.

H. Proposed Final DSCSA Pilot Project Program Report

    To ensure that all supply chain members benefit from the
information generated by the DSCSA Pilot Project Program, FDA intends
to make the following information about each of the program's pilot
projects available to the public in a final program report: (1) The
names and industry sector(s) of the pilot project participant(s); (2)
the pilot project's objectives and evaluation methods; (3) the duration
of the pilot project; and (4) the key findings and lessons learned from
the pilot project. The information related to the DSCSA Pilot Project
Program and the final program report will be posted on FDA's Web site.

I. Proposed Recordkeeping

    Any records generated by a participant for conducting a pilot
project should be maintained as an entity would as in a normal course
of business. For participants that involve partnering entities, the
partnering entities can decide who is responsible for the records
generated by conducting a pilot project. FDA recommends that the
progress reports and the final report that participants create and
submit to FDA for a pilot project should be maintained for at least 1
year after completion of the pilot project.

J. Initiation of FDA's DSCSA Pilot Project Program

    FDA does not intend to begin the proposed DSCSA Pilot Project
Program or accept requests to participate in the program until OMB has
approved the proposed collection of information described in this
notice.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from OMB for each
collection of information that 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 to
solicit comment for each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing this notice of the proposed collection
of information set forth in this document.
    With respect to the collection of information associated with the
DSCSA Pilot Project Program, FDA invites comments on the following
topics: (1) Whether the proposed information collected is necessary for
the proper performance of FDA's functions, including whether the
information will have practical utility; (2) the accuracy of FDA's
estimated burden of the proposed information collected, 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 information collected on the
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    The estimated burden for the information collection associated with
the DSCSA Pilot Project Program consists of the following:
    Submitting a request to participate and reporting activities. FDA
estimates that no more than 10 respondents (i.e., the submitter or
point of contact identified on the request to participate) will submit
a request to participate, and that it will take approximately 80 hours
to complete a request and submit the request to FDA. FDA estimates that
certain respondents will coordinate with partnering entities to submit
a request to participate; the burden estimate associated with that
coordination follows. FDA estimates that it will select no more than
eight participants for the pilot program. The estimated total time for
respondents to submit a request to participate in the program is 800
hours. Once the request

to participate is accepted, the submitter is now a participant of the
DSCSA Pilot Project Program. FDA estimates that the eight respondents
(i.e., participants) will submit an average of five progress reports to
FDA. Because the duration of a pilot project should not exceed 6
months, the frequency of progress reports will vary based on the length
of the individual pilot project. Pilot projects of relatively shorter
duration may result in shorter time intervals between progress reports
so that the reports will be sufficient to capture progress while the
pilot project is ongoing. FDA estimates that it will take approximately
8 hours to compile and submit each progress report. The estimated total
number of hours for submitting progress reports would be 320 hours.
After completion of their pilot project, each respondent will provide
one final report to FDA. FDA estimates that it will take the eight
respondents approximately 40 hours to submit a final report. The
estimated total number of hours for submitting the final report is 320
hours. The total hours for the estimated reporting burden are 1,440
hours (table 2).
    Recordkeeping activities. Recordkeeping activities include storing
and maintaining records related to submitting a request to participate
in the program and compiling reports. Respondents can use current
record retention capabilities for electronic or paper storage to
achieve these activities. FDA estimates that no more than 10
respondents will have recordkeeping activities related to program
participation. FDA believes that it will take 0.5 hour/year to ensure
that the documents related to submitting a request to participate in
the program are retained properly for a minimum of 1 year after the
pilot project is completed (as recommended by FDA). The resulting total
to maintain the records related to submitting a request is 5 hours
annually. For retaining records related to progress reports and the
final report properly for a minimum of 1 year after the pilot project
is completed (as recommended by FDA), FDA estimates that it will take
approximately 0.5 hour/year. As noted previously, FDA estimates that
the eight respondents will submit an average of five progress reports
and one final report to FDA. The estimated total for maintaining
progress reports and the final report is 20 and 4 hours, respectively.
The total recordkeeping burden is estimated to be 29 hours (table 3).
    In developing its burden estimate for records associated with the
proposed pilot projects, FDA has taken account of existing industry
practices for keeping records in the normal course of their business.
In particular, FDA is aware of various supply chain stakeholders that
have conducted pilot projects over the past few years, including some
pilot projects that occurred before the DSCSA was enacted. These pilot
projects covered topics related to serialization, movement of product
data, aggregation of data, and verification of product identifiers of
returned products. Members of the supply chain who conduct pilot
projects of their own accord created associated records as a matter of
usual and customary business practice. Therefore, the burden estimates
for like records associated with the proposed FDA pilot project program
are not included in the calculation of the recordkeeping burden (see 5
CFR 1320.3(b)(2)). FDA welcomes comments on the activities identified
for conducting a pilot project that FDA considers to be usual and
customary business practice.
    Third-party disclosure activities. For those pilot projects that
involve a participant composed of partnering entities in the program,
FDA is taking into consideration the time that partnering entities will
spend coordinating with each other in a pilot project. For the initial
request to participate, FDA estimates that eight respondents will work
with their respective partnering entities, and the average number of
partnering entities will be two. FDA estimates that each respondent
will spend 8 hours coordinating with each partnering entity. Thus, for
eight respondents with an average of two partnering entities, the
estimated total burden for coordinating with partnering entities
related to the submission of the request to participate in the program
is 128 hours. FDA estimates that seven respondents will need to
coordinate with an average of two partnering entities to create
progress reports and the final report to submit to FDA. Earlier, FDA
estimated that an average of five progress reports will be submitted to
FDA per respondent. If a respondent has an average of 2 partners, it
will coordinate 10 times with those partners on the progress reports.
FDA estimates that for each progress report, it will take 4 hours to
coordinate with each partner, resulting in a total of 280 hours. FDA
estimates that for each final report, it will take approximately 20
hours to coordinate with each partner, resulting in a total of 280
hours. The total estimation for third-party disclosure burden is 688
hours (table 4).

                                     Table 2--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 DSCSA pilot project program       Number of       responses per       Total         Hours per      Total hours
                                  respondents       respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Requests to participate......                 10               1              10              80             800
Progress reports.............                  8               5              40               8             320
Final report to FDA..........                  8               1               8              40             320
                              ----------------------------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............           1,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                            Table 3--Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
         DSCSA Pilot project program               Number of        records per    Total records             Hours per record               Total hours
                                                 recordkeepers     recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records related to requests to participate...                 10               1              10  0.5 (30 minutes)......................               5
Records related to progress reports..........                  8               5              40  0.5 (30 minutes)......................              20
Records related to the final report to FDA...                  8               1               8  0.5 (30 minutes)......................               4
                                              ----------------------------------------------------------------------------------------------------------

    Total....................................  .................  ..............  ..............  ......................................              29
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                   Table 4--Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 DSCSA pilot project program       Number of        disclosures        Total         Hours per      Total hours
                                  respondents     per respondent    disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Coordination with partnering                   8               2              16               8             128
 entities related to requests
 to participate..............
Coordination with partnering                   7              10              70               4             280
 entities related to progress
 reports.....................
Coordination with partnering                   7               2              14              20             280
 entities related to final
 reports.....................
                              ----------------------------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............             688
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15203 Filed 7-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Page 50879]
[FR Doc No: 2021-19677]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1061-103]

Pacific Gas and Electric Company; Notice of Waiver Period for
Water Quality Certification Application

    On August 26, 2021, Pacific Gas and Electric Company submitted to
the Federal Energy Regulatory Commission (Commission) a copy of their
application for a Clean Water Act section 401(a)(1) water quality
certification filed with the California State Water Resources Control
Board (California Water Board), in conjunction with the above captioned
project. Pursuant to 40 CFR 121.6, we hereby notify the California
Water Board of the following:
    Date of Receipt of the Certification Request: August 26, 2021.
    Reasonable Period of Time to Act on the Certification Request: One
year.
    Date Waiver Occurs for Failure to Act: August 26, 2022.
    If the California Water Board fails or refuses to act on the water
quality certification request by the above waiver date, then the
agency's certifying authority is deemed waived pursuant to section
401(a)(1) of the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: September 7, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-19677 Filed 9-10-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 18, 2007 (Volume 72, Number 137)]
[Notices]
[Page 39399-39401]
[DOCID:fr18jy07-54]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

July 10, 2007.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER01-2741-004; ER02-237-007; ER07-734-001; ER07-
407-001.
    Applicants: Plains End, LLC; J. Aron & Company; Plains End II, LLC;
High Prairie Wind Farm II, LLC.
    Description: J Aron & Co, Plains End, LLC, Plains End II, LLC and
High Prairie Wind Farm, LLC submits a notice of non-material change in
status, in compliance with Order 652.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0076.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER03-345-009.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc submits a Semi-Annual Status
Report on Load Response Programs for the period October 2006 through
March 2007.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0075.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-43-002.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits its responses
to the 1/30/07 deficiency letter issued its request to cancel the 1968
Purchase and Transmission Agreement etc.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0077.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-740-001.
    Applicants: Southwestern Electric Power Company.
    Description: Southwestern Electric Power Co submits their
compliance filing consisting of power supply agreement with Hope Water
and Light Commission.
    Filed Date: 06/29/2007.
    Accession Number: 20070702-0057.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-741-001.
    Applicants: Southwestern Electric Power Company.
    Description: Southwestern Electric Power Co submits the Power
Supply Agreement for requirements service dated 12/13/06 with City of
Bentonville, Arkansas in compliance with FERC's 5/31/07 letter order.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0114.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-752-002; ER07-753-002; ER07-754-002; ER07-755-
002; ER07-756-002.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits Substitute First Revised
Sheet 2, under FERC Electric Tariff, Volume 11 for the City of
Burlingame etc amending the weekly cap.
    Filed Date: 06/28/2007.
    Accession Number: 20070703-0115.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 19, 2007.

    Docket Numbers: ER07-883-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Service
Agreement for Network Integration Transmission Service with Kansas City
Power and Light Company.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0113.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-886-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits the Network
Operating Agreement to their 5/11/07 filing of an executed service
agreement with Kansas Electric Power Coop, Inc.
    Filed Date: 06/29/2007.
    Accession Number: 20070702-0059.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-913-001.
    Applicants: Atlantic City Electric Company.
    Description: Atlantic City Electric Company submits Substitute
First Sheet 298B et al. to FERC Electric Tariff, Sixth Revised Volume
1.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0116.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1077-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits clarifications re the amendment to the ISO Tariff and the June
2007 Congestion Revenue Rights Credit Policy Amendment.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0060.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1097-000.
    Applicants: New England Power Pool Participants Committee.
    Description: New England Power Pool Participants Committee submits
counterpart signature pages of the New England Power Pool Agreement.
    Filed Date: 06/29/2007.
    Accession Number: 20070702-0056.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1098-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool Inc submits an unexecuted
services agreement for Network Integration Transmission Service
Agreement with Grand River Dam Authority.
    Filed Date: 06/29/2007.
    Accession Number: 20070702-0063.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1099-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool Inc submits an unexecuted service
agreement for Network Transmission Service with Western Farmers
Electric Cooperative Inc.
    Filed Date: 06/29/2007.
    Accession Number: 20070702-0062.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1101-000.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc et al. submit a limited revision
to the Forward Capacity Market, Market Rules conditionally accepted by
FERC on 4/16/07 to extend stakeholder process etc.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0023.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1102-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits agreements for
Network

Integration Transmission Service under PJM Open Access Transmission
Tariff and notices of cancellation for 2 NITSAs that has been
superseded.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0022.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1103-000.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Niagara Mohawk Power Corporation dba National Grid
submits a power purchase agreement, dated 6/30/98 with Indeck-Oswego
Limited Partnership.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0021.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1104-000.
    Applicants: Fitchburg Gas and Electric Light Company.
    Description: Fitchburg Gas and Electric Light Company submits its
data and schedules used to calculate its annual transmission revenue
requirement for Non-PTF Local Network Transmission Services etc.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0020.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1105-000.
    Applicants: Cedar Creek Wind Energy, LLC.
    Description: Cedar Creek Wind Energy LLC submits an application for
authorization to make wholesale sales of energy and capacity and
ancillary services at negotiated, market-based rates.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0019.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1106-000.
    Applicants: ArcLight Energy Marketing, LLC.
    Description: ArcLight Energy Marketing, LLC submits its application
for order accepting market-based tariff, granting waivers and blanket
authorization and request for expedited action.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0018.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1107-000.
    Applicants: Central Maine Power Company.
    Description: Central Maine Power Company submits its Annual
Informational Filing which consists of the annual update to the formula
rates in Schedule 21-CMP of the ISO-NE Transmission, Markets, and
Services Tariff etc.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0017.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1108-000.
    Applicants: American Electric Power Service Corp.
    Description: AEP Operating Companies submits and requests
acceptance of an original Interconnection and Local Delivery Service
Agreement with the City of Dover, Ohio designated as Service Agreement
1677.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0016.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1109-000.
    Applicants: American Electric Power Service Corp.
    Description: American Electric Power Service Corporation agent for
Ohio Power Company et al. submits and requests acceptance of a ninth
revision to the Interconnection and Local Delivery Service Agreement
etc.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0015.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1110-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits a Small
Generator Interconnection Agreement and a Service Agreement for
Wholesale Distribution Service with Brea Power Partners, LP.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0014.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1111-000.
    Applicants: Appalachian Power Company.
    Description: Appalachian Power Company submits a Cost-Based Formula
Rate Agreement for Full Requirements Electric Service (including
Appendices A through C) dated 6/28/07 with American Electric Power
Service Corp et al.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0013.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1112-000.
    Applicants: BE Allegheny LLC.
    Description: Application of BE Allegheny LLC for order accepting
rates for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0073.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1113-000.
    Applicants: BE CA LLC.
    Description: BE CA, LLC's application for order accepting rates as
designated as Original Sheet 1 et al to FERC Electric Tariff, Original
Volume 1 for filing & granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0074.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1114-000.
    Applicants: BE Cleco LLC.
    Description: Application of BE Cleco LLC for order accepting rates
for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0062.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1115-000.
    Applicants: BE Coloquitt LLC.
    Description: Application of BE Colquitt LLC for order accepting
rates for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0063.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1116-000.
    Applicants: BE Ironwood LLC.
    Description: Application of BE Ironwood LLC for order accepting
rates for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0064.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1117-000.
    Applicants: BE KJ LLC.
    Description: Application of BE KJ LLC for order accepting rates for
filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0065.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1118-000.
    Applicants: BE Rayle LLC.
    Description: Application of BE Rayle LLC for order accepting rates
for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0066.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1119-000.
    Applicants: BE Red Oak LLC.
    Description: Application of BE Red Oak LLC for order accepting
rates for filing and granting waivers and blanket approvals under ER07-
1119.
    Filed Date: 06/29/2007.

    Accession Number: 20070703-0067.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1120-000.
    Applicants: BE Satilla LLC.
    Description: Application of BE Satilla LLC for order accepting
rates for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0068.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1121-000.
    Applicants: BE Tenaska LLC.
    Description: Application of BE Tenaska LLC for order accepting
rates for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0069.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1122-000.
    Applicants: BE Walton LLC.
    Description: Application of BE Waltlon LLC for order accepting
rates for filing and granting waivers and blanket approvals.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0070.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1123-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits revised
sheets to the Laguna Bell-Vermon Interconnection Service Agreement with
the City of Vernon, CA designated Rate Schedule 472.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0071.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1124-000.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Niagara Mohawk Power Corporation dba National Grid
submits its Notice of Cancellation of the Amended and Restated Power
Sales Agreement with Fulton Cogeneration Associates LP.
    Filed Date: 06/29/2007.
    Accession Number: 20070703-0072.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Docket Numbers: ER07-1127-000.
    Applicants: Wisconsin Public Service Corporation.
    Description: Wisconsin Public Service Corp notifies FERC that its
Service Agreement 9 dated 10/26/05 w/Washington Island Electric
Cooperative under FERC Electric Tariff, Fifth Revised Vol 1 has been
terminated effective 6/1/07.
    Filed Date: 06/29/2007.
    Accession Number: 20070705-0195.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Take notice that the Commission received the following public
utility holding company filings:
    Docket Numbers: PH07-25-000.
    Applicants: Ecofin Holdings Limited.
    Description: FERC-65A Exemption Notification of Status of Ecofin
Holdings Ltd as Passive Investors under PH07-25.
    Filed Date: 06/29/2007.
    Accession Number: 20070629-4023.
    Comment Date: 5 p.m. Eastern Time on Friday, July 20, 2007.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-13818 Filed 7-17-07; 8:45 am]

BILLING CODE 6717-01-P