[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Rules and Regulations]
[Pages 45460-45462]
[FR Doc No: 2013-18134]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2013-0002; Internal Agency Docket No. FEMA-8291]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.

    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

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

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region III

Virginia: Arlington County             515520  July 24, 1970,     Aug. 19, 2013.........  Aug. 19, 2013.
                                                Emerg; December
                                                31, 1976, Reg;
                                                August 19, 2013,
                                                Susp.

           Region IV

South Carolina:
    Clarendon County,                  450051  July 23, 1975,     ......do*.............   Do.
     Unincorporated Areas.                      Emerg; June 3,
                                                1991, Reg;
                                                August 19, 2013,
                                                Susp.
    Manning, City of, Clarendon        450052  June 12, 1975,     ......do..............   Do.
     County.                                    Emerg; April 15,
                                                1986, Reg;
                                                August 19, 2013,
                                                Susp.
    Summerton, Town of,                450054  January 13, 1975,  ......do..............   Do.
     Clarendon County.                          Emerg; June 3,
                                                1986, Reg;
                                                August 19, 2013,
                                                Susp.

            Region V
Ohio:
    Brunswick, City of, Medina         390380  April 5, 1973,     ......do..............   Do.
     County.                                    Emerg; January
                                                2, 1981, Reg;
                                                August 19, 2013,
                                                Susp.
    Chippewa Lake, Village of,         390910  February 24,       ......do..............   Do.
     Medina County.                             2000, Emerg;
                                                August 4, 2008,
                                                Reg; August 19,
                                                2013, Susp.
    Gloria Glens Park, Village         390381  September 12,      ......do..............   Do.
     of, Medina County.                         1975, Emerg;
                                                August 19, 1985,
                                                Reg; August 19,
                                                2013, Susp.
    Lodi, Village of, Medina           390382  July 7, 1975,      ......do..............   Do.
     County.                                    Emerg; August 4,
                                                2008, Reg;
                                                August 19, 2013,
                                                Susp.
    Medina, City of, Medina            390383  May 30, 1975,      ......do..............   Do.
     County.                                    Emerg; September
                                                30, 1988, Reg;
                                                August 19, 2013,
                                                Susp.
    Medina County,                     390378  September 6,       ......do..............   Do.
     Unincorporated Areas.                      1978, Emerg;
                                                August 15, 1983,
                                                Reg; August 19,
                                                2013, Susp.
    Seville, Village of, Medina        390384  September 23,      ......do..............   Do.
     County.                                    1975, Emerg;
                                                April 15, 1986,
                                                Reg; August 19,
                                                2013, Susp.

           Region VII
Iowa:
    Cedar County,                      190050  July 16, 1981,     ......do..............   Do.
     Unincorporated Areas.                      Emerg; August 5,
                                                1985, Reg;
                                                August 19, 2013,
                                                Susp.
    Dubuque, City of, Dubuque          195180  May 15, 1970,      ......do..............   Do.
     County.                                    Emerg; April 2,
                                                1971, Reg;
                                                August 19, 2013,
                                                Susp.
    Dubuque County,                    190534  May 24, 1974,      ......do..............   Do.
     Unincorporated Areas.                      Emerg; September
                                                1, 1983, Reg;
                                                August 19, 2013,
                                                Susp.
    Durant, City of, Cedar             190922  November 5, 1975,  ......do..............   Do.
     County.                                    Emerg; June 11,
                                                1976, Reg;
                                                August 19, 2013,
                                                Susp.
    Tipton, City of, Cedar             190057  July 2, 1975,      ......do..............   Do.
     County.                                    Emerg; September
                                                4, 1985, Reg;
                                                August 19, 2013,
                                                Susp.
    West Branch, City of, Cedar        190058  December 15,       ......do..............   Do.
     County.                                    1975, Emerg;
                                                March 16, 1983,
                                                Reg; August 19,
                                                2013, Susp.

            Region X
Alaska: Juneau, City and               020009  May 22, 1970,      ......do..............   Do.
 Borough                                        Emerg; February
                                                4, 1981, Reg;
                                                August 19, 2013,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*-do- = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp--Suspension.

    Dated: July 8, 2013.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2013-18134 Filed 7-26-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27323-27325]
[FR Doc No: 2015-11537]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting on the reauthorization of the Prescription Drug User
Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA
authorizes FDA to collect user fees for the process for the review of
human drugs. The current legislative authority for PDUFA expires in
September 2017. At that time, new legislation will be required for FDA
to continue collecting user fees in future fiscal years. The Federal
Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA begin the
PDUFA reauthorization process by publishing a notice in the Federal
Register requesting public input and holding a public meeting where the
public may present its views on the reauthorization. FDA invites public
comment as the Agency begins the

process to reauthorize the program in FYs 2018-2022.

DATES: The public meeting will be held on July 15, 2015, from 9 a.m. to
2 p.m. Registration to attend the meeting must be received by June 30,
2015. See section III.B for information on how to register for the
meeting. Submit either electronic or written comments by August 15,
2015.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, Sections B and C of the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
    Transcripts of the meeting will be available on the FDA Web site
(http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM2005475.htm) approximately 30 days after the meeting.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a public meeting to begin the reauthorization
process of PDUFA, the legislation that authorizes FDA to collect user
fees for the process for the review of human drugs by various
components in FDA including the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, the Office
of the Commissioner, and the Office of Regulatory Affairs. The current
authorization of the program (PDUFA V) expires in September 2017.
Without new legislation, FDA will no longer be able to collect user
fees for future fiscal years to fund the human drug review process.
Section 736B(d)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires
that before FDA begins negotiations with the regulated industry on
PDUFA reauthorization, we do the following: (1) Publish a notice in the
Federal Register requesting public input on the reauthorization, (2)
hold a public meeting where the public may present its views on the
reauthorization, (3) provide a period of 30 days after the public
meeting to obtain written comments from the public, and (4) publish the
comments on the FDA Web site at http://www.regulations.gov. This
notice, the public meeting, the 30-day comment period after the
meeting, and the posting of the comments on the FDA Web site will
satisfy these requirements. The purpose of the meeting is to hear
stakeholder views on PDUFA as we consider the features to propose,
update, and discontinue in the next PDUFA. FDA is interested in
responses to the following three questions and welcomes any other
pertinent information stakeholders would like to share:
     What is your assessment of the overall performance of
PDUFA V thus far?
     What current features of PDUFA should be reduced or
discontinued to ensure the continued efficiency and effectiveness of
the human drug review process?
     What new features should FDA consider adding to the
program to enhance the efficiency and effectiveness of the human drug
review process?
    The following information is provided to help potential meeting
participants better understand the history and evolution of PDUFA and
its current status.

II. What is PDUFA? What does it do?

    PDUFA is a law that authorizes FDA to collect fees from drug
companies that submit marketing applications for certain human drug and
biological products. PDUFA was originally enacted in 1992 as the
Prescription Drug User Fee Act (Pub. L. 102-571) for a period of 5
years. In 1997, Congress passed the FDA Modernization Act of 1997
(FDAMA, Pub. L. 105-115) which reauthorized the program (PDUFA II) for
an additional 5 years. In 2002, Congress extended PDUFA again through
FY 2007 (PDUFA III) in the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Pub. L. 107-188). In 2007, Title
I of the Food and Drug Administration Amendments Act of 2007 (FDAAA,
Pub. L. 110-85) reauthorized PDUFA through FY 2012 (PDUFA IV). Most
recently, PDUFA was reauthorized through FY 2017 (PDUFA V) as Title I
of the Food and Drug Administration Safety and Innovation Act (FDASIA,
Pub. L. 112-144).
    PDUFA's intent is to provide additional revenues so that FDA can
hire more staff, improve systems, and establish a better managed human
drug review process to make important therapies available to patients
sooner without compromising review quality or FDA's high standards for
safety, efficacy, and quality. As part of FDA's agreement with industry
during each reauthorization, the Agency agrees to certain performance
goals. These goals apply to the process for the review of original new
human drug and biological product applications, resubmissions of
original applications, and supplements to approved applications. During
the first few years of PDUFA I, the additional funding enabled FDA to
eliminate backlogs of original applications and supplements. Phased in
over the 5 years of PDUFA I, the goals were to review and act on 90
percent of priority new drug applications (NDAs), biologics license
applications (BLAs), and efficacy supplements within 6 months of
submission of a complete application; to review and act on 90 percent
of standard original NDAs, BLAs, and efficacy supplements within 12
months, and to review and act on resubmissions and manufacturing
supplements within 6 months. Over the course of PDUFA I, FDA exceeded
all of these performance goals and significantly reduced median review
times of both priority and standard NDAs and BLAs.
    Under PDUFA II, the review performance goals were shortened and new
procedural goals were added to improve FDA's interactions with industry
sponsors and to help facilitate the drug development process. The
procedural goals, for example, articulated timeframes for scheduling
sponsor-requested meetings intended to address issues or questions
regarding specific drug development programs, as well as timeframes for
the timely response to industry-submitted questions on special study
protocols. FDA met or exceeded nearly all of the review and procedural
goals under PDUFA II. However, concerns grew that overworked review
teams often had to return applications as ``approvable'' because they
did not have the resources and sufficient staff time to work with the
sponsors to resolve issues so that applications could be approved in
the first review cycle.
    A sound financial footing and support for limited postmarket risk
management were key themes of PDUFA III. Base user fee resources were
significantly increased and a mechanism to account for changes in human
drug review workload was adopted. PDUFA III also

expanded the scope of user fee activities to include postmarket
surveillance of new therapies for up to 3 years after marketing
approval. FDA committed to the development of guidance for industry on
risk assessment, risk management, and pharmacovigilance as well as
guidance to review staff and industry on Good Review Management
Principles and Practices (GRMPs). Initiatives to improve application
submission and Agency-sponsor interactions during the drug development
and application review processes were also adopted.
    With PDUFA's reauthorization under FDAAA Title I (PDUFA IV), FDA
obtained a significant increase in base fee funding and committed to
full implementation of GRMPs, which includes providing a planned review
timeline for premarket review, development of new guidance for industry
on innovative clinical trials, modernization of postmarket safety, and
elimination of the 3-year limitation on fee support for postmarket
surveillance. Additional provisions in FDAAA (Titles IV, V, and IX)
gave FDA additional statutory authority that increased the pre- and
postmarket review process requirements, added new deadlines, and
effectively increased review workload. Specifically, the new provisions
expanded FDA's drug safety authorities such as the authority to require
risk evaluation mitigation strategies (REMS), order safety labeling
changes, and require postmarket studies.
    With the current authorization of PDUFA under Title I of FDASIA,
FDA implemented a new review program (``the Program'') to promote
greater transparency and increase communication between the FDA review
team and the applicant on the most innovative products reviewed by the
Agency. The Program applies to all new molecular entity (NME) NDAs and
original BLAs received by the Agency from October 1, 2012 through
September 30, 2017. The Program adds new opportunities for
communication between the FDA review team and the applicant during
review of a marketing application, including mid-cycle communications
and late-cycle meetings, while adding 60 days to the review clock to
provide for this increased interaction and to address review issues for
these complex applications. PDUFA V also required two assessments of
the impact of the Program. The first of these, the interim assessment,
is available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf.
    In addition to continued commitment to a significant set of review,
processing, and procedural goals, PDUFA V also included commitments
related to enhancing regulatory science and expediting drug
development, enhancing benefit-risk assessment in regulatory
decisionmaking, modernizing the FDA drug safety system, and improving
the efficiency of human drug review by requiring electronic submissions
and standardization of electronic drug application data. The PDUFA V
Commitment Letter (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf) requires
that FDA report on the progress in satisfying these commitments in the
annual PDUFA performance report. The FY 2014 report can be found at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm440180.htm. More information about FDA's
implementation of PDUFA V can also be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm. Key Federal
Register documents, PDUFA-related guidances, performance reports, and
financial reports can also be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.

III. Public Meeting Information

A. Purpose and Scope of the Meeting

    Through this notice, FDA is announcing a public meeting to hear
stakeholder views on what features the Agency should propose in the
reauthorization of PDUFA for FYs 2018-2022. In general, the meeting
format most likely will include presentations by FDA and a series of
panels representing different stakeholder groups. We will also provide
an opportunity for other stakeholders to provide public comment at the
meeting. FDA policy issues are beyond the scope of these
reauthorization discussions. Accordingly, the presentations should
focus on process enhancements and funding issues, and not focus on
policy issues.
    Please consider the following questions for this meeting:
     What is your assessment of the overall performance of
PDUFA V thus far?
     What new features should FDA consider adding to the
program to enhance the efficiency and effectiveness of the human drug
review process?
     What current features of PDUFA should be reduced or
discontinued to ensure the continued efficiency and effectiveness of
the human drug review process?

B. Meeting Attendance and Participation

    We will conduct the meeting on July 15, 2015, at Building 31 of the
FDA White Oak Campus (see ADDRESSES). If you wish to attend this
meeting, visit http://pdufapublicmeeting.eventbrite.com. Please
register by June 30, 2015. If you are unable to attend the meeting in
person, you can register to view a live Web cast of the meeting. You
will be asked to indicate in your registration if you plan to attend in
person or via the Web cast. Your registration must also contain your
complete contact information, including name, title, affiliation,
address, email address, and phone number. Seating will be limited, so
early registration is recommended. Registration is free and will be on
a first-come, first-served basis. However, FDA may limit the number of
participants from each organization based on space limitations.
Registrants will receive confirmation once their registrations have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. If you need special accommodations because
of a disability, please contact Graham Thompson (see FOR FURTHER
INFORMATION CONTACT) at least 7 days before the meeting.
    In addition, any person may submit either electronic comments
regarding this document to http://www.regulations.gov or written
comments to the Division of Dockets Management (see ADDRESSES). It is
only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov. To ensure consideration, all
comments must be received by August 15, 2015.
    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM2005475.htm.

    Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11537 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 29, 2005 (Volume 70, Number 249)]
[Notices]
[Page 77203]
[DOCID:fr29de05-97]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 1-09700]

Issuer Delisting; Notice of Application of The Charles Schwab
Corporation To Withdraw Its Common Stock, $.01 Par Value, From Listing
and Registration on the New York Stock Exchange, Inc.

December 22, 2005.
    On December 16, 2005, The Charles Schwab Corporation, a Delaware
corporation (``Issuer''), filed an application with the Securities and
Exchange Commission (``Commission''), pursuant to Section 12(d) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 12d2-2(d)
thereunder,\2\ to withdraw its common stock, $.01 par value
(``Security''), from listing and registration on the New York Stock
Exchange, Inc. (``NYSE'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(d).
    \2\ 17 CFR 240.12d2-2(d).
---------------------------------------------------------------------------

    On December 9, 2005, the Board of Directors (``Board'') of the
Issuer unanimously approved a resolution to withdraw the Security from
listing and registration on NYSE and to continue to list the Security
on the Nasdaq National Market (``Nasdaq''). The Issuer stated that it
has determined that Nasdaq's electronic trading platform is the
preferred marketplace for investors trading the Security.
    The Issuer stated that it has complied with the requirements of
NYSE's rules governing an issuer's voluntary withdrawal of a security
from listing and registration by obtaining approval from the Board and
by providing NYSE with a copy of the Board resolution prior to filing
the application.
    The Issuer's application relates solely to the withdrawal of the
Security from listing on NYSE and from registration under Section 12(b)
of the Act,\3\ and shall not affect its obligation to be registered
under Section 12(g) of the Act.\4\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78l(b).
    \4\ 15 U.S.C. 78l(g).
---------------------------------------------------------------------------

    Any interested person may, on or before January 17, 2006, comment
on the facts bearing upon whether the application has been made in
accordance with the rules of NYSE, and what terms, if any, should be
imposed by the Commission for the protection of investors. All comment
letters may be submitted by either of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/delist.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

the File Number 1-09700 or;

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.

All submissions should refer to File Number 1-09700. This file number
should be included on the subject line if e-mail is used. To help us
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
Internet Web site (http://www.sec.gov/rules/delist.shtml). Comments are

also available for public inspection and copying in the Commission's
Public Reference Room. All comments received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.
    The Commission, based on the information submitted to it, will
issue an order granting the application after the date mentioned above,
unless the Commission determines to order a hearing on the matter.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\5\
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    \5\ 17 CFR 200.30-3(a)(1).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-8049 Filed 12-28-05; 8:45 am]

BILLING CODE 8010-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, OECA, Manufacturing, Energy, and Trans. Div 2. OMB control number b. G None a 2060 0357 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title MACT  Flexible Polyurethane Foam Production , 40 CFR Part 63, Subpart III 8. Agency form number( s) ( If applicable) 1783.02 9. Keywords polyurethane, foam, methylene chloride, slabstock foam, rebond foam, molded foam 10. Abstract This MACT affects owners and operators of flexible polyurethane foam production facilities. This includes facilities making slabstock flexible polyurethane foam, rebond flexible polyurethane foam, and molded flexible polyurethane foam. Owners and operators of slabstock foam facilities must submit initial notifications, notifications of compliance status, pre compliance reports, and semiannual status reports. Molded and rebond foam producers only submit a notification of compliance status report.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 132 b. Total annual responses 143 1. Percentage of these responses collected electronically % c. Total annual hours requested 6,400 d. Current OMB inventory 17,796 e. Difference ( 11,396) f. Explanation of difference 1. Program Change 2. Adjustment ( 11,396) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initial & semiannual 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Gregory Fried Phone: ( 202) 564 7016 OMB 83 I 12/ 99 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official John B. Rasnic, Director Manufacturing, Energy, and Transportation Division Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Information ( OPPE) Date OMB 83 I 12/ 99


[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Rules and Regulations]
[Pages 11812-11814]
[FR Doc No: 2020-03251]

Vol. 85

Thursday,

No. 39

February 27, 2020

Part VI

Environmental Protection Agency

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40 CFR Part 52

Air Quality State Implementation Plans; Final Rule

Federal Register / Vol. 85 , No. 39 / Thursday, February 27, 2020 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2019-0439; FRL-10005-31-Region 9]

Air Plan Approval; California; Mojave Desert Air Quality
Management District; California; Ventura County; 8-Hour Ozone
Nonattainment Area Requirements; Clean Air Plans; 2008 8-Hour Ozone
Nonattainment Area Requirements; Determination of Attainment by the
Attainment Date; Imperial County, CA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the Mojave Desert Air Quality Management
District (MDAQMD) portion of the California State Implementation Plan
(SIP). These revisions concern emissions of volatile organic compounds
(VOC) from Metal Parts and Products Coating Operations, and Polyester
Resin Operations. We are approving two local rules that regulate these
emission sources under the Clean Air Act (CAA or the Act) as well as
approving negative declarations for three subcategories of control
techniques guidelines (CTG) sources in the MDAQMD. In addition, we are
converting the partial conditional approval of the District's
reasonably available control technology (RACT) SIPs for the 1997 and
2008 ozone standards, as it applies to these two rules, to a full
approval.

DATES: These rules and negative declarations will be effective on March
30, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2019-0439. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On December 4, 2019 (84 FR 66345), the EPA proposed to approve the
following rules and negative declarations into the California SIP.

----------------------------------------------------------------------------------------------------------------
                                                                                Amended/
              Local agency                            Document title                  adopted        Submitted
----------------------------------------------------------------------------------------------------------------
MDAQMD.................................  Rule 1115 Metal Parts and Products           01/22/2018      05/23/2018
                                          Coating Operations.
MDAQMD.................................  Rule 1162 Polyester Resin Operations...      04/23/2018      07/16/2018
MDAQMD.................................  Federal Negative Declarations for Two        04/23/2018      07/16/2018
                                          Control Techniques Guidelines Source
                                          Categories.
MDAQMD.................................  Federal Negative Declaration for One         10/22/2018      12/07/2018
                                          Control Techniques Guidelines Source
                                          Category (Motor Vehicle Materials).
----------------------------------------------------------------------------------------------------------------

We proposed to approve these rules and negative declarations because we
determined that they comply with the relevant CAA requirements. Our
proposed action contains more information on the rules, negative
declarations and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.\1\
---------------------------------------------------------------------------

    \1\ The EPA received one submission on this docket through
www.regulations.gov but that submission was blank.
---------------------------------------------------------------------------

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, the EPA is fully approving these rules and
negative declarations into the California SIP. The EPA is also removing
from 40 CFR 52.248(d)(1) the conditional approval of the District's
RACT SIPs for the 1997 and 2008 ozone standards, with respect to these
two rules.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
MDAQMD rules described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive 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 Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the 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).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 27, 2020. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: January 29, 2020.
Deborah Jordan,
Acting Regional Administrator, Region IX.
    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

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 F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(239)(i)(A)(3),
(c)(354)(i)(B)(2), and (c)(518)(i)(A)(2), revising paragraph (c)(519)
introductory text, and adding paragraphs (c)(519)(i)(A)(2),
(c)(519)(ii), and (c)(531) to read as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (c) * * *
    (239) * * *
    (i) * * *
    (A) * * *
    (3) Previously approved on December 23, 1997 in paragraph
(c)(239)(i)(A)(2) of this section and now deleted with replacement in
paragraph (c)(518)(i)(A)(2) of this section, Rule 1115, adopted on
March 2, 1992 and amended on April 22, 1996.
* * * * *
    (354) * * *
    (i) * * *
    (B) * * *
    (2) Previously approved on November 24, 2008 in paragraph
(c)(354)(i)(B)(1) of this section and now deleted with replacement
paragraph (c)(519)(i)(A)(2) of this section, Rule 1162, ``Polyester
Resin Operations,'' adopted on August 27, 2007.
* * * * *
    (518) * * *
    (i) * * *
    (A) * * *
    (2) Rule 1115, ``Metal Parts and Products Coating Operations,''
amended on January 22, 2018.
* * * * *
    (519) New and amended regulations and additional materials for the
following APCDs were submitted on July 16, 2018 by the Governor's
designee.
    (i) * * *
    (A) * * *
    (2) Rule 1162, ``Polyester Resin Operations,'' amended on April 23,
2018.
* * * * *
    (ii) Additional materials. (A) Mojave Desert Air Quality Management
District.
    (1) Federal Negative Declaration (8 hr Ozone Standard) for Two
Control Technologies Guidelines Source Categories, approved on April
23, 2018.
    (2) [Reserved]
    (B) [Reserved]
* * * * *
    (531) The following additional material was submitted on December
7, 2018 by the Governor's designee.
    (i) [Reserved]
    (ii) Additional materials. (A) Mojave Desert Air Quality Management
District.
    (1) Federal Negative Declaration (8 hr Ozone Standard) for One
Control Technologies Guidelines Source Category, approved on October
22, 2018.
    (2) [Reserved]
* * * * *

0
3. Section 52.222 is amended by adding paragraphs (a)(1)(viii) and (ix)
to read as follows:

Sec.  52.222  Negative declarations.

    (a) * * *
    (1) * * *
    (viii) The following negative declarations for the 2008 ozone
standard were adopted by the District on April 23, 2018 and submitted
to EPA on July 16, 2018: Miscellaneous Metal and Plastic Parts Coatings
(EPA-453/R-08-003), Table 3--Plastic Parts and Products, and Table 4--
Automotive/Transportation and Business Machine Plastic Parts.
    (ix) The following negative declaration for the 2008 ozone standard
was adopted by the District on October 22, 2018, and submitted to EPA
on December 7, 2018: Miscellaneous Metal and Plastic Parts Coatings
(EPA-453/R-08-003), Table 6--Motor Vehicle Materials.
* * * * *

Sec.  52.248  [Amended]

0
4. Section 52.248 is amended by removing and reserving paragraphs
(d)(1)(vi) and (x).

[FR Doc. 2020-03251 Filed 2-26-20; 8:45 am]
 BILLING CODE 6560-50-P