[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51018-51019]
[FR Doc No: 2011-20891]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP11-2350-000.
    Applicants: Williston Basin Interstate Pipeline Company.
    Description: Williston Basin Interstate Pipeline Company submits
tariff filing per 154.204: Non-Conforming Service Agreement--Nesson to
be effective 9/1/2011.
    Filed Date: 08/02/2011.
    Accession Number: 20110802-5114.
    Comment Date: 5 p.m. Eastern Time on Monday, August 15, 2011.

    Docket Numbers: RP11-2351-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Trunkline Gas Company, LLC submits tariff filing per
154.204: Negotiated Rates Filing--12 to be effective 7/16/2011.
    Filed Date: 08/04/2011.
    Accession Number: 20110804-5085.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: RP11-2352-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Trunkline Gas Company, LLC submits tariff filing per
154.203: Baseline Filing Volume No. 1-A to be effective 7/16/2011.
    Filed Date: 08/04/2011.
    Accession Number: 20110804-5089.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: RP11-2353-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits tariff
filing per 154.204: 2011 ACA Filing to be effective 10/1/2011.
    Filed Date: 08/04/2011.
    Accession Number: 20110804-5099.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 17, 2011.

    Docket Numbers: RP11-2354-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Gulf Crossing Pipeline Company LLC submits tariff
filing per 154.204: Enterprise K12-7 Amendment to Negotiated Rate
Agreement to be effective 8/6/2011.
    Filed Date: 08/05/2011.
    Accession Number: 20110805-5014.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 17, 2011.

    Docket Numbers: RP11-2355-000.
    Applicants: Williston Basin Interstate Pipeline Company.
    Description: Williston Basin Interstate Pipeline Company submits
tariff filing per 154.204: Sheyenne Expansion Additional Contracts to
be effective 9/5/2011.
    Filed Date: 08/05/2011.
    Accession Number: 20110805-5033.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 17, 2011.

    Docket Numbers: RP11-2356-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits tariff
filing per 154.203: 2011 August 5 Compliance Filing (RP04-274-023) to
be effective 9/1/2011.
    Filed Date: 08/05/2011.
    Accession Number: 20110805-5060.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 17, 2011.

    Docket Numbers: RP11-2357-000.
    Applicants: PostRock KPC Pipeline, LLC.
    Description: PostRock KPC Pipeline, LLC submits tariff filing per
154.402: KPC ACA Filing to be effective 10/1/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5031.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.

    Docket Numbers: RP11-2358-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: Virginia Natural Gas Negotiated Rate Agreement and
Amendment to be effective 8/6/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5032.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.

    Docket Numbers: RP11-2359-000.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Tres Palacios Gas Storage LLC submits tariff filing
per 154.204: Tres Palacios Gas Storage LLC--Revisions to FERC Gas
Tariff to be effective 9/8/2011.
    Filed Date: 08/09/2011.
    Accession Number: 20110809-5020.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP11-2199-001.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Transcontinental Gas Pipe Line Company, LLC. submits
tariff filing per 154.203: Revised Compliance Filing for Volume No. 2
Baseline and Rate Schedule X-275 to be effective 7/20/2011.
    Filed Date: 08/03/2011.
    Accession Number: 20110803-5080.
    Comment Date: 5 p.m. Eastern Time on Monday, August 15, 2011.

    Docket Numbers: RP11-2323-001.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc. submits tariff filing per
154.205(b): DTI--July 29, 2011 Negotiated Rate Amendment to be
effective 8/1/2011.
    Filed Date: 08/05/2011.
    Accession Number: 20110805-5064.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 17, 2011.

    Docket Numbers: RP11-2308-001.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.205(b): Winter Operations Supplemental Filing to be effective
9/1/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5092.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 9, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20891 Filed 8-16-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33494-33495]
[FR Doc No: 2017-15246]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1494-441]

Grand River Dam Authority: Notice of Application for Temporary
Variance and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Temporary variance from the Article 401
reservoir elevation rule curve in order to keep reservoir levels in the
Grand Lake O' the Cherokees (Grand Lake) higher than normal for the
period of August 16, 2017 through October 31, 2017.
    b. Project No.: 1494-441.
    c. Date Filed: July 11, 2017.
    d. Applicant: Grand River Dam Authority (GRDA).
    e. Name of Project: Pensacola Hydroelectric Project.
    f. Location: The project is located on the Grand River in Craig,
Delaware, Mayes, and Ottawa Counties, Oklahoma.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Daniel S. Sullivan, Chief Executive Officer,
Grand River Dam Authority, P.O. Box. 409, Vinita, OK 74301; telephone:
(918) 256-5545.
    i. FERC Contact: B. Peter Yarrington, telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>or Jeremy Jessup, telephone (202) 502-
6779, email<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 15 days from the issuance date of this notice by the Commission.
    All documents 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/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll

free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail a copy to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. Please include the project number (P-1494-441) on
any comments or motions filed.
    k. Description of Request: GRDA requests a temporary variance to
deviate from the Article 401 reservoir elevation rule curve during the
period of August 16, 2017 through October 31, 2017. GRDA says the
requested variance would protect safety and property by reducing the
risk of vessel groundings in late summer, improve recreation during a
peak recreation season, and provide additional water storage to assist
in making releases for maintenance of dissolved oxygen concentrations
downstream.
    This temporary variance request is separate from the application
GRDA filed May 6, 2016, which proposes a permanent amendment of the
project's Article 401 rule curve requirements. The May 6, 2016
permanent amendment application is currently under Commission review.
    Under GRDA's proposed temporary variance, between August 16 and
September 15, 2017, GRDA would maintain the reservoir at elevation 743
feet Pensacola Datum (PD), which is up to two feet higher than the
current rule curve. Between September 16 and September 30, the
elevation would be lowered from 743 to 742 feet PD, which up to two
feet higher than the current rule curve. Between October 1 and October
31, the reservoir would then be maintained at elevation 742 feet PD,
which is up to one foot higher than the current rule curve. After
October 31, reservoir elevations would follow the current rule curve.
    As part of its application, GRDA includes a Storm Adaptive
Management Plan that would be followed to address high water conditions
upstream and downstream of Grand Lake during major precipitation events
in the river basin. GRDA also includes a Drought Adaptive Management
Plan that would be followed to determine project operation, including
deviations from the rule curve elevations, to allow releases for
maintenance of downstream water quality and reliable operation of
GRDA's downstream Salina Pumped Storage Project if certain drought
conditions occur.
    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/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    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,
.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. Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the title COMMENTS, PROTEST, or MOTION TO
INTERVENE as applicable; (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 protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to project works which
are the subject of the amendment application. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application. 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. A copy of all other filings in reference to
this application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: July 13, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-15246 Filed 7-19-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18452-18453]
[FR Doc No: 2014-07238]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51

[EPA-HQ-OAR-2010-0114; FRL-9908-99-OAR]
RIN 2060-AQ01

Revisions To Test Methods and Testing Regulations; Technical
Amendment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; technical amendment.

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SUMMARY: The Environmental Protection Agency (EPA) published a final
rule in the Federal Register on February 27, 2014, that made technical
and editorial corrections for source testing of emissions and
operations. The revisions will improve data quality and provide
additional flexibility by allowing the use of newly approved
alternative procedures. The purpose of this action is to correct an
omission to Method 202.

DATES: This technical amendment is effective on April 2, 2014.

FOR FURTHER INFORMATION CONTACT: Ms. Lula H. Melton, U.S. Environmental
Protection Agency, Office of Air Quality Planning and Standards, Air
Quality Assessment Division, Measurement Technology Group (E143-02),
Research Triangle Park, North Carolina 27711; telephone number: (919)
541-2910; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Summary of Amendment

    This action corrects a publication error for Method 202. Two
paragraphs, namely <IP_ADDRESS> and <IP_ADDRESS>, were inadvertently omitted
from Method 202 in the promulgated rule. This action inserts paragraphs
<IP_ADDRESS> and <IP_ADDRESS> and adds a transition statement in paragraph
11.2.1 that indicates if the sample was collected by Method 202,
extract the CPM filter as indicated in paragraphs <IP_ADDRESS> and
<IP_ADDRESS>.
    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(3)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for making this technical amendment final without
prior proposal and opportunity for public comment because only simple
publication errors are being corrected that do not substantially change
the agency actions taken in the final rule. Thus, notice and public
procedure are unnecessary. We find that this constitutes good cause
under 5 U.S.C. 553(b)(3)(B). (See also the final sentence of section
307(d)(1) of the Clean Air Act (CAA), 42 U.S.C. 307(d)(1), indicating
that the good cause provisions in subsection 553(b) of the APA continue
to apply to this type of rulemaking under section 307(d) of the CAA.)

II. Statutory and Executive Order Reviews

    Under Executive Order 12866, Regulatory Planning and Review, and
Executive Order 13563, Improving Regulation and Regulatory Review (58
FR 51735, October 4, 1993), this action is not a ``significant
regulatory action'' and is, therefore, not subject to review by the
Office of Management and Budget. This action is not a ``major rule'' as
defined by 5 U.S.C. 804(2). The technical amendment does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    Because the EPA has made a ``good cause'' finding that this action
is not subject to notice and comment requirements under the APA or any
other statute (see Section I), it is not subject to the regulatory
flexibility provisions of the Regulatory Flexibility Act [5 U.S.C. 601
et seq.], or to sections 202 and 205 of the Unfunded Mandates Reform
Act of 1995 (UMRA) [Pub. L. 104-4]. In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in sections 203 and
204 of the UMRA.
    This action also does not significantly or uniquely affect the
communities of tribal governments, as specified by Executive Order
13175, Consultation and Coordination With Indian Tribal Governments (65
FR 67249, November 9, 2000). This amendment also is not subject to
Executive Order 13045, Protection of Children From Environmental Health
and Safety Risks (62 FR 19885, April 23, 1997) because it is not
economically significant.
    This technical amendment does not involve changes to the technical
standards related to test methods or monitoring requirements; thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272) do not apply.
    This technical amendment does not involve special consideration of

environmental justice-related issues as required by Executive Order
12898, Federal Actions To Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    The Congressional Review Act (CRA), 5 U.S.C. 801 et seq., as added
by the Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA), generally provides that before a rule may take effect, the
agency determination 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. Section 808 allows the
issuing agency to make a rule effective sooner than otherwise provided
by the CRA if the agency makes a good cause finding that notice and
public procedure is impracticable, unnecessary, or contrary to the
public interest. This determination must be supported by a brief
statement, 5 U.S.C. 808(2). As stated previously, the EPA has made such
a good cause finding, including the reasons, and therefore established
an effective date of April 2, 2014. The EPA will submit a report
containing this final 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 this action in the Federal
Register. This action is not a ``major'' rule as defined by 5 U.S.C.
804(2). This action will be effective April 2, 2014.
    This technical amendment does not have substantial direct effects
on the states, or on the relationship between the national government
and the states, or on the distribution of power and responsibilities
among the various levels of government, as specified in Executive Order
13132, Federalism (64 FR 43255, August 10, 1999).
    This technical amendment is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because this action is
not a significant regulatory action under Executive Order 12866.

List of Subjects in 40 CFR Parts 51

    Air pollution control, Environmental protection, Performance
specifications, and Test methods and procedures.

    Dated: March 24, 2014.
Janet G. McCabe,
Acting Assistant Administrator.

    For the reasons stated in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS

0
1. The authority citation for part 51 continues to read as follows:

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

0
2. Amend appendix M to part 51 under 11.0 Analytical Procedures by
revising paragraph 11.2.1 and adding paragraphs <IP_ADDRESS> and <IP_ADDRESS>
to read as follows:

Appendix M to Part 51--Recommended Test Methods for State
Implementation Plans

* * * * *
    11.2.1 Container 3, CPM Filter Sample. If the sample
was collected by Method 17 or Method 201A with a stack temperature
below 30 [deg]C (85[emsp14][deg]F), transfer the filter and any
loose PM from the sample container to a tared glass weighing dish.
(See Section 3.0 for a definition of constant weight.) Desiccate the
sample for 24 hours in a desiccator containing anhydrous calcium
sulfate. Weigh to a constant weight and report the results to the
nearest 0.1 mg. [Note: In-stack filter samples collected at 30
[deg]C (85[emsp14][deg]F) may include both filterable insoluble
particulate and condensable particulate. The nozzle and front half
wash and filter collected at or below 30 [deg]C (85[emsp14][deg]F)
may not be heated and must be maintained at or below 30 [deg]C
(85[emsp14][deg]F).] If the sample was collected by Method 202,
extract the CPM filter as follows:
    <IP_ADDRESS> Extract the water soluble (aqueous or inorganic) CPM
from the CPM filter by folding the filter in quarters and placing it
into a 50-ml extraction tube. Add sufficient deionized, ultra-
filtered water to cover the filter (e.g., 10 ml of water). Place the
extractor tube into a sonication bath and extract the water-soluble
material for a minimum of two minutes. Combine the aqueous extract
with the contents of Container 1. Repeat this extraction
step twice for a total of three extractions.
    <IP_ADDRESS> Extract the organic soluble CPM from the CPM filter by
adding sufficient hexane to cover the filter (e.g., 10 ml of
hexane). Place the extractor tube into a sonication bath and extract
the organic soluble material for a minimum of two minutes. Combine
the organic extract with the contents of Container 2.
Repeat this extraction step twice for a total of three extractions.
* * * * *
[FR Doc. 2014-07238 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Notices]
[Pages 42762-42765]
[FR Doc No: 2010-17921]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2010-0040]

Agency Information Collection Activities: Proposed Collection;
Comment Request, OMB No. 1660-0015; Revisions to National Flood
Insurance Program Maps: Application Forms and Instructions for (C)LOMAs
and (C)LOMR-Fs

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; revision of a
currently approved information collection; OMB No. 1660-0015; FEMA Form
086-0-26 Property Information; FEMA Form 08-0-26A Elevation; FEMA Form
086-0-26B Community Acknowledgement; FEMA Form 086-0-22, Application
Form for Single Residential Lot or Structure Amendments to National
Flood Insurance Program Maps; FEMA Form 086-0-22A, Application Form for
Single Residential Lot or Structure Amendments to National Flood
Insurance Program Maps (Spanish).

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SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this Notice seeks comments concerning information required by FEMA to
amend or revise National Flood Insurance Program Maps to remove certain
property from the 1-percent annual chance floodplain.

DATES: Comments must be submitted on or before September 20, 2010.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2010-0040. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Office of Chief Counsel,
Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.

    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2010-0040 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available on the Privacy and Use Notice link on the
Administration Navigation Bar of www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Ms. Ava Hammond, Program
Analyst, Mitigation Directorate, Risk Analysis Division, FEMA at (202)
646-3276 for additional information. You may contact the Office of
Records Management for copies of the proposed collection of information
at facsimile number<PHONE_NUMBER> or e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: With the passage of the Flood Disaster
Protection Act of 1973 (42 U.S.C. 4001 et seq.), an owner of a
structure, with a federally backed mortgage, located in the 1-percent
annual chance floodplain, is required to purchase Federal flood
insurance. This was in response to the escalating damage caused by
flooding and the unavailability of flood insurance from commercial
insurance companies. As part of this effort, the Federal Emergency
Management Agency (FEMA) mapped the 1-percent annual chance floodplain
in communities. However, due to scale limitations, individual
structures that may be above the base flood cannot always be shown as
being out of the 1-percent annual chance floodplain. Title 44 CFR 65.17
and 44 CFR 70.3 outline the data that must be submitted for a review of
the determination that the structure is not above the base flood level
if the owner of the structure wishes to request such. If the
information supplied warrants a reversal of the determination, FEMA
will issue a Letter of Map Amendment (LOMA) to waive the Federal
requirement for flood insurance when data is submitted to show that the
property or structure is at or above the elevation of the base flood.

 Collection of Information

    Title: Revisions to National Flood Insurance Program Maps:
Application Forms and Instructions for (C)LOMAs and (C)LOMR-Fs.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0015.
    Form Titles and Numbers: FEMA Form 086-0-26 Property Information;
FEMA Form 08-0-26A Elevation; FEMA Form 086-0-26B Community
Acknowledgement; FEMA Form 086-0-22 Application Form for Single
Residential Lot or Structure Amendments to National Flood Insurance
Program Maps; FEMA Form 086-0-22A Application Form for Single
Residential Lot or Structure Amendments to National Flood Insurance
Program Maps (Spanish).
    Abstract: This collection of information allows owners of
structures that have been found to be in a designated Special Flood
Hazard Area (SFHA) the opportunity to request a review of this
determination. With the submission of the appropriate documentation,
FEMA will conduct a review of the structure in question and either
certify the original finding or modify the designation so that it no
longer indicates a SFHA identifier. If the structure is found to not be
in a SFHA, FEMA will issue a written determination and the appropriate
map is modified by a Letter of Map Amendment (LOMA) or a Letter of Map
Revision--Based on Fill (LOMR-F). The structure then qualifies for a
waiver of flood insurance.
    Affected Public: Individuals or households; business or other for
profit.
    Estimated Total Annual Burden Hours: 129,320 hours.

                                                       Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                Avg. burden     Total                     Total
                                                                Number of    responses      Total         per         annual    Avg. hourly     annual
         Type of respondent            Form name/form number   respondents      per       number of     response    burden (in   wage rate    respondent
                                                                             respondent   responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Homeowners..........................  Property Information          26,870            1       26,870         1.63       43,798       $29.26   $1,281,529
                                       Form/FEMA Form 086-0-
                                       26.
Surveyors...........................  Elevation Form/FEMA           18,809            1       18,809         1.25       23,511        35.66      838,402
                                       Form 086-0-26A.
Engineers...........................  Elevation Form/FEMA            8,061            1        8,061         1.25       10,076        50.22      506,017
                                       Form 086-0-26A.
Community Officials.................  Community                      4,076            1        4,076         1.38        5,625        55.97      314,831
                                       Acknowledgment Form/
                                       FEMA Form 086-0-26B.
Homeowners..........................  On-line LOMA/LOMR-F            2,499            1        2,499          0.5        1,250        29.26       36,575
                                       Tutorial.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................  .......................       60,315  ...........       60,315  ...........       84,260  ...........    2,977,354
--------------------------------------------------------------------------------------------------------------------------------------------------------

Homeowner...........................  Application Form for          16,428            1       16,428          1.2       19,714        29.26      576,832
                                       Single Residential Lot
                                       or Structure
                                       Amendments to National
                                       Flood Insurance
                                       Program Maps/FEMA Form
                                       086-0-22.
Homeowner...........................  Application Form for           2,347            1        2,347          1.2        2,816        29.26       82,396
                                       Single Residential Lot
                                       or Structure
                                       Amendments to National
                                       Flood Insurance
                                       Program Maps (Spanish)/
                                       FEMA Form 086-0-22A.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................  .......................       18,775  ...........       18,775  ...........       22,530  ...........      659,228
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveyor............................  Application Form for          11,500            1       11,500          1.2       13,800        35.66      492,108
                                       Single Residential Lot
                                       or Structure
                                       Amendments to National
                                       Flood Insurance
                                       Program Maps/FEMA Form
                                       086-0-22.
Surveyor............................  Application Form for           1,643            1        1,643          1.2        1,972        35.66       70,322
                                       Single Residential Lot
                                       or Structure
                                       Amendments to National
                                       Flood Insurance
                                       Program Maps (Spanish)/
                                       FEMA Form 086-0-22A.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................  .......................       13,143  ...........       13,143  ...........       15,772  ...........      562,430
--------------------------------------------------------------------------------------------------------------------------------------------------------
Engineer............................  Application Form for           4,928            1        4,928          1.2        5,913        50.22      296,951
                                       Single Residential Lot
                                       or Structure
                                       Amendments to National
                                       Flood Insurance
                                       Program Maps/FEMA Form
                                       086-0-22.

Engineer............................  Application Form for             704            1          704          1.2          845        50.22       42,436
                                       Single Residential Lot
                                       or Structure
                                       Amendments to National
                                       Flood Insurance
                                       Program Maps (Spanish)/
                                       FEMA Form 086-0-22A.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................  .......................        5,632  ...........        5,632  ...........        6,758  ...........      339,437
                                                              ------------------------------------------------------------------------------------------
        Total.......................  .......................       97,865  ...........       97,865  ...........      129,320  ...........    4,370,376
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: The estimated annual operations and maintenance
costs for technical services is $20,540,250. There are no annual start-
up or capital costs.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: July 16, 2010.
Tammi Hines,
Acting Director, Records Management Division, Mission Support Bureau,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2010-17921 Filed 7-21-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Page 70181]
[FR Doc No: 2019-27492]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[EL18-201-001]

Notice of Filing

    Louisiana Public Service Commission v. Entergy Services,
Inc.,Entergy Arkansas, Inc. Entergy Louisiana, LLC, Entergy
Mississippi, LLC, Entergy New Orleans, LLC, Entergy Texas, Inc.

    Take notice that on December 13, 2019, Entergy Arkansas, LLC,
Entergy Louisiana, LLC, Entergy Mississippi, LLC, Entergy New Orleans,
LLC, and Entergy Texas, Inc., submitted updated accounting entries and
rate calculations in compliance with the Commission's Order on
Complaint in Louisiana Public Service Commission v. Entergy Services,
Inc., et al.\1\
---------------------------------------------------------------------------

    \1\ Louisiana Public Service Commission v. Entergy Services,
Inc., et al., 168 FERC ] 61,210 (2019) (Order on Complaint).
---------------------------------------------------------------------------

    Any person desiring 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, 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 comment date. On or
before the comment date, it is not necessary to 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 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible online 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 website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on January 3, 2019.

    Dated: December 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-27492 Filed 12-19-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Proposed Rules]
[Pages 6491-6494]
[FR Doc No: 2020-02140]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2019-0518; FRL-10004-91-Region 5]

2008 Ozone National Ambient Air Quality Standards; Wisconsin;
Determination of Attainment by the Attainment Date for Inland
Sheboygan; Reclassification of Shoreline Sheboygan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing two
actions related to the attainment date for two areas classified as
``Moderate'' for the 2008 ozone National Ambient Air Quality Standards
(NAAQS). First, EPA is proposing to determine that the Inland
Sheboygan, Wisconsin (WI) nonattainment area attained the standard by
the July 20, 2019, extended attainment date. Second, EPA is proposing
to determine that the Shoreline Sheboygan, WI nonattainment area failed
to attain the standard by the extended attainment date. The effect of
failing to attain by the attainment date is that the area will be
reclassified by operation of law to ``Serious'' upon the effective date
of the final reclassification action. Consequently, the Wisconsin
Department of Natural Resources (WDNR) must submit State Implementation
Plan (SIP) revisions required to satisfy the statutory and regulatory
requirements for Serious areas for the 2008 ozone NAAQS. EPA is
proposing deadlines for submittal of those SIP revisions and
implementation of the related control requirements.

DATES: Comments must be received on or before March 6, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2019-0518 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Eric Svingen, Environmental Engineer,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This SUPPLEMENTARY INFORMATION
section is arranged as follows:

I. Background
II. Determination of Attainment by the Attainment Date for the
Inland Sheboygan Area
III. Reclassification of the Shoreline Sheboygan Area
IV. Summary of Proposed Actions
V. Statutory and Executive Order Reviews

I. Background

    Under section 181(b)(2) of the Clean Air Act (CAA), EPA is required
to determine whether areas designated nonattainment for an ozone NAAQS
attained the standard by the applicable attainment date, and to take
certain steps for areas that failed to attain.
    On May 21, 2012, EPA designated the entirety of Sheboygan County in
Wisconsin as nonattainment for the 2008 ozone NAAQS (77 FR 30088). At
the time of its designation, the Sheboygan County, WI nonattainment
area for the 2008 ozone NAAQS was classified as Marginal with an
attainment date of July 20, 2015. On May 4, 2016, EPA determined that
the Sheboygan nonattainment area qualified for a one-year attainment
date extension to July 20, 2016 (81 FR 26697). On December 19, 2016,
EPA determined that the area had failed to attain the standard by its
extended attainment date, and EPA reclassified the Sheboygan
nonattainment area as Moderate with an attainment date of July 20, 2018
(81 FR 91841).
    On July 15, 2019, EPA revised the designation for the Sheboygan
nonattainment area for the 2008 ozone NAAQS, by splitting the original
area into two distinct nonattainment areas that together cover the
identical geographic area of the original nonattainment area (84 FR
33699). One of the separate areas, called the Shoreline Sheboygan
County, WI nonattainment area, consists of the eastern portion of the
original area, including the Sheboygan Kohler Andrae monitor. The other
separate area, called the Inland Sheboygan County, WI nonattainment
area, consists of the western portion of the original area, including
the Sheboygan Haven monitor. On August 23, 2019, EPA determined that
the Inland Sheboygan area and Shoreline Sheboygan area qualified for
one-year attainment date extensions to July 20, 2019 (84 FR 44238).
    For a concentration-based standard, such as the 2008 ozone NAAQS, a
determination of attainment \1\ is based on a nonattainment area's
design value. The design value for the 2008 ozone NAAQS is the 3-year
average of the annual fourth highest daily maximum 8-hour average ozone
concentration. The 2008 ozone NAAQS is met at an ambient monitoring
site when the design value does not exceed 0.075 parts per million
(ppm). The attainment date design value is based on the three most
recent, complete calendar years of data preceding the attainment date.
In this case, EPA's proposed determinations for each area are based on
the complete, quality-assured and certified ozone monitoring data from
calendar years 2016, 2017, and 2018. As such, EPA's proposed
determinations for each Sheboygan area are based upon the complete,
quality-assured and certified ozone monitoring data from calendar years
2016, 2017, and 2018.
---------------------------------------------------------------------------

    \1\ The criteria for determining if an area is attaining the
2008 ozone NAAQS are set out in 40 CFR 50.15 and 40 CFR part 50,
appendix P.
---------------------------------------------------------------------------

    All monitors in an area must be considered when determining if the
area attains the NAAQS. To make the determination that an area attains
the NAAQS, each monitor must have a valid \2\ design value meeting the
standard. If one or more monitors in an area have a design value that
exceeds the standard, the area does not attain the NAAQS. For the
Inland Sheboygan area, EPA must consider the design value from the
Sheboygan Haven monitor with site ID 55-117-0009, and for the Shoreline
Sheboygan area, EPA must consider the design value from the Sheboygan
Kohler Andrae monitor with

site ID 55-117-0006. Data from these monitors are presented in Table 1.
---------------------------------------------------------------------------

    \2\ Design values attaining the 2008 ozone NAAQS must also meet
minimum data completeness requirements specified in 40 CFR part 50,
appendix P to be considered valid.

 Table 1--Annual and Three-Year Average of the 4th High Daily Maximum 8-Hour Ozone Concentrations for the Inland
                                   Sheboygan Area and Shoreline Sheboygan Area
----------------------------------------------------------------------------------------------------------------
                                                   2016 4th high   2017 4th high   2018 4th high     2016-2018
             Area                    Monitor           (ppm)           (ppm)           (ppm)      average  (ppm)
----------------------------------------------------------------------------------------------------------------
Inland Sheboygan County, WI...  Sheboygan Haven            0.074           0.070           0.070           0.071
                                 (55-117-0009).
Shoreline Sheboygan County, WI  Sheboygan Kohler           0.085           0.075           0.083           0.081
                                 Andrae (55-117-
                                 0006).
----------------------------------------------------------------------------------------------------------------

    Additional background and rationale for EPA's actions making
determinations of attainment, reclassifications, and establishing SIP
submission and implementation deadlines for reclassified areas for many
of the other 2008 Moderate ozone nonattainment areas is provided in our
August 23, 2019 final rulemaking (84 FR 44238), as well as in our
November 14, 2018 proposal of that rulemaking (83 FR 56781).

II. Determination of Attainment by the Attainment Date for the Inland
Sheboygan Area

    The Inland Sheboygan area had a design value that did not exceed
0.075 ppm based on the 2016-2018 data. Thus, EPA proposes to determine,
in accordance with CAA section 181(b)(2)(A), that the area attained the
standard by the applicable attainment date of July 20, 2019.\3\
---------------------------------------------------------------------------

    \3\ On July 15, 2019, EPA made a Clean Data Determination for
the Inland Sheboygan area and, in accordance with 40 CFR 51.1118,
suspended the requirements for the state to submit an attainment
demonstration and associated RACM, RFP plans, contingency measures,
and other planning elements related to attainment of the 2008 ozone
NAAQS (84 FR 33699). Today's proposed action does not alter the
status of the final Clean Data Determination for the Inland
Sheboygan area.
---------------------------------------------------------------------------

    This proposed determination of attainment by the attainment date
does not constitute a formal redesignation to attainment as provided
for under CAA section 107(d)(3). Redesignations to attainment require
states to meet the statutory criteria set out at CAA section
107(d)(3)(E), which include requirements that the state has met the
applicable requirements under CAA section 110 and part D, and EPA has
approved a maintenance plan to ensure continued attainment of the
standard for 10 years following redesignation, as provided under CAA
section 175A.

III. Reclassification of the Shoreline Sheboygan Area

    EPA is proposing to determine that the Shoreline Sheboygan area
failed to attain the 2008 ozone NAAQS by the extended attainment date
of July 20, 2019. This area is not eligible for a second 1-year
attainment date extension because the area does not meet the extension
criteria under CAA section 181(a)(5) as interpreted by EPA in 40 CFR
51.1107. Under these criteria, for an area to qualify for a second 1-
year extension, the area's 4th highest daily maximum 8-hour value,
averaged over both the original attainment year and the first extension
year must be 0.075 ppm or less.
    Section 181(b)(2)(B) of the CAA requires EPA to publish a
determination of failure to attain and accompanying reclassification in
the Federal Register no later than 6 months after the attainment date,
which in the case of the Shoreline Sheboygan area would be no later
than January 20, 2020.
    As required under CAA section 181(b)(2)(A), if EPA finalizes the
determination that the area failed to attain by the attainment date, it
will be reclassified to Serious by operation of law. The reclassified
area will then be subject to the Serious area requirement to attain the
2008 ozone NAAQS as expeditiously as practicable, but not later than
July 20, 2021.
    Once reclassified as Serious, the state must submit to EPA the SIP
revisions for the area that satisfy the statutory and regulatory
requirements applicable to Serious areas established in CAA section
182(c) and in the SIP Requirements Rule. However, the statutory
timeframes for SIP submissions applicable to areas originally
classified as Serious have passed. For instance, 40 CFR 51.1108
established the deadline for Serious-area attainment demonstrations to
be 48 months after the effective date of nonattainment designation, or
July 20, 2016. Under CAA section 182(i), reclassified areas are
required to meet the requirements associated with their newly
reclassified status according to the schedules prescribed in connection
with such requirements, except that the Administrator may adjust
applicable deadlines (other than attainment dates) to the extent such
adjustment is ``necessary or appropriate to assure consistency among
the required submissions.''
    In our August 23, 2019, rulemaking, EPA exercised its discretion
under CAA section 182(i) to adjust the deadlines for other areas in the
country that were reclassified to ``Serious'' for submitting SIP
revisions required by CAA section 182(c) (84 FR 44238). In accordance
with CAA section 182(i), in order to ``assure consistency among the
required submissions'', EPA proposes that the same SIP submission due
dates and implementation deadlines finalized for other areas
reclassified to Serious in our August 23, 2019, rulemaking will apply
to the Shoreline Sheboygan area upon its reclassification to Serious.
With regard to reasonably available control technology (RACT), EPA's
August 23, 2019, rulemaking made a distinction between RACT measures
that would be needed for purposes of meeting reasonable further
progress (RFP) requirements or for attaining the NAAQS expeditiously,
and the possible set of RACT measures that nevertheless are required to
be adopted and implemented under the CAA but would not necessarily be
needed for a state to meet RFP or demonstrate timely attainment in a
particular nonattainment area. These two ``categories'' of RACT
measures are referred to as ``RACT measures tied to attainment'' and
``RACT measures not tied to attainment,'' respectively.

A. Due Date for Serious Area SIP Revisions (Including RACT Measures
Tied to Attainment), and Implementation Deadline for RACT Measures Tied
to Attainment

    EPA is proposing August 3, 2020, as the due date for Serious area
SIP revisions, including RACT measures tied to attainment. EPA is also
proposing August 3, 2020, as the implementation deadline for RACT
measures tied to attainment for the Shoreline Sheboygan area. These
deadlines are the same as for the other

areas reclassified to Serious in EPA's August 23, 2019, rulemaking.
    The state submittal requirements for attainment plans, in general,
are provided under CAA section 172(c); the SIP requirements that apply
to Serious areas for the 2008 ozone NAAQS are listed under CAA section
182(c) and include: (1) Enhanced monitoring; (2) attainment
demonstration and RFP plan; (3) an enhanced vehicle inspection and
maintenance program, if applicable; (4) clean-fuel vehicle programs and
transportation control; (5) nonattainment New Source Review program
revisions; and (6) contingency measures. States must also provide an
analysis of--and adopt all--reasonably available control measures
(RACM), including RACT needed for purposes of meeting RFP or timely
attaining the NAAQS. Such an analysis should include: (1) An evaluation
of controls for sources emitting 100 tons per year (tpy) or more that
may have become reasonably available since the January 1, 2017,
Moderate area deadline for adopting and implementing RACT, and (2) an
evaluation of controls that are currently reasonably available for
sources emitting 50 tpy or more, consistent with the Serious area
classification.

B. Due Date for Submitting SIP Revisions for RACT Measures Not Tied to
Attainment

    For Serious areas reclassified from Moderate, the requirement for
RACT expands to include all sources that emit, or have the potential to
emit, 50 tpy of volatile organic compounds (VOC) or nitrogen oxides
(NOX). State air agencies responsible for Moderate areas are
already required to implement RACT for major sources, defined as
sources that emit or have the potential to emit 100 tpy. Thus, states
must revise their RACT SIPs to include those other sources emitting or
having the potential to emit 50 to 100 tpy. EPA proposes that the State
submit its SIP revisions for any RACT not otherwise needed for
attainment purposes for the Shoreline Sheboygan area by March 23, 2021.
This deadline is the same as for the other areas reclassified to
Serious in EPA's August 23, 2019, rulemaking.

C. Implementation Deadline for RACT Measures Not Tied to Attainment

    EPA is proposing July 20, 2021, the Serious area attainment date,
as the deadline for implementation of RACT measures not tied to
attainment for the Shoreline Sheboygan area. This deadline is the same
as for the other areas reclassified to Serious in EPA's August 23,
2019, rulemaking.

IV. Summary of Proposed Actions

    EPA is proposing to determine that the Inland Sheboygan area
attained the 2008 ozone NAAQS by the July 20, 2019, extended attainment
date. EPA is also proposing to determine that the Shoreline Sheboygan
area failed to attain the standard by the extended attainment date. The
effect of failing to attain by the attainment date is that the area
will be reclassified by operation of law to ``Serious'' upon the
effective date of the final reclassification action. WDNR will then be
required to submit SIP revisions to satisfy the statutory and
regulatory requirements for Serious areas for the 2008 ozone NAAQS. EPA
is proposing deadlines for submittal of those SIP revisions and
implementation of the related control requirements.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This proposed action is not a ``significant regulatory action''
subject to review by the Office of Management and Budget.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

D. Regulatory Flexibility Act (RFA)

    This action is certified as not having a significant economic
impact on a substantial number of small entities under the Regulatory
Flexibilities Act (5 U.S.C. 601 et seq.)

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. It will not have a substantial direct effect on
one or more Indian tribes, since EPA's proposed determination of
attainment by the attainment date and reclassification do not impact
any areas of Indian country. Furthermore, these regulation revisions do
not affect the relationship or distribution of power and
responsibilities between the Federal government and Indian tribes. The
CAA and the Tribal Air Rule establish the relationship of the Federal
government and tribes in developing plans to attain the NAAQS, and
these revisions to the regulations do nothing to modify that
relationship. Thus, Executive Order 13175 does not apply to this
action.

H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order. This action is not subject to Executive Order
13045 because it does not concern an environmental health risk or
safety risk.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA believes that this action does not have disproportionately high
and adverse human health or environmental effects on minority
populations, low income populations and/or indigenous populations as
specified in Executive

Order 12898 (59 FR 7629, February 16, 1994).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: January 17, 2020.
Cheryl Newton,
Deputy Regional Administrator, Region 5.
[FR Doc. 2020-02140 Filed 2-4-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Rules and Regulations]
[Pages 16410-16411]
[FR Doc No: 2013-06026]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0126]

Drawbridge Operation Regulation, Delaware Bay, Delaware River, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Tacony-Palmyra Bridge (Route 73),
across the Delaware River, mile 107.2 between the townships of Tacony,
PA and Palmyra, NJ. This deviation is necessary to facilitate the
replacement of the second part of the bascule span deck. This deviation
will not reduce the vertical clearance of the bridge.

DATES: This deviation is effective from 9 p.m. on April 26, 2013, until
9 a.m. on May 11, 2013.

ADDRESSES: The docket for this deviation [USCG-2013-0126] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on the Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation, West Building, 1200 New Jersey Avenue
SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
temporary deviation, call or email Kashanda Booker, Bridge Management
Specialist, Fifth Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on reviewing the
docket, call Barbara Hairston, Program Manager,

Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Burlington County Bridge Commission, who
owns and operates this bascule drawbridge, has requested a temporary
deviation from the current operating regulations set out in 33 CFR
117.5 and 117.716 to facilitate the replacement of the bascule span
deck.
    The Tacony-Palmyra Bridge (Route 73) at mile 107.2, across the
Delaware River, between Pennsylvania and New Jersey, has a vertical
clearance in the closed position to vessels of 53 feet above mean high
water (MHW). At no time during this work will there be a reduction in
the vertical clearance.
    Under this temporary deviation, the replacement repairs will
restrict the operation of the draw span every day from April 26, 2013,
until May 11, 2013. Vessel openings will be provided with at least 12
hours advance notice given to the bridge operator at<PHONE_NUMBER> or
via marine radio on Channel 13.
    Vessels than can pass under the bridge without a bridge opening may
do so at all times. There are no alternate routes for vessels
transiting this section of the Delaware River.
    The Coast Guard has coordinated this deviation with the Delaware
Pilots, and will inform the users of the waterways through our Local
and Broadcast Notices to Mariners of the closure period for the bridge
so that vessels can arrange their transits to minimize any impact
caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 7, 2013.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District .
[FR Doc. 2013-06026 Filed 3-14-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Proposed Rules]
[Pages 45578-45580]
[FR Doc No: 2018-19436]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1085; Product Identifier 2016-SW-094-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK
117 A-1, MBB-BK 117A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2,
MBB-BK 117 C-1, and MBB-BK 117 C-2 helicopters. This proposed AD would
require repetitive inspections of the tail rotor (T/R) gearbox housing.
This proposed AD is prompted by a report that a crack was found in a T/
R gearbox housing. The actions of this proposed AD are intended to
address an unsafe condition on these products.

DATES: We must receive comments on this proposed AD by November 9,
2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.

     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1085; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2016-0134, dated July 8, 2016,
to correct an unsafe condition on Airbus Helicopters Model MBB-BK 117
A-1, MBB-BK 117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2,
MBB-BK 117 C-1, MBB BK 117 C-2, and MBB-BK 117 C-2e helicopters. EASA
advises that a crack was found in the T/R gearbox housing of a Model
MBB-BK117 C-2 helicopter. According to EASA, investigations determined
high vibrations caused by T/R imbalance were a contributing factor to
the crack. EASA states that this condition, if not detected and
corrected, could lead to the loss of the T/R gearbox and subsequent
loss of control of the helicopter. As a result, the EASA AD requires
repetitive inspections of the T/R gearbox housing and replacing the
housing if a crack is found.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin (ASB) MBB-
BK117-30A-119, Revision 0, dated May 24, 2016, for Model MBB-BK 117 A-
1, MBB-BK 117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2, and
MBB-BK 117 C-1 helicopters and ASB MBB-BK117 C-2-65A-007, Revision 0,
dated May 24, 2016, for MBB-BK 117 C-2 helicopters. This service
information specifies an initial and repetitive inspections of the T/R
gearbox housing for cracks.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require within 100 hours time-in-service
(TIS) and thereafter at intervals not to exceed 100 hours TIS, cleaning
and visually inspecting the T/R gearbox housing for a crack. If there
is a crack, this proposed AD would require replacing the T/R gearbox
before further flight.

Differences Between This Proposed AD and the EASA AD

    The EASA AD applies to Model MBB-BK117 C-2e helicopters, and this
proposed AD would not because it is not an FAA type-certificated model.
The EASA AD allows a non-cumulative tolerance of 10 hours TIS for the
inspections, and this proposed AD would not. The EASA AD requires
performing the inspection after a certain maintenance action and before
a T/R gearbox housing is installed, and this proposed AD would not.

Costs of Compliance

    We estimate that this proposed AD would affect 176 helicopters of
U.S. Registry and that labor costs average $85 a work-hour. Based on
these estimates, we expect that inspecting the T/R gearbox would
require 1 work-hour and no parts would be required for a cost of $85
per helicopter and $14,960 for the U.S. fleet per inspection cycle.
Replacing the T/R gearbox would require 4.5 work-hours and parts would
cost $69,219 for a cost of $69,602 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus Helicopters Deutschland GmbH: Docket No. FAA-2017-1085;
Product Identifier 2016-SW-094-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
MBB-BK 117 A-1, MBB-BK 117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-
BK 117 B-2, MBB-BK 117 C-1, and MBB-BK 117 C-2 helicopters,
certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a tail rotor
(T/R) gearbox housing. This condition could result in the loss of
the T/R gearbox and subsequent loss of helicopter control.

(c) Comments Due Date

    We must receive comments by November 9, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 100 hours time-in-service (TIS) and thereafter at
intervals not to exceed 100 hours TIS, clean and visually inspect
the T/R gearbox housing for a crack in the area depicted in Figure 1
of Airbus Helicopters Alert Service Bulletin (ASB) MBB-BK117-30A-
119, Revision 0, dated May 24, 2016, or ASB MBB-BK117 C-2-65A-007,
Revision 0, dated May 24, 2016, as applicable to your model
helicopter. If there is a crack, replace the T/R gearbox before
further flight.

(f) Special Flight Permits

    Special flight permits are prohibited.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2016-0134, dated July 8, 2016. You may view the
EASA AD on the internet at http://www.regulations.gov in the AD
Docket.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor
Gearbox.

    Issued in Fort Worth, Texas, on August 27, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-19436 Filed 9-7-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46836-46837]
[FR Doc No: 2014-18943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1076]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Dispute Resolution:
Scientific and Technical Issues Related to Pharmaceutical Current Good
Manufacturing Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information resulting from the guidance to manufacturers of veterinary
and human drugs, including human biological drug products, on how to
resolve disputes of scientific and technical issues relating to current
good manufacturing practice (CGMP).

DATES: Submit either electronic or written comments on the collection
of information by October 10, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Formal Dispute Resolution: Scientific and
Technical Issues Related to Pharmaceutical Current Good Manufacturing
Practice (OMB Control Number 0910-0563)--Extension

    The guidance is intended to provide information to manufacturers of
veterinary and human drugs, including human biological drug products,
on how to resolve disputes of scientific and technical issues relating
to CGMP. Disputes related to scientific and

technical issues may arise during FDA inspections of pharmaceutical
manufacturers to determine compliance with CGMP requirements, or during
FDA's assessment of corrective actions undertaken as a result of such
inspections. The guidance provides procedures that encourage open and
prompt discussion of disputes and lead to their resolution. The
guidance describes procedures for raising such disputes to the Office
of Regulatory Affairs (ORA) and center levels and for requesting review
by the dispute resolution (DR) Panel.
    When a scientific or technical issue arises during an FDA
inspection, the manufacturer should initially attempt to reach
agreement on the issue informally with the investigator. Certain
scientific or technical issues may be too complex or time consuming to
resolve during the inspection. If resolution of a scientific or
technical issue is not accomplished through informal mechanisms prior
to the issuance of Form FDA 483, the manufacturer can formally request
DR and can use the formal two-tiered DR process described in the
guidance.
    Tier one of the formal DR process involves scientific or technical
issues raised by a manufacturer to the ORA and center levels. If a
manufacturer disagrees with the tier-one decision, tier two of the
formal DR process would then be available for appealing that decision
to the DR panel. The written request for formal DR to the appropriate
ORA unit should be made within 30 days of the completion of an
inspection, and should include all supporting documentation and
arguments for review, as described in this document. The written
request for formal DR to the DR Panel should be made within 60 days of
receipt of the tier-one decision and should include all supporting
documentation and arguments, as described in the following paragraphs.
    All requests for formal DR should be in writing and include
adequate information to explain the nature of the dispute and to allow
FDA to act quickly and efficiently. Each request should be sent to the
appropriate address listed in the guidance and include the following:
     Cover sheet that clearly identifies the submission as
either a request for tier-one DR or a request for tier-two DR;
     name and address of manufacturer inspected (as listed on
FDA Form 483);
     date of inspection (as listed on Form FDA 483);
     date Form FDA 483 issued (from Form FDA 483);
     facility Establishment Identifier Number, if available
(from Form FDA 483);
     FDA employee names and titles that conducted inspection
(from Form FDA 483);
     office responsible for the inspection (e.g., district
office, as listed on Form FDA 483);
     application number if the inspection was a preapproval
inspection;
     comprehensive statement of each issue to be resolved:
    [cir] Identify the observation in dispute;
    [cir] clearly present the manufacturer's scientific position or
rationale concerning the issue under dispute with any supporting data;
    [cir] state the steps that have been taken to resolve the dispute,
including any informal DR that may have occurred before the issuance of
Form FDA 483;
    [cir] identify possible solutions; and
    [cir] state expected outcome.
     Name, title, telephone and FAX number, and email address
(as available) of manufacturer contact.
    The guidance was initiated in response to industry's request for a
formal DR process to resolve differences related to scientific and
technical issues that arise between investigators and pharmaceutical
manufacturers during FDA inspections of foreign and domestic
manufacturers. In addition to encouraging manufacturers to use
currently available DR processes, the guidance describes the formal
two-tiered DR process explained previously. The guidance also covers
the following topics:
     The suitability of certain issues for the formal DR
process, including examples of some issues with a discussion of their
appropriateness for the DR process.
     Instructions on how to submit requests for formal DR and a
list of the supporting information that should accompany these
requests.
     Public availability of decisions reached during the DR
process to promote consistent application and interpretation of drug
quality-related regulations.
    Description of Respondents: Pharmaceutical manufacturers of
veterinary and human drug products and human biological drug products.
    FDA estimates that approximately two manufacturers will submit
approximately two requests annually for a tier-one DR and that there
will be one appeal of these requests to the DR Panel (request for tier-
two DR). FDA estimates that it will take manufacturers approximately 30
hours to prepare and submit each request for a tier-one DR and
approximately 8 hours to prepare and submit each request for a tier-two
DR. Table 1 provides an estimate of the annual reporting burden for
requests for tier-one and tier-two DRs.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Requests for Tier-One DR........               2               1               2              30              60
Requests for Tier-Two DR........               1               1               1               8               8
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              68
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: August 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18943 Filed 8-8-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49244-49246]
[FR Doc No: 2015-20228]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2843]

Qualification of Biomarker--Total Kidney Volume in Studies for
Treatment of Autosomal Dominant Polycystic Kidney Disease; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Qualification of Biomarker--Total Kidney Volume in Studies for
Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This draft
guidance provides a qualified context of use (COU) for total kidney
volume (TKV), measured at baseline, to be used as a prognostic
enrichment biomarker to select patients with autosomal dominant
polycystic kidney disease (ADPKD) at high risk for a ``progressive
decline'' in renal function, defined as a confirmed 30 percent decline
in the patient's estimated glomerular filtration rate (eGFR), for
inclusion in interventional clinical trials. This draft guidance also
describes the experimental conditions and constraints for which this
biomarker is qualified through the Center for Drug Evaluation and
Research (CDER) Biomarker Qualification Program. This biomarker can be
used by drug developers for the qualified COU in submissions of
investigational new drug applications, new drug applications, and
biologics license applications without the relevant CDER review group
reconsidering and reconfirming the suitability of the biomarker.
    In the Federal Register of January 7, 2014, FDA announced the
availability of a final guidance for industry entitled ``Qualification
Process for Drug Development Tools'' that described the process that
would be used to qualify Drug Development Tools (DDTs) and to make new
DDT qualification recommendations available on FDA's Web site. The
qualification recommendations in this draft guidance were developed
using the process described in that guidance.

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 October 16, 2015.

ADDRESSES: 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.
    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: Marianne Noone, Center for Drug
Evaluation and Research (Office of Translational Sciences, Immediate
Office), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
21, Rm. 4528, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Qualification of Biomarker--Total Kidney Volume in Studies
for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This
draft guidance provides qualification recommendations for the use of
TKV, measured at baseline, as a prognostic enrichment biomarker to
select patients with ADPKD at high risk for a ``progressive decline''
in renal function, defined as a confirmed 30 percent decline in the
patient's eGFR, for inclusion in interventional clinical trials. This
biomarker may be used in combination with the patient's age and
baseline eGFR as an enrichment factor in these interventional clinical
trials. Specifically, this draft guidance provides the COU for which
this biomarker is qualified through the CDER Biomarker Qualification
Program. Qualification of this biomarker for this specific COU
represents the conclusion that analytically valid measurements of the
biomarker can be relied on to have a specific use and interpretable
meaning. This biomarker can be used by drug developers for the
qualified COU in submission of investigational new drug applications,
new drug applications, and biologics license applications without the
relevant CDER review group reconsidering and reconfirming the
suitability of the biomarker. ``Qualification'' means that the use of
this biomarker in the specific COU is not limited to a single, specific
drug development program. Making the qualification recommendations
widely known and available for use by drug developers will contribute
to drug innovation, thus supporting public health.
    In the Federal Register of January 7, 2014 (79 FR 831), FDA
announced the availability of a final guidance for industry entitled
``Qualification Process for Drug Development Tools'' that described the
process that would be used to qualify DDTs and to make new DDT
qualification recommendations available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. The current draft guidance is an attachment to that final
guidance.
    CDER has initiated this formal qualification process to work with
developers of these biomarker DDTs to guide them as they refine and
evaluate DDTs for use in the regulatory context. Once qualified,
biomarker DDTs will be publicly available for use in any drug
development program for the qualified COU. As described in the January
2014 guidance, biomarker DDTs should be developed and reviewed using
this process. For more information on FDA's DDTs Qualification
Programs, refer to the following Web page: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm.
    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 Agency's current thinking on the use of
TKV, measured at baseline, as a prognostic enrichment biomarker to
select patients with ADPKD at high risk for a progressive decline in
renal function, defined as a confirmed 30 percent decline in eGFR, for
inclusion in interventional clinical trials. This biomarker may be used
in combination with patient age and baseline eGFR, as an enrichment
factor in these interventional clinical trials. It does not establish
any rights for any person and 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. The Paperwork Reduction Act of 1995

    This guidance contains an information collection that is 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 information collection
has been approved under the OMB control numbers 0910-0001 and 0910-
0014. The information requested in this guidance is currently submitted
to FDA to support medical product effectiveness (see 21 CFR 312.30, 21
CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).

III. Comments

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

IV. Electronic Access

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

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20228 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P