[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Pages 20406-20407]
[FR Doc No: 2012-8039]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0288]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Statistical Evaluation of Stability
Data, VICH GL51; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (219) entitled
``Draft Guidance for Industry on Statistical Evaluation of Stability
Data, VICH GL51.''
    This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
VICH guidance document is intended to provide recommendations on how to
use stability data generated in accordance with the principles detailed
in the VICH guidance entitled ``Stability Testing of New Veterinary
Drug Substances and Medicinal Products, GL3(R)'' to propose a retest
period or shelf life in a registration application.

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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request. 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for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Mai Huynh, Center for Veterinary
Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(219) entitled, ``Draft Guidance for Industry on Statistical
Evaluation of Stability Data, VICH GL51.'' In recent years, many
important initiatives have been undertaken by regulatory authorities
and industry associations to promote the international harmonization of
regulatory requirements. FDA has participated in efforts to enhance
harmonization and has expressed its commitment to seek scientifically
based harmonized technical procedures for the development of
pharmaceutical products. One of the goals of harmonization is to
identify and then reduce differences in technical requirements for drug
development among regulatory agencies in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
VICH is concerned with developing harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and includes input from both regulatory
and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, the European Medicines Evaluation Agency,
the European Federation of Animal Health, the Committee on Veterinary
Medicinal Products, FDA, the U.S. Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary Pharmaceutical Association,
the Japanese Association of Veterinary Biologics, and the Japanese
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.

II. Draft Guidance on Statistical Evaluation of Stability Data

    The VICH Steering Committee held a meeting on November 14, 2011,
and agreed that the draft guidance document entitled ``Draft Guidance
for Industry on Statistical Evaluation of Stability Data, VICH GL51''
should be made available for public comment. This draft VICH guidance
document is intended to provide recommendations on how to use stability
data generated in accordance with the principles detailed in the VICH
guidance entitled, ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products, GL3(R)'' to propose a retest period
or shelf life in a registration application. This draft guidance
describes when and how extrapolation can be considered when proposing a
retest period for a drug substance or a shelf life for a veterinary
medicinal product that extends beyond the period covered by available
data from the stability study under the long-term storage condition.
    This draft guidance addresses the evaluation of stability data that
should be submitted in registration applications for new molecular
entities and associated veterinary medicinal products. The draft
guidance provides recommendations on establishing retest periods and
shelf lives for drug substances and veterinary medicinal products
intended for storage at or below ``room temperature.'' It covers
stability studies using single- or multi-factor designs and full or
reduced designs.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the Agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

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

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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.

VI. Electronic Access

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

    Dated: March 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-8039 Filed 4-3-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Page 38685]
[FR Doc No: 2015-16642]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9930-10-OA]

National Environmental Education Advisory Council

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Under the Federal Advisory Committee Act, EPA gives notice of
a teleconference meeting of the National Environmental Education
Advisory Council (NEEAC). The NEEAC was created by Congress to advise,
consult with, and make recommendations to the Administrator of the
Environmental Protection Agency (EPA) on matters related to activities,
functions and policies of EPA under the National Environmental
Education Act (the Act). 20 U.S.C. 5508(b).
    The purpose of this teleconference is to discuss specific topics of
relevance for consideration by the council in order to provide advice
and insights to the Agency on environmental education.

DATES: The National Environmental Education Advisory Council will hold
a public teleconference on Monday, July 13th, 2015, from 3:00 p.m.
until 4:00 p.m. Eastern Daylight Time.

FOR FURTHER INFORMATION CONTACT: Javier Araujo, Designated Federal
Officer<EMAIL_ADDRESS>202-564-2642, U.S. EPA, Office of
Environmental Education, William Jefferson Clinton North Room, 1426,
1200 Pennsylvania Avenue NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION: Members of the public wishing to gain access
to the teleconference, make brief oral comments, or provide a written
statement to the NEEAC must contact Javier Araujo, Designated Federal
Officer, at<EMAIL_ADDRESS>or<PHONE_NUMBER> by 10 business days
prior to each regularly scheduled meeting.
    Meeting Access: For information on access or services for
individuals with disabilities or to request accommodations, please
contact Javier Araujo at<EMAIL_ADDRESS>or<PHONE_NUMBER>,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

    Dated: June 26, 2015.
Sarah Sowell,
Deputy Director, Office of Environmental Education.
Javier Araujo,
(NEEAC) Designated Federal Officer.
[FR Doc. 2015-16642 Filed 7-6-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 210 (Wednesday, November 1, 2017)]
[Notices]
[Pages 50645-50646]
[FR Doc No: 2017-23723]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC17-14-000]

Commission Information Collection Activities (FERC-725U); Comment
Request

AGENCY: Federal Energy Regulatory Commission.

ACTION: Comment request.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is submitting its information collection (FERC-725U, Mandatory
Reliability Standards: Mandatory Reliability Standard CIP-014) to the
Office of Management and Budget (OMB) for review of the information
collection requirements. Any interested person may file comments
directly with OMB and should address a copy of those comments to the
Commission as explained below. The Commission previously issued a
Notice in the Federal Register (82 FR 41618, 9/1/2017) requesting
public comments. The Commission received no comments on the FERC-725U
and is making this notation in its submittal to OMB.

DATES: Comments on the collection of information are due by December 1,
2017.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0274, should be sent via email to the Office of Information and
Regulatory Affairs: [email protected]. Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC17-14-000, by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at [email protected], or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT:  Ellen Brown may be reached by email
at [email protected], by telephone at<PHONE_NUMBER>, and by fax
at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: Mandatory Reliability Standards: Reliability Standard CIP-
014.
    OMB Control No.: 1902-0274.
    Type of Request: Three-year extension of the FERC-725U information
collection requirements with no changes to the reporting requirements.
    Abstract: Reliability Standard CIP-014-2 \1\ requires applicable
transmission owners and transmission operators to identify and protect
transmission stations and transmission substations, and their
associated primary control centers that if rendered inoperable or
damaged as a result of a physical attack could result in instability,
uncontrolled separation, or cascading within an Interconnection.
---------------------------------------------------------------------------

    \1\ Reliability Standard CIP-014-2 was implemented by the letter
Order in Docket No. RD15-4-000 issued on 7/14/2015. Docket No. RD15-
4-000 was not submitted to OMB because it did not implicate the
Paperwork Reduction Act. The revised standard became effective on
10/2/2015 and is now being included in the FERC-725U information
collection.
---------------------------------------------------------------------------

    Transmission owners and transmission operators must keep data or
evidence to show compliance with the standard for three years unless
directed by its Compliance Enforcement Authority. If a responsible
entity is found non-compliant, it must keep information related to the
non-compliance until mitigation is complete and approved, or for the
three years, whichever is longer.
    Type of Respondents: Transmission owners (TO) and transmission
operators (TOP).
    Estimate of Annual Burden: \2\ The Commission estimates the annual
public reporting burden for the information collection as:
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    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

                  FERC-725U--Mandatory Reliability Standards: Reliability Standard CIP-014 \3\
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                               Number and type     Number of     Total  number   hours and cost    Total burden
                                of respondents   responses per   of  responses    per response   hours and total
                                                  respondent                          \4\              cost
                               (1)............             (2)     (1) * (2) =  (4)............  (3) * (4)
                                                                           (3)
----------------------------------------------------------------------------------------------------------------
Year 1:
    R1.......................  334 TO.........               1             334  20 hrs.; $1,280  6,680 hrs.;
                                                                                $427,520.
    R2.......................  334 TO.........               1             334  34 hrs; $2,448.  11,356 hrs.;
                                                                                $817,632.
    R3.......................  2 TOP..........               1               2  1 hrs.; $129...  2 hrs.; $258.
    R4.......................  30 TO and 2 TOP               1              32  80 hrs.; $5,120  2,560 hrs.;
                                                                                $163,840.
    R5.......................  30 TO and 2 TOP               1              32  320 hrs.;        10,240 hrs.;
                                                                                $20,480.         $655,360.
    R6.......................  30 TO and 2 TOP               1              32  304 hrs.;        9,728 hrs.;
                                                                                $19,456.         $622,592.
    Record Retention.........  334 TO and 2                  1             336  2 hrs.; $76....  672 hrs.;
                                TOP.                                                              $25,536.
Year 2:
    Record Retention.........  334 TO and 2                  1             336  2 hrs.; $76....  672 hrs.;
                                TOP.                                                              $25,536.
Year 3:
    R1.......................  30 TO..........               1              30  20 hrs.; $1,280  600 hrs.;
                                                                                $38,400.
    R2.......................  30 TO..........               1              30  34 hrs.; $2,436  1,020 hrs.;
                                                                                $73,080.
    R3.......................  2 TOP..........               1               2  1 hrs.; $129...  2 hrs.; $258.
    R4.......................  30 TO and 2 TOP               1              32  80 hrs.; $5,120  2,560 hrs.;
                                                                                $163,840.
    R5.......................  30 TO and 2 TOP               1              32  80 hrs.; $5,120  2,560 hrs.;
                                                                                $163,840.
    R6.......................  30 TO and 2 TOP               1              32  134 hrs.;        4,288 hrs.;
                                                                                $8,576.          $274,432.
    Record Retention.........  334 TO and 2                  1             336  2 hrs.; $76....  672 hrs.;
                                TOP.                                                              $25,536.
        Year 1 Total.........  ...............  ..............  ..............  ...............  41,238 hrs.;
                                                                                $2,712,738.
        Year 2 Total.........  ...............  ..............  ..............  ...............  672 hrs.;
                                                                                $25,536.
        Year 3 Total.........  ...............  ..............  ..............  ...............  11,702 hrs.;
                                                                                $739,386.
            Total (for Years   ...............  ..............  ..............  ...............  53,612 hrs.;
             1-3).                                                                                $3,477,660.
            Average Annual     ...............  ..............  ..............  ...............  17,871 hrs.;
             Burden and Cost                                                                      $1,159,220.
             (for Years 1-3).
----------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
---------------------------------------------------------------------------

    \3\ For each Reliability Standard, the Measure shows the
acceptable evidence for the associated Reporting Requirement (R
numbers), and the Compliance section details the related
Recordkeeping Requirement.
    \4\ The estimates for cost per response are derived using the
following formula: Average Burden Hours per Response * XX per Hour =
Average Cost per Response.
    The hourly cost figures are based on data for wages plus
benefits from the Bureau of Labor Statistics (as of 11/9/2016) at
https://www.bls.gov/oes/current/naics2_22.htm and http://www.bls.gov/news.release/ecec.nr0.htm. The figures are rounded for
the purposes of calculations in this table and are:
    1. For electrical engineers (occupation code: 17-2071), $64.29/
hr., rounded to $64/hr.
    2. For attorneys (occupation code: 23-0000), $129.12/hr.,
rounded to $129/hr.
    3. For administrative staff (occupation code: 43-0000), $37.75/
hr., rounded to $38/hr.
    The record retention cost is based on the administrative staff
category; R3 is based on the attorney category; Requirements R1, R4,
R5 and R6 are based on the electrical engineer category; and R2 is a
mix of the electrical engineer and related engineering review
process (30 hrs. at $64/hr.) and attorney (4 hrs. at $129/hr.)
categories. The resulting average hourly figure is $71.65, rounded
to $72/hr.

    Dated: October 25, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-23723 Filed 10-31-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12907-12908]
[FR Doc No: 2016-05490]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0715]

Acrylamide in Foods; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Acrylamide in
Foods.'' The guidance finalizes the ``Draft Guidance for Industry on
Acrylamide in Foods,'' modified where appropriate in response to
comments we received on the draft guidance dated November 2013. This
guidance is intended to provide information that may help growers,
manufacturers, and food service operators reduce acrylamide levels in
certain foods, which may mitigate potential human health risks from
exposure to acrylamide.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
[FDA-2013-D-0715] for the guidance document. Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to The
Division of Plant Products and Beverages, Office of Food Safety, Center
for Food Safety and Applied Nutrition, HFS-317, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Guidance for Industry: Acrylamide in Foods.'' We are issuing
this guidance consistent with our good guidance practices regulation
(21 CFR 10.115). The guidance represents our current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
    In the Federal Register of November 15, 2013, (78 FR 68852), we
made available a draft guidance for Industry entitled ``Draft Guidance
for Industry on Acrylamide in Foods'' and provided an opportunity for
comment prior to our work on the final version of the guidance. The
final guidance has been modified in response to comments. The guidance
announced in this notice finalizes the draft guidance dated November
2013.
    This guidance is intended to provide information that may help
growers, manufacturers, and food service operators reduce acrylamide
levels in certain foods. Acrylamide is a chemical that can form in some
foods during certain types of high-temperature cooking. Acrylamide is a
concern because it can cause cancer in laboratory animals at high
doses, and is reasonably anticipated to be a human carcinogen. Reducing
acrylamide levels in foods may mitigate potential human health risks
from exposure to

acrylamide. The guidance is intended to suggest a range of possible
approaches to reducing acrylamide levels and not to identify specific
recommended approaches.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05490 Filed 3-10-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Rules and Regulations]
[Pages 7116-7117]
[FR Doc No: 2011-2776]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

EPA-R10-OAR-2010-0921, FRL-9257-1]

Approval and Promulgation of Implementation Plans; Alaska:
Prevention of Significant Deterioration; Greenhouse Gas Permitting
Authority and Tailoring Rule Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is approving a revision to the State Implementation
Plan (SIP), submitted by the Commissioner of the Alaska Department of
Environmental Conservation (ADEC) to EPA on November 19, 2010. The SIP
revision updates Alaska's Prevention of Significant Deterioration (PSD)
program to reflect changes to the Federal PSD program relating to the
permitting of greenhouse gas (GHG) emissions.

DATES: This action is effective on March 11, 2011.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R10-OAR-2010-0921. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed
in the index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at EPA Region 10, Office of Air, Waste, and Toxics, AWT-
107, 1200 Sixth Avenue, Seattle, Washington 98101. EPA requests that
you contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Scott Hedges at telephone number:
(206) 553-0296, e-mail address<EMAIL_ADDRESS>or the above EPA,
Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.
    Information is organized as follows:

Table of Contents

I. Background
II. Public Comments on the Proposed Action
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    On December 6, 2010, EPA published in the Federal Register, a
proposal to approve a draft revision to the Alaska SIP, submitted by
the Commissioner of ADEC to EPA on October 25, 2010, for parallel
processing if the final SIP revision submitted by ADEC to EPA was
consistent with the draft SIP revision. See 75 FR 75658. The draft SIP
revision reflected changes to the Federal PSD program as of August 2,
2010 relating to the permitting of GHGs. In the proposal, EPA made the
preliminary determination that the draft SIP revision was approvable as
a SIP strengthening measure because it was consistent with the Clean
Air Act (CAA) and EPA regulations regarding PSD permitting for GHGs.
    ADEC submitted to EPA a final SIP revision relating to the
permitting of GHGs on November 19, 2010. The final SIP revision is
consistent with the draft SIP revision.
    ADEC has also made other changes to its PSD permitting rule and
other air regulations at the same time as this GHG-related revision.
EPA will be acting on these other changes in a subsequent and separate
rulemaking.

II. Public Comments on the Proposed Action

    EPA provided a 30-day review and comment period and solicited
comments on our proposal published in the December 6, 2010, Federal
Register (75 FR 75658). EPA received one comment, submitted by ADEC,
which supported the proposed action.

III. Final Action

    Pursuant to section 110 of the CAA, EPA is approving as a SIP
strengthening measure the State of Alaska's SIP revision that reflects
changes to the Federal PSD program as of August 2, 2010, relating to
the permitting of GHGs. The SIP revision provides Alaska with the
authority to regulate GHGs under its

PSD program and establishes appropriate emissions thresholds for
determining PSD applicability to new and modified GHG-emitting sources
in accordance with EPA's regulations regarding PSD permitting for GHGs.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by State
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and the EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 11, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, and Reporting and recordkeeping
requirements.

    Dated: January 18, 2011.
Dennis J. McLerran,
Regional Administrator, Region 10.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart C--Alaska

0
2. Section 52.70 is amended by adding paragraph (c)(38) to read as
follows:

Sec.  52.70  Identification of plan

* * * * *
    (c) * * *
    (38) On November 19, 2010, the Alaska Department of Environmental
Conservation (ADEC) submitted a revision to the State of Alaska
Implementation Plan that adds a definition of ``Subject to regulation''
as it applies to greenhouse gases in Alaska's Prevention of Significant
Deterioration (PSD) permit rule.
    (i) Incorporation by reference. (A) The following section of ADEC's
air quality regulations: The incorporation by reference date for 40 CFR
52.21 in 18 AAC 50.040(h), introductory paragraph, but only with
respect to its incorporation by reference of the definition of
``Subject to regulation'' in 40 CFR 52.21(b)(49) for the purpose of
greenhouse gases only; State effective December 9, 2010.

0
3. Section 52.96 is amended by revising paragraph (a) to read as
follows:

Sec.  52.96  Significant deterioration of air quality.

    (a) The State of Alaska Department of Environmental Conservation
Air Quality Control Regulations as in effect on December 3, 2005
(specifically 18 AAC 50.010 except (7) and (8); 50.015; 50.020;
50.030(6) and (7); 50.035(a)(4) and (5); 50.040(h) except (17), (18),
and (19); 50.215 except (a)(3); 50.250; 50.306 except (b)(2) and
(b)(3); 50.345 except (b), (c)(3) and (l); and 50.990 except (21) and
(77)) are approved as meeting the requirements of part C for preventing
significant deterioration of air quality. The introductory paragraph to
18 AAC 50.040(h) as in effect on December 9, 2010 is also approved as
meeting the requirements of part C for preventing significant
deterioration of air quality, but only with respect to its
incorporation by reference of the definition of ``Subject to
regulation'' in 40 CFR 52.21(b)(49) for the purpose of greenhouse gases
only.
* * * * *
[FR Doc. 2011-2776 Filed 2-8-11; 8:45 am]
BILLING CODE 6560-50-P