[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)]
[Notices]
[Pages 532-533]
[FR Doc No: 2017-28435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6854]

Good Abbreviated New Drug Application Submission Practices; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Good ANDA
Submission Practices.'' This guidance is intended to assist applicants
preparing to submit to FDA abbreviated new drug applications (ANDAs).
This draft guidance highlights common, recurring deficiencies that may
lead to a delay in the approval of an ANDA. It also makes
recommendations to applicants on how to avoid these deficiencies with
the goal of minimizing the number of review cycles necessary for
approval.

DATES: Submit either electronic or written comments on the draft
guidance by March 5, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6854 for ``Good ANDA Submission Practices.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential

with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the 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: Michelle Sollenberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 240-
402-0981.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Good ANDA Submission Practices.'' This draft guidance is
intended to assist applicants preparing to submit ANDAs to FDA. It
highlights common, recurring deficiencies that may lead to a delay in
the approval of an ANDA. This draft guidance also makes recommendations
to applicants on how to avoid these deficiencies so that applicants can
submit ANDAs that may be approved in the first review cycle. This draft
guidance has been developed as part of FDA's ``Drug Competition Action
Plan,'' which, in coordination with the Generic Drug User Fee
Amendments (GDUFA I and II) (Pub. L. 112-144 and Pub. L. 115-52,
respectively) and other FDA activities, is expected to increase
competition in the market for prescription drugs, facilitate entry of
high-quality and affordable generic drugs, and improve public health.
    In conjunction with this draft guidance, FDA is issuing a Good ANDA
Assessment Practices Manual of Policies and Procedures, which
establishes good ANDA assessment practices for the Office of Generic
Drugs and the Office of Pharmaceutical Quality to increase their
operational efficiency and effectiveness. This draft guidance and the
Manual of Policies and Procedures are intended to build upon the
success of the GDUFA program and to help reduce the number of review
cycles for an ANDA to attain approval.
    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 good ANDA
submission practices. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This draft guidance is not subject to Executive Order
12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in the draft guidance have been
approved under OMB control numbers 0910-0001 and 0910-0786.

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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28435 Filed 1-3-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34836-34837]
[FR Doc No: 2018-15697]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-18-000]

Notice of Availability of the Environmental Assessment for the
Proposed Gateway Expansion Project, Transcontinental Gas Pipe Line
Company, LLC

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Gateway Expansion Project, proposed by Transcontinental Gas Pipe Line
Company, LLC (Transco) in the above-referenced docket. Transco requests
authorization to modify certain facilities in Essex and Passaic
Counties, New Jersey, to increase the firm transportation capacity on
the existing pipeline to allow greater access to natural gas supplies.
The proposed modifications would occur within existing facilities, with
no new permanent right-of-way.
    The EA assesses the potential environmental effects of the
construction and operation of the Gateway Expansion Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with appropriate mitigating measures, would not constitute a
major federal action significantly affecting the quality of the human
environment.
    The proposed Gateway Expansion Project includes the following
facilities:

Essex County

Compressor Station 303

     Expansion of the building and installation of a 33,000
horsepower electric-motor driven compression unit and ancillary
equipment; and
     extension of security fencing and access to new equipment.

Roseland Meter and Regulator

     Installation of a 36-inch-diameter Main Line block valve
with automation controls.

Roseland Electric Substation

     Installation of an electric transformer unit.

Passaic County

Paterson Meter and Regulator

     Replacing the existing 12-inch-diameter headers with two
new 6-inch-diameter ultrasonic meter skids and associated equipment;
and

     installation of ancillary equipment.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; and newspapers and libraries in the project area. In addition,
the EA is available for public viewing on the FERC's website
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE, Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before 5:00 p.m.
Eastern Time on August 16, 2018.
    For your convenience, there are three methods you can use to file
your comments to the Commission. In all instances, please reference the
project docket number (CP18-18-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or
[email protected].
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\1\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \1\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP18-
18). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: July 17, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-15697 Filed 7-20-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Proposed Rules]
[Page 75626-75628]
[DOCID:fr12de08-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0863; FRL-8751-5]

Revisions to the California State Implementation Plan, Approval
of the Ventura County Air Pollution Control District--Reasonably
Available Control Technology Analysis

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Ventura County
Air Pollution Control District (VCAPCD) portion of the California State
Implementation Plan (SIP). These revisions concern the District's
analysis of whether its rules meet Reasonably Available Control
Technology (RACT) under the 8-hour ozone National Ambient Air Quality
Standard (NAAQS). We are approving the analysis under the Clean Air Act
as amended in 1990 (CAA or the Act). We are taking comments on this
proposal and plan to follow with a final action.

DATES: Any comments must arrive by January 12, 2009.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2008-0863, 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: Andrew Steckel (Air-4), 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: Stanley Tong, EPA Region IX, (415)
947-4122<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What document did the State submit?
    B. Are there other versions of this document?
    C. What is the purpose of the submitted RACT SIP analysis?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the RACT SIP analysis?
    B. Does the analysis meet the evaluation criteria?
    C. EPA recommendations to strengthen the SIP
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What document did the State submit?

    Table 1 lists the document addressed by this proposal with the date
that it was adopted by the local air agency and submitted by the
California Air Resources Board.

                                           Table 1--Submitted Document
----------------------------------------------------------------------------------------------------------------
                 Local agency                                  Document                   Adopted     Submitted
----------------------------------------------------------------------------------------------------------------
VCAPCD........................................  2006 Reasonably Available Control          06/27/06     01/31/07
                                                 Technology Analysis.
----------------------------------------------------------------------------------------------------------------

    This submittal became complete by operation of law on July 31,
2007.

B. Are there other versions of this document?

    There is no previous version of this document in the SIP.

C. What is the purpose of the submitted RACT SIP analysis?

    VOCs and NOX help produce ground-level ozone and smog,
which harm human health and the environment. Section 110(a) of the CAA
requires States to submit regulations that control VOC and
NOX emissions. Section 172(c)(1) and 182 require areas that
are designated as moderate or above for ozone non-attainment to adopt
RACT. The VCAPCD falls under this requirement as it is designated as a
moderate ozone non-attainment area under the 8-hour NAAQS for ozone (40
CFR 81.305; 69 FR 23858, at 23889, April 30, 2004). On May 20, 2008,
EPA granted California's request for voluntary reclassification of the
Ventura County ozone non-attainment area from ``moderate'' to
``serious''. (73 FR 29073). Therefore, under both the 2004
classification as a moderate ozone non-attainment area, and the 2008
reclassification as a serious ozone non-attainment area, the VCAPCD
must, at a minimum, adopt RACT-level controls for sources covered by a
Control Techniques Guidelines (CTG) document and for any major non-CTG
source. EPA evaluated VCAPCD's submittal based on a moderate ozone non-
attainment area classification since the District adopted its 2006
certification based on this classification. We note, however, that the
VCAPCD still has an obligation to submit a RACT SIP certification for
the serious classification.
    Section IV.G. of EPA's final rule to implement the 8-hour ozone
NAAQS (70 FR 71612, November 29, 2005) discusses RACT requirements. It
states in part that where a RACT SIP is required, State SIPs
implementing the 8-hour standard generally must assure that RACT is
met, either through a certification that previously required RACT
controls represent RACT for 8-hour implementation purposes or through a
new RACT determination. The submitted document provides VCAPCD's
analysis of their RACT rules for the 8-hour NAAQS for ozone. EPA's
technical support document (TSD) has more information about VCAPCD's
RACT analysis.

II. EPA's Evaluation and Action

A. How is EPA evaluating the RACT SIP analysis?

    Rules, guidance and policy documents that we use to evaluate
whether the analysis fulfills RACT include the following:
    1. Final Rule to Implement the 8-Hour Ozone National Ambient Air
Quality Standard (70 FR 71612; November 29, 2005).
    2. Letter from William T. Harnett to Regional Air Division
Directors, (May 18, 2006), ``RACT Qs & As--Reasonably Available Control
Technology (RACT) Questions and Answers''.
    3. State Implementation Plans, General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990 (57
FR 13498; April 16, 1992).
    4. RACT SIPs, Letter dated March 9, 2006 from EPA Region IX (Andrew
Steckel) to CARB (Kurt Karperos) describing Region IX's understanding
of what constitutes a minimally acceptable RACT SIP.
    5. RACT SIPs, Letter dated April 4, 2006 from EPA Region IX (Andrew
Steckel) to CARB (Kurt Karperos) listing EPA's current CTGs, ACTs, and
other documents which may help to establish RACT.
    6. Comment letter dated June 5, 2006 from EPA Region IX (Andrew
Steckel) to VCAPCD (Chuck Thomas) on the 8-hour Ozone Reasonably
Available Control Technology--State Implementation Plan (RACT SIP)
Analysis, draft staff report dated May 2006.

B. Does the analysis meet the evaluation criteria?

    VCAPCD's staff report included a listing of all CTG source
categories and matched those categories with the corresponding District
rule which implemented RACT. Given its designation as a moderate ozone
non-attainment area, VCAPCD was also required to analyze RACT for all
sources that emit or have the potential to emit at least 100 tons per
year (tpy) of VOC or NOX. VCAPCD staff searched their
permitting database for all facilities that emitted at least 25 tpy of
VOC or NOX, identified approximately 27 such facilities, and
listed them in Table B of their staff report. Table B also provides a
matrix of the major sources of VOC and NOX emissions in
Ventura County and the district rules applicable to those facilities.
We reviewed the California Air Resources Board's (CARB) emissions
database and did not identify any major sources in VCAPCD for which
there was no corresponding District rule. Generally, VCAPCD's
certification is based on the District's conclusion that District rules
met RACT because their rule development process requires them to
analyze CARB and EPA publications, including CTGs, to assess the
feasibility and the cost of control techniques, and California State
regulations require them to apply RACT and Best Available Retrofit
Technology (BARCT) because VCAPCD is classified as a severe ozone non-
attainment area for the State ozone standard. Based on a comparison of
a sampling of VCAPCD's rules with rules in other air districts and
States, we conclude that the VCAPCD rules meet RACT.
    Table A-2 of VCAPCD's staff report includes a listing of source
categories and CTG/ACTs for which there are no applicable District
Rules and no stationary sources within the District. The table lists
not only CTGs, but also ACTs and other documents relevant to
establishing RACT at major sources. Negative declarations are only
required for CTG source categories for which the District has no
sources covered by the CTGs. A negative declaration is not required for
ACTs or for major non-CTG source categories. Table 1 below lists the
CTG source categories that remain after excluding the ACTs and non-CTG
source categories from VCAPCD's Table A-2. EPA is acting on the
negative declarations listed in Table 1 below instead of VCAPCD's Table
A-2 which includes both CTGs and non-CTG source categories.

                  Table 1--VCAPCD Negative Declarations
------------------------------------------------------------------------
     CTG source category                 CTG reference document
------------------------------------------------------------------------
Automobile Coatings; Metal     EPA-450/2-77-008--Control of Volatile
 Coil, Container, and Closure.  Organic Emissions from Existing
                                Stationary Sources--Volume II: Surface
                                Coating of Cans, Coils, Paper, Fabrics,
                                Automobiles, and Light-Duty Trucks.
Wood Coating.................  EPA-450/2-78-032--Control of Volatile
                                Organic Emissions from Existing
                                Stationary Sources, Volume VII: Factory
                                Surface of Flat Wood Paneling.
Large Appliances, Surface      EPA-450/2-77-034--Control of Volatile
 Coating.                       Organic Emissions from Existing
                                Stationary Sources, Volume V: Surface
                                Coating of Large Appliances.

Magnetic Wire................  EPA-450/2-77-033--Control of Volatile
                                Organic Emissions from Existing
                                Stationary Sources, Volume IV: Surface
                                Coating of Insulation of Magnet Wire.
Synthetic Organic Chemical...  EPA-450/3-84-015--Control of VOC
                                Emissions from Air Oxidation Processes
                                in Synthetic Organic Manufacturing
                                Industry.
                               EPA-450/4-91-031--Control of VOC
                                Emissions from Reactor Processes and
                                Distillation Operations in SOCMI.
Pharmaceutical Products......  EPA-450/2-78-029--Control of Volatile
                                Organic Emissions from Manufacture of
                                Synthesized Pharmaceutical Products.
Rubber Tires.................  EPA-450/2-78-030--Control of Volatile
                                Organic Emissions from Manufacture of
                                Pneumatic Rubber Tires.
Polyester Resin..............  EPA-450/3-83-006--Control of VOC Fugitive
                                Emissions from Synthetic Organic
                                Chemical Polymer and Resin Manufacturing
                                Equipment.
                               EPA-450/3-83-008--Control of VOC
                                Emissions from Manufacture of High-
                                Density Polyethylene, Polypropylene, and
                                Polystyrene Resins.
------------------------------------------------------------------------

    VCAPCD's staff report indicates the District has a large
agricultural industry and that agricultural pesticide use is a
substantial source of VOCs in the county. The District points out,
however, that agricultural pesticide usage is regulated by the State of
California and not under the District's jurisdiction. EPA agrees the
California Department of Pesticide Regulation (DPR), and not the
VCAPCD, has jurisdiction over pesticide regulations in California.
VCAPCD is not required, therefore, to adopt RACT rules for these
activities.
    VCAPCD's RACT SIP analysis was made available for public comment
prior to being adopted by the District. The District did not receive
any public comments during the public comment period. We propose to
find that the RACT SIP analysis performed by the VCACPD is reasonable
and demonstrates their rules meet RACT. We also propose to find that
the analysis is consistent with the CAA, EPA regulations and the
relevant policy and guidance documents listed above. The TSD has more
information on our evaluation.

C. EPA Recommendation To Strengthen the SIP

    The TSD describes recommendations for further strengthening the
VCAPCD SIP by reviewing and tightening controls in the following rules
as appropriate: Rule 71.3, ``Transfer of Organic Reactive Compound
Liquids''; Rule 74.26, Crude Oil Storage, Degassing Operations; and
Rule 74.27, Gasoline and ROC Liquid Storage Tank Degassing Operations.
    EPA further notes that due to the recent reclassification of VCAPCD
to a serious ozone non-attainment area, it will need to certify in a
future action that District rules meet CTGs issued since 2006.

D. Public Comment and Final Action

    Because EPA believes the submitted analysis fulfills all relevant
requirements, we are proposing to fully approve it 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 this document 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 provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

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, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: November 20, 2008.
Jane Diamond,
Acting Regional Administrator, Region IX.
[FR Doc. E8-29468 Filed 12-11-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19215-19216]
[FR Doc No: E9-9601]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-109-000]

Kinder Morgan Interstate Gas Transmission LLC; Notice of
Application

April 17, 2009.
    Take notice that on April 6, 2009, Kinder Morgan Interstate Gas
Transmission LLC (KMIGT), 370 Van Gordon Street, Lakewood, CO 80228,
filed in Docket No. CP09-109-000 an application pursuant to section
7(c) of the Natural Gas Act (NGA) and part 157 of the Commission's
regulations, requesting a certificate of public convenience and
necessity authorizing the construction and operation of certain
facilities comprising its proposed Huntsman 2009 Expansion Project.
KMIGT is requesting authorization to construct and operate certain
storage facilities necessary to increase the capability of the Huntsman
Storage Facility in Cheyenne County, Nebraska to expand storage
services available to the Cheyenne Market Center hub. KMIGT also
requests approval of new incremental rates for the project facilities
under its currently effective Rate Schedule CMC-2. The proposed project
facilities will create an incremental storage capacity for up to
1,000,000 dekatherms (Dth), with an associated injection capability of
approximately 6,400 dekatherms per day (Dth/day) and associated
withdrawal deliverability of approximately 10,400 Dth/day. The total
estimated cost for the proposed Huntsman 2009 Expansion Project is
$13,120,330, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. The filing may
also be viewed on the Web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For

assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Robert
F. Harrington, Vice President, Regulatory, Kinder Morgan Interstate Gas
Transmission LLC, 370 Van Gordon Street, Lakewood, CO 80228-8304 at
(303)-763-3258 or by e-mail at<EMAIL_ADDRESS>    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 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: May 8, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-9601 Filed 4-27-09; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Pages 30929-30930]
[FR Doc No: 2013-12226]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Drug Safety and Risk Management Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Drug Safety and Risk Management Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 10, 2013, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Information regarding special accommodations due
to a disability, visitor parking, and transportation may be accessed
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the
heading ``Resources for You,'' click on ``Public Meetings at the FDA
White Oak Campus.'' Please note that visitors to the White Oak Campus
must enter through Building 1.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The Food and Drug Administration Amendments Act of 2007
requires FDA to bring, at least annually, one or more drugs with Risk
Evaluation and Mitigation Strategies (REMS) with elements to assure
safe use (ETASU) before its Drug Safety and Risk Management Advisory
Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the
risk management of LOTRONEX (alosetron hydrochloride) tablets, by
Prometheus Laboratories Inc., which is approved for the treatment of
women with severe diarrhea predominant irritable bowel syndrome (IBS-
d). The Agency will seek the committee's comments as to whether the
REMS with ETASU for this drug assures safe use, is not unduly
burdensome to patient access to the drug, and to the extent
practicable, minimizes the burden to the health care delivery system.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
25, 2013. Oral presentations from the public will be scheduled between
approximately 1 p.m. to 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before June 17, 2013. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by June 18, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on public conduct during advisory
committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-12226 Filed 5-22-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Page 17849]
[FR Doc No: 2017-07433]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3375-EM; Docket ID FEMA-2017-0001]

Michigan; Amendment No. 2 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Michigan (FEMA-3375-EM), dated January 16, 2016, and
related determinations.

DATES: Effective Date: August 14, 2016.

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 the incident
period for this emergency is closed effective August 14, 2016.

(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.)

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-07433 Filed 4-12-17; 8:45 am]
BILLING CODE 9111-23-P