[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Rules and Regulations]
[Pages 16789-16791]
[FR Doc No: 2019-08111]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0593; FRL-9991-86]

Bacteriophage Active Against Xylella fastidiosa; Exemption From
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of lytic bacteriophage active against
Xylella fastidiosa in or on all food commodities when the bacteriophage
are sequenced and have sequences free of toxins and lysogenic genes and
are used in accordance with label directions and good agricultural
practices. Otsuka Pharmaceutical Co., Ltd. (c/o Technology Sciences
Group Inc.) submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of bacteriophage active against
Xylella fastidiosa in or on all food commodities under FFDCA.

DATES: This regulation is effective April 23, 2019. Objections and
requests for hearings must be received on or before June 24, 2019, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0593, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0593 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 24, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0593, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is

available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F8562) by Otsuka Pharmaceutical Co., Ltd. (Otsuka), 2-9
Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (c/o Technology
Sciences Group Inc., 712 Fifth St., Suite A, Davis, CA 95616). The
petition requested that 40 CFR part 180 be amended by establishing an
exemption from the requirement of a tolerance for residues of the
bactericide bacteriophages active against Xylella fastidiosa in or on
all food commodities. That document referenced a summary of the
petition prepared by the petitioner Otsuka (c/o Technology Sciences
Group Inc.) and available in the docket via http://www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit III.C.
    Based upon review of data and other information supporting the
petition, EPA is granting a tolerance exemption that differs slightly
from what the petition requested. The reason for this difference is
explained in Unit III.D.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on
bacteriophage active against Xylella fastidiosa and considered their
validity, completeness, and reliability, as well as the relationship of
this information to human risk. A full explanation of the data upon
which EPA relied and its risk assessment based on those data can be
found within the document entitled ``Federal Food, Drug, and Cosmetic
Act (FFDCA) Safety Determination for Bacteriophage Active Against
Xylella fastidiosa'' (Safety Determination). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
    The available data demonstrated that, with regard to humans,
bacteriophage active against Xylella fastidiosa are not anticipated to
be toxic, pathogenic, or infective via any route of exposure.
Furthermore, humans, including infants and children, have been exposed
to bacteriophage through food and water, where they are commonly found,
with no known adverse effects. Although there may be some exposure to
residues when bacteriophage active against Xylella fastidiosa is used
on food commodities in accordance with label directions and good
agricultural practices (only grape for now), there is a lack of concern
due to the lack of potential for adverse effects. EPA also determined
in the Safety Determination that retention of the Food Quality
Protection Act (FQPA) safety factor was not necessary as part of the
qualitative assessment conducted for bacteriophage active against
Xylella fastidiosa.
    Based upon its evaluation in the Safety Determination, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of bacteriophage active against Xylella
fastidiosa. Therefore, an exemption from the requirement of a tolerance
is established for residues of lytic bacteriophage active against
Xylella fastidiosa in or on all food commodities when the bacteriophage
are sequenced and have sequences free of toxins and lysogenic genes and
are used in accordance with label directions and good agricultural
practices.

B. Analytical Enforcement Methodology

    An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation.

C. Response to Comments

    Nine comments were received in response to the notice of filing.
EPA reviewed the comments and determined that they are irrelevant to
the tolerance exemption in this action.

D. Differences Between Petition and Tolerance Exemption Rule

    In its petition, the petitioner requested generally that EPA issue
an exemption from the requirement of a tolerance for residues of
bacteriophage active against Xylella fastidiosa in or on all food
commodities. The petitioner's supporting materials indicated that the
actual pesticide that would be used would be safe because the
bacteriophage were lytic and were sequenced and have sequences free of
toxins and lysogenic genes. EPA believes that only bacteriophage that
have these same characteristics as the organism tested would be safe
and should be exempt from the requirement of a tolerance. Therefore,
EPA is issuing a tolerance exemption that differs slightly from the
petition by limiting the exemption to residues of the bacteriophage
that possess the same characteristics as the bacteriophage that were
tested to support this exemption.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act, 44

U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 12, 2019.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1365 to subpart D to read as follows:

Sec.  180.1365  Bacteriophage active against Xylella fastidiosa;
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of lytic bacteriophage active against Xylella fastidiosa in or
on all food commodities when the bacteriophage are sequenced and have
sequences free of toxins and lysogenic genes and are used in accordance
with label directions and good agricultural practices.

[FR Doc. 2019-08111 Filed 4-22-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11089-11090]
[FR Doc No: 2020-03859]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5625]

Recommendations for Dual 510(k) and Clinical Laboratory
Improvement Amendments Waiver by Application Studies; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Recommendations for
Dual 510(k) and CLIA Waiver by Application Studies.'' It describes
study designs for generating data that may support both 510(k)
clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver.
Use of the Dual 510(k) and CLIA Waiver by Application pathway is
optional; however, FDA believes this pathway is in many instances the
least burdensome and fastest approach for manufacturers to obtain a
CLIA waiver at the same time as 510(k) clearance for new in vitro
diagnostic (IVD) tests. FDA believes increased use of this pathway will
speed up the process of bringing simple and accurate IVD tests to CLIA-
waived settings, which will better serve patients and providers.

DATES: The announcement of the guidance is published in the Federal
Register on February 26, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5625 for ``Recommendations for Dual 510(k) and CLIA Waiver
by Application Studies.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Recommendations for Dual 510(k) and CLIA Waiver by Application
Studies'' to the Office of

Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3435, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Typically, in an application for CLIA waiver (CLIA Waiver by
Application) a manufacturer submits evidence to FDA that a previously
cleared or approved test, initially categorized as moderate complexity,
meets the CLIA statutory criteria for waiver (see 42 U.S.C. 263a(d)(3))
and requests that FDA categorize the test as waived. This means that
historically a CLIA Waiver by Application has followed clearance or
approval of an IVD test.
    While a premarket notification (510(k); 21 U.S.C. 360(k)) and CLIA
Waiver by Application each include discrete elements not required in
the other, both submissions generally include comparison and
reproducibility studies. For a 510(k), such studies are often performed
by trained operators (i.e., test operators who meet the qualifications
to perform moderate complexity testing; sometimes referred to as
``moderate complexity users''). For a CLIA Waiver by Application, we
believe such studies should be conducted by the intended user (i.e.,
test operators in waived settings and with limited or no training or
hands-on experience in conducting laboratory testing; sometimes
referred to as ``untrained operators'' or ``waived users'') (see 42
U.S.C. 263a(d)(3)).
    An applicant may choose to conduct a single set of comparison and
reproducibility studies with untrained operators to satisfy certain
requirements to establish both substantial equivalence under section
513(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i))
for 510(k) clearance and simplicity and insignificant risk of erroneous
results under 42 U.S.C. 263a(d)(3) for CLIA waiver. To streamline the
review of such data, the Dual 510(k) and CLIA Waiver by Application
(Dual Submission) pathway was established as part of the Medical Device
User Fee Amendments of 2012, allowing the review of both a 510(k) and
CLIA Waiver by Application within a single submission with a reduced
overall review time compared to separate, sequential submissions.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of November 29, 2018 (83 FR 61387).
FDA revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Recommendations for Dual 510(k) and CLIA
Waiver by Application Studies.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Recommendations for Dual 510(k) and CLIA Waiver by
Application Studies'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 16038 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Recommendations for Clinical      CLIA Waiver                0910-0598
 Laboratory Improvement Amendments   Applications.
 of 1988 (CLIA) Waiver
 Applications for Manufacturers of
 In Vitro Diagnostic Devices''.
``Administrative Procedures for     CLIA Categorizations       0910-0607
 Clinical Laboratory Improvement
 Amendments of 1988
 Categorization''.
``Requests for Feedback and         Q-submissions.......       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------

    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03859 Filed 2-25-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]
[Page 78771-78772]
[DOCID:fr23de08-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-30-000]

Atmos Energy Corporation; Notice of Application

December 16, 2008.
    Take notice that on December 10, 2008, Atmos Energy Corporation
(Atmos), Lincoln Centre III, 5430 LBJ Freeway, Dallas, Texas 75240,
filed in Docket No. CP09-30-000 an application pursuant to section 7(f)
of the Natural Gas Act (NGA), as amended, and Part 157 of the
regulations of the Federal Energy Regulatory Commission (Commission),
requesting the determination of a service area within which Atmos may,
without further Commission authorization, provide natural gas
distribution service, all as more fully set forth in the application
which is on file with the Commission and open to public inspection. The
filing may also be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Douglas C. Walther, Associate General Counsel, Atmos Energy
Corporation, P.O. Box 650205, Dallas, Texas 75265-0205 at (972) 855-
3102 or by e-mail at<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either complete
its environmental assessment (EA) and place it into the Commission's
public record (eLibrary) for this proceeding; or issue a Notice of
Schedule for Environmental Review. If a Notice of Schedule for
Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify Federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's

environmental review process. Environmental commentors will not be
required to serve copies of filed documents on all other parties.
However, the non-party commentors will not receive copies of all
documents filed by other parties or issued by the Commission (except
for the mailing of environmental documents issued by the Commission)
and will not have the right to seek court review of the Commission's
final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: January 5, 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-30394 Filed 12-22-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72356-72359]
[FR Doc No: 2012-29498]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]

Animal Drug User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following
meeting: Animal Drug User Fee Act. The topic to be discussed is
proposed recommendations for the reauthorization of the Animal Drug
User Fee Act (ADUFA III).
    Date and Time: The meeting will be held on December 18, 2012, from
9 a.m. to 12 p.m.
    Location: The meeting will be held at FDA's Metro Park North
Campus, 7519 Standish Pl., third floor, Meeting Room A, Rockville, MD
20855. There is parking near the building.
    Contact: Jacqueline Farmer, Center for Veterinary Medicine (HFV-
10), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), and written material and requests to make oral
presentations, to the contact person by December 11, 2012.
    If you need special accommodations due to a disability, please
contact Jacqueline Farmer at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
    Comments: Interested persons may submit either written comments
regarding this meeting to the Division of Dockets Management (see
Transcripts) or electronic comments to http://www.regulations.gov. 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. So that FDA can consider
comments and revise the recommendations as necessary, we request that
comments be submitted to the docket by January 4, 2013.

SUPPLEMENTARY INFORMATION:

I. The ADUFA Program

A. What is ADUFA? What does it do?

    FDA considers the timely review of the safety and effectiveness of
new animal drug applications (NADAs) to be central to the Agency's
mission to protect and promote the public health. Prior to 2004, the
timeliness and predictability of the new animal drug review program was
a concern. The Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-
130; hereinafter referred to as ``ADUFA I''), authorized FDA to collect
user fees that were to be dedicated to expediting the review of new
animal drug applications in accordance with certain performance goals
and to expand and modernize the new animal drug review program. The
Agency agreed, under this new Act, to meet a comprehensive set of
performance goals established to show significant improvement in the
timeliness and predictability of the new animal drug review process.
The implementation of ADUFA I provided a significant funding increase
that enabled FDA to increase the number of staff dedicated to the new
animal drug application review process by 30 percent since 2003.
    In 2008, before ADUFA I expired, Congress passed the Animal Drug
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to
as ``ADUFA II'') which included an extension of ADUFA for an additional
5 years--fiscal year (FY) 2009 to FY 2013. ADUFA II performance goals
were established based on ADUFA I FY 2008 review timeframes. In
addition, FDA provided program enhancements to reduce review cycles and
improve communications during reviews. The ADUFA programs have enabled
FDA to speed up the application review process for new animal drugs
without compromising the quality of the Agency's review.

B. ADUFA Achievements

    As part of ADUFA I, FDA established review performance goals that
were phased in over a 5-year period. These performance goals, set from
FY 2004 through FY 2008, enabled FDA to achieve progressive, yearly
improvements in the time allotted for review of new animal drug
applications. By the final year of ADUFA I ending on September 30,
2008, FDA reviewed and acted on 90 percent of the following submission
types within the times specified:
     New animal drug applications and reactivations of such
applications within 180 days after submission date.
     Non-manufacturing supplemental new animal drug
applications and reactivations of such supplemental applications within
180 days after submission date.
     Manufacturing supplemental new animal drug applications
and reactivations of such supplemental applications within 120 days
after submission date.
     Investigational new animal drug study submissions within
180 days after submission date.
     Investigational new animal drug submissions consisting of
protocols without substantial data within 60 days after submission
date.
     Administrative new animal drug applications within 60 days
after submission date.
    With the reauthorization of ADUFA for an additional 5 years under
ADUFA II (FY 2009 to FY 2013), FDA agreed to enhance and further
improve the review process via the following changes.
    A key improvement under ADUFA II is the ``end-review amendment''
(ERA) process that allows FDA reviewers to work with the drug sponsor
to amend certain pending submissions. The ERA process allows us to
decrease the number of review cycles, which ultimately leads to a
shorter time to approval. Improved communication early in the process
has the greatest potential of reducing review cycles. The greatest
impact of this new tool in the first 3 years under ADUFA II has been
with submissions of investigational new animal drug (INAD) studies and
study protocols, which are the earliest review processes impacted by
ADUFA performance goals.
    The development of an electronic submission tool has enabled
sponsors to submit applications and submissions electronically, and has
provided FDA reviewers with the ability to evaluate submissions online.
    The joint participation of FDA and the regulated industry in 10
public workshops by the end of FY 2013 on mutually agreed-upon topics
has enhanced communication and transparency on topics critical to the
animal drug review and approval process. To date, FDA and the regulated
industry have participated in eight workshops with the final two
planned for FY 2013.
    FDA is committed to improving the animal drug review and business
processes to facilitate the timely scheduling and conducting of foreign
preapproval inspections. Because of processes developed under ADUFA II,
sponsors are now able to voluntarily submit an annual facilities list
and notification 30 days prior to submitting an NADA, a supplemental
NADA, or an INAD submission to inform FDA that the application or
submission includes a foreign manufacturing facility.
    FDA has published a number of reports that provide useful
background on ADUFA I and ADUFA II. ADUFA-related Federal Register
notices, guidances, legislation, performance reports, and financial
reports can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

II. Proposed ADUFA III Recommendations

A. Enhancing the Process for Premarket Review

    We are proposing changes to the performance goals that ADUFA II
established to further enhance the process for review of animal drug
applications.
    The ERA procedure implemented as part of ADUFA II resulted in an
increase in the number of one-cycle reviews; however, certain
challenges associated with the process restricted its full utilization.
We are proposing, among other changes, to further improve the review
process by replacing the ERA with shorter review times for certain
resubmissions and reactivations. To allow time for the programming and
system changes required to make this and other changes, we are
proposing to maintain the ADUFA II ERA process and associated review
performance goals for FY 2014 for non-administrative animal drug
applications, non-manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug submissions consisting of protocols without substantial
data.
    Starting on October 1, 2014 (for FYs 2015 to 2018), we are
proposing to discontinue the ERA procedures and replace them with the
process for shorter review times for reactivations and resubmissions.
The performance goals listed below for the shorter reactivation and
resubmission times only apply when the sponsor provides submissions for
the NADA and the INAD through the use of the eSubmitter electronic
submission tool.
    The Agency will review and act on 90 percent of non-administrative
NADAs within 180 days after the submission date. An application is
incomplete if it would require additional data or information to enable
the Agency to complete a comprehensive review of the application and
reach a decision on the issue(s) presented in the application.
    The Agency will review and act on 90 percent of reactivated
applications:

     Within 180 days after the reactivated NADA submission date
if the Agency determines and notifies the sponsor that the deficiencies
are substantial;
     Within 135 days after the reactivated NADA submission date
if the Agency determines and notifies the sponsor that the deficiencies
are not substantial; and the NADA reactivation must be submitted no
more than 120 days after the Agency's dated incomplete letter to
qualify for the shorter review time; and
     Within 180 days after the reactivated NADA submission date
if the NADA reactivation is submitted after 120 days of the Agency's
dated incomplete letter or new substantial information is provided in
the reactivated application.
    The Agency will review and act on 90 percent of non-manufacturing
supplemental animal drug applications (i.e., supplemental animal drug
applications for which safety or effectiveness data are required)
within 180 days after the submission date. A supplemental application
is incomplete if it would require additional data or information to
enable the Agency to complete a comprehensive review of the supplement
and reach a decision on the issue(s) presented in the supplement.
     The Agency will review and act on 90 percent of
reactivated supplements:
     Within 180 days after the resubmission date if the Agency
determines and notifies the sponsor that the deficiencies are
substantial.
     Within 135 days after the resubmission date if the Agency
determines and notifies the sponsor that the deficiencies are not
substantial; and the resubmission to the supplemental application must
be submitted no more than 120 days after the Agency's dated incomplete
letter to qualify for the shorter review time; and
     Within 180 days after the resubmission date if the
resubmission to the supplemental application is submitted after 120
days of the Agency's dated incomplete letter or new substantial
information is provided in the resubmission.
    The Agency will review and act on 90 percent of INAD study
submissions within 180 days after the submission date. An INAD study
submission is incomplete if it would require additional data or
information to enable the Agency to complete a comprehensive review of
the submission and reach a decision on the issue(s) presented in the
submission.
    The Agency will review and act on 90 percent of resubmitted INAD
study submissions:
     Within 180 days after the resubmitted INAD study
submission date if the Agency determines and notifies the sponsor that
the deficiencies are substantial;
     Within 60 days after the resubmitted INAD study submission
date if the Agency determines and notifies the sponsor that the
deficiencies are not substantial; and the resubmission must be
submitted no more than 120 days after the Agency's dated incomplete
letter to qualify for the shorter review time; and
     Within 180 days after the resubmitted INAD study
submission date if the resubmission is submitted after 120 days of the
Agency's dated incomplete letter or new substantial information is
provided in the resubmission.
    The Agency will review and act on 90 percent of INAD submissions
consisting of protocols without data that the Agency and the sponsor
consider to be an essential part of the basis for making the decision
to approve or not approve an animal drug application or supplemental
animal drug application within 50 days after the submission date. An
INAD protocol without data submission is incomplete if it would require
additional information to enable the Agency to complete a comprehensive
review of the protocol and reach a decision on the issue(s) presented
in the protocol.
    The Agency will review and act on 90 percent of resubmitted INAD
protocol without data submissions:
     Within 50 days after the resubmission date if the Agency
determines and notifies the sponsor that the deficiencies are
substantial;
     Within 20 days after the resubmitted INAD protocol without
data submission date if the Agency determines and notifies the sponsor
that the deficiencies are not substantial; and the resubmission must be
submitted no more than 120 days after the Agency's dated nonconcurrence
letter to qualify for the shorter review time; and
     Within 50 days after the resubmission date if the
resubmission is submitted after 120 days of the Agency's dated
nonconcurrence letter or new substantial information is provided in the
resubmission.

B. Additional Review Enhancements Proposal for FYs 2015 to 2018

    The Agency will review and act on 90 percent of microbial food
safety hazard characterization submissions within 100 days after the
submission date.
    The Agency will review and act on 90 percent of qualifying labeling
supplements as described in 21 CFR 514.8(c)(2)(i)(A) and (D) within 60
days after the submission date. Qualifying labeling supplements are
defined as those submitted through the use of the eSubmitter electronic
submission tool, for which the sponsor provides and certifies a
complete list of label changes made in the application and that CVM can
determine upon initial review do not decrease the safety of drug use.
    The Agency will review and act on 90 percent of non-qualifying
supplemental applications within 180 days after the submission date.

C. Performance Goals Proposal Affecting All Fiscal Years of ADUFA III
(2014 to 2018)

    The Agency will maintain the ADUFA II goals regarding work queue
procedures, timely meetings with industry, review of administrative
NADAs, and preapproval foreign inspections.
    The Agency will review and act on 90 percent of manufacturing
supplemental animal drug applications within 120 days after the
submission date. A submission is incomplete if it would require
additional data or information to enable the Agency to complete a
comprehensive review of the submission and reach a decision on the
issue(s) presented in the submission.
     If the Agency determines and notifies the sponsor that the
deficiencies are not substantial for manufacturing supplements
requiring prior approval according to Sec.  514.8(b), the Agency will
permit the manufacturing supplements to be resubmitted as
``Supplement--Changes Being Effected in 30 Days'' as described in Sec.
514.8(b)(3).
     If the Agency determines and notifies the sponsor that the
deficiencies are substantial or new substantial information is provided
in the resubmission, the Agency will review and act on 90 percent of
reactivated manufacturing supplements within 120 days after the
resubmission date.
    The Agency will permit comparability protocols as described in
Sec.  514.8(b)(2)(v) to be submitted as protocols without substantial
data in an INAD file. The Agency will review and act on 90 percent of
INAD submissions consisting of protocols without substantial data
within 50 days after the submission date of the protocol.
    The Agency will develop guidance for a two-phased Chemistry,
Manufacturing, and Controls (CMC) technical section submission and
review process under the INAD file by the end of FY 2014.
    The Agency and the regulated industry agree that data and/or
information which uniquely describes

the general attributes of the new animal drug (e.g., the known
characteristics of the drug that can impact safety, effectiveness, and/
or quality) needs to be submitted early in the new animal drug
development process in order to enable the parties to reach agreement
at a presubmission conference or to begin review of a protocol.
Predicated on submission of this information:
     The Agency will allow short justifications within INAD
protocols without data submissions that are limited in scope.
     The Agency will allow for the concurrent submission of
supporting data and protocols provided that the protocol is not
submitted until the supporting data has been in the Agency's queue for
at least 50 days.
    The Agency will allow for the inclusion of this data and/or
information in presubmission conferences, however it would not preclude
holding a presubmission conference without such data. Presubmission
conferences will be held approximately 100 days after the submission of
the data supporting the request.
    The Agency and the regulated industry agree that dosage
characterization is part of the effectiveness technical section of an
investigational new animal drug file. In instances where data and/or
information about the dosage is integral to the review of a protocol,
the Agency and the regulated industry agree that this data and/or
information should be submitted as supporting data well in advance of
the protocol submission.
    The Agency agrees to explore the feasibility of pursuing statutory
revisions, consistent with the Agency's mission to protect and promote
the public health, that may expand the use of conditional approvals to
other appropriate categories of new animal drug applications and that
may modify the current requirement that the use of multiple new animal
drugs in the same medicated feed be subject to an approved application.

D. ADUFA III Enhancements for a Modified Inflation Adjuster and
Workload Adjuster

    ADUFA III financial enhancements include a new statutory inflation
adjuster provision that accounts for changes in FDA's costs related to
payroll compensation and benefits as well as changes in nonpayroll
costs through use of the Consumer Price Index. ADUFA III also modifies
the base years for calculating the workload adjuster, as specified in
the ADUFA III performance goals letter, to ensure that it adequately
captures changes in FDA's workload during ADUFA III.

E. Impact of ADUFA III Enhancements on User Fee Revenue

    The following table summarizes the FY 2014 baseline and added
funding to support ADUFA III program:

------------------------------------------------------------------------
                     Financial baseline                        Dollars
------------------------------------------------------------------------
FY 2014 Base Revenue \1\...................................   21,600,000
One-Time Information Technology (IT) Funding...............    2,000,000
Total Statutory Revenue for FY 2014........................   23,600,000
------------------------------------------------------------------------
\1\ For each year in FY 2015 to FY 2018, the annual fee revenue will be
  further adjusted according to the new statutory provision for the
  inflation adjuster and may be further adjusted by the workload
  adjuster. In fiscal years 2016 to 2018, if applicable, the annual fee
  revenue is subject to a number of possible adjustments, including for
  inflation and collection shortfalls.

    The statutory revenue for 2009, the first year of ADUFA II, was
$15,260,000. The statutory revenue for the first year of ADUFA III will
be $23,600,000, which includes one-time IT funding in the amount of
$2,000,000 for FY 2014. The statute specifies annual revenue of
$21,600,000 for each of the FY 2015 through FY 2018, however this
amount is subject to a number of possible adjustments, including for
inflation and collection shortfalls.
    Additionally, ADUFA III offers the following financial
recommendations:
     A new provision for recovering collection shortfalls is
being offered to ensure adequate funding for the animal drug review
process. For example, when FDA sets fees for FY 2016, it may add to the
fee revenue the amount of any shortfall in fees collected in FY 2014.
This process would follow in subsequent years through the final year
adjustment, as specified in the statute.
     FDA has modified the fee revenue distribution from 25
percent for each fee type in ADUFA II to 20 percent in application, 27
percent in product, 27 percent in sponsor, and 26 percent in
establishment fees in ADUFA III. The purpose of changing the fee
distribution is to increase the revenue stream stability, reduce
application fee costs, and minimize the potential for collection
shortfalls.

III. What information should you know about the meeting?

    We will convene a public meeting to hear the public's views on the
proposed recommendations for reauthorization of the ADUFA program. We
will conduct the meeting on December 18, 2012, at FDA's Metro Park
North Campus (see Location). The meeting will include a presentation by
FDA and we will provide an opportunity for other organizations and
individuals to make presentations at the meeting or to submit written
comments to the docket. So that FDA can consider comments and revise
the recommendations as necessary, we request that comments be submitted
to the docket by January 4, 2013.

    Dated: December 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29498 Filed 12-3-12; 4:15 pm]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 31 (Wednesday, February 15, 2023)]
[Notices]
[Pages 9964-9966]
[FR Doc No: 2023-03224]

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DEPARTMENT OF TRANSPORTATION

Bureau of Transportation Statistics

[Docket ID Number DOT-OST-2014-0031]

Agency Information Collection: Activity under OMB Review; Report
of Traffic and Capacity Statistics--The T-100 System

AGENCY: Bureau of Transportation Statistics (BTS), DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public
Law 104-13, the Bureau of Transportation Statistics invites the general
public, industry and other governmental parties to comment on the
continuing need for and usefulness of DOT requiring U.S. and foreign
air carriers to file traffic and capacity data pursuant to 14 CFR
241.19 and Part 217, respectively. These reports are used to measure
air transportation activity to, from, and within the United States.

DATES: Written comments should be submitted by April 17, 2023.
    Comments: Comments should identify the associated OMB approval #
2138-0040 and Docket ID Number DOT-OST-2014-0031. Persons wishing the
Department to acknowledge receipt of their comments must submit with
those comments a self-addressed stamped postcard on which the following
statement is made: Comments on OMB # 2138-0040, Docket--DOT-OST-2014-
0031. The postcard will be date/time stamped and returned.

ADDRESSES: You may submit comments identified by DOT Docket ID Number
DOT-OST-2014-0031 by any of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
    Mail: Docket Services: U.S. Department of Transportation, 1200 New
Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington,
DC 20590-0001.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m. ET, Monday through
Friday, except Federal holidays.
    Fax:<PHONE_NUMBER>.
    Instructions: Identify docket number, DOT-OST-2014-0031, at the
beginning of your comments, and send two copies. To receive
confirmation that DOT received your comments, include a self-addressed
stamped postcard. Internet users may access all comments received by
DOT at http://www.regulations.gov. All comments are posted
electronically without charge or edits, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

Electronic Access

    You may access comments received for this notice at http://www.regulations.gov, by searching docket DOT-OST-2014-0031.

FOR FURTHER INFORMATION CONTACT: Jennifer Rodes, Office of Airline
Information, RTS-42, Room E34-420, OST-R, BTS, 1200 New Jersey Avenue
SE, Washington, DC 20590-0001, Telephone Number<PHONE_NUMBER>, Fax
Number<PHONE_NUMBER> or EMAIL [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Approval No. 2138-0040.
    Title: Report of Traffic and Capacity Statistics--The T-100 System.
    Form No.: Schedules T-100 and T-100(f).
    Type of Review: Extension of a currently approved collection.
    Respondents: Certificated, commuter and foreign air carriers that
operate to, from or within the United States.

T100 Form

    Number of Respondents: 119.
    Number of Annual responses 1,428.
    Total Burden per Response: 6 hours.
    Total Annual Burden: 8,568 hours.
    T100F Form:
    Number of Respondents: 190.
    Number of Annual responses 2,280.
    Total Burden per Response: 2 hours.
    Total Annual Burden: 4,560 hours
    Needs and Uses:

Airport Improvement

    The Federal Aviation Administration uses enplanement data for U.S.
airports to distribute the annual Airport Improvement Program (AIP)
entitlement funds to eligible primary airports, i.e., airports which
account for more than 0.01 percent of the total passengers enplaned at
U.S. airports. Enplanement data contained in Schedule T-100/T-100(f)
are the sole data base used by the FAA in determining airport funding.
U.S. airports receiving significant service from foreign air carriers
operating small aircraft could be receiving less than their fair share
of AIP entitlement funds. Collecting Schedule T-100(f) data for small
aircraft operations will enable the FAA to distribute these funds more
fairly.

Air Carrier Safety

    The FAA uses traffic, operational and capacity data as important
safety indicators and to prepare the air carrier traffic and operation
forecasts that are used in developing its budget and staffing plans,
facility and equipment funding levels, and environmental impact and
policy studies. The FAA monitors changes in the number of air carrier
operations as a way to allocate inspection resources and in making
decisions as to increased safety surveillance. Similarly, airport
activity statistics are used by the FAA to develop airport profiles and
establish priorities for airport inspections.

Acquisitions and Mergers

    While the Justice Department has the primary responsibility over
air carrier acquisitions and mergers, the Department reviews the
transfer of international routes involved to determine if they would
substantially reduce competition, or determine if the transaction would
be inconsistent with the public interest. In making these
determinations, the proposed transaction's effect on competition in the
markets served by the affected air carriers is analyzed. This analysis
includes, among other things, a consideration of the volume of traffic
and available capacity, the flight segments and origins-destinations
involved, and the existence of entry barriers, such as limited airport
slots or gate capacity. Also included is a review of the volume of
traffic handled by each air carrier at specific airports and in
specific markets which would be affected by the proposed acquisition or
merger. The Justice Department uses T-100 data in carrying out its
responsibilities relating to airline competition and consolidation.

Traffic Forecasting

    The FAA uses traffic, operational and capacity data as important
safety indicators and to prepare the air carrier traffic and operation
forecasts. These forecasts are used by the FAA, airport managers, the
airlines and others in the air travel industry as planning and
budgeting tools.

Airport Capacity Analysis

    The mix of aircraft types are used in determining the practical
annual capacity (PANCAP) at airports as prescribed in the FAA Advisory
Circular Airport Capacity Criteria Used in Preparing the National
Airport Plan. The PANCAP is a safety-related measure of the annual
airport capacity or level of operations. It is a predictive measure
which indicates potential capacity problems, delays, and possible
airport expansions or runway construction needs. If the level of
operations at an airport exceeds PANCAP significantly, the frequency
and length of delays will increase, with a potential concurrent risk of
accidents. Under this program, the FAA develops ways of increasing
airport capacity at congested airports.

Airline Industry Status Evaluations

    The Department apprizes Congress, the Administration and others of
the effect major changes or innovations are having on the air
transportation industry. For this purpose, summary traffic and capacity
data as well as the detailed segment and market data are essential.
These data must be timely and inclusive to be relevant for analyzing
emerging issues and must be based upon uniform and reliable data
submissions that are consistent with the Department's regulatory
requirements.

Mail Rates

    The Department is responsible for establishing international and
intra-Alaska mail rates. International mail rates are set based on
scheduled operations in four geographic areas: Trans-border, Latin
America, operations

over the Atlantic Ocean and operations over the Pacific Ocean. Separate
rates are set for mainline and bush Alaskan operations. The rates are
updated every six months to reflect changes in unit costs in each rate-
making entity. Traffic and capacity data are used in conjunction with
cost data to develop the required unit cost data.

Essential Air Service

    The Department reassesses service levels at small domestic
communities to assure that capacity levels are adequate to accommodate
current demand

System Planning at Airports

    The FAA is charged with administering a series of grants that are
designed to accomplish the necessary airport planning for future
development and growth. These grants are made to state metropolitan and
regional aviation authorities to fund needed airport systems planning
work. Individual airport activity statistics, nonstop market data, and
service segment data are used to prepare airport activity level
forecasts.

Review of IATA Agreements

    The Department reviews all of the International Air Transport
Association (IATA) agreements that relate to fares, rates, and rules
for international air transportation to ensure that the agreements meet
the public interest criteria. Current and historic summary traffic and
capacity data, such as revenue ton-miles and available ton-miles, by
aircraft type, type of service, and length of haul are needed to
conduct these analyses: to (1) develop the volume elements for
passenger/cargo cost allocations, (2) evaluate fluctuations in volume
of scheduled and charter services, (3) assess the competitive impact of
different operations such as charter versus scheduled, (4) calculate
load factors by aircraft type, and (5) monitor traffic in specific
markets.

Foreign Air Carriers Applications

    Foreign air carriers are required to submit applications for
authority to operate to the United States. In reviewing these
applications, the Department must find that the requested authority is
encompassed in a bilateral agreement, other intergovernmental
understanding, or that granting the application is in the public
interest. In the latter cases, T-100 data are used in assessing the
level of benefits that carriers of the applicant's homeland presently
are receiving from their U.S. operations. These benefits are compared
and balanced against the benefits U.S. carriers receive from their
operations to the applicant's homeland.

Air Carrier Fitness

    The Department determines whether U.S. air carriers are and
continue to be fit, willing and able to conduct air service operations
without undue risk to passengers and shippers. The Department monitors
a carrier's load factor, operational, and enplanement data to compare
with other carriers with similar operating characteristics. Carriers
that expand operations at a high rate are monitored more closely for
safety reasons.

International Civil Aviation Organization

    Pursuant to an international agreement, the United States is
obligated to report certain air carrier data to the International Civil
Aviation Organization (ICAO). The traffic data supplied to ICAO are
extracted from the U.S. air carriers' Schedule T-100 submissions.
    The Confidential Information Protection and Statistical Efficiency
Act of 2002 (44 U.S.C. 3501 Note), requires a statistical agency to
clearly identify information it collects for non-statistical purposes.
BTS hereby notifies the respondents and the public that BTS uses the
information it collects under this OMB approval for non-statistical
purposes including, but not limited to, publication of both
Respondent's identity and its data, submission of the information to
agencies outside BTS for review, analysis and possible use in
regulatory and other administrative matters.

    Issued on February 9, 2023.
William Chadwick, Jr.,
Director, Office of Airline Information, Bureau of Transportation
Statistics, U.S. Department of Transportation.
[FR Doc. 2023-03224 Filed 2-14-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8951-8952]
[FR Doc No: 2016-03617]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC16-63-000.
    Applicants: High Lonesome Mesa, LLC.
    Description: Amendment to January 27, 2016 Application for
authorization for disposition of jurisdictional facilities under
Section 203 of the FPA of High Lonesome Mesa, LLC.
    Filed Date: 2/12/16.
    Accession Number: 20160212-5273.
    Comments Due: 5 p.m. ET 2/22/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-945-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Notice of Termination by Midcontinent Independent
System Operator, Inc. of Service Agreements Nos. 568 and 569 among
Northern Indiana Public Service Company and the Indiana Municipal Power
Agency under ER16-945.
    Filed Date: 2/16/16.
    Accession Number: 20160216-5254.
    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: ER16-946-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: Rev. to Schedules 22, 23 &
25 of the OATT Relating to Interconnection Process to be effective 4/
17/2016.
    Filed Date: 2/16/16.

    Accession Number: 20160216-5279.
    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: ER16-947-000.
    Applicants: Big Sandy Peaker Plant, LLC, Wolf Hills Energy, LLC,
Middle River Power II, LLC.
    Description: Joint Request of Big Sandy Peaker Plant, LLC, Wolf
Hills Energy, LLC and Middle River Power II LLC for Waiver and Request
for Expedited Consideration.
    Filed Date: 2/16/16.
    Accession Number: 20160216-5278.
    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: ER16-948-000.
    Applicants: Midcontinent Independent System Operator, Inc., Otter
Tail Power Company.
    Description: Compliance filing: 2016-02-16_SA 2897 OTP-GRE FSA
Compliance to be effective 8/26/2015.
    Filed Date: 2/16/16.
    Accession Number: 20160216-5292.
    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: ER16-949-000.
    Applicants: Escalante Solar I, LLC.
    Description: Sec.  205(d) Rate Filing: Tenant In Common and Shared
Facilities Agreement to be effective 4/2/2016.
    Filed Date: 2/16/16.
    Accession Number: 20160216-5301.
    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: ER16-950-000.
    Applicants: Escalante Solar II, LLC.
    Description: Sec.  205(d) Rate Filing: Tenant in Common and Shared
Facilities Agreement to be effective 4/2/2016.
    Filed Date: 2/16/16.
    Accession Number: 20160216-5305.
    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: ER16-951-000.
    Applicants: Escalante Solar III, LLC.
    Description: Sec.  205(d) Rate Filing: Tenant In Common and Shared
Facilities Agreement to be effective 4/2/2016.
    Filed Date: 2/16/16.
    Accession Number: 20160216-5306.
    Comments Due: 5 p.m. ET 3/8/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    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: February 16, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-03617 Filed 2-22-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Page 49726]
[FR Doc No: 2019-20504]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AD19-20-000 and ER02-2001-000]

Electric Quarterly Report Users Group Meeting and Electric
Quarterly Reports; Notice of Electric Quarterly Report Users Group
Meeting

    Take notice that on December 4, 2019 staff of the Federal Energy
Regulatory Commission (Commission) will hold an Electric Quarterly
Report (EQR) Users Group meeting. The meeting will take place from 1:00
p.m. to 5:00 p.m. (EST) in Hearing Room 1 at 888 First Street NE,
Washington, DC 20426. All interested persons are invited to attend. For
those unable to attend in person, access to the meeting will be
available via webcast.
    This meeting provides a forum for dialogue between Commission staff
and EQR users to discuss potential improvements to the EQR program and
the EQR filing process. Prior to the meeting, staff would like input on
discussion topics. Individuals may suggest agenda topics for
consideration by emailing<EMAIL_ADDRESS>    Please note that matters pending before the Commission and subject
to ex parte limitations cannot be discussed at this meeting. An agenda
of the meeting will be provided in a subsequent notice.
    Due to the nature of the discussion, those interested in
participating are encouraged to attend in person. All interested
persons (whether attending in person or via webcast) are asked to
register http://www.ferc.gov/whats-new/registration/12-04-19-form.asp.
There is no registration fee. Anyone with internet access can listen to
the meeting by navigating to www.ferc.gov's Calendar of Events,
locating the EQR Users Group Meeting on the Calendar, and clicking on
the link to the webcast. The webcast will allow persons to listen to
the technical conference and they can email questions during the
meeting to<EMAIL_ADDRESS>    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about the EQR Users Group meeting, please
contact Jeff Sanders of the Commission's Office of Enforcement at (202)
502-6455, or send an email to<EMAIL_ADDRESS>
    Dated: September 17, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-20504 Filed 9-20-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Rules and Regulations]
[Pages 44497-44498]
[FR Doc No: 2012-18493]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2012-0003; Internal Agency Docket No. FEMA-B-1260]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Interim rule.

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SUMMARY: This interim rule lists communities where modification of the
Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because
of new scientific or technical data. New flood insurance premium rates
will be calculated from the modified BFEs for new buildings and their
contents.

DATES: These modified BFEs are currently in effect on the dates listed
in the table below and revise the Flood Insurance Rate Maps (FIRMs) in
effect prior to this determination for the listed communities.
    From the date of the second publication of these changes in a
newspaper of local circulation, any person has ninety (90) days in
which to request through the community that the Deputy Associate
Administrator for Mitigation reconsider the changes. The modified BFEs
may be changed during the 90-day period.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each
community in this interim rule. However, the address of the Chief
Executive Officer of the community where the modified BFE
determinations are available for inspection is provided.
    Any request for reconsideration must be based on knowledge of
changed conditions or new scientific or technical data.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required either to adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, together with the floodplain management
criteria required by 44 CFR 60.3, are the minimum that are required.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities. The changes in BFEs are in
accordance with 44 CFR 65.4.
    National Environmental Policy Act. This interim rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This interim rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This interim rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This interim rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

    Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Date and name of
         State and county           Location and case No.     newspaper where     Chief executive officer   Effective date of  modification   Community
                                                           notice was published         of community                                             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Florida: Sumter...................  Unincorporated areas   Sept. 22, 2011,       The Honorable Don          Jan. 27, 2012..................       120296
                                     of Sumter County (11-  Sept. 29, 2011, The   Burgess, Chairman,
                                     04-4816P).             Sumter County Times.  Sumter County Board of
                                                                                Commissioners, 7375
                                                                                Powell Road, Wildwood,
                                                                                FL 34785.
North Carolina: Orange............  Town of Chapel Hill    Nov. 23, 2011, Nov.   The Honorable Mark         Mar. 29, 2012..................       370180
                                     (10-04-6903P).         30, 2011, The         Kleinschmidt, Mayor,
                                                            Chapel Hill Herald.   Town of Chapel Hill, 405
                                                                                Martin Luther King, Jr.
                                                                                Boulevard, Chapel Hill,
                                                                                NC 27514.
Texas: Bexar......................  City of San Antonio    Nov. 28, 2011, Dec.   The Honorable Julian       Dec. 21, 2011..................       480045
                                     (11-06-2247P).         5, 2011, The San      Castro, Mayor, City of
                                                            Antonio Express-      San Antonio, 100
                                                            News.                 Military Plaza, San
                                                                                Antonio, TX 78205.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: July 12, 2012.
Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2012-18493 Filed 7-27-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Notices]
[Page 35880]
[FR Doc No: 2011-15157]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-3784-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits tariff filing per 35.13(a)(2)(iii):
Idaho Power Hemingway Point to Point Agreements to be effective 6/1/
2011.
    Filed Date: 06/13/2011.
    Accession Number: 20110613-5000.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 05, 2011.

    Docket Numbers: ER11-3785-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits tariff filing per 35.15: Idaho
Power Hemingway Point to Point Agreements Termination to be effective
6/1/2011.
    Filed Date: 06/13/2011.
    Accession Number: 20110613-5001.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 05, 2011.

    Docket Numbers: ER11-3786-000.
    Applicants: Tampa Electric Company.
    Description: Request for Waiver of Tampa Electric Company.
    Filed Date: 06/10/2011.
    Accession Number: 20110610-5217.
    Comment Date: 5 p.m. Eastern Time on Monday, June 20, 2011.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 13, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-15157 Filed 6-17-11; 8:45 am]
BILLING CODE 6717-01-P


PM2.5 Implementation Plan Proposed Rule ( PM2.5 Implementation Proposal  OMB Draft # 3 Redline  8/ 11/ 05) FHWA Comments 8/ 23/ 05   Page 1; should note that designations were effective April 5, 2005.

  Page 60; in the paragraph on nitrates, it states, " The main sources of NOx are combustion of fossil fuel in boilers and onroad mobile sources. Together they account for almost 80 percent of NOx emissions, with stationary and mobile source fuel combustion each accounting for about half of these emissions." This seems to be incorrect   possibly " onroad" should be deleted from the first sentence. In 2002, onroad emissions of NOx were approximately 35%.

  Page 83; conformity applies 1 year from the " effective" date of nonattainment designation ( i. e., April 5, 2006).

  Page 83, footnote 39; needs to reference the May 6, 2005 conformity rule amendments that addressed precursors. Also, this is not the complete rule, but only portions of it. Instead, this footnote should reference 40 CFR Parts 51 and 93, which are the actual conformity regulations.

  Page 84 86 and elsewhere throughout the NPRM; the proposal discusses " SO2" ( sulfur dioxide) as the precursor instead of " SOx," which is in contrast to the conformity rule.

  Page 87; the section on ammonia is misleading and seems to be in conflict with the conformity rule. Even if the State finds that ammonia emissions contribute to the nonattainment problem, that does not mean that they will control emissions from onroad sources, or create an emissions budget. Conformity for ammonia will only apply if the SIP actually creates an on road budget. Again, EPA needs to reference the transportation conformity regulations when issues related to on road mobile sources and transportation conformity are discussed.

  Page 95; EPA is proposing an option ( although not preferred) that would classify PM2.5 areas, and give some areas a later attainment date. EPA needs to discuss how this option will affect the implementation of other PM2.5 requirements, such as transportation conformity.

  Page 107; this section on attainment dates seems to be based on option 1 for classifications. However, this is not clear and is somewhat confusing. It seems that the two sections need to be consistent, and two options presented here as well, or at least this section needs to explain how it would work if the second option is chosen for classifications.   Pages 124, 161, 307, 402, and 406; reference that 2002 is the baseline year for PM2.5 and 8 hour ozone. However, the Phase 2 8 hour ozone implementation plan now contains a provision that would allow a change to a more recent baseline year.

  Page 131; " The EPA has also provided grant funding to STAPPA/ ALAPCO to develop a " menu of options" document to provide State and local agencies and the general public with additional information on sources of emissions, potential control measures, and their associated costs and air quality benefits." EPA needs to provide more information on this effort, and DOT should be involved in any review of transportation control strategies.

  Page 204 and page 405; request comments on an option that would " include all sources ( rather than just selected sources) within 200 kilometers of the nonattainment area." This approach could have serious ramifications on transportation conformity. If on road mobile sources are included, than it would logically seem that these reductions would figure into the motor vehicle emissions budget. This would in turn seem to try to apply transportation conformity beyond the nonattainment area. This is specifically inconsistent with Section 176 of the Clean Air Act which limits conformity to nonattainment and maintenance areas. EPA needs to discuss how this option would affect transportation conformity and motor vehicle emissions budgets. If the RFP SIP establishes a motor vehicle emissions budget, it should only be for the nonattainment area, as conformity only applies in nonattainment or maintenances areas.

  Page 204; states " Except in those rare cases where an area is violating only the 24 hour standard, the State should design the emission inventory to reflect annual average emission levels." First, we have been told that all PM2.5 nonattainment areas are violating the annual standard ( i. e., there are no areas just violating the 24 hour standard.) Second, this approach would allow RFP only for the annual standard. This conflicts with the approach EPA has given for transportation conformity that would require that areas that are violating, or in near violation, of the 24 hour standard, must demonstrate conformity for both standards and calculate emissions estimates for both standards. EPA should provide more information on how inventories for just the annual standard would meet requirements for the 24 hour standard, and why the approach is more stringent for transportation conformity. See also page 229 which states, "  the annual PM2.5 standard is considered to be the ` controlling' standard ( as opposed to the 24 hour standard), and the fact that all sites violating the PM2.5 standards are violating the annual standard rather than only the 24 hour standard " In addition, see page 308 regarding emissions inventories. Would inventories be required for both the annual and 24 hour standards? A consistent approach should be used to address the 24 hour standard.

  Page 263 and 411; states " In the past under other SIP programs, States may have rejected a single measure under consideration as RACM because the emission reduction benefits from that measure alone would not advance the attainment date by one year. The EPA does not believe this approach is appropriate under section 172." We previously commented on this policy as well. Why is EPA changing this interpretation? Is this consistent with the RACM court decision ( Sierra Club v. EPA, 294 F. 3d 155 ( D. C. Cir. 2002)? If this is not current policy for ozone and other pollutants, then we would strongly object to any changes to this definition of RACM.

  Page 270; states " However, under current EPA policy we do not presume that all of these measures are reasonably available in all areas." This should be revised to state, " However, under current EPA policy we do not presume that any or all of these measures are reasonably available in any areas." As written, the proposal still implies that some of the measures are reasonably available for all areas, and this is not the case.

  Page 271; states " we do not believe it is appropriate to include a presumption that each of these measures should be considered RACM for every PM2.5 nonattainment area." Revise to state, "  we do not believe it is appropriate to include a presumption that any of these measures should be considered RACM for any PM2.5 nonattainment area." See preceding comment.

  Page 271; states " PM2.5 monitoring data show that organic and elemental carbon typically make up a significant percentage ( e. g., 25 percent or more) of the PM2.5 mass in most urban areas, and analyses have shown that transportation sources are significant emitters of these PM2.5 components. For this reason, we believe that States should give serious consideration to TCMs in their RACM analyses." We strongly disagree with this conclusion. This recommendation should be deleted from the proposal. It is not needed anyway, as the proposal already states that all measures must be considered. There is no reason to specifically call out TCMs here. Although transportation sources may be significant sources of PM2.5 in some areas, we are not sure whether TCMs are the most cost effective way to achieve significant emission reductions.

  Page 271; states " However, experience has shown that local circumstances vary to such a degree from city to city that it would not be reasonable to assume that all section 108( f) measures are reasonably available in all areas." Revise to state, " However, experience has shown that local circumstances vary to such a degree from city to city that it would not be reasonable to assume that any section 108( f) measures are reasonably available in any areas.

  On page 274, the proposal states, " Programs to expand use of clean burning fuels ( such as biodiesel)." Can't biodiesel actually increase NOx emissions? If this is the case, it is recommended that the phrase " such as biodiesel" be deleted.

  On page 275, " Reduce dust from paved and unpaved roads" is listed as an area source. This should be moved under mobile sources. Dust from paved and unpaved roads, if significant, will need to become part of the on road motor vehicle emissions budget. There has been a great deal of confusion in regards to this issue in the past. As listed under areas sources, this may confuse readers. In addition, dust from highway and transit construction activities ( next item), if found significant, may also be part of the on road motor vehicle emissions budget.

  Page 280; states " Examples of voluntary mobile source measures include transportation control measures, ozone action plans, reduced switchboard locomotive idling, and trip reduction strategies." This implies that all TCMs are voluntary measures, and this is not correct. Recommend deleting " transportation control measures from this sentence, and if necessary replace with a specific example of a voluntary measure.

  Page 286; states " Travel on paved and unpaved roads results in re entrained road dust which contributes to measured PM2.5 violations." This is not accurate or consistent with the transportation conformity rulemaking. Re entrained road dust " may" contribute to PM2.5 air quality problems.

  Page 288; states " By the end of the one year conformity grace period metropolitan and donut areas ( defined below), if designated nonattainment for PM2.5, must also make a conformity determination for PM2.5." This should more accurately state that by the end of the one year grace period a conformity of metropolitan plans and transportation improvement programs ( TIPs) must be determined, reflecting the metropolitan area and any associated donut areas ( defined below).

  Page 292; states " not been included in the MPO's conformity determination, new projects and project phases could not be approved in the metropolitan area or the donut area." This should state new " nonexempt" projects and project phases could not be approved

  Page 297; states " In another rulemaking action, we will propose to establish de minimis emission levels for federal projects or actions covered by the general conformity program. However, on page 298, it states " Currently, we are reviewing the general conformity regulations and are considering whether it would be appropriate to revise them in the near future." Will EPA propose changes to the general conformity regulations, or are they just considering whether it would be appropriate?

  Page 307; should be updated and revised to reflect MOBILE6.2 as the most current emissions model outside of California, and EMFAC2002 for California.

  Page 394 395; " consultation with appropriate State and EPA technical representatives" should be revised to include consultation with State and local transportation agencies, and MPOs, in accordance with interagency consultation requirements in 40 CFR 93.105 and the State's conformity SIP.