[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Page 77769]
[FR Doc No: 2013-30796]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

CompuSonics Video Corporation, Order of Suspension of Trading

December 20, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
CompuSonics Video Corporation because it has not filed any periodic
reports since the period ended April 30, 2006.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed company is suspended for
the period from 9:30 a.m. EST on December 20, 2013, through 11:59 p.m.
EST on January 6, 2014.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2013-30796 Filed 12-20-13; 4:15 pm]
BILLING CODE P


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20779-20780]
[DOCID:fr17ap08-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

FEDERAL RESERVE SYSTEM

12 CFR Part 218

[Regulation R; Docket No. R-1274]

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 247

[Release No. 34-56501A; File No. S7-22-06]
RIN 3235-AJ74

Definitions of Terms and Exemptions Relating to the ``Broker''
Exceptions for Banks

AGENCIES: Board of Governors of the Federal Reserve System (``Board'')
and Securities and Exchange Commission (``SEC'' or ``Commission'')
(collectively, the Agencies).

ACTION: Final rule; technical amendments.

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SUMMARY: The Board and the Commission jointly are adopting technical
amendments to Regulation R, which the Agencies jointly adopted in
September 2007. Regulation R implements certain of the exceptions for
banks from the definition of the term ``broker'' in section 3(a)(4) of
the Securities Exchange Act of 1934 (``Exchange Act''), as amended by
the Gramm-Leach-Bliley Act (``GLBA''). The technical amendments correct
cross-references and other typographical errors in the regulation.

DATES: Effective Date: The technical amendments are effective April 17,
2008.
    Compliance Date: As provided in 12 CFR 218.781 and 17 CFR 247.100
of Regulation R, banks are exempt from complying with Regulation R and
the ``broker'' exceptions in section 3(a)(4)(B) of the Exchange Act
until the first day of their first fiscal year that commences after
September 30, 2008.

FOR FURTHER INFORMATION CONTACT: Board: Andrea Tokheim, Counsel, (202)
452-2300, or Brian Knestout, Attorney,<PHONE_NUMBER>, Legal Division,
Board of Governors of the Federal Reserve System, 20th Street and
Constitution Avenue, NW., Washington, DC 20551. Users of
Telecommunication Device for Deaf (TDD) only, call<PHONE_NUMBER>.
    SEC: Linda Stamp Sundberg, Senior Special Counsel, at (202) 551-
5550, Office of the Chief Counsel, Division of Trading and Markets,
Securities and Exchange Commission, 100 F Street, NE., Washington, DC
20549.

SUPPLEMENTARY INFORMATION:

A. Overview of Technical Amendment

    In September 2007, the Board and the SEC jointly adopted a single
set of final rules called Regulation R that implement certain of the
exceptions for banks from the definition of the term ``broker'' in
section 3(a)(4) of the Exchange Act, as amended by the GLBA.\1\
Regulation R defines terms used in these statutory exceptions and
includes certain related exemptions. The Board and the SEC are jointly
adopting these technical amendments to correct certain cross-references
and typographical errors in the final rules.
---------------------------------------------------------------------------

    \1\ See 72 FR 56514, Oct. 3, 2007, which added parts 12 CFR 218
and 17 CFR 247 to the Code of Federal Regulations.
---------------------------------------------------------------------------

    In particular, paragraph (b) of Rule 701 is revised to add a colon
at the end of the paragraph.\2\ Paragraphs (a)(6) and (a)(7) of Rule
721 are redesignated as paragraphs (a)(5) and (a)(6) because there was
no numbered paragraph (a)(5). Paragraph (c)(2) of Rule 721 is revised
to correctly cross-reference paragraph (h)(2), rather than paragraph
(g)(2). Paragraph (e)(3) of Rule 723 is revised to correctly refer to
``this paragraph (e)'', rather than ``this paragraph (d)''. For
consistency, paragraphs (a)(1)(A) and (a)(1)(B) of Rule 741 are
redesignated as paragraphs (a)(1)(i) and (a)(1)(ii). Finally, paragraph
(b)(1)(i) of Rule 775 is revised to add a dash to the citation of 15
U.S.C. 80a-5(a)(1).
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    \2\ The final rules adopted by the Board and the SEC within
their respective titles of the Code of Federal Regulations (12 CFR
part 218 for the Board and 17 CFR part 247 for the SEC) are
identically numbered from Sec.  --.100 to Sec.  --.781. For ease of
reference, the single set of final rules adopted by each Agency are
referred to in this release as Rule --, excluding title and part
designations. A similar format was used to refer to the single set
of rules issued by the Agencies.
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B. Administrative Procedure Act

    The Agencies find, in accordance with sections 553(b) and (d) of
the Administrative Procedure Act,\3\ that good cause exists to make
these amendments effective upon publication in the Federal Register
without providing prior notice and an opportunity for comment.
Specifically, the Agencies find that notice and comment and a delayed
effective date are unnecessary because the amendments make only
technical changes to Regulation R and there is no substantive change on
which the public could provide meaningful comment.\4\
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    \3\ 5 U.S.C. 553(b)(3)(A) and (d)(3).
    \4\ For similar reasons, the amendments do not require analysis
under the Regulatory Flexibility Act or analysis of major rule
status under the Small Business Regulatory Enforcement Fairness Act.
See 5 U.S.C. 601(2) (for purposes of Regulatory Flexibility Act
analyses, the term ``rule'' means any rule for which the agency
publishes a general notice of proposed rulemaking); 5 U.S.C.
804(3)(C) (for purposes of Congressional review of agency
rulemaking, the term ``rule'' does not include any rule of agency
organization, procedure, or practice that does not substantially
affect the rights or obligations of non-agency parties).
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C. Paperwork Reduction Act

    Finally, the technical amendments do not contain any new or
additional collections of information as defined by the Paperwork
Reduction Act of 1995, as amended.\5\
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    \5\ 44 U.S.C. 3501.
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List of Subjects

12 CFR Part 218

    Banks, Brokers, Securities.

17 CFR Part 247

    Banks, Brokers, Securities.

Federal Reserve System

Authority and Issuance

0
For the reasons set forth in the preamble, the Board amends 12 CFR part
218 as set forth below:

PART 218--REGULATION R--EXCEPTIONS FOR BANKS FROM THE DEFINITION OF
BROKER IN THE SECURITIES EXCHANGE ACT OF 1934 (REGULATION R)

0
1. The Authority citation for part 218 continues to read as follows:

    Authority: 15 U.S.C. 78c(a)(4)(F).

Securities and Exchange Commission

Authority and Issuance

0
For the reasons set forth in the preamble, the Commission amends 17 CFR
part 247 as set forth below:

PART 247--REGULATION R--EXEMPTIONS AND DEFINITIONS RELATED TO THE
EXCEPTIONS FOR BANKS FROM THE DEFINITION OF BROKER

0
2. The authority citation for part 247 continues to read as follows:

    Authority: 15 U.S.C. 78c, 78o, 78q, 78w, and 78mm.

Common Rules

    The common rules adopted by the Board as Part 218 of Title 12,
Chapter II of the Code of Federal Regulations and by the Commission as
Part 247 of Title 17, Chapter II of the Code of Federal Regulations are
amended as follows:

0
3. Paragraph (b) of common rule Sec.  --.701 is revised to read as
follows:

Sec.  --.701  Exemption from the definition of ``broker'' for certain
institutional referrals.

* * * * *
    (b) Required disclosures. The disclosures provided to the high net
worth customer or institutional customer pursuant to paragraphs
(a)(2)(i) or (a)(3)(i) of this section shall clearly and conspicuously
disclose:
* * * * *

0
4. In common rule Sec.  --.721, paragraphs (a)(6) and (a)(7) are
redesignated as paragraphs (a)(5) and (a)(6), respectively, and
paragraph (c)(2) is revised to read as follows:

Sec.  --.721  Defined terms relating to the trust and fiduciary
activities exception from the definition of ``broker.''

* * * * *
    (c) * * *
    (2) Advertisement. For purposes of this section, the term
advertisement has the same meaning as in Sec.  --.760(h)(2).

0
5. Paragraph (e)(3) of common rule Sec.  --.723 is revised to read as
follows:

Sec.  --.723  Exemptions for special accounts, transferred accounts,
foreign branches and a de minimis number of accounts.

* * * * *
    (e) * * *
    (3) The bank did not rely on this paragraph (e) with respect to
such account during the immediately preceding year.

Sec.  --.741  [Amended]

0
6. In common rule Sec.  --.741, paragraphs (a)(1)(A) and (a)(1)(B) are
redesignated as paragraphs (a)(1)(i) and (a)(1)(ii), respectively.

0
7. In common rule Sec.  --.775, paragraph (b)(1)(i) is revised to read
as follows:

Sec.  --.775  Exemption from the definition of ``broker'' for banks
effecting certain excepted or exempted transactions in investment
company securities.

* * * * *
    (b) * * *
    (1) * * *
    (i) Any security issued by an open-end company, as defined by
section 5(a)(1) of the Investment Company Act (15 U.S.C. 80a-5(a)(1)),
that is registered under that Act; and
* * * * *

    By order of the Board of Governors of the Federal Reserve
System, acting through the Secretary of the Board under delegated
authority, April 11, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
    Dated: April 11, 2008.
Florence Harmon,
By the Securities and Exchange Commission, Deputy Secretary.
 [FR Doc. E8-8270 Filed 4-16-08; 8:45 am]

BILLING CODE 6210-01-P


[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Proposed Rules]
[Pages 17592-17599]
[FR Doc No: 2011-7454]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2011-0310; FRL-9287-8]

Approval and Promulgation of Implementation Plans; State of
Nebraska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve the State Implementation Plan
(SIP) submittal from the state of Nebraska addressing the requirements
of Clean Air Act (CAA) sections 110(a)(1) and (2) for the 1997
revisions to the National Ambient Air Quality Standards (NAAQS) for
ozone. Section 110(a)(1) requires that each state adopt and submit a
SIP to support implementation of each new or revised NAAQS promulgated
by the EPA and these SIPs are commonly referred to as
``infrastructure'' SIPs. EPA believes that Nebraska's infrastructure
SIP adequately addresses the elements described in section 110(a)(2)
and further described in the October 2, 2007 guidance for
infrastructure SIPs issued by the EPA Office of Air Quality Planning
and Standards. However, because EPA already approved the portion of
Nebraska's SIP submittal relating to the interstate transport
infrastructure element, section 110(a)(2)(D)(i), this proposed
rulemaking does not address the interstate transport element, nor does
this proposal reopen any aspect of EPA's prior action on the interstate
transport element. Furthermore, this action does not address
infrastructure requirements with respect to the 1997 PM2.5
NAAQS or the 2006 revisions to the NAAQS. Those requirements will be
addressed in future rulemaking.

DATES: Comments must be received on or before April 29, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2011-0310 by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Ms. Elizabeth Kramer, Air Planning and Development Branch,
U.S. Environmental Protection Agency, Region 7, Air and Waste
Management Division, 901 North 5th Street, Kansas City, Kansas 66101.
    4. Hand Delivery or Courier: Deliver your comments to Ms. Elizabeth
Kramer, Air Planning and Development Branch, U.S. Environmental
Protection Agency, Region 7, Air and Waste Management Division, 901
North 5th Street, Kansas City, Kansas 66101.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2011-0310. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov or e-mail information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and should be
free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Region 7, 901 North 5th Street, Kansas City, Kansas
66101, from 8 a.m. until 4:30 p.m., Monday through Friday, excluding
legal holidays. The interested persons wanting to examine these
documents should make an appointment with the office at least 24 hours
in advance.

FOR FURTHER INFORMATION CONTACT:  Ms. Elizabeth Kramer, Air Planning
and Development Branch, U.S. Environmental Protection Agency, Region 7,
901 North 5th Street, Kansas City, Kansas 66101; telephone number:
(913) 551-7186; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we refer to EPA. This section provides
additional

information by addressing the following questions:

I. What is a section 110(a)(1) and (2) infrastructure SIP?
II. What elements are applicable under section 110(a)(1) and (2)?
III. What is EPA's evaluation of how the state addressed the
relevant elements of section 110(a)(1) and (2)?
IV. What action is EPA proposing?
V. Statutory and Executive Order Reviews

I. What is a section 110(a)(1) and (2) infrastructure SIP?

    Section 110(a)(1) and (2) of the CAA require, in part, that states
submit to EPA plans to implement, maintain and enforce each of the
NAAQS promulgated by EPA. These provisions require states to address
basic SIP requirements including, for example, adequate provisions for
emission inventory development, monitoring, and modeling to assure
attainment and maintenance of the applicable standards. By statute,
SIPs meeting the requirements of section 110(a)(1) and (2) are to be
submitted by States within three years after promulgation of a new or
revised standard. These SIPs are commonly referred to as
``infrastructure'' SIPs.

II. What elements are applicable under section 110(a)(1) and (2)?

    On October 2, 2007, EPA issued guidance to address infrastructure
SIP elements required under section 110(a)(1) and (2) for the 1997 8-
hour ozone and PM2.5 NAAQS.\1\ EPA will address these elements below
under the following headings: (A) Emission limits and other control
measures; (B) Ambient air quality monitoring/data system; (C) Program
for enforcement of control measures (PSD, New Source Review for
nonattainment areas, and construction and modification of all
stationary sources); (D) Interstate and international transport; (E)
Adequate authority, resources, implementation, and oversight; (F)
Stationary source monitoring system; (G) Emergency authority; (H)
Future SIP revisions; (I) Nonattainment areas; \2\ (J) Consultation
with government officials, public notification, prevention of
significant deterioration (PSD), and visibility protection; \3\ (K) Air
quality and modeling/data; (L) Permitting fees; and (M) Consultation/
participation by affected local entities.\4\
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    \1\ William T. Harnett, Director, Air Quality Policy Division,
Office of Air Quality Planning and Standards. ``Guidance on SIP
Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-
hour Ozone and PM2.5 National Ambient Air Quality
Standards.'' Memorandum to EPA Air Division Directors, Regions I-X,
October 2, 2007.
    \2\ As discussed in further detail below, subsection
110(a)(2)(I) is not applicable for the infrastructure SIP approval
process and therefore EPA will take action on the requirements of
part D attainment plans separately.
    \3\ As discussed in further detail below, subsection
110(a)(2)(J), as it relates to visibility protection, is also not
applicable for the infrastructure SIP approval process, and
therefore EPA is not addressing it in today's proposed rulemaking.
    \4\ This action also does not address infrastructure
requirements with respect to the 1997 PM2.5 NAAQS or the
2006 revisions to the NAAQS. Those requirements will be addressed in
future rulemaking.
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III. What is EPA's evaluation of how the state addressed the relevant
elements of section 110(a)(1) and (2)?

    On July 18, 1997, EPA promulgated new 8-hour ozone and new fine
particulate matter primary and secondary NAAQS. (62 FR 38894; 62 FR
38711). On December 7, 2007, EPA Region 7 received the state of
Nebraska's ozone infrastructure SIP submittal. EPA has reviewed the
state's formal submission and the relevant statutory and regulatory
authorities and provisions generally referenced in the submittal from
Nebraska.
    As described below, today's proposed action only pertains to the
1997 ozone standard; it does not pertain to EPA's 1997 promulgation of
the PM2.5 standards. In addition, it does not address issues
relating to interstate transport under section 110(a)(2)(D)(i), which
have already been addressed for the 1997 ozone and PM2.5
NAAQS in prior rulemaking (72 FR 71245).
    Nebraska's SIP submittal addresses the provisions of section
110(a)(1) and (2) as described below. EPA believes that Nebraska has
the adequate infrastructure needed to address all applicable elements
of section 110(a)(1) and (2) for the 1997 8-hour ozone NAAQS.
    (A) Emission limits and other control measures: Section
110(a)(2)(A) requires SIPs to include enforceable emission limits and
other control measures, means or techniques, schedules for compliance
and other related matters as needed to implement, maintain and enforce
each NAAQS.
    The state of Nebraska's statutes and Air Quality Regulations
authorize the Nebraska Department of Environmental Quality (NDEQ) to
regulate air quality and implement air quality control regulations.
Section 81-1504 of the Nebraska Revised Statutes authorizes NDEQ to
act, among other things, as the state air pollution control agency for
all purposes of the CAA and to develop comprehensive programs for the
prevention, control and abatement of new or existing pollution to the
air of the state. Air pollution is defined in Section 81-1502 of the
Nebraska Revised Statutes as the presence in the outdoor atmosphere of
one or more air contaminants or combinations thereof in such quantities
and of such duration as are or may tend to be injurious to human,
plant, or animal life, property, or the conduct of business.
    Section 81-1505(1) of the Nebraska Revised Statutes authorizes the
Nebraska Environmental Quality Council (EQC) to adopt and promulgate
rules which set air standards that will protect public health and
welfare. The EQC is also authorized to classify air contaminant sources
according to levels and types of discharges, emissions or other
characteristics.
    Chapter 4, Section 005 of Title 129 of the Nebraska Administrative
Code (NAC) (``Ambient Air Quality Standards'') adopts the 1997 ozone
standards promulgated by EPA (i.e., 0.08 parts per million). In
addition, the Nebraska rules incorporate, by reference, Appendix I in
40 CFR Part 50 for determining whether the ozone standards have been
attained. Therefore, ozone is an air contaminant which may be regulated
under Nebraska law.
    EPA notes that Chapter 35, Section 001 of the NAC provides that
sources may submit information relating to excess emissions during a
startup, shutdown or malfunction (SSM) events. Nevertheless,
notwithstanding this provision, the regulations expressly give the
Director of NDEQ the ability to take appropriate enforcement action.
See chapter 35, Sections 001, 006, and 008 of the NAC. In today's
proposed rulemaking, EPA is not proposing to approve or disapprove any
existing state provisions with regard to excess emissions during a SSM
of operations at a facility. EPA believes that a number of states have
SSM provisions that are contrary to the Clean Air Act and existing EPA
guidance,\5\ and the Agency plans to address such state regulations in
the future. In the meantime, EPA encourages any state having a
deficient SSM provision to take steps to correct it as soon as
possible.
---------------------------------------------------------------------------

    \5\ Steven Herman, Assistant Administrator for Enforcement and
Compliance Assurance, and Robert Perciasepe, Assistant Administrator
for Air and Radiation. ``State Implementation Plans (SIPs): Policy
Regarding Excess Emissions During Malfunctions, Startup, and
Shutdown.'' Memorandum to EPA Air Division Directors, September 20,
1999.
---------------------------------------------------------------------------

    EPA notes that the Section 81-1513 of the Nebraska Revised Statutes
contain provisions that give the Director of NDEQ the authority, under
certain circumstances, to grant variances from rules and regulations
established

pursuant to the Clean Air Act.\6\ EPA also notes that the Nebraska
regulations contain provisions which allow the Director of NDEQ the
discretion to approve alternatives to the Nebraska regulations (see,
e.g., chapter 6, Section 004 of the NAC, which allows the Director to
approve alternate test methods and procedures for use in determining
actual emissions). In this action, EPA is not proposing to approve or
disapprove any existing state rules with regard to such ``variance'' or
``Director's discretion'' provisions. EPA believes that a number of
states have such provisions that are contrary to the Clean Air Act and
existing EPA guidance \7\, and the Agency plans to take action in the
future to address such state regulations. In the meantime, EPA
encourages any state having a ``variance'' or ``Director's discretion''
provision that is contrary to the Clean Air Act and EPA guidance to
take steps to correct the deficiency as soon as possible.
---------------------------------------------------------------------------

    \6\ The statutory variance provisions are not included in the
Nebraska SIP and are not recognized under federal law. In any event,
a variance from an EPA-approved SIP requirement would not be
recognized as a revision to the SIP unless approved by EPA under the
CAA requirements for SIP revisions (see, 40 CFR 51.104(d)).
    \7\ J. Craig Potter, Assistant Administrator for Air and
Radiation, Thomas L. Adams, Jr., Assistant Administrator for
Enforcement and Compliance Monitoring, and Francis S. Blake, General
Counsel, Office of General Counsel. ``Review of State Implementation
Plans and Revisions for Enforceability and Legal Sufficiency.''
Memorandum, September 23, 1987. See also 52 FR 45109 (November 24,
1987).
---------------------------------------------------------------------------

    EPA believes that Nebraska has statutory and regulatory authority
to establish additional emissions limitations and other measures, as
necessary to address attainment and maintenance of the ozone standards.
Therefore, EPA believes that the Nebraska SIP adequately addresses the
requirements of section 110(a)(2)(A) for the 1997 8-hour ozone NAAQS.
    (B) Ambient air quality monitoring/data system: Section
110(a)(2)(B) requires SIPs to include provisions to provide for
establishment and operation of ambient air quality monitors, collection
and analysis of ambient air quality data, and making these data
available to EPA upon request.
    To address this element, section 81-1505(12)(o) of the Nebraska
Revised Statutes provides the enabling authority necessary for Nebraska
to fulfill the requirements of Section 110(a)(2)(B). This provision
gives the EQC the authority to promulgate rules and regulations
concerning the monitoring of emissions. The Air Quality Division within
NDEQ implements these requirements. Along with their other duties, the
monitoring program within NDEQ's Air Compliance & Enforcement Program
collects air monitoring data, quality assures the results, and reports
the data.
    NDEQ submits annual monitoring network plans to EPA for approval,
including plans for its ozone monitoring network, as required by 40 CFR
58.10. Prior to submission to EPA, Nebraska makes the plans available
for public review on NDEQ's Web site. See, http://www.deq.state.ne.us/Publica.nsf/a9f87abbcc29fa1f8625687700625436/3f5f30d938b93ef38625730800516a57?OpenDocument, for NDEQ's 2009 Ambient
Air Monitoring Network Plan. This Plan includes, among other things,
the locations for the ozone monitoring network. On February 23, 2010,
EPA approved Nebraska's 2009 ambient air network monitoring plan.
According to this Plan (at page 15), NDEQ also plans to conduct five-
year monitoring network assessments, including the ozone monitoring
network, as required by 40 CFR 58.10(d). As mentioned previously under
element (A), Title 129, Chapter 4, Section 005 of the NAC requires that
attainment with the ozone standard be determined in accordance with the
applicable Federal regulations in 40 CFR Part 50, App. I. Nebraska
submits air quality data to EPA's Air Quality System (AQS) quarterly,
pursuant to the provisions of work plans developed in conjunction with
EPA grants to the state.
    Based on the foregoing, EPA believes that the Nebraska SIP meets
the requirements of section 110(a)(2)(B) for the 1997 8-hour ozone
NAAQS.
    (C) Program for enforcement of control measures (PSD, New Source
Review for nonattainment areas, and construction and modification of
all stationary sources): Section 110(a)(2)(C) requires states to
include the following elements in the SIP: (1) A program providing for
enforcement of all SIP measures described in Section 110(a)(2)(A); (2)
a program for the regulation of the modification and construction of
stationary sources as necessary to protect the applicable NAAQS; and
(3) a permit program to meet the major source permitting requirements
of the Act (including the program for areas designated as not attaining
the NAAQS, and a program for the prevention of significant
deterioration of air quality program in other areas). Note that all
areas of Nebraska are currently in attainment with the NAAQS. In
addition, as discussed in further detail below, this proposed
infrastructure SIP rulemaking will not address the Nebraska program for
nonattainment area-related provisions, since these submittals are not
applicable for the infrastructure SIP approval process.
    (1) With respect to enforcement of requirements of the SIP, Section
81-1504(1) of the Nebraska Revised Statutes provide authority for NDEQ
to enforce the requirements of the Nebraska Environmental Protection
Act, and any regulations, permits, or final compliance orders issued
under the provisions of that law. In addition, Section 81-1504(7)
authorizes NDEQ to issue orders prohibiting or abating discharges of
waste into the air and requiring the modification, extension or
adoption of remedial measures to prevent, control, or abate air
pollution. Section 81-1507 authorizes NDEQ to commence an enforcement
action for any violations of the Environmental Protection Act, any
rules or regulations promulgated thereunder, or any orders issued by
NDEQ. This enforcement action can not only seek civil penalties, but
also require that the recipient take corrective action to address the
violation. See Section 81-1508.02. Section 81-1508.01 provides for
criminal penalties for knowing or willful violations of the statute,
regulations or permit conditions, in addition to other acts described
in that section.
    (2) Section 110(a)(2)(C) also requires that the SIP include
measures to regulate construction and modification of stationary
sources to protect the NAAQS. Nebraska has a program under Title 129,
Chapter 17 of the NAC that requires such sources to first obtain a
construction permit from NDEQ. The permitting process is designed to
ensure that new and modified sources will not interfere with NAAQS
attainment. NDEQ has the authority to require the source applying for
the permit to undergo an air quality impact analysis. If NDEQ
determines that emissions from a constructed or modified source
interfere with attainment of the NAAQS, it may deny the permit until
the source makes the necessary changes to obviate the objections to the
permit issuance. See Chapter 17, Sections 008 and 009 of the NAC.
    EPA has determined that Nebraska's minor new source review (NSR)
program adopted pursuant to section 110(a)(2)(C) of the Act regulates
emissions of ozone and its precursors. EPA has also determined that
certain provisions of the state's minor NSR program adopted pursuant to
section 110(a)(2)(C) of the Act likely do not meet all the requirements
found in EPA's regulations implementing that provision. See 40 CFR
51.160-51.164. EPA previously approved Nebraska's

minor NSR program into the SIP, and at the time there was no objection
to the provisions of this program. See 37 FR 10842 (May 31, 1972) and
60 FR 372 (January 4, 1995). Since then, the state and EPA have relied
on the existing state minor NSR program to assure that new and modified
sources not captured by the major NSR permitting programs do not
interfere with attainment and maintenance of the NAAQS.
    In this action, EPA is proposing to approve Nebraska's
infrastructure SIP for ozone with respect to the general requirement in
Section 110(a)(2)(C) to include a program in the SIP that regulates the
modification and construction of any stationary source as necessary to
assure that the NAAQS are achieved. EPA is not proposing to approve or
disapprove the state's existing minor NSR program itself to the extent
that it is inconsistent with EPA's regulations governing this program.
EPA believes that a number of states may have minor NSR provisions that
are contrary to the existing EPA regulations for this program. EPA
intends to work with states to reconcile state minor NSR programs with
EPA's regulatory provisions for the program. The statutory requirements
of Section 110(a)(2)(C) provide for considerable flexibility in
designing minor NSR programs, and EPA believes it may be time to
revisit the regulatory requirements for this program to give the states
an appropriate level of flexibility to design a program that meets
their particular air quality concerns, while assuring reasonable
consistency across the country in protecting the NAAQS with respect to
new and modified minor sources.
    (3) Nebraska also has a program approved by EPA which meets the
requirements of Part C, relating to prevention of significant
deterioration of air quality. Nebraska's implementing rule, Title 129,
Chapter 19, incorporates the relevant portions of the Federal rule, 40
CFR 52.21 (as of July 1, 2004), by reference. In this action, EPA is
not proposing to approve or disapprove any state rules with regard to
NSR reform requirements. EPA will act on NSR reform submittals through
a separate rulemaking process. For Nebraska, we have previously
approved Nebraska's NSR reform rules for attainment areas, and, as
previously stated, Nebraska currently has no nonattainment areas. See
76 FR 15852, March 22, 2011.
    The Nebraska SIP also contains a permitting program for major
sources and modifications in nonattainment areas (see Title 129,
Chapter 17, Section 013). This section is currently not applicable to
Nebraska because all areas of Nebraska are currently in attainment with
the NAAQS. Even if it were applicable, the SIP's discussion of
nonattainment areas is not addressed in this rulemaking (see discussion
of the Section 110(a)(2)(I) requirements for nonattainment areas,
below).
    With respect to the PSD program, the Nebraska SIP provides that
ozone precursors (volatile organic compounds--VOCs and oxides of
nitrogen--NOx) are regulated. For example, a stationary source that is
major for VOCs is also major for ozone, pursuant to Chapter 2, Section
005 of the NAC. In addition, a source that undergoes an emissions
increase or a net emissions increase of 40 tons per year of VOCs also
is considered to have undergone an emissions increase or net emissions
increase of 40 tons per year of ozone under the state's prevention of
significant deterioration of air quality program. See Chapter 19,
Section 010.06 of the NAC. In addition, because Nebraska defines
``regulated NSR pollutant'' to include pollutants for which a NAAQS has
been promulgated and any precursors for such pollutants that have been
identified by EPA,\8\ VOCs and NOx are therefore regulated by Nebraska
as precursors for ozone.
---------------------------------------------------------------------------

    \8\ The regulations at 40 CFR 52.21(b)(50) specifically state
that nitrogen oxides and VOCs are considered precursors for ozone.
---------------------------------------------------------------------------

    Finally, EPA notes that on March 22, 2011, in a separate
rulemaking, EPA approved the state of Nebraska's revisions to its SIP
to regulate GHGs under the Nebraska New Source Review Prevention of
Significant Deterioration program. 76 FR 15852. Thus, we have
previously determined that the Nebraska SIP meets the PSD requirements
with respect to GHGs.
    On the basis of the foregoing, EPA believes that the Nebraska SIP
and underlying statutory authority are adequate to meet the
requirements of section 110(a)(2)(C) for the 1997 8-hour ozone NAAQS.
    (D) Interstate and international transport: Section 110(a)(2)(D)(i)
requires SIPs to include provisions prohibiting any source or other
type of emissions activity in one state from contributing significantly
to nonattainment in, or interfering with maintenance by, another state
with respect to the NAAQS, or from interfering with measures required
in another state to prevent significant deterioration of air quality or
to protect visibility.
    Nebraska addressed the provisions of Section 110(a)(2)(D)(i), as it
relates to the 1997 ozone and PM standards, in the SIP submission
received by EPA on May 18, 2007. EPA approved the portion of the
Nebraska SIP submittal relating to Section 110(a)(2)(D)(i), on December
17, 2007 (72 FR 71245). Therefore, the proposed action addressed in
this notice does not include the interstate transport elements, nor
does this rulemaking reopen any aspect of EPA's prior action on the
transport elements for Nebraska for the 1997 standards.
    Section 110(a)(2)(D)(ii) requires that the SIP insure compliance
with the applicable requirements of sections 126 and 115, relating to
interstate and international pollution abatement.
    Section 126(a) of the Act requires new or modified sources to
notify neighboring states of potential impacts from sources within the
state. Although Nebraska sources have not been identified by EPA as
having any interstate or international impacts under Section 126 or
Section 115 in any pending actions relating to the 1997 ozone
standards, the Nebraska regulations address abatement of the effects of
interstate pollution. Title 129, Chapter 14, Section 010.03 of the NAC
requires NDEQ, after receiving a complete PSD permit application, to
notify EPA, as well as officials and agencies having cognizance where
the proposed construction is to occur. This includes state or local air
pollution control agencies and the chief executives of the city and
county where the source would be located; any comprehensive regional
land use planning agency; and any state, Federal Land Manager, or
Indian governing body whose lands may be affected by emissions from the
source or modification. Finally, we believe that Nebraska could use the
same statutory authorities previously discussed, primarily Section 81-
1505 of the Nebraska Revised Statutes, to respond to any future
findings with respect to the 1997 ozone standards.
    Based on the foregoing, EPA believes that Nebraska has the adequate
infrastructure needed to address Section 110(a)(2)(D)(ii) for the 1997
8-hour ozone NAAQS.
    (E) Adequate authority, resources, implementation, and oversight:
Section 110(a)(2)(E) requires that SIPs provide for the following: (1)
Necessary assurances that the state (and other entities within the
state responsible for implementing the SIP) have adequate personnel,
funding, and authority under state or local law to implement the SIP,
and that there are no legal impediments to such implementation; (2)
requirements that the state comply with the requirements relating to
state boards, pursuant to Section 128 of the

Act; and (3) necessary assurances that the state has responsibility for
implementation of any plan provision for which it relies on local
governments or other entities to carry out that portion of the plan.
    (1) With respect to adequate authority, we have previously
discussed Nebraska's authority to implement the SIP for the 1997 ozone
standards, primarily in the discussion of Section 110(a)(2)(A). Neither
Nebraska nor EPA has identified any legal impediments to implementation
of those standards.
    With respect to adequate resources, NDEQ asserts that it has
adequate personnel to implement the SIP. State statutes provide NDEQ
the authority to establish bureaus, divisions and or sections to carry
out the duties and powers granted by the Nebraska state law to address
the control of air pollution, to be administered by full-time salaried,
bureau, division or section chiefs. See Nebraska Revised Statutes
Section 81-1504(14). NDEQ's Air Quality Division is currently divided
into the Permitting Section, the Compliance Section, and the Program
Planning and Development Unit.
    With respect to funding, the Nebraska statutes require the EQC to
establish various fees for sources, in order to fund the reasonable
costs of implementing various air pollution control programs. For
example, Section 81-1505(12)(e) of the Nebraska Revised Statutes
requires the EQC to establish a requirement for sources to pay fees
sufficient to pay the reasonable direct and indirect costs of
developing and administering the air quality operating permit program.
These costs include overhead charges for personnel, equipment,
buildings and vehicles; enforcement costs; costs of emissions and
ambient monitoring; and modeling analyses and demonstrations. See
Nebraska Revised Statutes Section 81-1505.04(2)(b). Similarly, Section
81-1505(12)(a) requires the EQC to establish application fees for air
contaminant sources seeking to obtain a permit prior to construction.
    Section 81-1505.05 of the Nebraska Revised Statutes provides that
all fees collected pursuant to Section 81-1505.04 be credited to the
``Clean Air Title V Cash Fund'' to be used solely to pay for the direct
and indirect costs required to develop and administer the air quality
permit program. Similarly, Section 81-1505.06 provides that all fees
collected pursuant to Section 81-1505(12) be deposited in the ``Air
Quality Permit Cash Fund.''
    Nebraska uses funds in the non-Title V subaccounts, along with
General Revenue funds and EPA grants under, for example, Sections 103
and 105 of the Act, to fund the programs. EPA conducts periodic program
reviews to ensure that the state has adequate resources and funding to,
among others, implement the SIP.
    (2) Conflict of interest provisions--Section 128
    Section 110(a)(2)(E) also provides that the state must meet the
requirements of Section 128, relating to representation on state boards
and conflicts of interest by members of such boards. We note that this
particular provision is not related to promulgation or revision of any
NAAQS, and we have not determined that Nebraska must show specifically
that it meets this requirement with respect to the ozone infrastructure
SIP for the 1997 standards. However, the following discussion shows how
Nebraska generally meets the requirements of Section 128.
    Section 128 requires that a SIP-implementing body which approves
permits or enforcement orders under the Act must have at least a
majority of members who represent the public interest and do not derive
a ``significant portion'' of income from entities or individuals
subject to permits and enforcement orders under the Act. In addition,
Section 128 requires that members of such a body or the agency head
with similar authorities adequately disclose any potential conflicts of
interest.
    Section 81-1503 of the Nebraska Revised Statutes generally tracks
the language of Section 128 of the Act. It provides guidelines on the
composition of the 17 members of the Environmental Quality Council. It
also requires that the Director of NDEQ (who is the person responsible
for issuing permits and enforcement orders in Nebraska), before he or
she enters the duty of his or her office, attest that he or she does
not receive a significant portion of his or her income from permit-
holders or applicants for a permit. Furthermore, Title 116 of the NAC
provides the Code of Ethics for NDEQ, which includes prohibitions on
conflicts of interest for all employees (including officers, employees,
and directors).
    (3) With respect to assurances that the state has responsibility to
implement the SIP when it authorizes local or other agencies to carry
out portions of the plan, Section 81-1504(18) of the Nebraska Revised
Statutes grants NDEQ the authority to encourage local units of
government to handle air pollution problems within their own
jurisdictions. NDEQ may delegate, by contract with governmental
subdivisions which have adopted air pollution control programs, the
enforcement of state-adopted air pollution control regulations within a
specified region surrounding the jurisdictional area of the
governmental subdivision. See Section 81-1504(23). However, the
Nebraska statutes also retain authority in NDEQ to carry out the
provisions of state air pollution control law. Section 81-1504(1) gives
NDEQ ``exclusive general supervision'' of the administration and
enforcement of the Nebraska Environmental Protection Act. In addition,
Section 81-1504(4) designates NDEQ as the air pollution control agency
for the purposes of the Clean Air Act.
    The state of Nebraska relies on two local agencies for assistance
in implementing portions of the air pollution control program: Lincoln/
Lancaster County Health Department and Omaha Air Quality Control. NDEQ
oversees the activities of these local agencies to ensure adequate
implementation of the plan. NDEQ utilizes subgrants to the local
agencies to provide adequate funding, and as an oversight mechanism.
EPA conducts reviews of the local program activities in conjunction
with its oversight of the state program. Based on the foregoing, EPA
believes that Nebraska has the adequate infrastructure needed to
address Section 110(a)(2)(E) for the 1997 8-hour ozone NAAQS.
    (F) Stationary source monitoring system: Section 110(a)(2)(F)
requires states to establish a system to monitor emissions from
stationary sources and to submit periodic emission reports. That
section also requires that the state correlate the source reports with
emission limitations or standards established under the Act and make
reports available for public inspection.
    To address this element, Section 81-1505(12)(o) of the Nebraska
Revised Statutes gives the EQC the authority to promulgate rules and
regulations for air pollution control, including requirements for owner
or operator testing and monitoring of emissions. It also gives the EQC
the authority to promulgate similar rules and regulations for the
periodic reporting of these emissions. See Section 81-1505(12)(l).
Chapter 34, Section 002 of the NAC incorporates various EPA reference
methods for testing source emissions, including methods for
NOX and VOCs. The Federal test methods are in 40 CFR Part
60, App. A.
    The Nebraska regulations also require that all Class I and Class II
operating permits include requirements for monitoring of emissions. See
Chapter 8, Sections 004.01 and 015 of the NAC. Furthermore, Chapter 34,
Section 001 of the NAC allows NDEQ to order an emissions source to make
or have tests

made to determine the rate of contaminant emissions from the source
whenever NDEQ has reason to believe that the existing emissions from
the source exceed the applicable emissions limits.
    The Nebraska regulations also impose reporting requirements on
sources subject to permitting requirements. See Chapter 6, Section 001;
Chapter 8, Sections 004.03 and 015 of the NAC. Nebraska makes all
monitoring reports submitted as part of Class I or Class II permit a
publicly available document. Although sources can submit a claim of
confidentiality for some of the information submitted, Nebraska
regulations specifically exclude emissions data from being entitled to
confidential protection. See Chapter 7, Section 004 of the NAC.
Nebraska uses this information to track progress towards maintaining
the NAAQS, developing control and maintenance strategies, identifying
sources and general emission levels, and determining compliance with
emission regulations and additional EPA requirements.
    EPA believes that Nebraska has the adequate infrastructure needed
to address section 110(a)(2)(F) for the 1997 8-hour ozone NAAQS.
    (G) Emergency authority: Section 110(a)(2)(G) requires states to
provide for authority to address activities causing imminent and
substantial endangerment to public health or welfare or the environment
(comparable to the authorities provided in Section 303 of the Act),
including contingency plans to implement the emergency authorities.
    Section 81-1507 of the Nebraska Revised Statutes states that
whenever the Director of NDEQ finds that an emergency exists requiring
immediate action to protect the public health and welfare, he or she
may issue an order requiring that such action be taken as the Director
deems necessary to meet the emergency. Chapter 38, Section 003 of the
NAC states that the conditions justifying the proclamation of an air
pollution alert, air pollution warning, or air pollution emergency
exist whenever the Director determines that the accumulation of air
pollutants in any place is attaining or has attained levels which
could, if such levels are sustained or exceeded, lead to a substantial
threat to the health of persons. This regulation also establishes
action levels for various air pollutants, including ozone. The action
levels (which include ``Air Pollution Alert,'' ``Air Pollution
Warning,'' and ``Air Pollution Emergency'') and associated contingency
measures vary depending on the severity of the ozone concentrations.
Appendix I to Title 129 of the NAC provides an Emergency Response Plan
with actions to be taken under each of the severity levels. These steps
are designed to prevent the excessive build-up of air pollutants to
concentrations which can result in imminent and substantial danger to
public health. Both the regulation at Chapter 38 and the Emergency
Response Plan are contained in the federally approved SIP.
    EPA believes that the Nebraska SIP adequately addresses section
110(a)(2)(G) for the 1997 8-hour ozone NAAQS.
    (H) Future SIP revisions: Section 110(a)(2)(H) requires states to
have the authority to revise their SIPs in response to changes in the
NAAQS, availability of improved methods for attaining the NAAQS, or in
response to an EPA finding that the SIP is substantially inadequate to
attain the NAAQS.
    As discussed previously, Section 81-1504 of the Nebraska Revised
Statutes authorizes NDEQ to regulate air quality and implement air
quality control regulations. It also authorizes NDEQ to act as the
state air pollution control agency for all purposes of the Clean Air
Act. Section 81-1505(1) gives the EQC the authority to adopt and
promulgate rules which set air standards that will protect public
health and welfare. This authority includes the authority to revise
rules as necessary to respond to a revised NAAQS (see, for example, the
discussion above regarding Nebraska's adoption of the 1997 ozone
NAAQS).
    EPA believes that Nebraska has the adequate authority to address
section 110(a)(2)(H) for the 1997 8-hour ozone NAAQS.
    (I) Nonattainment areas: Section 110(a)(2)(I) requires that in the
case of a plan or plan revision for areas designated as nonattainment
areas, states must meet applicable requirements of Part D of the Act,
relating to SIP requirements for designated nonattainment areas.
    This section is currently not applicable to Nebraska because all
areas of Nebraska are currently in attainment with the NAAQS.
Nevertheless, EPA notes that the Nebraska regulations have provisions
in place which address construction or modification of sources in
nonattainment areas. See Chapter 17, Section 013 of the NAC. These
regulations are contained in the federally approved SIP.
    EPA has not addressed section 110(a)(2)(I) in its recent
infrastructure SIP guidance because Part D SIPs are due on a different
schedule than the infrastructure SIP submittal schedule. (See, e.g.,
the infrastructure SIP guidance for the revised lead standard, 73 FR
67034, n. 113, Nov. 12, 2008, and the infrastructure SIP guidance for
the revised NO2 standards, 75 FR 6523, n. 27, Feb. 9, 2010.)
Therefore, this proposal does not address section 110(a)(2)(I). EPA
will take action on any part D nonattainment plans through a separate
rulemaking.
    (J) Consultation with government officials, Public Notification,
PSD and visibility protection: Section 110(a)(2)(J) requires SIPs to
meet the applicable requirements of the following CAA provisions: (1)
Section 121, relating to interagency consultation regarding certain CAA
requirements; (2) Section 127, relating to public notification of NAAQS
exceedances and related issues; and (3) Part C of the Act, relating to
prevention of significant deterioration of air quality and visibility
protection.
    (1) With respect to interagency consultation, Section 81-1504(3)
authorizes NDEQ to advise and consult and cooperate with other Nebraska
state agencies, the Federal government, other states, interstate
agencies, and with affected political subdivisions, for the purpose of
implementing its air pollution control responsibilities. Nebraska also
has appropriate interagency consultation provisions in its
preconstruction permit program. See, e.g., Chapter 14, Section 010 of
the NAC (requiring NDEQ to send a copy of a notice of public comment on
construction permit applications to any state or local air pollution
control agency; the chief executives of the city and county in which
the source would be located; any comprehensive regional land use
planning agency; and any state, Federal Land Manager, or Indian
governing body whose lands may be affected by emissions from the source
or modification).
    (2) With respect to the requirements for public notification in CAA
Section 127, Chapter 38 of the NAC, discussed previously in connection
with the state's authority to address emergency episodes, contains
provisions for public notification of elevated ozone and other air
pollutant levels. Appendix I to Title 129 of the NAC includes measures
which can be taken by the public to reduce concentrations. In addition,
information regarding air pollution and related issues, is provided on
an NDEQ Web site, http://www.deq.state.ne.us/NDEQSite.nsf/AirDivSecProg?OpenView&Start=1&ExpandView&Count=500. NDEQ also prepares
an annual report on air quality in the state which is available to the
public on its Web site, at http://www.deq.state.ne.us/Publica.nsf/
c4afc76e4e077e1186256877

0059b73f/b278ea4efe682747862575e60050d633?OpenDocument.
    (3) With respect to the applicable requirements of Part C, relating
to prevention of significant deterioration of air quality and
visibility protection, we previously noted in the discussion of Section
110(a)(2)(C) (relating to enforcement of control measures) how the
Nebraska SIP meets the PSD requirements, incorporating the Federal rule
by reference. With respect to the visibility component of Section
110(a)(2)(J), we reiterate the statutory requirement providing, in
relevant part, that each plan must meet the ``applicable requirements''
of Part C (of Title I of the Act) relating to visibility protection. We
note that the other Part C requirements specified in section
110(a)(2)(J) (applicable requirements relating to prevention of
significant deterioration of air quality), specifically relate to the
1997 and 2006 NAAQS (as well as other pollutants regulated under the
CAA), and a state must be able to implement those requirements with
respect to a new or revised NAAQS when promulgated. In contrast to the
PSD program, the visibility protection requirements are not directly
related to the promulgation of, or revision to, a NAAQS. While the SIP
must independently meet the visibility protection requirements of Part
C by virtue of the specific SIP requirements in sections 169A and 169B
of the Act, EPA believes that the visibility protection requirements
are not ``applicable requirements'' within the meaning of section
110(a)(2)(J) and that the infrastructure SIP is not required to be
revised with respect to visibility protection merely due to
promulgation of, or revision to, these 1997 ozone NAAQS.
    For the reasons stated above, EPA believes that Nebraska has met
the applicable requirements of Section 110(a)(2)(J) for the 1997 8-hour
ozone NAAQS in the state.
    (K) Air quality and modeling/data: Section 110(a)(2)(K) requires
that SIPs provide for performing air quality modeling, as prescribed by
EPA, to predict effects on ambient air quality of emissions of any
NAAQS pollutant, and for submission of such data to EPA upon request.
    Nebraska has authority to conduct air quality modeling and report
the results of such modeling to EPA. Section 81-1504(5) provides NDEQ
with the authority to encourage, participate in, or conduct studies,
investigations, research and demonstrations relating to air pollution
and its causes and effects. As an example of regulatory authority to
perform modeling for purposes of determining NAAQS compliance, the
regulations at Chapter 19, Section 019 provide for the use of EPA-
approved air quality models (e.g., those found in 40 CFR Part 51, App.
W) for construction permitting. If the use of these models is
inappropriate, the model may be modified or an alternate model may be
used with the approval of NDEQ and EPA.
    The Nebraska regulations also give NDEQ the authority to require
that modeling data be submitted for analysis. Chapter 19, Section
021.02 states that upon request by NDEQ, the owner or operator of a
proposed source or modification must provide information on the air
quality impact of the source or modification, including all
meteorological and topographical data necessary to estimate such
impact.
    EPA believes that Nebraska has the adequate infrastructure needed
to address Section 110(a)(2)(K) for the 1997 8-hour ozone NAAQS.
    (L) Permitting Fees: Section 110(a)(2)(L) requires SIPs to require
each major stationary source to pay permitting fees to the permitting
authority to cover the cost of reviewing, approving, implementing and
enforcing a permit. That section provides that the fee requirement
applies until a fee program established by the state pursuant to Title
V of the Act, relating to operating permits, is approved by EPA.
    Section 81-1505 of the Nebraska Revised States provides authority
for NDEQ to collect permit fees, including Title V fees. For example,
Section 81-1505(e) requires that the EQC establish fees sufficient to
pay the reasonable direct and indirect of developing and administering
the air quality permit program. Nebraska's Title V program, including
the fee program addressing the requirements of the Act and 40 CFR 70.9
relating to Title V fees, was approved by EPA on October 18, 1995 (60
FR 53872). Therefore, EPA believes that the requirements of Section
110(a)(2)(L) are met.
    (M) Consultation/participation by affected local entities: Section
110(a)(2)(M) requires SIPs to provide for consultation and
participation by local political subdivisions affected by the SIP.
    Section 81-1504 of the Nebraska Revised Statutes gives NDEQ the
authority to encourage local governments to handle air pollution
problems within their respective jurisdictions and at the same time
provide them with technical and consultative assistance. NDEQ is also
authorized to delegate the enforcement of air pollution control
regulations down to governmental subdivisions which have adopted air
pollution control programs. As discussed previously, NDEQ currently
relies on two local agencies for assistance in implementing portions of
the air pollution control program: Lincoln/Lancaster County Health
Department and Omaha Air Quality Control.
    In addition, as previously noted in the discussion about Section
110(a)(2)(J), Nebraska's statutes and regulations require that NDEQ
consult with local political subdivisions for the purposes of carrying
out its air pollution control responsibilities.
    Therefore, EPA believes that Nebraska has the adequate
infrastructure needed to address Section 110(a)(2)(M) for the 1997 8-
hour ozone NAAQS.

IV. What action is EPA proposing?

    EPA proposes to approve the State Implementation Plan (SIP)
submittal from the state of Nebraska which addresses the requirements
of Clean Air Act section 110(a)(2) for the 1997 revisions to the
National Ambient Air Quality Standards (NAAQS) for ozone. As described
above, EPA believes that Nebraska has the required infrastructure to
address all elements of section 110(a)(2) to ensure that the revised
ozone standards are implemented in the state.
    We are hereby soliciting comment on this proposed action. Final
rulemaking will occur after consideration of any comments.

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, 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities

under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

Statutory Authority

    The statutory authority for this action is provided by Section 110
of the CAA, as amended (42 U.S.C. 7410).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone.

    Dated: March 23, 2011.
Karl Brooks,
Regional Administrator, Region 7.
[FR Doc. 2011-7454 Filed 3-29-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75276-75278]
[FR Doc No: 2022-26661]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-3012]

Teva Branded Pharmaceutical Products R and D, Inc., et al.;
Withdrawal of Approval of 35 New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 35 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.

DATES: Approval is withdrawn as of January 9, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec.  314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
      Application No.                  Drug                Applicant
------------------------------------------------------------------------
NDA 006536.................  Urecholine (bethanechol  Teva Branded
                              chloride) Injection, 5   Pharmaceutical
                              milligram (mg)/          Products R and D,
                              milliliter (mL).         Inc., 145
                             Urecholine (bethanechol   Brandywine Pkwy.,
                              chloride) Tablets, 5     West Chester, PA
                              mg, 10 mg, 25 mg, and    19380.
                              50 mg.
NDA 011707.................  Opana (oxymorphone       Endo
                              hydrochloride (HCl))     Pharmaceuticals,
                              Injection, 1 mg/mL and   Inc., 1400
                              1.5 mg/mL.               Atwater Dr.,
                                                       Malvern, PA
                                                       19355.

NDA 012209.................  Fluorouracil Injection,  Spectrum
                              500 mg/10 mL and 2.5     Pharmaceuticals,
                              grams (g)/50 mL.         Inc., 157
                                                       Technology Dr.,
                                                       Irvine, CA 92618.
NDA 016772.................  Resectisol in plastic    B. Braun Medical
                              container (mannitol)     Inc., 901 Marcon
                              Solution for             Blvd., Allentown,
                              Irrigation, 5 g/100 mL.  PA 18109-9341.
NDA 017354.................  Loestrin Fe 1/20         Teva Branded
                              (ethinyl estradiol and   Pharmaceutical
                              norethindrone acetate)   Products R and D,
                              Tablets, 0.02 mg/1 mg.   Inc.
NDA 017355.................  Loestrin Fe 1.5/30       Do.
                              (ethinyl estradiol and
                              norethindrone acetate)
                              Tablets, 0.03 mg/1.5
                              mg).
NDA 017716.................  Ovcon-35 (ethinyl        Warner Chilcott
                              estradiol and            Co., LLC, c/o
                              norethindrone) 28-Day    Warner Chilcott
                              Tablets, 0.035 mg/0.4    (U.S.) LLC, 100
                              mg.                      Enterprise Dr.,
                                                       NJ 07866.
NDA 017875.................  Loestrin 1.5/30          Teva Branded
                              (ethinyl estradiol and   Pharmaceutical
                              norethindrone acetate)   Products R and D,
                              21-Day Tablets, 0.03     Inc.
                              mg/1.5 mg.
NDA 017876.................  Loestrin 1/20 (ethinyl   Do.
                              estradiol and
                              norethindrone acetate)
                              21-Day Tablets, 0.02
                              mg/1 mg.
NDA 018127.................  Ovcon-35 (ethinyl        Warner Chilcott
                              estradiol and            Co., LLC, c/o
                              norethindrone) 21-Day    Warner Chilcott
                              Tablets, 0.035 mg/0.4    (U.S.) LLC.
                              mg.
NDA 018238.................  Micro-K (potassium       Nesher
                              chloride) Extended-      Pharmaceuticals
                              release Capsules, 8      USA, LLC, 13910
                              milliequivalents (mEQ).  Saint Charles
                             Micro-K 10 (potassium     Rock Rd.,
                              chloride) Extended-      Bridgeton, MO
                              release Capsules, 10     63044.
                              mEQ.
NDA 018405.................  Aygestin (norethindrone  Teva Branded
                              acetate) Tablets, 5 mg.  Pharmaceutical
                                                       Products R&D,
                                                       Inc.
NDA 018603.................  Zovirax (acyclovir       GlaxoSmithKline
                              sodium) for Injection,   LLC, 2929 Walnut
                              equivalent to (EQ) 250   St., Suite 1700,
                              mg base/vial, EQ 500     Philadelphia, PA
                              mg base/vial, and EQ 1   19104.
                              g base/vial.
NDA 018764.................  Metronidazole Tablets,   Watson
                              250 mg and 500 mg.       Laboratories,
                                                       Inc., an
                                                       indirect, wholly
                                                       owned subsidiary
                                                       of Teva
                                                       Pharmaceuticals
                                                       USA, Inc., 400
                                                       Interpace Pkwy.,
                                                       Parsippany, NJ
                                                       07054.
NDA 018796.................  Pilopine HS              Alcon
                              (pilocarpine HCl)        Laboratories,
                              Ophthalmic Gel, 4%.      Inc., 6201 South
                                                       Freeway, Fort
                                                       Worth, TX 76134-
                                                       2099.
NDA 019211.................  Theophylline in          Hospira, Inc., 275
                              Dextrose 5% in plastic   North Field Dr.,
                              containers, Injection,   Bldg. HI-3S, Lake
                              4 mg/mL, 40 mg/100 mL,   Forest, IL 60045.
                              80 mg/100 mL, 160 mg/
                              100 mL, 200 mg/100 mL,
                              320 mg/100 mL, and 400
                              mg/100 mL.
NDA 019926.................  Hexalen (altretamine)    Eisai, Inc., 155
                              Capsules, 50 mg.         Tice Blvd.,
                                                       Woodcliff Lake,
                                                       NJ 07611.
NDA 020130.................  Estrostep Fe (ethinyl    Allergan
                              estradiol and            Pharmaceuticals
                              norethindrone acetate)   International
                              Tablets, (white          Ltd., c/o
                              triangle) Tablets,       Allergan Sales,
                              0.02 mg ethinyl          LLC, 5 Giralda
                              estradiol and 1 mg       Farms, Madison,
                              norethindrone acetate;   NJ 07940.
                              (white square)
                              Tablets, 0.03 mg
                              ethinyl estradiol and
                              1 mg norethindrone
                              acetate; (white round)
                              Tablets, 0.035 mg
                              ethinyl estradiol and
                              1 mg norethindrone
                              acetate.
                             Estrostep 21 (ethinyl
                              estradiol and
                              norethindrone acetate)
                              Tablets, (white
                              triangle) Tablets,
                              0.02 mg ethinyl
                              estradiol and 1 mg
                              norethindrone acetate;
                              (white square)
                              Tablets, 0.03 mg
                              ethinyl estradiol and
                              1 mg norethindrone
                              acetate; and (white
                              round) Tablets, 0.035
                              mg ethinyl estradiol
                              and 1 mg norethindrone
                              acetate.
NDA 020667.................  Mirapex (pramipexole     Boehringer
                              dihydrocholoride)        Ingelheim
                              Tablets, 0.125 mg,       Pharmaceuticals,
                              0.25 mg, 0.5 mg, 0.75    Inc., 900
                              mg, 1 mg, 1.25 mg, and   Ridgebury Rd.,
                              1.5 mg.                  P.O. Box 368,
                                                       Ridgefield, CT
                                                       06877.
NDA 020713.................  Mircette (ethinyl        Teva Branded
                              estradiol; desogestrel   Pharmaceutical
                              and ethinyl estradiol)   Products R and D,
                              Tablets, (yellow)        Inc.
                              Tablets, 0.01 mg
                              ethinyl estradiol and
                              (white) Tablets, 0.15
                              mg desogestrel and
                              0.02 mg ethinyl
                              estradiol.
NDA 020903.................  Rebetol (ribavirin)      Merck Sharp and
                              Capsules, 200 mg.        Dohme Corp., a
                             Rebetol (ribavirin)       subsidiary of
                              Capsules, 200 mg         Merck & Co.,
                              (comarketed as           Inc., 126 East
                              Rebetron Combination     Lincoln Ave.,
                              Therapy with             P.O. Box 2000,
                              Interferon ALFA-2B,      Rahway, NJ 07065.
                              Recombinant (INTRON
                              A)).
NDA 021200.................  Zelnorm (tegaserod       Alfasigma USA,
                              maleate) Tablets, EQ 2   Inc., 550 Hills
                              mg base and EQ 6 mg      Dr., Suite 110B,
                              base.                    Bedminster, NJ
                                                       07921.
NDA 021546.................  Rebetol (rivavirin)      Merck Sharp and
                              Oral Solution, 40 mg/    Dohme Corp., a
                              mL.                      subsidiary of
                                                       Merck & Co., Inc.
NDA 021858.................  Boniva (ibandronate      Hoffmann La Roche
                              sodium) Injection, EQ    Inc., c/o
                              3 mg base/3 mL.          Genentech, Inc.,
                                                       1 DNA Way, South
                                                       San Francisco, CA
                                                       94080-4900.
NDA 021871.................  Loestrin 24 Fe (ethinyl  Teva Branded
                              estradiol and            Pharmaceutical
                              norethindrone acetate    Products R and D,
                              tablets, 0.02 mg/1mg;    Inc.
                              and ferrous fumarate
                              tablets, 75 mg).
NDA 022266.................  Onsolis (fentanyl        Adalvo Limited c/o
                              citrate) Buccal Film,    Biotech Research
                              EQ 0.2 mg base, EQ 0.4   Group, 3810 Gunn
                              mg base, EQ 0.6 mg       Highway, Tampa,
                              base, EQ 0.8 mg base,    FL 33618.
                              and EQ 1.2 mg base.
NDA 022569.................  Lazanda (fentanyl        BTcP Pharma LLC, c/
                              citrate) Nasal Spray,    o West
                              EQ 0.1 mg base, EQ 0.3   Therapeutic
                              mg base, and EQ 0.4 mg   Development, LLC,
                              base.                    1033 Skokie
                                                       Blvd., Suite 620,
                                                       Northbrook, IL
                                                       60062.
NDA 040024.................  Dexferrum (ferric        American Regent,
                              oxyhydroxide)            Inc., 5 Ramsey
                              Injection, EQ 50 mg      Rd., Shirley, NY
                              iron/mL.                 11967.
NDA 202342.................  Esomeprazole Strontium   Belcher
                              Delayed-release          Pharmatech, LLC,
                              Capsules, 24.65 mg and   6911 Bryan Dairy
                              49.3 mg.                 Rd., Suite 220,
                                                       Largo, FL 33777.
NDA 202788.................  Subsys (fentanyl)        BTcP Pharma LLC, c/
                              Sublingual Spray, 0.1    o West
                              mg, 0.2 mg, 0.4 mg,      Therapeutic
                              0.6 mg, 0.8 mg, 1.2      Development, LLC.
                              mg, and 1.6 mg.
NDA 204325.................  Adzenys ER               Neos Therapeutics
                              (amphetamine) Extended-  Brands, Inc.,
                              release Oral             2940 N Highway
                              Suspension, EQ 1.25 mg   360, Suite 400,
                              base/mL.                 Grand Prairie, TX
                                                       75050.
NDA 205637.................  Bunavail (buprenorphine  BioDelivery
                              HCl and naloxone HCl)    Sciences
                              Buccal Film, EQ 2.1 mg   International,
                              base/EQ 0.3 mg base,     Inc., 4131 Park
                              EQ 4.2 mg base/EQ 0.7    Lake Ave.,
                              mg base, and EQ 6.3 mg   Raleigh, NC
                              base/EQ 1 mg base.       27612.
NDA 210045.................  Consensi (amlodipine     Purple Biotech
                              besylate and             LTD, 2520
                              celecoxib) Tablets, EQ   Meridian Pkwy.,
                              2.5 mg base/200 mg, EQ   Suite 200,
                              5 mg base/200 mg, and    Durham, NC 27713.
                              EQ 10 mg base/200 mg.
NDA 211281.................  Pizensy (lactitol) Oral  Braintree
                              Solution, 10 g.          Laboratories,
                                                       Inc., 60
                                                       Columbian St.
                                                       West, Braintree,
                                                       MA 02184.
NDA 212038.................  Adhansia XR              Purdue Pharma
                              (methylphenidate HCl)    L.P., One
                              Extended-release         Stamford Forum,
                              Capsules, 25 mg, 35      201 Tresser
                              mg, 45 mg, 55 mg, 70     Blvd., Stamford,
                              mg, and 85 mg.           CT 06901-3431.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 9, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms included in the application
but inadvertently missing from the table. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that
are listed in the table that are in inventory on January 9, 2023 may
continue to be dispensed until the inventories have been depleted or
the drug products have reached their expiration dates or otherwise
become violative, whichever occurs first.

    Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26661 Filed 12-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36589-36590]
[FR Doc No: 2023-11898]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5607]

Nonclinical Evaluation of the Immunotoxic Potential of
Pharmaceuticals; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Nonclinical Evaluation of the Immunotoxic Potential of
Pharmaceuticals.'' This guidance finalizes the draft guidance entitled
``Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs
and Biologics'' issued on February 20, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on June 5, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-5607 for ``Nonclinical Evaluation of the Immunotoxic
Potential of Pharmaceuticals.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you

must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ronald Wange, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, MD 20993-0002, 301-
796-1304.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Nonclinical Evaluation of the Immunotoxic Potential of
Pharmaceuticals.'' The purpose of this guidance is to assist sponsors
in the nonclinical safety evaluation of the immunotoxic potential of
pharmaceuticals, which for purposes of the guidance is defined to
encompass drug products, including small molecule drugs, and
oligonucleotides, as well as certain biological products, such as
biotechnology-derived therapeutic proteins. Immunotoxicity is any
adverse unintended immunosuppression or stimulation, which can be the
result of off-target effects or exaggerated pharmacology of
pharmaceuticals that are intended to act as immunomodulators.
    This guidance finalizes the draft guidance entitled ``Nonclinical
Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics''
issued February 20, 2020 (85 FR 9784). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes made in
the draft guidance in response to public comment were focused on
placing this guidance within the appropriate context as it relates to
other guidances relevant to the assessment of immunotoxicity.
Additionally, the scope was rewritten to better clarify the types of
products that were to be considered within or outside of the scope.
    Although the 2020 draft guidance was issued by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research, the finalized guidance is being issued by CDER only.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Nonclinical Evaluation of the Immunotoxic
Potential of Pharmaceuticals.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 312 and 314 have been approved under OMB
control numbers 0910-0014 and 0910-0001, respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11898 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6837-6838]
[FR Doc No: 2011-2667]

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

SECURITIES AND EXCHANGE COMMISSION

[Rule 163; OMB Control No. 3235-0619; SEC File No. 270-556]

Proposed Collection; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 163, OMB Control No. 3235-0619, SEC File No. 270-556.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection

of information to the Office of Management and Budget for approval.
    Rule 163 (17 CFR 230.163) provides an exemption from Section 5(c)
under the Securities Act of 1933 (15 U.S.C. 77a et seq.) for certain
communications by or on behalf of a well-known seasoned issuer. The
information filed under Rule 163 is publicly available. We estimate
that it takes approximately 0.24 burden hours per response to provide
the information required under Rule 163 and that the information is
filed by approximately 53 respondents for a total annual reporting
burden of 13 hours. We estimate that 25% of 0.24 hours per response
(0.06 hours) is prepared by the respondent for a total annual burden of
3 hours (0.06 hours per response x 53 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comment to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, Virginia 22312; or
send an e-mail to<EMAIL_ADDRESS>
    Dated: February 1, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-2667 Filed 2-7-11; 8:45 am]
BILLING CODE 8011-01-P