[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Rules and Regulations]
[Pages 13768-13771]
[FR Doc No: 2015-05964]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2010-0121; A-1-FRL-9915-05-Region 1]

Approval and Promulgation of Air Quality Implementation Plans;
Connecticut; Low Emission Vehicle Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of
Connecticut. The regulations adopted by Connecticut include the
California Low Emission Vehicle (LEV) II light-duty motor vehicle
emission standards effective in model year 2008, the California LEV II
medium-duty vehicle standards effective in model year 2009, and
greenhouse gas emission standards for light-duty motor vehicles and
medium-duty vehicles effective with model year 2009. The Connecticut
LEV regulation submitted also includes a zero emission vehicle (ZEV)
provision, as well as emission control label and environmental
performance label requirements. Connecticut has adopted these revisions
to reduce emissions of volatile organic compounds (VOC) and nitrogen
oxides (NOX) in accordance with the requirements of the
Clean Air Act (CAA), as well as to reduce greenhouse gases (carbon
dioxide, methane, nitrous oxide, and hydrofluorocarbons). In addition,
Connecticut has worked to ensure that their program is identical to
California's, as required by the CAA. The intended effect of this
action is to approve the Connecticut LEV II program. In addition, EPA
is approving the removal of the definition and regulation of
``composite motor vehicles'' from the Connecticut's SIP-approved
vehicle inspection and maintenance program. These actions are being
taken in accordance with the CAA.

DATES: This rule is effective on April 16, 2015.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2010-0121. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
www.regulations.gov or in hard copy at the Office of Ecosystem
Protection, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, Air Quality Planning
Unit, 5 Post Office Square-Suite 100, Boston, MA. EPA requests that if
at all possible, you contact the contact listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday, 8:30
a.m. to 4:30 p.m., excluding legal holidays.
    Copies of the documents relevant to this action are also available
for public inspection during normal business hours, by appointment at
the Bureau of Air Management, Department of Energy and Environmental
Protection, State Office Building, 79 Elm Street, Hartford, CT 06106-
1630.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5
Post Office Square-Suite 100, (Mail code OEP05-2), Boston, MA 02109-
3912, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background and Purpose
II. Response to Public Comments
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On January 27, 2014 (79 FR 4308), EPA published a Notice of
Proposed Rulemaking (NPR) for the State of Connecticut, ``Approval and
Promulgation of Air Quality Implementation Plans; Connecticut; Low
Emission Vehicle Program.'' The NPR proposed approval of Connecticut's
Low Emissions Vehicle II (LEV II) program, as adopted by Connecticut on
December 4, 2004, and subsequently amended on December 22, 2005 and
August 4, 2009. The Connecticut LEV II program is cited as a weight-of-
evidence measure in Connecticut's Attainment Demonstration SIP for the
1997 8-hour ozone standard, submitted to EPA on February 1, 2008. The
formal LEV II SIP revision was submitted by Connecticut on January 22,
2010.
    On December 4, 2004, Connecticut repealed the provisions of section
22a-174-36 of the Regulations of Connecticut State Agencies, rescinding
both the California Low Emission Vehicle I program and the National Low
Emission Vehicle (NLEV) program. In accordance with section 177 of the
Clean Air Act (CAA) and as required by Connecticut Public Act 04-84,
Connecticut adopted section 22a-174-

36b, the California Low Emission Vehicle II (LEV II) program, including
all ``zero emission vehicle'' program elements, commencing with 2008
model year vehicles.
    On December 22, 2005, Connecticut amended section 22a-174-36b of
the Regulations of Connecticut State Agencies, making minor technical
corrections and clarifications; adopting California LEV II emission
standards and related provisions for medium-duty vehicles commencing
with the 2009 model year; adopting recently announced revisions
concerning LEV II greenhouse gas emission standards and related
provisions for passenger cars, light duty trucks and medium-duty
passenger vehicles commencing with the 2009 model year in accordance
with section 177 of the CAA and Connecticut Public Act 04-84; and
providing additional clarification and flexibility with respect to the
implementation of the zero emissions vehicle (ZEV) program in
Connecticut.
    On August 4, 2009, Connecticut adopted a third amendment consisting
of revisions to two sections of the air quality regulations concerning
motor vehicles. The recall, warranty, ZEV, and ZEV travel provision
amendments update the Connecticut LEV program consistent with changes
California made to its LEV program.
    In addition to the amendments to the Connecticut LEV program,
Connecticut's January 22, 2010 SIP revision includes a change in its
motor vehicle inspection and maintenance (I/M) program to exempt
composite vehicles from I/M program testing.
    Other specific requirements of Connecticut's LEV II and motor
vehicle I/M programs and the rationale for EPA's proposed action are
explained in the NPR and will not be restated here.

II. Response to Public Comments

    EPA received comments on the NPR from one anonymous commenter. This
commenter supported the effort of Connecticut and other states to
follow California's lead in implementing a low emission vehicle
program. The commenter went on to identify three specific issues: (1)
Market failure with public transportation; (2) cars manufactured before
2008; and (3) monitoring emissions.
    The action before EPA is to approve or disapprove Connecticut's
request to revise its SIP to include California LEV II light-duty motor
vehicle emission standards (effective in model year 2008), the
California LEV II medium-duty vehicle standards (effective in model
year 2009), and greenhouse gas emission standards for light-duty motor
vehicles and medium-duty vehicles (effective with model year 2009). The
Connecticut LEV program submitted is identical to California's program,
as required by the Clean Air Act, and includes a ZEV provision, as well
as emission control label and environmental performance label
requirements. Connecticut's SIP revision also includes a minor
amendment to the state's motor vehicle inspection and maintenance (I/M)
program which exempts composite vehicles from I/M program testing.
    The workings of the public transportation system and the
development of new light rail transportation systems referenced by the
commenter is not germane to the approval of the submitted Connecticut
SIP revision.
    In addition, motor vehicles manufactured prior to 2008 are not
covered by Connecticut's LEV II program. These vehicles were required
to be manufactured in accordance with the Federal Tier 1 and Tier 2
Vehicle and Gasoline Sulfur Program, as well as the Northeast National
Low Emission Vehicle Program, the programs in place at that time. Pre-
2008 motor vehicles registered in Connecticut are also subject to
Connecticut's I/M program which is further discussed below.
    In the third and final issue, the commenter asks how emissions
would be monitored and ``how often the rule/law require[s] drivers to
go have a reading made.'' This issue is not relevant to the approval of
Connecticut's LEV II program. The Connecticut LEV II program includes
requirements that apply to the manufacturer of motor vehicles, not the
drivers of motor vehicles. Connecticut's motor vehicle I/M program
does, however, contain requirements for drivers. EPA previously
approved Connecticut's I/M program into the SIP on December 5, 2008 (73
FR 74019). This program requires biennial inspections for all subject
motor vehicles that are at least four years old. Connecticut's I/M
program covers all gasoline and diesel vehicles, light duty trucks, and
heavy duty vehicles that are 25 years old and newer and registered in
the State. In today's action, EPA is approving a minor amendment to
that program. Specifically, composite vehicles are being exempted from
I/M program testing. As explained in EPA's NPR, this exemption would
exempt only 100 vehicles from Connecticut's I/M program which applies
to approximately 1,959,000 vehicles, and will not have significant air
quality impacts. Other aspects of Connecticut's I/M program including
the periodic inspection requirement remain as approved by EPA on
December 5, 2008 (73 FR 74019).

III. Final Action

    EPA is approving Connecticut's Low Emission Vehicle Program as a
revision to the Connecticut SIP. Specifically, EPA is incorporating
into the SIP Regulations of Connecticut State Agencies (RCSA) section
22a-174-36b entitled ``Low Emission Vehicles II Program,'' effective in
the State of Connecticut on August 10, 2009.
    EPA is also approving Connecticut's revised Motor Vehicle
Inspection and Maintenance Program as a revision to the Connecticut
SIP. Specifically, EPA is incorporating into the SIP Regulations of
Connecticut State Agencies (RCSA) section 22a-174-27 entitled
``Emission standards and on-board diagnostic II test requirements for
periodic motor vehicle inspection and maintenance,'' effective in the
State of Connecticut on August 10, 2009.

IV. 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.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 18, 2015. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: July 29, 2014.
H. Curtis Spalding,
Regional Administrator, EPA New England.
Editorial note: This document was received for publication by the
Office of Federal Register on March 11, 2015.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart H--Connecticut

0
2. Section 52.370 is amended by redesignating paragraph (c)(98)(i)(A)
as (c)(98)(i)(A)(1) and adding paragraphs (c)(98)(i)(A)(2) and (c)(105)
to read as follows:

Sec.  52.370  Identification of plan.

* * * * *
    (c) * * *
    (98) * * *
    (i) * * *
    (A) * * *
    (2) In revisions to the State Implementation Plan submitted by the
Connecticut Department of Environmental Protection on January 22, 2010
section 22a-174-27 (e) was repealed by the State of Connecticut
effective August 10, 2009. Section 22a-174-27 (e), which was approved
in paragraph (c)(98)(i)(A)(1), is removed from the SIP without
replacement; see paragraph (c)(105)(i)(B) of this section.
* * * * *
    (105) Revisions to the State Implementation Plan submitted by the
Connecticut Department of Environmental Protection on January 22, 2010.
    (i) Incorporation by reference.
    (A) Regulations of Connecticut State Agencies (RCSA) section 22a-
174-36b entitled ``Low Emission Vehicles II Program,''
    (1) Regulations of Connecticut State Agencies (RCSA) section 22a-
174-36b entitled ``Low Emission Vehicles II Program,'' effective
December 22, 2005, revisions to the following provisions (including the
text that appears in underline): Sections 22a-174-36b (a), (b), (d),
(f) through (j), (l), (m), (n), and (o).
    (2) Regulations of Connecticut State Agencies (RCSA) section 22a-
174-36b entitled ``Low Emission Vehicles II Program,'' effective August
10, 2009, revisions to the following provisions: Sections 22a-174-36b
(c), (e), and (k), as published in the Connecticut Law Journal on
September 8, 2009.
    (B) Regulations of Connecticut State Agencies (RCSA) section 22a-
174-27 entitled ``Emission standards and on-board diagnostic II test
requirements for periodic motor vehicle inspection and maintenance,''
effective August 10, 2009, revisions to Section 22a-174-27 (b), as
published in the Connecticut Law Journal on September 8, 2009.

0
3. In Sec.  52.385, Table 52.385 is amended by revising the second
entry for state citation 22a-174-27; adding a new entry for state
citation 22a-174-27 after the existing two entries; and adding two new
entries for state citation 22a-174-36b in numerical order to read as
follows:

Sec.  52.385  EPA-approved Connecticut regulations.

* * * * *

                                                         Table 52.385--EPA-Approved Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Dates
                                                          --------------------------------    Federal Register
    Connecticut State  citation         Title/Subject       Date adopted    Date approved         citation         Section 52.370   Comments/Description
                                                              by State         by EPA
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
22a-174-27........................  Emission standards            8/25/04        12/05/08  74 FR 74019                    (c)(98)  DEP regulations
                                     and on-board                                                                                including emissions
                                     diagnostic II test                                                                             standards and OBD2
                                     requirements for                                                                               requirements.
                                     periodic motor                                                                                Paragraph
                                     vehicle inspection                                                                             52.370(c)(98) was
                                     and maintenance.                                                                               revised March 17,
                                                                                2015 by
                                                                                redesignating
                                                                                paragraph
                                                                                (c)(98)(i)(A) as
                                                                                (c)(98)(i)(A)(1) and
                                                                                adding paragraph
                                                                                (c)(98)(i)(A)(2) to
                                                                                read as follows: (2)
                                                                                In revisions to the
                                                                                State Implementation
                                                                                Plan submitted by
                                                                                the Connecticut
                                                                                Department of
                                                                                Environmental
                                                                                Protection on
                                                                                January 22, 2010
                                                                                section 22a-174-27
                                                                                (e) was repealed by
                                                                                the State of
                                                                                Connecticut
                                                                                effective August 10,
                                                                                2009. Section 22a-
                                                                                174-27 (e), which
                                                                                was approved in
                                                                                paragraph
                                                                                (c)(98)(i)(A)(1), is
                                                                                removed from the SIP
                                                                                without replacement;
                                                                                see paragraph
                                                                                (c)(105)(i)(B) of
                                                                                this section.
22a-174-27........................  Emission standards            8/10/09         3/17/15  [Insert Federal               (c)(105)  This SIP revision
                                     and on-board                                           Register citation]                      includes a change to
                                     diagnostic II test                                                                             exempt composite
                                     requirements for                                                                               vehicles from
                                     periodic motor                                                                                tailpipe
                                     vehicle inspection                                                                             inspections.
                                     and maintenance.                                                                               Revision to Section
                                                                                22a-174-27 (b) and
                                                                                removal of Section
                                                                                22a-174-27 (e).

                                                                      * * * * * * *
22a-174-36b.......................  Low Emission Vehicles        12/22/05         3/17/15  [Insert Federal               (c)(105)  Adoption of
                                     II Program..                                           Register citation]                      Connecticut's Low
                                                                                Emissions Vehicle II
                                                                                (LEV II) Program.
                                                                                Sections 22a-174-36b
                                                                                (a), (b), (d), (f)
                                                                                through (j), (l),
                                                                                (m), and new
                                                                                sections (n) and
                                                                                (o).
22a-174-36b.......................  Low Emission Vehicles         8/10/09         3/17/15  [Insert Federal               (c)(105)  Sections 22a-174-36b
                                     II Program..                                           Register citation]                      (c), (e), and (k).

                                                                      * * * * * * *
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[FR Doc. 2015-05964 Filed 3-16-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Pages 55187-55188]
[FR Doc No: 2018-23951]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3903]

Chronic Hepatitis B Virus Infection: Developing Drugs for
Treatment; 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 ``Chronic
Hepatitis B Virus Infection: Developing Drugs for Treatment.'' The
purpose of this guidance is to assist sponsors in the clinical
development of drugs and biologics for the treatment of chronic
hepatitis B virus (HBV) infection from the initial investigational new
drug application (IND) through the new drug application (NDA)/biologics
license application (BLA) and postmarketing phases.

DATES: Submit either electronic or written comments on the draft
guidance by January 2, 2019 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-2018-D-3903 for ``Chronic Hepatitis B Virus Infection: Developing
Drugs for Treatment.'' 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: Poonam Mishra, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6100, Silver Spring, MD 20993, 301-796-
1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for
Treatment.'' The purpose of this guidance is to assist sponsors in the
clinical development of drugs and biologics for the treatment of
chronic HBV infection from the initial IND through the NDA/BLA and
postmarketing phases. The guidance includes general considerations for
nonclinical toxicology and virology studies, early phase clinical
development, clinical pharmacology assessments, and phase 3 safety and
efficacy trials. The guidance discusses phase 3 trial design
considerations and efficacy endpoints for the development of
combination therapies for the treatment of chronic HBV infection. Drug
development considerations for specific subpopulations such as patients
coinfected with hepatitis D virus or human immunodeficiency virus and
pediatric HBV-infected patients are also included.
    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 ``Chronic
Hepatitis B Virus Infection: Developing Drugs for Treatment.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). The collections of information in 21 CFR parts 312 and 314
have been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The submission of prescription drug labeling under 21 CFR
201.56 and 201.57 has been approved under OMB control number 0910-0572.

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: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23951 Filed 11-1-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Notices]
[Page 54650-54651]
[DOCID:fr26se07-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12470-001]

City of Broken Bow, Oklahoma; Notice Soliciting Comments and
Final Terms and Conditions, Recommendations, and Prescriptions

September 19, 2007.
    Take notice that the following hydroelectric application and
applicant-prepared environmental assessment have been filed with the
Commission and are available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: 12470-001.
    c. Date filed: July 26, 2006.
    d. Applicant: City of Broken Bow, Oklahoma.
    e. Name of Project: Broken Bow Re-Regulation Dam Hydropower
Project.
    f. Location: On the Mountain Fork River in McCurtain County,
Oklahoma. The project would be located at the United States Army Corps
of Engineers' (Corps) Broken Bow Re-Regulation Dam and would occupy
lands administered by the Corps.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)--825(r).
    h. Applicant Contact: Olen Hill, City Manager, City of Broken Bow,
Oklahoma, 210 North Broadway, Broken Bow, Oklahoma 74728; (405) 584-
2282.
    i. FERC Contact: Peter Leitzke at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
    j. Deadline for filing comments, and final terms and conditions,
recommendations, and prescriptions: 60 days from the issuance of this
notice. All reply comments must be filed with the Commission within 105
days from the date of this notice.
    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
intervenors 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 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.
    Comments, terms and conditions, recommendations, and prescriptions
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) under the ``e-Filing'' link.

    k. This application has been accepted.
    l. The proposed run-of-river project, using the Corps' existing
Broken Bow Re-Regulation Dam and Reservoir, would consist of: (1) Three
93.5-foot-long penstocks through the eastern portion of the re-
regulation dam; (2) a 112-foot-wide by 129-foot-long powerhouse
containing three turbine-generator units, having a total installed
capacity of 4 megawatts; (3) a 170-foot-long tailrace that would return
flows to the Mountain Fork River; (4) a 1,891-foot-long, 13.8-kilovolt
transmission line; and (5) appurtenant facilities. The project would
have an average annual generation of 17,500 megawatt-hours.
    m. A copy of the application 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>. A copy is also available for
inspection and reproduction at the address in item h above.
    All filings must: (1) Bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS'', ``TERMS AND
CONDITIONS'', or ``PRESCRIPTIONS''; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions, or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    You may also register online at http://www.ferc.gov.esubscribenow.htm
 to be notified via e-mail of new filings

and issuances related to this or other pending projects. For
assistance, contact FERC Online Support.
    n. Procedural Schedule: The Commission staff proposes to issue a
single Environmental Assessment (EA) rather than issuing a draft and
final EA. Staff intends to allow at least 30 days for entities to
comment on the EA. The Commission will take into consideration all
comments received on the EA before taking final action on the license
application. The application will be processed according to the
following schedule, but revisions to the schedule may be made as
appropriate:
    Issue Notice of availability of the EA: March 2008.
    o. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-18906 Filed 9-25-07; 8:45 am]

BILLING CODE 6717-01-P