[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Proposed Rules]
[Pages 8230-8233]
[FR Doc No: 2020-02829]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2020-0039; FRL-10005-03-Region 7]

Air Plan Approval; Missouri; Removal of Control of Emissions From
the Application of Automotive Underbody Deadeners

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing
approval of a State Implementation Plan (SIP) revision submitted by the
State of Missouri on December 3, 2018, and supplemented by letter on
May 22, 2019. Missouri requests that the EPA remove a rule related to
control of emissions from the application of automotive underbody
deadeners in the Kansas City, Missouri area from its SIP. This removal
does not have an adverse effect on air quality. The EPA's proposed
approval of this rule revision

is in accordance with the requirements of the Clean Air Act (CAA).

DATES: Comments must be received on or before March 16, 2020.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2020-0039 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: William Stone, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551-
7714; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?
III. Background
IV. What is the EPA's analysis of Missouri's SIP revision request?
V. Have the requirements for approval of a SIP revision been met?
VI. What action is the EPA taking?
VII. Incorporation by Reference
VIII. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2020-
0039 at https://www.regulations.gov. Once submitted, comments cannot be
edited or removed from Regulations.gov. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve the removal of 10 Code of State
Regulations (CSR) 10-2.310, Control of Emissions from the Application
of Automotive Underbody Deadeners, from the Missouri SIP.
    According to the May 22, 2019 letter from the Missouri Department
of Natural Resources, available in the docket for this proposed action,
Missouri rescinded the rule because the only source subject to the rule
ceased operations in 1988, and the rule is no longer necessary for
attainment and maintenance of the 1979, 1997, or 2008 National Ambient
Air Quality Standards (NAAQS) for Ozone.

III. Background

    The EPA established a 1-hour ozone NAAQS in 1971. 36 FR 8186 (April
30, 1971). On March 3, 1978, the EPA designated Clay, Platte and
Jackson counties (hereinafter referred to in this document as the
``Kanas City Area'') in nonattainment of the 1971 1-hour ozone
NAAQS,\1\ as required by the CAA Amendments of 1977. 43 FR 8962 (March
3, 1978). On February 8, 1979, the EPA revised the 1-hour ozone NAAQS,
referred to as the 1979 ozone NAAQS. 44 FR 8202 (February 8, 1979). On
February 20, 1985, the EPA notified Missouri that the SIP was
substantially inadequate (hereinafter referred to as the ``SIP Call'')
to attain the 1-hour ozone NAAQS in the Kansas City Area. See 50 FR
26198 (July 25, 1985).
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    \1\ Missouri's May 22, 2019 letter incorrectly states that the
Kansas City area was designated as a nonattainment area for the 1979
ozone NAAQS in 1978.
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    To address the SIP Call, Missouri submitted an attainment
demonstration on May 21, 1986, and volatile organic compound (VOC)
control regulations on December 18, 1987. See 54 FR 10322 (March 13,
1989) and 54 FR 46232 (November 2, 1989). The EPA subsequently approved
the revised control strategy for the Kansas City Area. See id. The VOC
control regulations approved by EPA into the SIP included reasonably
available control technology (RACT) rules as required by CAA section
172(b)(2), including 10 CSR 10-2.310 Control of Emissions from the
Application of Automotive Underbody Deadeners.
    The EPA redesignated the Kansas City Area to attainment of the 1979
1-hour ozone standard on July 23, 1992. 57 FR 27939 (June 23, 1992).
Pursuant to section 175A of the CAA, the first 10-year maintenance
period for the 1-hour ozone standard began on July 23, 1992, the
effective date of the redesignation approval. The maintenance plan for
the second maintenance period was effective February 12, 2004. 69 FR
1921 (January 13, 2004). Missouri achieved the required maintenance of
the 1979 1-hour ozone standard in 2014 after completing a twenty-two
year maintenance period.
    On April 30, 2004, the EPA published a final rule in the Federal
Register stating the 1-hour ozone NAAQS would no longer apply (i.e.,
would be revoked) for an area one year after the effective date of the
area's designation for the 8-hour ozone NAAQS. 69 FR 23951 (April 30,
2004). The effective date of the revocation of the 1979 1-hour ozone
standard for the Kansas City Area was June 15, 2005. See 70 FR 44470
(August 3, 2005).
    As noted above, 10 CSR 10-2.310, Control of Emissions from the
Application of Automotive Underbody Deadeners, was approved into the
Missouri SIP as a RACT rule on March 13, 1989. 54 FR 10322 (March 13,
1989). At the time that the rule was approved into the SIP, 10 CSR 10-
2.310 applied to all installations in the Clay, Jackson and Platte
Counties in Missouri that had the uncontrolled potential to emit more
than 100 tons per year or 250 kilograms per day of VOCs from the
application of automotive underbody deadeners.
    By letter dated December 3, 2018, Missouri requested that the EPA
remove 10 CSR 10-2.310 from the SIP. Section 110(l) of the CAA
prohibits EPA from approving a SIP revision that interferes with any
applicable requirement concerning attainment and reasonable further
progress (RFP), or any other applicable requirement of the CAA. The
State supplemented its SIP revision with a March 22, 2019 letter in
order to address the requirements of section 110(l) of the CAA.

IV. What is the EPA's analysis of Missouri's SIP revision request?

    In its May 22, 2019 letter, Missouri states that it intended its
RACT rules, such as 10 CSR 10-2.310, to solely apply to existing
sources in accordance with section 172(c)(1) of the CAA.\2\ Missouri
states that although the applicability section of 10 CSR 10-2.310

states that the rule applies to all installations (located within the
Clay, Jackson and Platte Counties), the rule applied to a single
existing source, the Leeds General Motors plant, as indicated in the
general provisions and emission limit sections of the rule. In
addition, Missouri states that the rule does not impose an emission
limit for any other source besides the Leeds General Motors plant.
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    \2\ The EPA agrees with Missouri's interpretation of CAA section
172(c)(1) in regards to whether RACT is required for existing
sources, but also notes that the State regulation establishing RACT
may apply to new sources as well, dependent upon the State
regulation's language.
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    Missouri, in its May 22, 2019 letter, indicates that the Leeds
General Motors plant ceased operations in 1988 and the emitting
equipment was subsequently decommissioned. Missouri also states that
the General Motors Corporation sold the facility in June 1993. The EPA
has confirmed that the facility is decommissioned and is no longer
subject to 10 CSR 10-2.310.
    As stated above, Missouri argues that 10 CSR 10-2.310 may be
removed from the SIP because section 172(c)(1) of the CAA requires RACT
for existing sources, and because 10 CSR 10-2.310 was applicable to a
single source that has permanently ceased operations and therefore the
rule no longer reduces VOC emissions. Because the Leeds General Motor
plant was the only source that was subject to the rule, and because the
facility has been shut-down and dismantled since 1988, the EPA is
proposing to find that the rule no longer provides an emission
reduction benefit to the Kansas City Area and is proposing to remove it
from the SIP.
    Missouri's May 22, 2019 letter states that any new sources or major
modifications of existing sources are subject to new source review
(NSR) permitting. Under NSR, a new major source or major modification
of an existing source with a (potential to emit) PTE of 250 tons per
year (tpy) or more of any NAAQS pollutant is required to obtain a
Prevention of Significant Deterioration (PSD) permit when the area is
in attainment or unclassifiable, which requires an analysis of Best
Available Control Technology (BACT) in addition to an air quality
analysis and an additional impacts analysis. Sources with a PTE greater
than 100 tpy, but less than 250 tpy, are required to obtain a minor
permit in accordance with Missouri's New Source Review permitting
program, which is approved into the SIP.\3\ The EPA agrees with this
analysis.
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    \3\ EPA's latest approval of Missouri's NSR permitting program
rule was published in the Federal Register on October 11, 2016. 81
FR 70025.
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    Missouri's May 22, 2019 letter also includes information concerning
ozone air quality in the Kansas City area from 1996 through 2018 that
indicates a downward trend in monitored ozone design values. Missouri
states that despite promulgation of more stringent ozone NAAQS in 1997,
2008 and 2015, the Kansas City area continues to monitor attainment.
The EPA has confirmed that certified ambient air quality data for
Kansas City Area as monitored at the Rocky Creek, Clay County state and
local air monitoring station is compliant with the most recent ozone
standard--the 2015 ozone NAAQS.\4\ The 2016-2018 design value for that
monitor is 70 parts per million.\5\
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    \4\ In accordance 40 CFR part 50.19(b), the 2015 8-hour primary
O3 NAAQS is met at an ambient air quality monitoring site
when 3-year average of the annual fourth-highest daily maximum 8-
hour average O3 concentration is less than or equal to
0.070 ppm, as determined in accordance with appendix U to 40 CFR
part 50.
    \5\ The monitoring data was reported, quality assured, and
certified in accordance with the requirements set forth in 40 CFR
part 58.
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    Because Missouri has demonstrated that removal of 10 CSR 10-2.310
will not interfere with attainment of the NAAQS, RFP \6\ or any other
applicable requirement of the CAA because the single source subject to
the rule has permanently ceased operations and removal of the rule will
not cause VOC emissions to increase, the EPA proposes to approve
removal of 10 CSR 10-2.310 from the SIP.
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    \6\ RFP is not applicable to the Kansas City Area because the
area is in attainment of all applicable ozone standards.
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V. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from February 28,
2018, to April 5, 2018 and received five comments from the EPA that
related to Missouri's lack of an adequate demonstration that the rule
could be removed from the SIP in accordance with section 110(l) of the
CAA. Missouri's May 22, 2019 letter addressed the EPA's comments. In
addition, the revision meets the substantive SIP requirements of the
CAA, including section 110 and implementing regulations.

VI. What action is the EPA taking?

    The EPA is proposing to approve Missouri's request to rescind 10
CSR 2.310 from the SIP because the rule applied to a single source that
has permanently ceased operations and because the rule was not
applicable to additional sources, it no longer serves to reduce
emmissions. Additionally, the maintenance period for the 1979 ozone
NAAQS for the Kansas City Area ended in 2014 and the area continues to
monitor attainment of the 2015 Ozone NAAQS. Any new sources or major
modifications of existing sources in the Kansas City Area are subject
to NSR permitting. We are processing this as a proposed action because
we are soliciting comments on this proposed action. Final rulemaking
will occur after consideration of any comments.

VII. Incorporation by Reference

    In this document, the EPA is proposing to amend regulatory text
that includes incorporation by reference. As described in the proposed
amendments to 40 CFR part 52 set forth below, the EPA is proposing to
remove provisions of the EPA-Approved Missouri Regulation from the
Missouri State Implementation Plan, which is incorporated by reference
in accordance with the requirements of 1 CFR part 51.

VIII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive

Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: February 6, 2020.
James Gulliford,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR part 52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart AA--Missouri

Sec.  52.1320   [Amended]

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by removing
the entry ``10-2.310'' under the heading ``Chapter 2-Air Quality
Standards and Air Pollution Control Regulations for the Kansas City
Metropolitan Area''.

[FR Doc. 2020-02829 Filed 2-12-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72646-72647]
[FR Doc No: 2021-27662]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93802; File No. SR-NYSE-2021-72]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
for Non-Substantive Conforming Changes to Rule 18

December 16, 2021.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on December 9, 2021, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes non-substantive conforming changes to Rule
18. The proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes non-substantive conforming changes to Rule 18
(Compensation in Relation to Exchange System Failure).
    Earlier this year, the Exchange eliminated member and non-member
employee Floor Officials and transited the duties and responsibilities
of Floor Officials to newly created Trading Officials, who are Exchange
employees appointed by the NYSE CEO or his or her designee.\4\ As part
of this change, the Exchange amended, among other rules, Rule 18, which
sets forth the process for member organizations to seek reimbursement
for losses resulting from system failures. Specifically, former Rule
18(d) established a Compensation Review Panel consisting of three Floor
Governors and three Exchange employees to determine the eligibility of
a claim for payment. Since elimination of Floor Governors left Exchange
employees as the sole members of the Compensation Review Panel, the
Exchange eliminated the Compensation Review Panel and amended Rule
18(d) to provide that the Exchange will review claims submitted
pursuant to Rule 18 and determine eligibility of a claim for
payment.\5\
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    \4\ See Securities Exchange Act Release No. 92193 (June 16,
2021), 86 FR 33001 (June 23, 2021) (SR-NYSE-2020-105) (Order).
    \5\ See id., 86 FR at 33002. As described in the previous
filing, claims under Rule 18(d) would continue to be validated and
reviewed by Exchange employees but retention of the Compensation
Review Panel was unnecessary given that elimination of Floor
Officials, which would leave the panels composed solely of Exchange
employees.
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    As part of that filing, the Exchange inadvertently failed to amend
subsections (e) and (f) of Rule 18, which describe the workings of the
Compensation Review Panel, as well the deleting the references to the
Compensation Review Panel in subsections (c) and (d) of Supplementary
Material .10, which governs Rule 18 claims by the Exchange's affiliate
NYSE American LLC. The Exchange accordingly proposes the following
conforming changes to Rule 18.
    Rule 18(e) provides that Compensation Review Panel determinations
are by majority vote and that in the event of a deadlock the final
determination will be made by the Chief Executive Officer of the
Exchange (``CEO'') or his or her designee. Consistent with the previous
filing, the Exchange proposes to delete subsection (e) as obsolete.
Current subsection (f), which provides that all determinations made
pursuant to Rule 18 by the Compensation Review Panel, the CEO or his or
her designee are final, would become new subsection (e). The phrase
``the Compensation Review Panel, the CEO or his or her designee'' in
subsection (f) would also be deleted. Proposed Rule 18(f) would
accordingly provide that all determinations made pursuant to the Rule
are final. Finally the references to Compensation Review Panel in
subsections (c) and (d) of Supplementary Material .10 would be replaced
with the Exchange.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\6\ in general, and furthers the objectives of Section 6(b)(5),\7\
in particular, because it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system and, in general, to protect investors and
the public interest.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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    In particular, the Exchange believes that the proposed non-
substantive conforming changes would remove impediments to and perfect
the mechanism of a free and open market and a national market system
and, in general, protect investors and the public interest because the
proposed non-substantive changes would add clarity, transparency and
consistency to the

Exchange's rules. The Exchange believes that market participants would
benefit from the increased clarity, thereby reducing potential
confusion and ensuring that persons subject to the Exchange's
jurisdiction, regulators, and the investing public can more easily
navigate and understand the Exchange's rules.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues but is rather concerned with
making non-substantive conforming changes to the Exchange rules. Since
the proposal does not substantively modify system functionality or
processes on the Exchange, the proposed changes will not impose any
burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) \9\
thereunder.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \10\ of the Act to determine whether the proposed
rule should be approved or disapproved.
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    \10\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSE-2021-72 on the subject line.

Paper Comments

     Send paper comments in triplicate to: Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File Number SR-NYSE-2021-72. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2021-72 and should be submitted on
or before January 12, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-27662 Filed 12-21-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Page 19410]
[FR Doc No: 2012-7724]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Schedule Information Submission Deadline for O'Hare
International Airport, San Francisco International Airport, John F.
Kennedy International Airport, and Newark Liberty International Airport
for the Winter 2012-2013 Scheduling Season

AGENCY: Department of Transportation, Federal Aviation Administration
(FAA).

ACTION: Notice of submission deadline.

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SUMMARY: Under this notice, the FAA announces the submission deadline
of May 10, 2012, for Winter 2012-2013 flight schedules at Chicago's
O'Hare International Airport (ORD), San Francisco International Airport
(SFO), New York's John F. Kennedy International Airport (JFK), and
Newark Liberty International Airport (EWR) in accordance with the
International Air Transport Association (IATA) Worldwide Slot
Guidelines. The deadline coincides with the schedule submission
deadline for the IATA Slot Conference for the Winter 2012-2013
scheduling season.

SUPPLEMENTARY INFORMATION: The FAA has designated ORD as an IATA Level
2 airport, SFO as a Level 2 airport, JFK as a Level 3 airport, and EWR
as a Level 3 airport. Scheduled operations at JFK and EWR are currently
limited by FAA Orders until a final Congestion Management Rule for
LaGuardia Airport, John F. Kennedy International Airport, and Newark
Liberty International Airport (RIN 2120-AJ89) becomes effective but not
later than October 26, 2013.\1\
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    \1\ Operating Limitations at John F. Kennedy International
Airport, 73 FR 3510 (Jan. 18, 2008) as amended 76 FR 18620 (Apr. 4,
2011); Operating Limitations at Newark Liberty International
Airport, 73 FR 29550 (May 21, 2008) as amended 76 FR 18618 (Apr. 4,
2011).
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    The FAA is primarily concerned about planned passenger and cargo
operations during peak hours, but carriers may submit schedule plans
for the entire day. At ORD, the peak hours are 0700 to 2100 Central
Time (1300 to 0300 UTC), at SFO from 0600 to 2300 Pacific Time (1400 to
0700 UTC), and at EWR and JFK from 0600 to 2300 Eastern Time (1100 to
0400 UTC). Carriers should submit schedule information in sufficient
detail including, at minimum, the operating carrier, flight number,
scheduled time of operation, frequency, and effective dates. IATA
standard schedule information format and data elements (Standard
Schedules Information Manual or SSIM) may be used.
    The U.S. winter scheduling season for these airports is from
October 28, 2012, through March 30, 2013, in recognition of the IATA
northern winter period. The FAA understands there may be differences in
schedule times due to different U.S. daylight saving time dates, and
the FAA will accommodate these differences to the extent possible.

DATES: Schedules must be submitted no later than May 10, 2012.

ADDRESSES: Schedules may be submitted by mail to the Slot
Administration Office, AGC-200, Office of the Chief Counsel, 800
Independence Ave. SW., Washington, DC 20591; by facsimile to: 202-267-
7277; or by email to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Robert Hawks, Office of the Chief
Counsel, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone number:<PHONE_NUMBER>; fax number: 202-
267-7971; email<EMAIL_ADDRESS>
    Issued in Washington, DC, on March 27, 2012.
Rebecca B. MacPherson,
Assistant Chief Counsel for Regulations.
[FR Doc. 2012-7724 Filed 3-29-12; 8:45 am]
BILLING CODE 4910-13-P


1 of 13 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING August 23  26, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2005 0172 TUESDAY, August 23, 2005 Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 ( 703) 807 2000 PRELIMINARY N METHYL CARBAMATE CUMULATIVE RISK ASSESSMENT

8: 30 A. M. Introduction and Identification of Panel Members  Stephen M. Roberts, Ph. D., FIFRA SAP Chair

8: 40 A. M. Administrative Procedures by Designated Federal Official  Ms. Myrta R. Christian

8: 45 A. M. Welcome  Clifford Gabriel, Ph. D. ( Director, Office of Science Coordination and Policy, EPA)

8: 50 A. M. Opening Remarks  Jim Jones ( Director, Office of Pesticide Programs, EPA)

8: 55 A. M. Opening Remarks  Tina Levine, Ph. D. ( Director, Health Effects Division, Office of Pesticide Programs, EPA)

9: 00 A. M. Background and Overview  Anna Lowit, Ph. D., David Miller ( Health Effects Division, Office of Pesticide Programs, EPA)

9: 20 A. M. Public Comments

10: 20 A. M. BREAK

10: 35 A. M. Preliminary Cumulative Hazard Assessment  Introduction  Anna Lowit, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

10: 45 A. M. Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates  R. Woodrow Setzer, Ph. D. ( Office of Research and Development, National Center for Computational Toxicology, EPA)

11: 30 A. M. Laboratory Studies with the N Methyl Carbamate Insecticides  Stephanie Padilla, Ph. D. ( Office of Research and Development, National Health and Environmental Effects Research Laboratory, EPA)

11: 55 A. M. Relative Potency Factors and Points of Departure  Elissa Reaves, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

12: 15 P. M. Preliminary Cumulative Hazard Assessment  Conclusions  Anna Lowit, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

12: 30 P. M. LUNCH 2 of 13

1: 30 P. M. Questions to the Panel HAZARD EPA's hazard and dose response chapter ( I. B) and associated appendices ( II. B. 1 6) of the Preliminary Cumulative Risk Assessment describe the application of the Relative Potency Factor ( RPF) method to the N methyl carbamate pesticides. These documents a) outline the steps in developing the dose response relationships for each pesticide and its capacity to inhibit AChE in rats; b) describe the data used in the assessment; c) summarize the empirical dose response modeling which provides the basis for the relative potency factors ( RPFs), points of departure ( PoDs), and estimates of AChE inhibition half life; and d) provide the rationale for selecting oxamyl as the index chemical.

HAZARD QUESTION # 1 Empirical Dose Response and Time Course Modeling At the February, 2005 meeting of the FIFRA SAP, EPA proposed an empirical model for use in the cumulative risk assessment of the N methyl carbamates. This model contains a dose response and a time to recovery component. Based on the comments from the Panel and following experience with its application, EPA made some modifications to this proposed model. EPA has applied this revised empirical model to the available RBC and brain cholinesterase data for the N methyl carbamates. BMD and BMDL estimates provided in the preliminary assessment were derived from cholinesterase data from multiple studies and in some cases, using different cholinesterase measurement techniques.

H1a. Please comment on the mathematical/ statistical approach to modeling cholinesterase data used to estimate benchmark dose values and time to half life recovery in the preliminary cumulative risk assessment. Please address biological and mathematical/ statistical considerations in your response.

H1b. Please comment on the adequacy, clarity, and transparency of the documentation provided for the empirical dose response and time course modeling.

3: 00 P. M. BREAK

3: 15 P. M. Questions to the Panel ( continued)

HAZARD QUESTION # 2 Selection of the Index Chemical 3 of 13 EPA's cumulative risk assessment guidance indicates that the index chemical should be selected based on the availability of high quality toxicity database for the common mechanism endpoint. The selection of the index chemical is an important step in the cumulative risk assessment; the BMD for oxamyl was used to calculate RPFs and the BMDL for oxamyl was used as the PoD for extrapolating cumulative risk.

H2. Please comment on the rationale provided for the selection of the index chemical. Should any additional factors be included in the rationale for the selection of oxamyl as the index chemical?

4: 15 P. M. BREAK

4: 30 P. M. Questions to the Panel ( continued)

HAZARD QUESTION # 3 Selection of Brain ChE data for developing RPFs and PoDs EPA has used data for brain ChE as the basis for the RPFs and PoDs. The rationale for this selection was provided in I. B.

H3. Please comment on the rationale provided for the selection of the brain ChE as the basis for RPFs and PoDs in the preliminary cumulative risk assessment. Should any additional factors be considered?

5: 30 P. M. ADJOURNMENT 4 of 13 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING August 23  26, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2005 0172 WEDNESDAY, August 24, 2005 Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 ( 703) 807 2000 PRELIMINARY N METHYL CARBAMATE CUMULATIVE RISK ASSESSMENT

8: 30 A. M. Introduction and Identification of Panel Members  Stephen M. Roberts, Ph. D., FIFRA SAP Chair

8: 40 A. M. Opening Remarks  Steven Bradbury, Ph. D. ( Director, Environmental Fate and Effects Division, Office of Pesticide Programs, EPA)

8: 45 A. M. Drinking Water Exposure Assessment: Ground Water Model Evaluation  Dirk Young, Ph. D. ( Environmental Fate and Effects Division, Office of Pesticide Programs, EPA)

9: 30 A. M. Drinking Water Exposure Assessment: Drinking Water Exposure Estimates  Nelson Thurman ( Environmental Fate and Effects Division, Office of Pesticide Programs, EPA)

10: 15 A. M. BREAK

10: 30 A. M. Questions to the Panel WATER QUESTION # 1 Revised Conceptual Model for Ground Water Based on recommendations of the February 2005 SAP, OPP revised its ground water modeling approach to estimate pesticide concentrations in the upper meter of a fixed saturated zone ( ground water) that starts at 3.5 m below the surface. The Agency has included two additional adjustments to the original conceptual model since the earlier SAP. The models consider variable degradation rates with depth and account for setback distances between the well and the application area by using lateral velocity to estimate the additional travel time for a pesticide to reach the well.

W1. Please comment on the Agency's revisions to the ground water modeling approach to account for variable degradation rates with depth and varying setback distances between the well and treated fields. 5 of 13

12: 00 P. M. LUNCH

1: 00 P. M. Questions to the Panel ( continued)

WATER QUESTION # 2 Comparisons of the Three Models The three models used by the Agency ( PRZM, RZWQM, and LEACHP) provided predicted concentrations that were similar on average, but short term concentration differences among the models varied considerably. Differences in peak concentration estimates ranged from a factor of 2 to 5 in Florida to as much as a factor of 20 in North Carolina; however, there was no consistency with regard to which model gave the highest or lowest predictions. Some of these differences may be due to differences in the way the models handle degradation temperature relationships, evapotranspiration, and weather generation.

W2. Given that no model stands out as superior when compared to the monitoring data evaluated so far, can the SAP suggest criteria for further evaluation of the models?

3: 00 P. M. BREAK

3: 15 P. M. Questions to the Panel ( continued)

WATER QUESTION # 3 Evaluation of the Ground Water Model Estimates The Agency compared NMC concentrations in ground water estimated with the three models ( PRZM, RZWQM, LEACHP) to results of available prospective ground water monitoring studies ( oxamyl in NC and MD and methomyl in GA), two well monitoring studies along the central ridge of FL, and published literature on in field monitoring studies. Using the FL well monitoring data, known fate characteristics of the NMC pesticides, and soil and hydrologic data, the Agency identified the conditions under which exposures similar to that estimated in the NMC CRA may occur: private wells drawing from shallow, acidic ground water with high to very high saturated hydraulic conductivities in the soil and vadose zone. This has allowed the Agency to move toward a spatially explicit characterization of potential high exposure areas.

W3. Please comment on the performance of the models against the available monitoring data. What additional considerations should be taken into account when applying modeled estimates to risk assessments for areas where monitoring data are not available?

5: 30 P. M. ADJOURNMENT 6 of 13 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING August 23  26, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2005 0172 THURSDAY, August 25, 2005 Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 ( 703) 807 2000 PRELIMINARY N METHYL CARBAMATE CUMULATIVE RISK ASSESSMENT

8: 30 A. M. Introduction and Identification of Panel Members  Steven G. Heeringa, Ph. D., FIFRA SAP Session Chair

8: 40 A. M. Opening Remarks  Tina Levine, Ph. D. ( Director, Health Effects Division, Office of Pesticide Programs, EPA)

8: 45 A. M. Dietary Assessment  David Hrdy ( Health Effects Division, Office of Pesticide Programs, EPA)

10: 00 A. M. BREAK

10: 15 A. M. Question to the Panel FOOD QUESTION # 1 The food portion of the N methyl carbamate cumulative risk assessment used similar data sources and techniques to those used for the organophosphate pesticide for estimating cumulative risk from food. This included use of both the USDA's Continuing Survey of Food Intakes by Individuals ( CSFII) as a data source for food consumption and Pesticide Data Program Data ( PDP) as a data source for food residues.

F1. Please comment on the planned intermediate and longer term activities associated with sensitivity analyses identified in Section I of the document. Does the Panel have any suggestions for other or additional activities which the Agency should consider?

11: 15 A. M. Residential Assessment  Jeff Evans, Steve Nako, Ph. D., and Philip Villanueva ( Health Effects Division, Office of Pesticide Programs, EPA)

12: 15 P. M. LUNCH

1: 15 P. M. Questions to the Panel 7 of 13 RESIDENTIAL QUESTION # 1 Use of REJV Data and Professional Judgment To generate estimates of exposure from residential use of NMC pesticides, the probabilistic models use a variety of inputs to address potential exposure from multiple use scenarios. Critical inputs include the percent of households applying the various pesticide products, and the timing of those applications. These two inputs, coupled with potential exposure from pesticide residues in drinking water and the diet, directly impact per capita estimates of cumulative exposure. In its February Case Study, the Agency presented background information on the Residential Exposure Joint Venture ( REJV) survey. The Agency used this database as the primary source for data on the inputs relating to timing of applications and percent of households using NMC products. Details regarding the empirical details of the REJV survey are presented in Appendix II. E. 1.

In February 2005, the SAP expressed reservations regarding the REJV data. In response to SAP concerns, EPA used other non survey information in this preliminary CRA, in addition to estimates from REJV, to develop use/ usage inputs and seasonal timelines of pesticide use which were representative of the Southern region of the U. S.

As previously mentioned, the REJV survey can be used to generate empirically based estimates of percent of household use and the frequency of product specific applications. But, because the REJV did not collect information regarding the reason for the reported pesticide use ( pest treated) or how much of the product was used, the empirical timing and frequency information ( based on a national survey) may not provide a clear picture of regional use. Therefore, to establish the timing of pesticide applications for the scenarios likely to result in the highest exposure, OPP made these estimates based on a combination of REJV data, product label information, professional judgment, and pest pressure information available from the Cooperative State Extension Services. Specific examples of how these sources were used to determine timing and frequency of pesticide use for PNMC residential assessment are presented in Section E of the preliminary NMC CRA document.

R1. Please comment on the use of information sources other than REJV to establish periods of pesticide use and other use/ usage information. Does the Panel suggest an alternative method to improve the use of REJV in the NMC assessment? Does the Panel know of other data sources that may be available?

RESIDENTIAL QUESTION # 2 Uncertainties Associated with the Hand To Mouth Assessment To assess non dietary ingestion ( mg/ day), the following four key factors are used in the models: 8 of 13

Residue Concentration ( turf residues, pet fur residues, and residues from hard indoor surfaces)

Hand to mouth frequency ( number of events per hour)

Surface area of the inserted hand parts ( cm2)

Exposure time ( hours/ day)

Other factors include both saliva extraction efficiency and wet hand adjustment factor. This exposure estimate is then used along with the Relative Potency Factor ( RPF) and Benchmark Dose to estimate risk. In the Preliminary N methyl carbamate assessment, risk estimates for non dietary oral exposure result in the lowest Margins of Exposure ( MOEs), and would therefore be of greatest concern to the Agency; however, these low MOEs appear to be due in part to the incorporation of micro activity data into our macro activity models. As a result, the non dietary ingestion scenarios in the Preliminary Nmethyl carbamate cumulative risk assessment are the least refined.

The residue concentration values are derived from individual residue dissipation or deposition studies which are discussed in the Residential Chapter ( Section E) of the Cumulative Risk Assessment document. The exposure durations are taken from the Agency's Exposure Factors Handbook. The hand to mouth frequencies and hand surface areas come from behavior studies relying either on observational data of young children using video tape analysis, trained observers, or parental observers. However, study data that evaluated hand to mouth frequency and surface area mouthed is difficult to interpret. Specifically, comparison of study results can be difficult due to differences in study practices and methodologies. For example, there are no standard definitions of mouthing ( superficial contact, licking, biting, fraction of hand inserted) and thus the data for these behaviors likely differs among studies as a result of the investigators definitions. In addition, the degree to which ancillary data ( such as surface area of hand contacted or inserted, the duration of contact, and the length of videotaping) are collected and reported differ among studies. This makes broad based and generally applicable interpretation difficult. Nevertheless, Drs. Zartarian and Xue allowed us to use their preliminary distributional analyses of these children's video data in this assessment. The studies used in the hand to mouth frequency analysis performed by Zartarian and Xue are briefly summarized in a table provided in a memorandum dated August 8, 2005 and provided to the Panel under separate cover.

The distributions of hand to mouth frequencies and surface area mouthed used in the Preliminary NMC CRA were based on the analysis performed by Zartarian and Xue ( as detailed above). In the aggregate models used in the NMC cumulative assessment, each separate iteration selects a single value for the hand to mouth events variable from a distribution of hand to mouth frequency values. Also, each separate iteration of the model selects a single surface area from a distribution of the fraction of hand mouthed. These values are multiplied by the residues and exposure durations which are similarly 9 of 13 selected from a distribution of residue and exposure durations as described above. This relatively simple selection process, however, ignores the numerous complexities and interrelationships involved in this critical behavior pattern. ( For example, the fraction of a hand which is mouthed during each mouthing event may be inversely correlated with the frequency with which the hand is mouthed. Specifically, a high frequency of hand tomouth events may be associated with a smaller fraction of the hand which is mouthed. The algorithms used in the NMC CRA however, ( as established by the OPP Residential Standard Operating Procedures ( SOP's)) assume independence between these two parameters. This assumption likely leads to overestimates of exposures when upper percentiles of the hand to mouth frequency and area of hand mouthed distributions are combined. In addition, the macroactivity approach used in the NMC CRA aggregate models is based on the following assumptions:

The mouthing frequency ( events per hour), as recorded during the course of observational studies, continues at the same rate for the entire exposure duration selected; in reality, a high end mouthing frequency recorded over a short time interval ( e. g., one hour) may be unlikely to continue at the same intensity over a longer time period ( e. g., 6 or 8 hours)

The hand is fully replenished with residues from a contaminated surface ( e. g., the lawn, pet or hard flooring) between each hand to mouth event

The contact frequency and surface area data used in this assessment are taken from observational studies in which all hand contacts were recorded as hand tomouth events, regardless of the fraction of hand mouthed. Additionally, no adjustment was made for the duration of time the hand remained in the mouth.

R2a. The methodology used in the NMC CRA in which micro activity data are used in macro activity approach likely leads to systematic overestimates of exposure when upper percentiles of mouthing frequency and surface area of hand mouthed are combined. Does the Panel agree that this methodology does indeed overestimate exposure? Can the Panel suggest improvements to this methodology to further refine exposure estimates?

R2b. Does the Panel have suggestions for an alternative approach to the one used to estimate the non dietary oral exposure pathway in the Preliminary NMC CRA? For example, would the use of a time weighted frequency value based on random hourly draws of hand frequency distributions more accurately estimate hand to mouth exposures?

3: 30 P. M. BREAK

3: 45 P. M. Questions to the Panel ( continued)

RESIDENTIAL QUESTION # 3 10 of 13 Distributional Analysis Assessing residential exposure to pesticides is a complex process that must consider exposure from a variety of sources via multiple routes. To account for exposure from different sources, the PNMC residential exposure assessment identifies scenarios where significant exposure may occur. Each of these scenarios is defined by a specific type of activity or set of activities that may result in exposure. Generally the relationships between these activities and the resulting exposures are well defined in that algorithms, equations, and standard operating procedures exist for calculating exposure based on the activity being performed. However the supporting data sets used to estimate exposure for various residential scenarios range from robust ( e. g. unit exposure values) to limited or sparse ( e. g. lawn sizes, area treated, duration of exposure, and saliva extraction factors). Additionally, information characterizing the extent to which each activity contributes to exposure for a particular scenario does not always exist ( e. g. the amount of time spent in home gardens performing activities such as hand weeding versus staking tomatoes or harvesting sweet corn).

In general, the Agency has attempted to fit distributions ( as described in Appendix II. E. 2 of the NMC CRA) to the exposure measurements for residential activities when supporting information exists to characterize the extent to which the activity contributes to exposure for the residential scenario of interest. However, the Agency has employed uniform distributions to the data sets for which such supporting information does not exist, ( e. g. lawn sizes, area treated, duration of exposure, and saliva extraction factors). The Agency has elected to create such distributions when the available data are limited to such an extent that it is uncertain how well they represent national variability. The Agency believes use of uniform distributions to be conservative in estimating potential exposure since uniform distributions tend to overestimate exposure.

R3a. Please comment specifically on the Agency's use of lognormal distributions to estimate residential exposure and the statistical methods and procedures by which the Agency has selected particular distributions ( e. g. probability plots and goodness of fit statistics).

R3b. Does the Panel agree that the Agency's approach to creating and using uniform distributions ( i. e., ranges of values) for residential scenarios lacking adequate supporting information tends to overestimate exposure? Is the Panel aware of other data sources that may be better suited for assessing residential exposure scenarios of interest? Does the Panel have any suggestions regarding alternative distributions to use for scenarios where supporting exposure information is inadequate? To what extent should sensitivity analyses be used to assess the appropriateness of alternative distributions?

R3c. When the Agency fits distributions to various exposure values, the maximum value entered into the probabilistic models for a particular 11 of 13 distribution is usually defined to be an upper percentile value such as the 99th percentile in order to ensure realistic input parameters. Recognizing that the Agency intends to perform sensitivity analyses to evaluate the effects of this truncation, please comment on the Agency's approach of truncating distributions that are input to the probabilistic models. Please comment on any other approaches that the Agency might use to evaluate uncertainties associated with choices about whether and where to truncate distributions.

5: 30 P. M. ADJOURNMENT 12 of 13 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING August 23  26, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2005 0172 FRIDAY, August 26, 2005 Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 ( 703) 807 2000 PRELIMINARY N METHYL CARBAMATE CUMULATIVE RISK ASSESSMENT

8: 30 A. M. Introduction and Identification of Panel Members  Steven G. Heeringa, Ph. D., FIFRA SAP Session Chair

8: 40 A. M. Opening Remarks  Tina Levine, Ph. D. ( Director, Health Effects Division, Office of Pesticide Programs, EPA)

8: 45 A. M. Model Results Comparison  Alan Dixon ( Health Effects Division, Office of Pesticide Programs, EPA)

9: 15 A. M. Cumulative Risk Assessment  David Hrdy ( Health Effects Division, Office of Pesticide Programs, EPA)

10: 00 A. M. BREAK

10: 15 A. M. Risk Characterization  Anna Lowit, Ph. D., Nelson Thurman, and David Miller ( Office of Pesticide Programs, EPA)

12: 00 P. M. LUNCH

1: 00 P. M. Questions to the Panel INTEGRATION QUESTION # 1 The cumulative risk assessment guidance describes key principles for conducting these risk assessments. One such principle is the need to consider the time frame of both the exposure ( e. g., When does exposure occur? What is the exposure duration?) and of the toxic effect ( e. g., What are the time to peak effects and the time to recovery? How quickly is the effect reversed?). EPA's Preliminary Cumulative Risk Assessment for the N methyl carbamates describes the current limitations in data and software to fully characterize the dynamic nature of exposure, effect, and recovery for this common mechanism group. In order to address these limitations, OPP performed an examination of the exposure patterns for records from the high end of exposure distribution and found that a large fraction (~ 70%) of daily records contributing to the upper tail of the food exposure distribution represent single eating occasions. Regarding drinking water and 13 of 13 residential/ nonoccupational exposure, EPA's preliminary assessment provided a characterization of the current availability regarding datasets and models and a description of the impact of these limitations on the risk estimates from specific exposure pathways ( i. e., drinking water, residential).

I1a. Please comment on clarity and adequacy of the risk characterization provided in the preliminary cumulative risk assessment. Are there important aspects with respect to the strengths and weaknesses of the risk characterization other than the ones we identified?

I1b. Is the Panel aware of additional data which would aid the Agency in its cumulative risk characterization for the N methyl carbamate pesticides? For example, is the Panel aware of any available data on the timing of water consumption events or can the Panel make any recommendations regarding reasonable assumptions that could be made to help characterize the estimated risk? Are there other sensitivity analyses and further investigations that would be equally or more important than the ones we identified?

3: 30 P. M. BREAK

3: 15 P. M. Questions to the Panel ( continued)

4: 30 P. M. ADJOURNMENT Please be advised that agenda times are approximate. Because this is one 4 day meeting with four separate sessions, sessions will begin as the preceding session is completed, which could be the same day. For further information, please contact the Designated Federal Official for this meeting, Ms. Myrta Christian, via telephone: ( 202) 564 8450; fax: ( 202) 564 8382; or email: christian. myrta@ epa. gov


[Federal Register: June 18, 2010 (Volume 75, Number 117)]
[Proposed Rules]
[Page 34657-34661]
[DOCID:fr18jn10-18]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0550; Directorate Identifier 2009-NM-124-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) Airplanes; Model CL-600-2C10 (Regional
Jet Series 700, 701, & 702) Airplanes; Model CL-600-2D15 (Regional Jet
Series 705) Airplanes; and Model CL-600-2D24 (Regional Jet Series 900)
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as: Two cases of a crack on a ``dry'' ADG [air driven
generator] (Hamilton Sundstrand part number in the 761339 series), in
the aft area of the strut and generator housing assembly, have been
reported on CL-600-2B19 aircraft. The same part is also installed on
CL-600-2C10, -2D15 and -2D24 aircraft. Investigation determined that
the crack was in an area of the strut where the wall thickness of the
casting was below specification, due to a manufacturing anomaly in a
specific batch of ADGs. Structural failure and departure of the ADG
during deployment could possibly result in damage to the aircraft
structure. If deployment was activated by a dual engine shutdown, ADG
structural failure would also result in loss of hydraulics for the
flight controls. The proposed AD would require actions that are
intended to address the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by August 2, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Craig Yates, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0550;
Directorate Identifier 2009-NM-124-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We have lengthened the 30-day comment period for proposed ADs that
address MCAI originated by aviation authorities of other countries to
provide adequate time for interested parties to submit comments. The
comment period for these proposed ADs is now typically 45 days, which
is consistent with the comment period for domestic transport ADs.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation, which is the aviation authority
for Canada, has issued Canadian Airworthiness Directive CF-2009-27,
dated June 8, 2009 (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    Two cases of a crack on a ``dry'' ADG [air driven generator]
(Hamilton Sundstrand part number in the 761339 series), in the aft
area of the strut and generator housing assembly, have been reported
on CL-600-2B19 aircraft. The same part is also installed on CL-600-
2C10, -2D15 and -2D24 aircraft. Investigation determined that the
crack was in an area of the strut where the wall thickness of the
casting was below specification, due to a manufacturing anomaly in a
specific batch of ADGs. Structural failure and departure of the ADG
during deployment could possibly result in damage to the aircraft
structure. If deployment was activated by a dual engine shutdown,
ADG structural failure would also result in loss of hydraulics for
the flight controls.
    This directive gives instructions to check the part number of
the installed ADG and, for ADGs with a part number in the 761339
series, the serial numbers of the ADG and strut and generator
housing assembly are also to be checked. If these serial numbers are
within specified ranges ***, a one-time fluorescent penetrant
inspection of the ADG strut is required [and replacement of the ADG
if necessary].
    Note: For ADGs with serial numbers in the *** specified ranges,
subsequent fluorescent penetrant inspections are required after each
scheduled in-flight or on-ground functional check of the ADG and
also after each unscheduled in-flight ADG deployment. These
inspection requirements are not mandated in this directive but are
specified in the approved maintenance program.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier has issued Alert Service Bulletin A601R-24-120, Revision
C, dated April 20, 2009; and Alert Service Bulletin A670BA-24-020,
Revision C, dated April 20, 2009. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in

general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1,073 products of U.S. registry. We also estimate
that it would take about 1 work-hour per product to comply with the
basic requirements of this proposed AD. The average labor rate is $85
per work-hour. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $91,205, or $85 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2010-0550; Directorate Identifier
2009-NM-124-AD.

Comments Due Date

    (a) We must receive comments by August 2, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, serial numbers 7305
through 8051 inclusive; Model CL-600-2C10 (Regional Jet Series 700,
701, & 702) airplanes, serial numbers 10003 through 10260 inclusive;
and Model CL-600-2D15 (Regional Jet Series 705) airplanes and Model
CL-600-2D24 (Regional Jet Series 900) airplanes, serial numbers
15001 through 15106 inclusive; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical Power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Two cases of a crack on a ``dry'' ADG [air driven generator]
(Hamilton Sundstrand part number in the 761339 series), in the aft
area of the strut and generator housing assembly, have been reported
on CL-600-2B19 aircraft. The same part is also installed on CL-600-
2C10, -2D15 and -2D24 aircraft. Investigation determined that the
crack was in an area of the strut where the wall thickness of the
casting was below specification, due to a manufacturing anomaly in a
specific batch of ADGs. Structural failure and departure of the ADG
during deployment could possibly result in damage to the aircraft
structure. If deployment was activated by a dual engine shutdown,
ADG structural failure would also result in loss of hydraulics for
the flight controls.
    This directive gives instructions to check the part number of
the installed ADG and, for ADGs with a part number in the 761339
series, the serial numbers of the ADG and strut and generator
housing assembly are also to be checked. If these serial numbers are
within specified ranges ***, a one-time fluorescent penetrant
inspection of the ADG strut is required [and replacement of the ADG
if necessary].

    Note: For ADGs with serial numbers in the * * * specified
ranges, subsequent fluorescent penetrant inspections are required
after each scheduled in-flight or on-ground functional check of the
ADG and also after each unscheduled in-flight ADG deployment. These
inspection requirements are not mandated in this directive but are
specified in the approved maintenance program.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Do the following actions.
    (1) Within 1,000 flight hours after the effective date of this
AD or before the first scheduled ADG functional test after the
effective date of this AD, whichever occurs first, inspect to
determine the part number of the installed ADG. A review of the
airplane maintenance records is acceptable in lieu of this
inspection if the part number can be conclusively determined from
that review.
    (i) If a Hamilton Sundstrand ADG having part number 1711405 is
installed, the strut thickness is within specification and no
further action is required by this AD.
    (ii) If a Hamilton Sundstrand ADG having a part number in the
761339 series is installed, within 1,000 flight hours after the
effective date of this AD or before the first scheduled ADG
functional test after the effective date of this AD, whichever
occurs first, inspect to determine the serial number of the ADG. A
review of the airplane maintenance records is acceptable in lieu of
this inspection if the serial number can be conclusively determined
from that review.
    (A) If the serial number of the ADG is 2000 or higher, the strut
wall thickness is within specification and no further action is
required by this AD.
    (B) If the serial number of the ADG is in the range 0101 through
1999 and symbol ``24-3'' is marked in the serial number block of the
identification plate, the strut wall thickness is within
specification, no further action is required by this AD.
    (C) If the serial number of the ADG is in the range 0101 through
1999 and the symbol

``24-3'' is not marked in the serial block of the identification
plate, within 1,000 flight hours after the effective date of this AD
or before the first scheduled ADG functional test after the
effective date of this AD, whichever occurs first, inspect to
determine the serial number of the strut and generator housing
assembly. A review of the airplane maintenance records is acceptable
in lieu of this inspection if the serial number can be conclusively
determined from that review.
    (1) If the serial number of the strut and generator housing
assembly is in the range 0001 through 2503, do a fluorescent
penetrant inspection in accordance with paragraph (g)(2) of this AD
at the times specified in paragraph (g)(2) of this AD.
    (2) If the serial number of the strut and generator housing
assembly is 2504 or higher, the strut wall thickness is within
specification and no further action is required by this AD.
    (3) If the serial number of the strut and generator housing
assembly is not inspected or it is not possible to determine the
serial number, do a fluorescent penetrant inspection in accordance
with paragraph (g)(2) of this AD at the times specified in paragraph
(g)(2) of this AD.
    (2) For ADGs having a strut and generator assembly identified in
paragraph (g)(1)(ii)(C)(1) or (g)(1)(ii)(C)(3) of this AD: Within
1,000 flight hours after the effective date of this AD or before the
first scheduled ADG functional test after the effective date of this
AD, whichever occurs first, do a fluorescent penetrant inspection
for cracking of the ADG strut, and if any crack is found, before
further flight, replace the ADG with a serviceable ADG, in
accordance with the Accomplishment Instructions of Bombardier Alert
Service Bulletin A601R-24-120, Revision C, dated April 20, 2009 (for
Model CL-600-2B19 airplanes); or Bombardier Alert Service Bulletin
A670BA-24-020, Revision C, dated April 20, 2009 (for Model CL-600-
2C10, CL-600-2D15, and CL-600-2D24 airplanes).
    (3) Fluorescent penetrant inspections accomplished before the
effective date of this AD in accordance with any applicable service
bulletin specified in Table 1 of this AD are considered acceptable
for compliance with the corresponding fluorescent penetrant
inspection specified in this AD.

                                        Table 1--Credit Service Bulletins
----------------------------------------------------------------------------------------------------------------
      Bombardier, Inc. Model--             Service Bulletin--            Revision--               Dated--
----------------------------------------------------------------------------------------------------------------
CL-600-2B19 airplanes...............  Bombardier Alert Service      Original............  April 20, 2005.
                                       Bulletin A601R-24-120.
CL-600-2B19 airplanes...............  Bombardier Alert Service      A...................  December 1, 2005.
                                       Bulletin A601R-24-120.
CL-600-2B19 airplanes...............  Bombardier Alert Service      B...................  December 7, 2006.
                                       Bulletin A601R-24-120.
CL-600-2C10 airplanes and CL-600-     Bombardier Alert Service      Original............  April 20, 2005.
 2D24 airplanes.                       Bulletin A670BA-24-020.
CL-600-2C10 airplanes; and CL-600-    Bombardier Alert Service      A...................  May 17, 2005.
 2D15 and CL-600-2D24 airplanes.       Bulletin A670BA-24-020.
CL-600-2C10 airplanes; and CL-600-    Bombardier Alert Service      B...................  December 7, 2006.
 2D15 and CL-600-2D24 airplanes.       Bulletin A670BA-24-020.
CL-600-2B19 airplanes; CL-600-2C10    Hamilton Sundstrand Service   Original............  April 14, 2005.
 airplanes; and CL-600-2D15 and CL-    Bulletin ERPS10AG-24-3.
 600-2D24 airplanes.
CL-600-2B19 airplanes; CL-600-2C10    Hamilton Sundstrand Service   1...................  April 19, 2005.
 airplanes; and CL-600-2D15 and CL-    Bulletin ERPS10AG-24-3.
 600-2D24 airplanes.
CL-600-2B19 airplanes; CL-600-2C10    Hamilton Sundstrand Service   2...................  November 14, 2006.
 airplanes; and CL-600-2D15 and CL-    Bulletin ERPS10AG-24-3.
 600-2D24 airplanes.
Bombardier, Inc. CL-600-2B19          Hamilton Sundstrand Service   3...................  March 12, 2009.
 airplanes; CL-600-2C10 airplanes;     Bulletin ERPS10AG-24-3.
 and CL-600-2D15 and CL-600-2D24
 airplanes.
----------------------------------------------------------------------------------------------------------------

    Note 1: For additional guidance on the ADGs specified in
paragraphs (g)(1)(ii)(C)(1)and (g)(1)(ii)(C)(3) of this AD and the
repetitive fluorescent penetrant inspections specified as part of
the periodic ADG functional check procedure, refer to the applicable
tasks identified in Table 2 of this AD. These tasks can be found in
Part 2 -Airworthiness Requirements, Appendix A--Certification
Maintenance Requirements (CMR) of the Bombardier (Canadair) Regional
Jet Maintenance Requirements Manual, and the Bombardier CRJ Series
Regional Jet Aircraft Maintenance Manual (AMM).

    Table 2--Guidance for the Periodic ADG Functional Check Procedure
------------------------------------------------------------------------
     Bombardier, Inc. Model--                Task Number (No.)--
------------------------------------------------------------------------
CL-600-2B19 airplanes.............  CMR Task No. C24-20-129-01 and AMM
                                     Task No: 24-23-01-720-803.
CL-600-2C10 airplanes.............  CMR Task No. 24-23-00-102 and AMM
                                     Task No. 24-23-01-720-802.
CL-600-2D15 and CL-600-2D24         CMR Task No. 24-23-00-102 and AMM
 airplanes.                          Task No. 24-23-01-720-802.
------------------------------------------------------------------------

    Note 2:  For additional guidance on the ADGs specified in
paragraph (g)(1)(ii)(C)(1), and the fluorescent penetrant inspection
necessary following each future unscheduled in-flight ADG
deployment, refer to following task specified in Table 3 of this AD.

  Table 3--Guidance for Inspection Following Unscheduled In-Flight ADG
                               Deployment
------------------------------------------------------------------------
            Bombardier, Inc. Model--                  AMM Task No.--
------------------------------------------------------------------------
CL-600-2B19 airplanes, serial numbers 7305              05-51-19-210-801
 through 8051 inclusive........................
CL-600-2C10 airplanes, serial numbers 10003             05-51-19-210-801
 through 10260 inclusive.......................
CL-600-2D15 and CL-600-2D24 airplanes, serial           05-51-19-210-801
 numbers 15001 through 15106 inclusive.........
------------------------------------------------------------------------

    Note 3: In Hamilton Sundstrand Service Bulletin ERPS10AG-24-3,
the fluorescent penetrant inspection is referred to as a ``Penetrant
Check.''

FAA AD Differences

    Note 4:  This AD differs from the MCAI and/or service
information as follows: No differences.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York, 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.
    (4) Special Flight Permits: Special flight permits, as described
in section 21.197 and section 21.199 of the Federal Aviation
Regulations (14 CFR 21.197 and 21.199), are not allowed.

Related Information

    (i) Refer to MCAI Canadian Airworthiness Directive CF-2009-27,
dated June 8, 2009; Bombardier Alert Service Bulletin A601R-24-120,
Revision C, dated April 20, 2009; and Bombardier Alert Service
Bulletin A670BA-24-020, Revision C, dated April 20, 2009; for
related information.

    Issued in Renton, Washington, on June 10, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-14769 Filed 6-17-10; 8:45 am]
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[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Page 53481]
[FR Doc No: 2023-16939]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2541-000]

Nevada Cogeneration Associates #2; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Nevada Cogeneration Associates #2's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 22, 2023.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: August 2, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-16939 Filed 8-7-23; 8:45 am]
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[Federal Register: September 10, 2010 (Volume 75, Number 175)]
[Notices]
[Page 55332-55333]
[DOCID:fr10se10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0527]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ULORIC

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for ULORIC and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product ULORIC
(febuxostat). ULORIC is indicated for chronic management of
hyperuricemia in patients with gout. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for ULORIC (U.S. Patent No. 5,614,520) from Teijin Pharma
Ltd., and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated February 17, 2010, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of ULORIC represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
ULORIC is 3,395 days. Of this time, 1,873 days occurred during the
testing phase of the regulatory review period, while 1,522 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
October 31, 1999. The applicant claims April 28, 1999, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 31, 1999,
which was 30 days after FDA receipt of the active IND.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 15,
2004. The applicant claims December 14, 2004, as the date the new drug
application (NDA) for Uloric (NDA 21-856) was initially submitted.
However, FDA records indicate that NDA 21-856 was submitted on December
15, 2004.
    3. The date the application was approved: February 13, 2009. FDA
has verified the applicant's claim that NDA 21-856 was approved on
February 13, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 5 years of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by November 9, 2010. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by March 9, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22521 Filed 9-9-10; 8:45 am]
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