[Federal Register: June 2, 2009 (Volume 74, Number 104)]
[Notices]
[Page 26387-26388]
[DOCID:fr02jn09-46]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-12495-002]

Cascade Creek, LLC; Notice of Scoping Meeting and Site Visit and
Soliciting Scoping Comments for an Applicant Prepared Environmental
Assessment Using the Alternative Licensing Process; Notice of Intent To
Prepare Environmental Impact Statement

May 26, 2009.
    a. Type of Application: Alternative Licensing Process.
    b. Project No.: 12495-002.
    c. Applicant: Cascade Creek, LLC.
    d. Name of Project: Cascade Creek Hydroelectric Project.
    e. Location: On Swan Lake and Cascade Creek, approximately 15 miles
northeast of Petersburg, Alaska. The project would occupy lands of the
Tongass National Forest.
    f. Filed Pursuant to: Federal Power Act, 16 USC 791(a)-825(r).
    g. Applicant Contact: Chris Spens, Project Manager, Cascade Creek
LLC, 3633 Alderwood Ave., Bellingham, WA 98225;<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    h. FERC Contact: David Turner, at<PHONE_NUMBER>.
    i. Deadline for filing scoping comments: July 20, 2009.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    Scoping comments may be filed electronically via the Internet in
lieu of paper. The Commission strongly encourages electronic filings.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``e-filing'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.''
    j. The project would consist of: (1) Swan Lake, with a high-flood
lake surface elevation of 1,520 feet and surface area of 579 acres at
the high-flood elevation; (2) a 9-foot-diameter lake siphon on Swan
Lake, housed in a 46-foot-long, 34-foot-wide, and 25-foot-high concrete
intake control structure that would also provide for a helicopter
landing area; (3) approximately 3 miles of predominately-unlined rock
tunnel; (4) a 600-foot-long, 9-foot-diameter buried steel penstock; (5)
a 120-foot-long, 60-foot-wide powerhouse with three 23-MW vertical-
shaft pelton-type turbines; (6) two housing units for construction
workers; (7) a 400-foot-long, 40-foot-wide tailrace connecting the
powerhouse to Thomas Bay; (8) new dock and/or road facilities; (9) a
transmission line beginning at the powerhouse and extending via a
combination of overhead and underwater lines to the existing Scow Bay
substation in Petersburg; and (10) appurtenant facilities.
    k. Scoping Process
    Cascade Creek, LLC (Cascade Creek) is using the Federal Energy
Regulatory Commission's (Commission) alternative licensing process
(ALP). Under the ALP, Cascade Creek will prepare an Applicant Prepared
Environmental Assessment (APEA) and license application for the Cascade
Creek Hydroelectric Project.
    Although Cascade Creek's intent is to prepare an EA, the Commission
will prepare an Environmental Impact Statement (EIS) for the project.
This meeting will satisfy the NEPA scoping requirements.
    The purpose of this notice is to inform you of the opportunity to
participate in the upcoming scoping meetings identified below, and to
solicit your scoping comments.

Scoping Meetings

    Cascade Creek and the Commission staff will hold two scoping
meetings, one in the daytime and one in the evening, to help us
identify the scope of issues to be addressed in the APEA.
    The daytime scoping meeting will focus on resource agency concerns,
while the evening scoping meeting is primarily for public input. All
interested individuals, organizations, and agencies are invited to
attend one or both of the meetings, and to assist the staff in
identifying the environmental issues that should be analyzed in the
APEA. The times and locations of these meetings are as follows:

Daytime Meeting: Thursday, June 18, 2009, 9 a.m., Tides Inn, 307 North
1st St., Petersburg, AK 99833.
Evening Meeting: Thursday, June 18, 2009, 7 p.m., Tides Inn, 307 North
1st St., Petersburg, AK 99833.

    To help focus discussions, Scoping Document 1 was mailed May 22,
2009, outlining the subject areas to be addressed in the APEA to the
parties on the mailing list. Copies of the SD1 also will be available
at the scoping meetings. SD1 is available for review at the Commission
in the Public Reference Room or may be viewed on the Commission's Web
site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Based on all written comments received, a Scoping Document 2 (SD2)
may be issued. SD2 will include a revised list of issues, based on the
scoping sessions.

Objectives

    At the scoping meetings, the staff will: (1) Summarize the
environmental issues tentatively identified for analysis in the APEA;
(2) solicit from the meeting participants all available information,
especially quantifiable data, on the resources at issue; (3) encourage
statements from experts and the public on issues that should be
analyzed in the APEA, including viewpoints in opposition to, or in
support of, the staff's preliminary views; (4) determine

the resource issues to be addressed in the APEA; and (5) identify those
issues that require a detailed analysis, as well as those issues that
do not require a detailed analysis.

Procedures

    The meetings will be recorded by a stenographer and will become
part of the formal record of the Commission proceeding on the project.
    Individuals, organizations, and agencies with environmental
expertise and concerns are encouraged to attend the meetings and to
assist Cascade Creek in defining and clarifying the issues to be
addressed in the APEA.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-12702 Filed 6-1-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28072-28074]
[FR Doc No: 2017-12836]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-3101]

Abbreviated New Drug Applications: Pre-Submission Facility
Correspondence Associated with Priority Submissions; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``ANDAs:
Pre-Submission Facility Correspondence Associated with Priority
Submissions.'' The Pre-Submission Facility Correspondence (PFC) process
was identified as part of the performance goals and program
enhancements for the Generic Drug User Fee Amendments reauthorization
for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC
allows the Agency to begin the facility assessment process in advance
of the planned abbreviated new drug application (ANDA) submission. This
draft guidance describes PFC content and format, as well as the
Agency's approach to assessing this information.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 18, 2017. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by September 18, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-3101 for ``ANDAs: Pre-Submission Facility Correspondence
Associated with Priority Submissions.'' 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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY

INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Nikhil Thakur, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4164, Silver Spring, MD 20993, 301-796-
5536.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``ANDAs: Pre-Submission Facility Correspondence Associated
with Priority Submissions.'' As one of the enhancements specified in
the GDUFA II commitment letter, the PFC is a mechanism to achieve
expedited review of priority ANDAs, prior approval supplements (PASs),
and their amendments (collectively ANDAs). Under the performance goals
and program enhancements for GDUFA II, FDA agreed to a shorter goal
date for action on a priority generic drug submission if:
     A complete and accurate PFC is submitted to FDA 2 months
ahead of the planned ANDA submission, and
     facility information remains unchanged in the ANDA.
    A complete and accurate PFC allows the Agency to begin the facility
assessment process in advance of the planned ANDA submission. This
critical 2-month lead time provides the Agency the opportunity to
determine whether facility inspections will be needed, and, when they
are, to initiate inspection planning earlier in the review of the ANDA,
enabling FDA to meet the shorter review timeframe.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``ANDAs: Pre-
Submission Facility Correspondence Associated with Priority
Submissions.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing the proposed collection
of information set forth in this notice of availability that would
result from the submission of PFCs.
    With respect to the following collection of information, FDA
invites comment on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
    Title: Draft Guidance for Industry on ANDAs: Pre-Submission
Facility Correspondence Associated with Priority Submissions.
    Description: As described in the draft guidance, the GDUFA II
commitments included an agreement to establish a mechanism to
facilitate a shortened GDUFA goal date for ANDAs, PASs, and their
amendments that have been designated as a ``Priority'' by FDA. For
planned ANDAs that successfully meet FDA's priority review criteria,
applicants may submit a PFC as a mechanism to facilitate evaluation of
facilities associated with a planned ANDA.
    Section IV of the draft guidance describes the information that
should be submitted in the PFC to enable FDA's facility assessment:
    A. General information, including the planned ANDA pre-assigned
number (which the applicant must request from FDA before submitting the
PFC), PFC submission date, and the applicant's identifying information;
    B. statement of ANDA eligibility for priority review;
    C. manufacturing process and testing facility information; and
    D. bioequivalence summary and site/organization information.
    The Appendix of the draft guidance describes the format that should
be used to submit the PFC, including a standardized format for
administrative information related to manufacturing process and testing
sites, and summary tables for bioequivalence sites and organizations
and for bioavailability studies.
    The PFC should be submitted in the PDF file format through the FDA
electronic submissions gateway, and, as explained in the draft
guidance, should be submitted 2 or 3 months ahead of the planned ANDA
submission.
    We estimate that a total of approximately 125 applicants ``number
of respondents'' in table 1) will submit annually approximately 275
PFCs as described in the draft guidance (``total annual responses'' in
table 1). We estimate that preparing and submitting each PFC as
described in the draft guidance will take approximately 32 hours
``hours per response'' in table 1). We base our estimates for the
number of applicants and the number of PFCs on information from our
database of annual ANDA submissions, and on the criteria set forth in
the FDA Center for Drug Evaluation's Manual of Policies and Procedures
5240.3 and the number of ``priority'' submissions. Our estimate of the
time applicants would need to prepare and submit each PFC takes into
consideration that much of the PFC includes information already
gathered for the ANDA submission. Thus, the burden estimate for the
submission of the PFC does not double-count the burden of gathering
information that is accounted for under OMB control number 0910-0001,
under which OMB has approved the submission of ANDAs and related
amendments, supplements, and other information required under Subpart C
of Part 314 in Title 21 of the CFR.
    We invite comments on these estimates.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of
                                                                          No. of       responses  per   Total  annual      Hours per       Total hours
                                                                       respondents       respondent       responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
PFC................................................................             125             2.20              275               32            8,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

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

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12836 Filed 6-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 10 (Wednesday, January 15, 2014)]
[Notices]
[Pages 2651-2652]
[FR Doc No: 2014-00543]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-34-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Application

    Take notice that on December 27, 2013, Transcontinental Gas Pipe
Line Company, LLC (Transco), P.O. Box 1396, Houston, Texas 77251, filed
an application in Docket No. CP14-34-000, pursuant to Section 7(b) of
the Natural Gas Act (NGA) and Part 157 of the Commission's regulations,
for a certificate of public convenience and necessity to abandon
certain pipeline lateral facilities. Specifically, Transco proposes (i)
The abandonment by sale to High Point Gas Gathering, LLC of Transco's
pipeline lateral extending from Mississippi Canyon Block 108 to South
Pass Block 53 offshore Louisiana, and (ii) the abandonment by
assignment to High Point Gas Transmission, LLC Transco's 25.3% interest
in the pipeline lateral extending from Mississippi Canyon Block 194 to
Romere Pass, located offshore and onshore Louisiana. Transco also
requests a finding that Transco's pipeline lateral extending from
Mississippi Canyon Block 108 to South Pass Block 53 will, upon
abandonment, be non-jurisdictional under Section 1(b) of the NGA, and
that the lines are gathering facilities exempt from the Commission's
jurisdiction under NGA Section 1(b), all as more fully set forth in the
application, which is on file with the Commission and open to public
inspection.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Any questions regarding this application should be directed to Ray
Green, Staff Analyst, Certificates & Tariffs<PHONE_NUMBER>, P.O. Box
1396, Houston, Texas 77251
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's

environmental mailing list, will receive copies of the environmental
documents, and will be notified of meetings associated with the
Commission's environmental review process. Environmental commentors
will not be required to serve copies of filed documents on all other
parties. However, the non-party commentors will not receive copies of
all documents filed by other parties or issued by the Commission
(except for the mailing of environmental documents issued by the
Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: January 29, 2014.

    Dated: January 8, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-00543 Filed 1-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Proposed Rules]
[Pages 7142-7144]
[FR Doc No: 2011-2862]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2007-1073; FRL-9263-8]

Revisions to the California State Implementation Plan, Imperial
County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve revisions to the Imperial County
Air Pollution Control District (ICAPCD) portion of the California State
Implementation Plan (SIP). These revisions clarify permitting
requirements, and update and revise exemptions from New Source Review
(NSR) permitting requirements, for various air pollution sources. We
are taking comments on this proposal and plan to follow with a final
action.

DATES: Any comments must arrive by March 11, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2007-1073, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Gerardo Rios (Air--3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-

mail directly to EPA, your e-mail address will be automatically
captured and included as part of the public comment. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules and rule
revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rules
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal, including the
dates they were adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
               Local agency                  Rule No.             Rule title             Amended      Submitted
----------------------------------------------------------------------------------------------------------------
ICAPCD...................................          201   Permits Required...........     10/10/06      08/24/07
ICAPCD...................................          202   Exemptions.................     10/10/06      08/24/07
----------------------------------------------------------------------------------------------------------------

    On September 17, 2007, EPA determined that the submittal for ICAPCD
Rules 201 and 202 met the completeness criteria in 40 CFR part 51
appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    We approved an earlier version of Rule 201 into the SIP on January
3, 2007 (72 FR 9). There are no previous versions of Rule 202 in the
SIP, but SIP approved Rule 103, also contains permit exemptions. Rule
103 was approved into the SIP on May 31, 1972 (37 FR 10842). The ICAPCD
originally adopted new Rule 202 on June 1, 1977 and also adopted
revisions on September 7, 1993 and September 14, 1999. Both of these
revisions were submitted to EPA, however EPA has not taken action on
either of these submittals. While we can act on only the most recently
submitted version, we have reviewed materials provided with previous
submittals.

C. What is the purpose of the submitted rules and rule revisions?

    Section 110(a) of the CAA requires states to submit regulations
that control volatile organic compounds, nitrogen oxides, particulate
matter and other air pollutants which harm human health and the
environment. Permitting rules were developed as part of the local air
district's programs to control these pollutants.
    The purpose of District Rule 201 (Permits Required) is to identify
when, and what permits, a source must obtain prior to construction and
operation.
    The purpose of District Rule 202 (Exemptions) is to identify
processes, articles, machines, equipment, or other contrivances for
which an Authority to Construct (ATC) or Permit to Operate (PTO) is not
required. Rule 202 also requires recordkeeping to verify and maintain
any exemption.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    The relevant statutory provisions for our review of the submitted
rules include CAA section 110(a) and section 110(l). Section 110(a)
requires that SIP rules be enforceable, while section 110(l) precludes
EPA approval of SIP revisions that would interfere with any applicable
requirement concerning attainment and reasonable further progress or
any other applicable requirement of the Act. In addition, we have
reviewed the submitted rules for compliance with EPA implementing
regulations for NSR, including 40 CFR 51.160 through 40 CFR 51.165.

B. Do the rules meet the evaluation criteria?

    EPA has reviewed the submitted rules in accordance with the Rule
Evaluation criteria described above. Consistent with the requirements
of 40 CFR subpart I, all major stationary sources are required to
obtain an ATC permit prior to construction. For minor sources, EPA
believes that emissions from the types and sizes of equipment and
operations exempted from NSR permit requirements are consistent with
the flexibility afforded to states to regulate only those sources as
necessary to assure attainment and maintenance of the National Ambient
Air Quality Standards (NAAQS). While several new provisions have been
added to Rule 202 that could be seen as a relaxation of the SIP because
more sources are specifically exempted from Rule 207 permit
requirements, in practice most of these sources have never been
required to obtain a NSR ATC permit due to their small size or state
law prohibitions. Because these rules will not actually worsen air
quality, and will in fact require many agricultural sources to obtain
permits and be subject to control requirements for the first time, EPA
believes that these revisions are a long overdue update to the SIP
which will provide an overall strengthening of the SIP without
interfering with the District's ability to attain and maintain the
NAAQS, and are therefore approvable under 110(l) of the CAA.
    The TSD has more information on our evaluation.

C. EPA Recommendations To Further Improve the Rules

    The TSD describes additional rule revisions that we recommend for
the next time the local agency modifies the rules.

D. Public Comment and Final Action

    Because EPA believes the submitted rules fulfill all relevant
requirements, we are proposing to fully approve them as described in
section 110(k)(3) of the Act. We will accept comments from the public
on this proposal for the next 30 days. Unless we receive convincing new
information during the comment period, we intend to publish a final
approval

action that will incorporate these rules into the federally enforceable
SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not interfere with Executive Order 12898 (59 FR 7629
(Feb. 16, 1994)) because EPA lacks the discretionary authority to
address environmental justice in this rulemaking.

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

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

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

    Dated: January 28, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-2862 Filed 2-8-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 19029-19031]
[FR Doc No: 2021-07406]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0030]

IAPMO Ventures, LLC dba IAPMO EGS: Grant of Expansion of
Recognition

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

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision on the
application of IAPMO Ventures, LLC dba IAPMO EGS for expansion of its
scope of recognition as a Nationally Recognized Testing Laboratory
(NRTL).

DATES: The expansion of the scope of recognition becomes effective on
April 12, 2021.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:

    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, phone:<PHONE_NUMBER> or
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, OSHA Office of Technical Programs and Coordination
Activities, Directorate of Technical Support and Emergency Management,
U.S. Department of Labor, phone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of IAPMO Ventures, LLC dba IAPMO EGS (IAPMO) as a NRTL.
IAPMO's expansion covers the addition of six test standards to the NRTL
scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification of the products.
    The agency processes applications by a NRTL for initial recognition
and for an expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides a preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including IAPMO, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    IAPMO submitted two applications to OSHA to expand their NRTL
recognition. The first application to add one standard to the NRTL
scope of recognition was received on September 29, 2019 (OSHA-2010-
0030-0014), and this application was amended on November 25, 2020
(OSHA-2010-0030-0015), to add five additional standards. The
applications would add six additional test standards to the NRTL scope
of recognition. OSHA staff performed a detailed analysis of the
application packets and reviewed other pertinent information. OSHA did
not perform any on-site reviews in relation to these applications.
    OSHA published the preliminary notice announcing IAPMO's expansion
applications in the Federal Register on February 23, 2021 (86 FR
11002). The agency requested comments by March 10, 2021, but no
comments were received in response to this notice. OSHA is now
proceeding with this final notice to grant expansion of IAPMO's NRTL
scope of recognition.
    To obtain or review copies of all public documents pertaining to
IAPMO's application, go to http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor, 200 Constitution Avenue NW, Room N-3653,
Washington, DC 20210. Docket No. OSHA-2013-0030 contains all materials
in the record concerning IAPMO's recognition. Please note: While OSHA's
Docket Office is continuing to accept and process submissions by
regular mail, due to the COVD-19 pandemic, the Docket Office is closed
to the public and not able to receive submissions to the docket by
hand, express mail, messenger, and courier service.

II. Final Decision and Order

    OSHA staff examined IAPMO's expansion application, its capability
to meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that
IAPMO meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the limitation and conditions listed below.
OSHA, therefore, is proceeding with this final notice to grant IAPMO's
scope of recognition. OSHA limits the expansion of IAPMO's recognition
to testing and certification of products for demonstration of
conformance to the test standards listed in Table 1 below.

  Table 1--List of Appropriate Test Standards for Inclusion in IAPMO's
                        NRTL Scope of Recognition
------------------------------------------------------------------------
      Test standard                     Test standard title
------------------------------------------------------------------------
UL 197...................  Standard for Commercial Electric Cooking
                            Appliances.
UL 962...................  Standard for Household and Commercial
                            Furnishings.
UL 676...................  Standard for Underwater Luminaires and
                            Submersible Junction Boxes.
UL 73....................  Standard for Safety Motor-Operated
                            Appliances.
UL 763...................  Standard for Commercial Safety for Motor-
                            Operated Commercial Food Preparing Machines.
UL 399...................  Drinking Water Coolers.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, OSHA may use the designation of the standards-
developing organization for the standard as opposed to the ANSI
designation. Under the NRTL Program's policy (see OSHA Instruction CPL
1-0.3, Appendix C, paragraph XIV), any NRTL recognized for a particular
test standard may use either the proprietary version of the test
standard or the ANSI version of that standard. Contact ANSI to
determine whether a test standard is currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
IAPMO must abide by the following conditions of the recognition:
    1. IAPMO must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. IAPMO must meet all the terms of its recognition and comply with
all

OSHA policies pertaining to this recognition; and
    3. IAPMO must continue to meet the requirements for recognition,
including all previously published conditions on IAPMO's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of IAPMO, subject to the limitation and conditions
specified above.

III. Authority and Signature

    James S. Frederick, Principal Deputy Assistant Secretary of Labor
for Occupational Safety and Health, 200 Constitution Avenue NW,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the agency is issuing this notice pursuant to Section 29
U.S.C. 655(6)(d), Secretary of Labor's Order No. 8-2020 (85 FR 58393;
Sept. 18, 2020), and 29 CFR 1905.11.

    Signed at Washington, DC, on April 5, 2021.
James S. Frederick,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2021-07406 Filed 4-9-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: November 18, 2010 (Volume 75, Number 222)]
[Notices]
[Page 70732]
[DOCID:fr18no10-73]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-92-001]

Enterprise Texas Pipeline LLC; Notice of Baseline Filing

November 10, 2010.
    Take notice that on November 9, 2010, Enterprise Texas Pipeline LLC
submitted a revised baseline filing of its Statement of Operating
Conditions for services provided under section 311 of the Natural Gas
Policy Act of 1978 (NGPA).
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing 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). 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. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Friday, November 19, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-29066 Filed 11-17-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Notices]
[Pages 36140-36141]
[FR Doc No: 2011-15311]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1983-DR; Docket ID FEMA-2001-0001]

Mississippi; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Mississippi (FEMA-1983-DR), dated May 11,
2011, and related determinations.

DATES: Effective Date: May 11, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated May 11, 2011, the President declared a major disaster under the
authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford Act''), as
follows:

    I have determined that the damage in certain areas of the State
of Mississippi resulting from flooding beginning on May 3, 2011, and
continuing, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists in the State of Mississippi.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance in the
designated areas and Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate subject to completion of Preliminary Damage Assessments
(PDAs), unless you determine that the incident is of such unusual
severity and magnitude that PDAs are not required to determine the
need for supplemental Federal assistance pursuant to 44 CFR
206.33(d).
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation and Other Needs Assistance will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Terry L. Quarles, of FEMA, is
appointed to act as the Federal Coordinating Officer for this declared
disaster.

    The following areas of the State of Mississippi have been
designated as adversely affected by this declared major disaster:

    Adams, Bolivar, Claiborne, Coahoma, DeSoto, Humphreys,
Issaquena, Jefferson, Sharkey, Tunica, Warren, Washington,
Wilkinson, and Yazoo Counties for Individual Assistance.
    All counties within the State of Mississippi are eligible to
apply for assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

    June 14, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-15311 Filed 6-20-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Page 26284]
[FR Doc No: 2011-11084]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2662-012-CT; Project No. 12968-001-CT]

FirstLight Hydro Generating Company, City of Norwich Dept. of
Public Utilities; Notice of Meeting

    a. Date and Time of Meeting: Tuesday, May 17, 2011 from 10 a.m. to
12 p.m. EDT.
    b. Place: Federal Energy Regulatory Commission, 888 First St., NE.,
Washington, DC 20426.
    c. FERC Contact: Janet Hutzel,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    d. Purpose of meeting: Commission staff will meet with FirstLight
Hydro Generating Company and the City of Norwich Dept. of Public
Utilities to discuss the requirements of a supporting design report
needed for the Scotland Hydroelectric Project (P-2662-012 and P-12968-
001, respectively).
    e. All local, State, and Federal agencies, tribes, and interested
parties are hereby invited to participate, and teleconference will be
available to those who cannot attend in person. Please contact Janet
Hutzel at<PHONE_NUMBER> or via email at<EMAIL_ADDRESS>by the
close of business on Thursday, May 12, 2011 to attend via
teleconference.

    Dated: May 2, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-11084 Filed 5-5-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44803-44804]
[FR Doc No: 2014-18134]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0634]

Draft Guidance for Industry on Cell-Based Products for Animal
Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry 218 entitled
``Cell-Based Products for Animal Use.'' This draft guidance describes
FDA's Center for Veterinary Medicine's (CVM) current thinking on cell-
based products for animal use that meet the definition of a new animal
drug. This draft guidance is for firms and individuals developing cell-
based products, including animal stem cell-based products (ASCPs).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 30, 2014.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft 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: Lynne Boxer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
218 entitled ``Cell-Based Products for Animal Use.'' CVM is
aware that many veterinary therapies may be produced using cell-based
products. Developers of such products for veterinary use have
approached CVM for clarification regarding the regulation of these
products. This draft guidance for industry describes CVM's current
thinking on cell-based products for animal use that meet the definition
of a new animal drug.
    Cell-based products meeting the definition of a new animal drug are
subject to the same statutory and regulatory requirements as other new
animal drugs. Although this draft guidance relates to other cell-based
products, this draft guidance focuses on ASCPs meeting the definition
of a new animal drug.
    This draft guidance addresses the following topics:
     How existing regulations apply to cell-based products for
veterinary use;
     A common vocabulary for ASCPs;
     A risk-based category structure for ASCPs; and
     Industry interaction with CVM early in product
development.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR

10.115). The draft guidance, when finalized, will represent the
Agency's current thinking on this topic. 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 requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 and 21 CFR 511.1 have
been approved under OMB control numbers 0910-0032 and 0910-0117
respectively.

IV. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18134 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 3, 2009 (Volume 74, Number 105)]
[Notices]
[Page 26680-26681]
[DOCID:fr03jn09-54]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1181-000]

Hoosier Wind, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

May 27, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Hoosier Wind, LLC's application for market-

based rate authority, with an accompanying rate tariff, noting that
such application includes a request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the Applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is June 17, 2009.
    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-referenced proceeding 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 docket(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-12866 Filed 6-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73619-73620]
[FR Doc No: 2014-29010]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4200-DR; Docket ID FEMA-2014-0003]

Missouri; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Missouri (FEMA-4200-DR), dated October 31,
2014, and related determinations.

DATES: Effective Date: October 31, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 31, 2014, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

I have determined that the damage in certain areas of the State of
Missouri resulting from severe storms, tornadoes, straight-line
winds, and flooding during the period of September 9-10, 2014, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Missouri.
In order to provide Federal assistance, you are hereby authorized to
allocate from funds available for these purposes such amounts as you
find necessary for Federal disaster assistance and administrative
expenses.
You are authorized to provide Public Assistance in the designated
areas and Hazard Mitigation throughout the State. Consistent with
the requirement that Federal assistance be supplemental, any Federal
funds provided under the Stafford Act for Hazard Mitigation will be
limited to 75 percent of the total eligible costs. Federal funds
provided under the Stafford Act for Public Assistance also will be
limited to 75 percent of the total eligible costs, with the
exception of projects that meet the eligibility criteria for a
higher Federal cost-sharing percentage under the Public Assistance
Alternative Procedures Pilot Program for Debris Removal implemented
pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for
the approved assistance to the extent allowable under the Stafford
Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Laura S. Hevesi, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Missouri have been designated
as adversely affected by this major disaster:

Adair, Andrew, Atchison, Daviess, Gentry, Grundy, Harrison, Holt,
Knox, Lewis, Linn, Livingston, Macon, Mercer, Nodaway, Putnam,
Ralls, Shelby, Sullivan, and Worth Counties for Public Assistance.
All areas within the State of Missouri are eligible for assistance
under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049,

Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-29010 Filed 12-10-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Rules and Regulations]
[Page 32840-32841]
[DOCID:fr07jn06-17]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OA-2005-0131; FRL-8181-2]

Protection of Stratospheric Ozone: Recordkeeping and Reporting
Requirements for the Import of Halon-1301 Aircraft Fire Extinguishing
Vessels

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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

SUMMARY: In response to adverse comment, EPA is withdrawing the direct
final rule published in the Federal Register on April 11, 2006 (71 FR
18219). This direct final rule sought to exempt importers of aircraft
fire extinguishing vessels containing halon-1301 (``aircraft halon
bottles'') from the import petition process in order to facilitate the
routine hydrostatic testing of these bottles for environmental and
safety purposes. In the direct final rule, the Agency indicated that
should we receive adverse comment by May 11, 2006, we would publish a
timely withdrawal notice in the Federal Register. We received adverse
comment on the direct final rule from one commenter and we will address
this comment in a subsequent final action based on the parallel
proposal also published on April 11, 2006 (71 FR 18259). As stated in
the parallel proposal, we will not institute a second comment period on
this action.

DATES: Effective June 7, 2006, EPA withdraws the direct final rule
published at 71 FR 18219 on April 11, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. OAR 2005-0131. All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http:// www.regulations.gov or in hard copy at the Air Docket, EPA/

DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC.
This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For further information about this
action, contact Hodayah Finman by telephone at<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>or by mail at Hodayah Finman, U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Overnight
or courier deliveries should be sent to 1310 L St., NW., Room 827M,
Washington, DC 20005; att: Hodayah Finman. You may also visit the Ozone
Depletion web site of EPA's Stratospheric Protection Division at http://www.epa.gov/ozone/index.html
 for further information about

EPA's Stratospheric Ozone Protection regulations, the science of ozone
layer depletion, and other topics.

List of Subjects in 40 CFR Part 82

    Environmental protection, Chemicals, Halon, Ozone, Reporting and
recordkeeping requirements, Treaties.

    Dated: June 1, 2006
William L. Wehrum,
Acting Assistant Administrator for the Office of Air and Radiation.
[FR Doc. E6-8831 Filed 6-6-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: September 3, 2009 (Volume 74, Number 170)]
[Notices]
[Page 45627-45628]
[DOCID:fr03se09-42]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12187-013]

Price Dam Partnership, Limited; Notice of Request for Extension
of Time To Commence and Complete Project Construction and Soliciting
Comments, Motions To Intervene, and Protests

August 27, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Request for Extension of Time.
    b. Project No: 12187-013.
    c. Date Filed: August 24, 2009.
    d. Applicant: Price Dam Partnership, Limited.
    e. Name of Project: Price Dam Hydroelectric Project.
    f. Location: At the existing St. Louis District's U.S. Army Corps
of Engineers' (Corps) Melvin Price Locks & Dam on the Mississippi
River, in the city of Alton, Wood River Township, Madison

County, Illinois. The project would occupy about 1.81 acres of Federal
lands.
    g. Pursuant to: Public Law 111-60, 123 STAT. 1995.
    h. Applicant Contact: John A. Whittaker, IV, Winston & Strawn, LLP,
1700 K Street, NW., Washington, DC 20006;<PHONE_NUMBER> and e-mail:
<EMAIL_ADDRESS>    i. FERC Contact: Diane M. Murray, Telephone:<PHONE_NUMBER> and e-
mail<EMAIL_ADDRESS>    j. Deadline for Filing Comments, Motions To Intervene, and
Protests: September 28, 2009. Please include the project number (P-
12187-013) on any comments.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Request: The licensee requests that the
Commission grant a two-year extension of time from the existing
deadline of July 28, 2009 to July 28, 2011 to commence project
construction of the Price Dam Hydroelectric Project. This will be the
first 2-year extension of three authorized by Public Law No. 111-60.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call toll-free 1-866-208-3676
or e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A
copy is also available for inspection and reproduction at the address
in item h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests, and interventions may be filed
electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-21244 Filed 9-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96140-96142]
[FR Doc No: 2016-31471]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79654; File No. SR-Phlx-2016-122]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Modify
Administrative Charges for Distributors of Proprietary Data Feed
Products

December 22, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 14, 2016, NASDAQ PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the Exchange's Pricing Schedule
under Section VIII, entitled ``NASDAQ PSX FEES,'' in the subsection
currently entitled ``Annual Administrative Fee,'' to change the billing
cycle for administrative fees paid by distributors of the Exchange's
market data from annual to monthly, and to: (1) Replace the current
$500 annual administrative fee assessed to distributors of delayed
market data with a $50 monthly administrative fee, and (2) replace the
current $1,000 annual administrative fee assessed to distributors of
real-time market data with a $100 monthly administrative fee. The
proposal is described further below.\3\
---------------------------------------------------------------------------

    \3\ The NASDAQ Stock Market LLC and NASDAQ BX, Inc. are filing
companion proposals similar to this one. All three proposals will
change the billing cycle for administrative fees paid by
distributors of market data from annual to monthly, and will: (1)
Replace the current $500 annual administrative fee assessed to
distributors of delayed market data with a $50 monthly
administrative fee, and (2) replace the current $1,000 annual
administrative fee assessed to distributors of real-time market data
with a $100 monthly administrative fee.
---------------------------------------------------------------------------

    While these amendments are effective upon filing, the Exchange has
designated the proposed amendments to be operative on January 1, 2017.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant 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 the proposed rule change is to change the billing
cycle for administrative fees paid by distributors of the Exchange's
market data from annual to monthly, and to: (1) Replace the current
$500 annual administrative fee assessed to distributors of delayed
market data with a $50 monthly administrative fee, and (2) replace the
current $1,000 annual administrative fee assessed to distributors of
real-time market data with a $100 monthly administrative fee.
Annual Administrative Fee
    The Exchange assesses an annual administrative fee to any market
data distributor that receives any proprietary Exchange data feed
product. The amount of that annual fee is $500 for delayed market data
and $1,000 for real-time market data. Distributors of both delayed and
real-time market data are not required to pay both fees; they are
charged only the higher fee. The time difference between ``delayed''
and ``real-time'' data varies by product. PSX Basic, for example, is
considered delayed after 15 minutes, while PSX TotalView-ITCH data is
considered delayed after midnight ET. The specific delay interval
applicable to each product is published on the Nasdaq Trader Web site.
The fee is not prorated if the distributor receives the data feed for
less than a year.
Proposed Changes
    The Exchange proposes to change the billing cycle for
administrative fees paid by distributors of the Exchange's market data
from annual to monthly, and to: (1) Replace the current $500 annual
administrative fee assessed to distributors of delayed market data with
a $50 monthly administrative fee, and (2) replace the current $1,000
annual administrative fee assessed to distributors of real-time market
data with a $100 monthly administrative fee.
    The purposes of the proposal are to: (1) Facilitate billing by
aligning the current annual administrative fee billing cycle with the
standard monthly billing cycle used by the Exchange; (2) allocate the
fee more equitably by charging distributors that receive less than a
year of market data an administrative fee only for those months that
they receive market data; and (3) bring the Exchange's administrative
fee into alignment with the Nasdaq and BX market data administrative
fees, which, after current proposals take effect, will be charged the
same administrative fees on the same billing cycle.
    The complexity of administering the Exchange's market data program
has increased significantly since the current fee was set in November
of 2011. New, more complex products and services require the Exchange
to expend more resources in administration and

monitoring. For example, the introduction of Enhanced Display
Solutions--which allow subscribers to view data from PSX TotalView on
computer monitors and export it to applications--required the Exchange
to create new reporting systems and review mechanisms for the use of
market data. New reporting and review mechanisms also had to be created
to implement Managed Data Solutions, which allow electronic systems
access to PSX TotalView without human intervention. These programs were
created in response to customer demand, and all require administrative
expenditures that had not been necessary when the amount of the
administrative fee was set in 2011.
    The administrative fee is entirely optional in that it applies only
to firms that elect to distribute the Exchange's market data.
    The proposed changes do not raise the cost of any other product
sold by the Exchange, except to the extent that they increase the total
cost of purchasing market data.

2. Statutory Basis

    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \6\
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission \7\
(``NetCoalition'') the D.C. Circuit upheld the Commission's use of a
market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\8\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \9\
---------------------------------------------------------------------------

    \7\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \8\ See NetCoalition, at 534-535.
    \9\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers' . . . .'' \10\
---------------------------------------------------------------------------

    \10\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca 2006-21)).
---------------------------------------------------------------------------

    The Exchange believes that the proposal to replace the current $500
annual administrative fee assessed to distributors of delayed market
data with a $50 monthly administrative fee, and the current $1,000
annual administrative fee assessed to distributors of real-time data
with a $100 monthly administrative fee, is fair and equitable in
accordance with Section 6(b)(4) of the Act, and not unreasonably
discriminatory in accordance with Section 6(b)(5) of the Act. As
described above, the proposed fee change is reasonable and necessary to
facilitate billing, allocate fees more equitably, and align the
administrative charges for market data with those of the Nasdaq and BX
exchanges. Moreover, administrative fees are constrained by the
Exchange's need to compete for order flow.
    The Exchange believes that the proposed change is an equitable
allocation and is not unfairly discriminatory because the Exchange will
apply the same fee to all similarly-situated distributors.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
    The proposal is to replace the current $500 annual administrative
fee assessed to distributors of delayed market data with a $50 monthly
administrative fee, and the current $1,000 annual administrative fee
assessed to distributors of real-time market data with a $100 monthly
administrative fee. If the changes proposed herein are unattractive to
market participants, it is likely that the Exchange will lose market
share as a result.
    Specifically, market forces constrain administrative fees in three
respects. First, all fees associated with proprietary data are
constrained by competition among exchanges and other entities
attracting order flow. Second, administrative fees impact the total
cost of market data, and are constrained by the total cost of the
market data offered by other entities. Third, competition among
distributors constrains the total cost of market data, including
administrative fees.
Competition for Order Flow
    Administrative fees are constrained by competition among exchanges
and other entities seeking to attract order flow. Order flow is the
``life blood'' of the exchanges. Broker-dealers currently have numerous
alternative venues for their order flow, including thirteen self-
regulatory organization (``SRO'') markets, as well as internalizing
broker-dealers (``BDs'') and various forms of alternative trading
systems (``ATSs''), including dark pools and electronic communication
networks (``ECNs''). Each SRO market competes to produce transaction
reports via trade executions, and two FINRA-regulated Trade Reporting
Facilities (``TRFs'') compete to attract internalized transaction
reports. The existence of fierce competition for order flow implies a
high degree of price sensitivity on the part of BDs, which may readily
reduce costs by directing orders toward the lowest-cost trading venues.

    The level of competition and contestability in the market for order
flow is demonstrated by the numerous examples of entrants that swiftly
grew into some of the largest electronic trading platforms and
proprietary data producers: Archipelago, Bloomberg Tradebook, Island,
RediBook, Attain, TracECN, BATS Trading and BATS/Direct Edge. A
proliferation of dark pools and other ATSs operate profitably with
fragmentary shares of consolidated market volume. For a variety of
reasons, competition from new entrants, especially for order execution,
has increased dramatically over the last decade.
    Each SRO, TRF, ATS, and BD that competes for order flow is
permitted to produce proprietary data products. Many currently do or
have announced plans to do so, including NYSE, NYSE Amex, NYSE Arca,
BATS, and IEX. This is because Regulation NMS deregulated the market
for proprietary data. While BDs had previously published their
proprietary data individually, Regulation NMS encourages market data
vendors and BDs to produce market data products cooperatively in a
manner never before possible. Order routers and market data vendors can
facilitate production of proprietary data products for single or
multiple BDs. The potential sources of proprietary products are
virtually limitless.
    The markets for order flow and market data are inextricably linked:
A trading platform cannot generate market information unless it
receives trade orders. As a result, the competition for order flow
constrains the prices that platforms can charge for proprietary data
products. Firms make decisions on how much and what types of data to
consume based on the total cost of interacting with an exchange.
Administrative fees are part of the total cost of proprietary data. A
supracompetitive increase in the fees charged for either transactions
or market data has the potential to impair revenues from both products.
Competition From Market Data Providers
    Administrative fees are constrained by competition from other
exchanges that sell market data. If administrative fees were to become
excessive, distributors may elect to discontinue one or two products or
services purchased from the Exchange, or reduce the level of their
purchases, to signal that the overall cost of market data had become
excessive. Such a reduction in purchases would act as a discipline to
the PSX administrative fees, and would constrain the Exchange in its
pricing decisions.
Competition Among Distributors
    Distributors provide another form of price discipline for market
data products. Distributors are in competition for users, and can
curtail their purchases of market data if the total price of market
data, including administrative fees, were set above competitive levels.
    In summary, market forces constrain the level of administrative
fees through competition for order flow, competition from other sources
of proprietary data, and in the competition among distributors for
customers. For these reasons, the Exchange has provided a substantial
basis demonstrating that the fee is equitable, fair, reasonable, and
not unreasonably discriminatory, and therefore consistent with and in
furtherance of the purposes of the Exchange Act.

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

    No written comments were either solicited or received.

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.\11\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2016-122 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2016-122. 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
10:00 a.m. and 3:00 p.m. Copies of such 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-Phlx-2016-122, and should be
submitted on or before January 19, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-31471 Filed 12-28-16; 8:45 am]
BILLING CODE 8011-01-P