[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Notices]
[Page 18271-18273]
[DOCID:fr21ap09-99]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59768; File No. SR-FINRA-2009-004]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Amendment No. 1 and Order Granting
Accelerated Approval to Proposed Rule Change, as Modified by Amendment
No. 1, To Expand the Definition of ``TRACE-Eligible Security''

April 14, 2009.

I. Introduction

    On February 11, 2009, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') (f/k/a the National Association of Securities Dealers,
Inc. (``NASD'')) filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to expand the definition of ``TRACE-eligible
security'' in FINRA Rule 6710(a). The proposed rule change was
published for comment in the Federal Register on March 11, 2009.\3\ The
Commission received two comments on the proposal.\4\ On April 9, 2009,
FINRA filed Amendment No. 1 to the proposed rule change, in which FINRA
also responded to the comments.\5\ The Commission is publishing this
notice and order to solicit comments on Amendment No. 1 and to approve
the proposed rule change, as modified by Amendment No. 1, on an
accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 59519 (March 5, 2009),
74 FR 10630 (``Notice'').
    \4\ See letter from Beth N. Lowson, The Nelson Law Firm, LLC, to
Elizabeth M. Murphy, Secretary, Commission, dated March 31, 2009
(``Nelson Letter''); letter from Sean C. Davy, Managing Director,
Securities Industry and Financial Markets Association (``SIFMA''),
to Elizabeth M. Murphy, Secretary, Commission, dated March 31, 2009
(``SIFMA Letter'').
    \5\ See infra Section III.
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II. Description of the Proposed Rule Change

    The current definition of ``TRACE-eligible security'' in Rule
6710(a) was adopted in 2002 and has not been amended. FINRA generally
believes that this definition is sufficiently broad to require the
reporting of, and provide price transparency for, a substantial portion
of corporate debt securities that are eligible for public sale.
However, FINRA has identified several situations where corporate debt
securities that are eligible for public sale in the secondary market
are trading without TRACE price transparency. According to FINRA, such
securities are in many cases ``exempted securities'' under Section 3 of
the Securities Act.\6\ For example, debt securities that are issued
subject to the jurisdiction and approval of a court of competent
jurisdiction in insolvency matters might be eligible for public sale
but not TRACE-eligible because they are not registered under the
Securities Act.\7\ In addition, debt securities issued as part of an
issuer exchange offer effected pursuant to Section 3(a)(9) of the
Securities Act \8\ and those issued by a bank or other financial
institutions under Section 3(a)(2) of the Securities Act \9\ generally
are not subject to TRACE reporting and dissemination for this reason.
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    \6\ 15 U.S.C. 77c.
    \7\ According to FINRA, if an insolvent corporation is
reorganized under Chapter 11 of the U.S. Bankruptcy Code, new debt
securities are often issued. The issuance is subject to the approval
of the trustee and the securities are not required to be registered
under the Securities Act. See 11 U.S.C. 101 et seq.
    \8\ 15 U.S.C. 77c(a)(9). For example, an issuer may exchange an
issue of corporate debt securities that are registered under the
Securities Act (and subject to both TRACE reporting and
dissemination) for new securities that are not registered in
reliance upon Section 3(a)(9), which permits such exchanges without
registration of the new securities. Although the exchanged security
was TRACE-eligible, the new security is not because it is not
registered, as required by existing FINRA Rule 6710(a).
    \9\ 15 U.S.C. 77c(a)(2).
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    Therefore, FINRA has proposed to amend Rule 6710(a), the definition
of ``TRACE-eligible security,'' by eliminating the requirement that
such securities be ``(1) registered under the Securities Act; or (2)
issued pursuant to Section 4(2) of the Securities Act and purchased or
sold pursuant to Securities Act Rule 144A.'' This change would expand
TRACE eligibility to include additional corporate debt securities that
are eligible for public sale, and may have participation by retail
investors. Moreover, FINRA notes that its obligation to conduct
surveillance in the corporate bond market is not limited to
transactions in securities that are registered under the Securities
Act, and that its equity trade reporting rules generally apply to any
equity securities eligible for public sale and do not consider
registration a factor. FINRA believes that expanding TRACE eligibility
in this manner ``is vital to its mandate to regulate the market, to
promote market integrity and to protect investors.'' \10\
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    \10\ Notice, 74 FR at 10631.
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    FINRA also has proposed to add the phrase ``and, if a `restricted
security' as defined in Securities Act Rule 144(a)(3)'' in place of the
deleted language discussed in the preceding paragraph. Thus, if a
security were a restricted security, it would be TRACE-eligible if it
were sold pursuant to Rule 144A under the Securities Act \11\ (assuming
it meets the other requirements for TRACE eligibility). The current
definition of TRACE-eligible security requires transaction reporting
for some but not all of the large market in corporate debt securities
that are restricted securities and sold to qualified institutional
buyers (``QIBs'') \12\ in transactions effected pursuant to Rule 144A.
Although a significant number of restricted securities sold in Rule
144A transactions are preceded by an offering that is exempt under
Section 4(2) of the Securities Act, the limitation in the current
definition excludes other Rule 144A transactions that FINRA believes
should be reported. Consequently,

FINRA proposed to amend Rule 6710(a) to include as TRACE eligible a
restricted security if it is ``sold pursuant to Securities Act Rule
144A.''
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    \11\ 17 CFR 230.144A.
    \12\ See 17 CFR 230.144A(a)(1) (defining QIB).
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III. Summary of Comments and Amendment No. 1

    The Commission received two comments on the proposed rule
change.\13\ One commenter expressed general support for FINRA's efforts
to broaden the range of securities that are subject to TRACE reporting
and thus to increase price transparency in the corporate bond market
generally. In addition, the commenter argued that the TRACE rules
should be amended to eliminate from FINRA's dissemination protocols the
``volume caps'' used when disseminating information on transactions
above a certain size.\14\ FINRA declined to respond to that comment
because it is not related to the proposed rule change.
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    \13\ See supra note 4.
    \14\ See Nelson Letter at 1.
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    Another commenter argued that FINRA has ``not provided any
direction or clarity regarding the operational requirements'' of
reporting certain Regulation S \15\ transactions that have not been
assigned a CUSIP number. The commenter also expressed concerns that
firms have not been able to assess the system changes necessary to
comply with the proposed rule change, and therefore are unable to
comment on what would be an appropriate implementation timeline.\16\ In
addition, the commenter suggested that FINRA consider implementing a
process for obtaining identifier information for securities (such as
many Regulation S securities) for which no identifying information has
previously been reported under FINRA Rule 6760, and requested that
FINRA provide firms a reasonable grace period to report transactions in
such securities.\17\
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    \15\ 17 CFR 230.901-905.
    \16\ See SIFMA Letter at 1.
    \17\ See id. at 2.
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    In response, FINRA stated that the proposed rule change does not
require members to report bona fide off-shore Regulation S transactions
to TRACE. If a security that is the subject of a Regulation S offering
were subsequently part of a U.S. transaction that is required to be
reported to TRACE, such securities generally would be assigned CUSIPs.
FINRA stated, however, that it would provide guidance on reporting
obligations if certain TRACE-eligible securities had for some reason
not been assigned a CUSIP number. Finally, FINRA stated that it would
establish an effective date that will provide firms sufficient time to
make any minor operational enhancements needed to report these types of
transactions.\18\
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    \18\ See Amendment No. 1 at 4.
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    FINRA also responded to the commenter's request for a grace period
to report transactions in securities offered under Regulation S and
other securities that a member finds are not in the TRACE system at the
time the member is required to report a transaction. FINRA responded
that members that are a party to a transaction in a TRACE-eligible
security are required to report the transaction, and if the CUSIP for a
TRACE-eligible security is not in the TRACE system, a member must
notify FINRA Operations promptly, provide the CUSIP and other
identifying information, and thereafter report the member's
transaction. FINRA stated that it takes into account a delay in
reporting that may occur if a member, upon trying to report a
transaction, determines that the member first must notify FINRA
Operations and provide the CUSIP and other identifying information for
the security to be added to TRACE. Rather than supporting the proposed
grace period, FINRA advises members to maintain a record of any
notifications the member provides to FINRA Operations, which FINRA
would view as a mitigating factor in reviewing the transaction
report(s) in such security of members providing notification. FINRA
further suggested that, where there has been prompt notification and
reporting of a security as soon as possible after the security is
included in TRACE, FINRA generally would not include such trades in any
regulatory inquiry directed to the firm and that, generally, it would
be unlikely for such late trades to form the factual basis for formal
or informal action, absent other regulatory concerns or violations.\19\
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    \19\ FINRA noted, however, that providing notification to FINRA
Operations would not be viewed as a mitigating factor or
circumstance during any review of late trade reports, if FINRA
determines that the member was obligated under Rule 6760 to provide
notice to FINRA Operations at or prior to the initial issuance of
the TRACE-eligible security. See Amendment No. 1 at 4.
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    Also in Amendment No. 1, FINRA deleted certain language from its
Form 19b-4 wherein it discussed the purpose of the proposed rule
change.\20\ These revisions are non-substantive and do not affect the
proposed rule text.
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    \20\ See id. at 5.
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IV. Discussion

    After carefully considering the proposal and the comments
submitted, the Commission finds that the proposed rule change is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
association.\21\ In particular, the Commission finds that the proposed
rule change is consistent with Section 15A(b)(6) of the Act,\22\ which
requires, among other things, that FINRA rules must be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, and, in general, to protect
investors and the public interest. The Commission does not believe that
the comments raise any issue that would preclude approval of the
proposal.
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    \21\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \22\ 15 U.S.C. 78o-3(b)(6).
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    The Commission believes that it is reasonable and consistent with
the Act for FINRA to broaden the definition of ``TRACE-eligible
security'' in the manner set forth in the proposal. The larger universe
of transactions in corporate debt securities that are subject to TRACE
reporting should result in greater transparency for market participants
and the public. Including in the audit trail additional corporate debt
securities that are eligible for public sale (and that otherwise meet
the standards for TRACE eligibility) should enhance FINRA's
surveillance efforts, as FINRA's obligation to conduct surveillance in
the corporate bond market is not limited to transactions in securities
that are registered under the Securities Act.
    In addition, the Commission believes that amending the definition
of ``TRACE-eligible security'' in Rule 6710(a) to include all
restricted securities sold pursuant to Rule 144A, rather than only
those preceded by an offering exempt pursuant to Securities Act Section
4(2), is a reasonable expansion of TRACE reporting. The additional
transaction data will allow FINRA to obtain a more complete audit trail
of transactions in corporate debt securities.
    The Commission finds good cause for approving the proposed rule
change, as modified by Amendment No. 1 thereto, before the thirtieth
day after the date of publication of notice of filing of Amendment No.
1 in the Federal Register. Amendment No. 1 makes only minor non-
substantive changes to the proposal, which otherwise was subject to a
full comment period. Therefore, the Commission finds good cause,
consistent with Section 19(b)(2) of the Act, to approve the proposal,
as modified by Amendment No. 1, on an accelerated basis.

V. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 1, including whether Amendment No. 1
is consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-FINRA-2009-004 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2009-004. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2009-004 and should be
submitted on or before May 12, 2009.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\23\ that the proposed rule change (File No. SR-FINRA-2009-004), as
modified by Amendment No. 1 thereto, be, and hereby is, approved on an
accelerated basis.
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    \23\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-9059 Filed 4-20-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 123 (Monday, June 27, 2011)]
[Rules and Regulations]
[Pages 37272-37274]
[FR Doc No: 2011-15866]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-0973; FRL-9319-2]

Approval and Promulgation of Air Quality Implementation Plans;
Illinois; Royal Fiberglass Pools, Inc. Adjusted Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving into the Illinois State Implementation Plan
(SIP) an adjusted standard for Royal Fiberglass Pools (``Royal'') at
its Dix, Illinois facility. On November 8, 2010, the Illinois
Environmental Protection Agency (IEPA) submitted to EPA for approval an
adjustment to the general rule, Use of Organic Material Rule, commonly
known as the eight pound per hour (8 lb/hr) rule, as it applies to
emissions of volatile organic matter (VOM) from Royal's pool
manufacturing facility. The adjusted standard relieves Royal from being
subject to the general rule for VOM emissions from its Dix facility.
EPA is approving this SIP revision because it will not interfere with
attainment or maintenance of the ozone National Ambient Air Quality
Standard (NAAQS).

DATES: This direct final rule will be effective August 26, 2011, unless
EPA receives adverse comments by July 27, 2011. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2010-0973, 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. Fax:<PHONE_NUMBER>.
    4. Mail: Doug Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Doug Aburano, Chief, Control Strategies Section,
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77
West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2010-0973. 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 information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. 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 be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., 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 Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Carolyn Persoon,
Environmental Engineer, at<PHONE_NUMBER>, before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
II. What is EPA's analysis of Royal's adjusted standard?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying

information (subject heading, Federal Register date and page number).
    2. Follow directions--The EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. What is EPA's analysis of Royal's adjusted standard?

Background of the 8 lb/hr Rule and the Adjusted Standard

    EPA approved the VOM general 8 lb/hr rule into the Illinois SIP on
February 21, 1980 (45 FR 11472). The rule states that ``no person shall
cause or allow the discharge of more than 3.6 kg/hr (8 lb/hr) of
organic material into the atmosphere from any emission source * * *.''
The basis for this rule is prevention of ground-level ozone formation
in order to meet the ozone NAAQS.
    Royal filed a petition for an adjusted standard on April 3, 2009,
in accordance with section 28.1 of the Illinois Environmental
Protection Act, 415 ILCS 5/28.1, and Illinois' regulations at 35 Ill.
Adm. Code section 215. Section 28.1 sets out the factors that a
petitioner must demonstrate to justify an adjusted standard. Royal
filed the petition describing the factors relating to its Dix facility
that are substantially and significantly different from the factors
relied on in adopting the general rule, specifically that the general
rule did not take into account the specific operations needed to make
composite fiberglass pools. Royal also provided an air quality impact
analysis to support its petition. On October 28, 2009, the Illinois
Pollution Control Board (IPCB) held a public hearing on the petition in
Mt. Vernon, Illinois where testimony was given to support Royal's
petition. A final order by the IPCB granted Royal an adjusted standard
on February 18, 2010. Among other things, the IPCB found that granting
the adjusted standard would not result in an adverse impact on air
quality in terms of exceeding the ozone NAAQS. The IPCB limited
applicability of the adjusted standard to the swimming pool
manufacturing emissions units existing as of August 20, 2009 at the Dix
facility.

Analysis of SIP Revision for the Adjusted Standard

    EPA's approval is based on consideration of whether the adjusted
standard meets the requirements of section 110(l) of the Clean Air Act
(CAA), 42 U.S.C. 4202(l). In particular, EPA considered whether
exempting Royal's Dix facility from compliance with 35 Ill. Adm. Code
215.301 will impact Illinois' ability to attain and maintain the ozone
NAAQS in the area in which the facility is located.
    Under CAA section 110(l) the state must show that the SIP revision
will not interfere with attainment and maintenance of both existing
eight-hour ozone standards, which would be 75 parts per billion (ppb)
promulgated in 2008 and the 84 ppb promulgated in 1997.\1\ Based on the
record presented to the IPCB, Royal provided evidence to IEPA after a
2006 notice of violation that Royal could not comply with the 8 lb/hour
rule. After reviewing the evidence, IEPA agreed that Royal should file
a petition for an adjusted standard. The monitor closest to Royal's Dix
facility is located in Hamilton County, Illinois. This monitor has been
and currently is attaining the eight-hour ozone standards with design
values of 68 ppb for 2007-2009 and 68 ppb for 2008-2010 using
preliminary quality assured (but not yet certified) data from 2010. See
EPA's Web site on design values for ozone at http://www.epa.gov/airtrends/values.html. Thus, Royal's facility in Dix, Illinois has not
been interfering with attainment of the standard at its current
production rate.
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    \1\ EPA has not yet designated areas for the 2008 eight-hour
ozone standard.
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    To support its petition, Royal did a conservative analysis of
emissions to determine an approximate ozone contribution that would
result from it operating at the maximum capacity which Royal is allowed
in its approved Title V permit. When adding this potential contribution
to the existing monitored data both the 75 and 84 ppb ozone standards
are still maintained even at the facility's maximum capacity.
    Although Royal is not required to comply with the 8 lb/hour rule,
Royal is required to operate its facility in compliance with Federal
regulations of reinforced composite manufacturing facilities set forth
at 40 CFR part 63 subpart WWWW, which requires certain operational
practices, recordkeeping, and emission limits for VOM. The emissions of
styrene from Royal's Dix facility are from three different types of
operations: (1) Open molding, corrosion resistant and/or high strength
resin applied by non-atomized spray, (2) open molding, corrosion
resistant and/or high strength resin manually applied, and (3) open
molding, resistant and/or high strength gel-coat. The Federal Maximum
Achievable Control Technology (MACT) requires emission limits on all of
these processes of 113 pounds of styrene per ton of material (lb/ton),
123 lb/ton, and 605 lb/ton, respectively. These emission limits are
enforceable VOM limits for the Dix Facility.

III. What action is EPA taking?

    EPA is approving into the Illinois SIP an adjusted standard of the
8 lb/hr general rule for VOM for Royal. The adjusted standard removes
the 8 lb/hr VOM limit for Royal's fiberglass facility in Dix, Illinois
in the SIP, and the Royal facility at Dix, Illinois is no longer
subject to this rule as it applies to VOM emissions. The adjusted
standard is approvable, since under worst case conditions it is not
interfering with attaining or maintaining the 75 and 84 ppb ozone
standards as prescribed by section 110(l) of the CAA.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan amendment if relevant
adverse written comments are filed. This rule will be effective August
26, 2011 without further notice unless we receive relevant adverse
written comments by July 27, 2011. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. The EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment. If we do not receive

any comments, this action will be effective August 26, 2011.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide 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.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 26, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: June 3, 2011.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart O--Illinois

0
2. Section 52.720 is amended by adding paragraph (c)(188) to read as
follows:

Sec.  52.720  Identification of plan.

* * * * *
    (c) * * *
    (188) On November 8, 2010, the Illinois Environmental Protection
Agency submitted a revision to its state implementation plan. The
revision to the SIP allows an adjusted standard to the general rule,
Use of Organic Material Rule, known as the eight pound per hour (8 lb/
hr) rule, for volatile organic matter, for Royal Fiberglass Pools, Inc.
manufacturing facility located in Dix, Illinois. The adjusted standard
is that 35 Ill. Adm. Code 217.301 does not apply to VOM emissions from
Royal's Dix, Illinois facility. The facility is subject to emission
limit requirements set forth in the MACT under 40 CFR 63 subpart WWWW
finalized in 68 FR 19402, April 21, 2003.
    (i) Incorporation by reference. (A) February 18, 2010, Opinion and
Order of the Illinois Pollution Control Board, AS-09-04, effective
February 18, 2010.

[FR Doc. 2011-15866 Filed 6-24-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40771-40772]
[FR Doc No: 2018-17715]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2970]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Surveys and Interviews With Investigational New Drug
Sponsors To Assess Current Communication Practices With Food and Drug
Administration Review Staff Under the Sixth Authorization of the
Prescription Drug User Fee Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed information collection involving
surveys and interviews of sponsors of commercial investigational new
drugs (INDs) to obtain feedback about communication practices with FDA
review staff.

DATES: Submit either electronic or written comments on the collection
of information by October 15, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 15, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2018-N-2970 for ``Surveys and Interviews with Investigational New
Drug (IND) Sponsors to Assess Current Communication Practices with FDA
Review Staff under the Sixth Authorization of the Prescription Drug
User Fee Act (PDUFA VI).'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Surveys and Interviews With Investigational New Drug (IND) Sponsors To
Assess Current Communication Practices With FDA Review Staff Under the
Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI)

OMB Control Number 0910--NEW

    In Fiscal Year (FY) 2017, FDA published guidance on communications
between FDA review staff and drug sponsors during the IND phase of drug
development. As part PDUFA VI, FDA committed to a third-party
assessment of current IND-phase communication practices, which should
reflect this guidance. The contractor for the assessment of IND
communication practices is Eastern Research Group, Inc. (ERG).
    Therefore, in accordance with the PDUFA VI Commitment Letter, FDA
proposes to have ERG conduct surveys and interviews with sponsors of up
to 150 active commercial INDs as follows:
     For each formal meeting between FDA review staff and
active commercial IND sponsors during the assessment period, send a
survey to the sponsor to solicit specific feedback about communication
practices employed for that meeting. For the purpose of this
assessment, formal meetings are Type A, B, B (End of Phase), and C
meetings during the IND phase of drug development.
     For each active commercial IND in the assessment, conduct
an interview with the sponsor to obtain broader feedback about all
communications with FDA review staff during the study period, including
telephone and email interactions in addition to meetings.
    The purpose of this information collection is to understand active
commercial IND sponsor perspectives on communication during drug
development with a focus on what is working well, ongoing challenges
and pain points, lessons learned, and opportunities for improvement.
The contractor will develop anonymized aggregated summaries of survey
and interview responses, analyze this information to identify common
themes, consider these results along with IND data and feedback from
FDA review staff to develop a set of findings and recommendations, and
prepare a report to be published on FDA's website. The contractor will
keep information collected private; ERG will not disclose personally
identifying information to FDA or any other party.
    The number of commercial INDs with activity is approximately 4,000
per year. ERG will interview 1 to 3 sponsor representatives at a time
for up to 150 INDs during the annual assessment period.
    Thus, FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
              Type of respondent                   Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND sponsors: Surveys.........................             150               1             150  0.17 (10 minutes).......................           25.50
IND sponsors: Interviews......................             450               1             450  1.5.....................................             675
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................          700.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that it will take each IND sponsor a maximum of 10
minutes to complete a survey. Up to 150 respondents will take part in
the survey, yielding a maximum burden of 25.5 hours. FDA estimates that
it will take each IND sponsor up to 90 minutes to respond to requests
for interviews and participate in interviews. Up to 450 respondents
will take part in interviews, yielding a maximum burden of 675 hours.
FDA's burden estimates are based on experience with information
collections for similar types of PDUFA-related assessments.

    Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17715 Filed 8-15-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53108]
[FR Doc No: 2021-20710]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4533-DR; Docket ID FEMA-2021-0001]

Alaska; Amendment No. 5 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alaska (FEMA-4533-DR), dated April 9, 2020, and
related determinations.

DATES: This amendment was issued August 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
dated April 9, 2020 for the State of Alaska is hereby amended to
include the Hazard Mitigation Grant Program.

    All areas within the State of Alaska are eligible for assistance
under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-20710 Filed 9-23-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Rules and Regulations]
[Pages 15313-15315]
[FR Doc No: 2018-06821]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1119; Product Identifier 2017-CE-037-AD; Amendment
39-19241; AD 2018-07-10]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Embraer
S.A. Models EMB-500 and EMB-505 airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) issued by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as improperly tied castle nuts on the aileron, rudder, and
elevator trim tab (or autotab) attachment bolts. We are issuing this AD
to require actions to address the unsafe condition on these products.

DATES: This AD is effective May 15, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of May 15, 2018.

ADDRESSES: You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1119; or in person at Docket Operations, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
    For service information identified in this AD, contact Embraer
S.A., Phenom Maintenance Support, Avenida Brigadeiro Faria Lima, 2170,
S[atilde]o Jos[eacute] dos Campos--SP-12227-901, P.O. Box 36/2, Brasil;
phone: +55 12 3927 1000; fax: +55 12 3927-2619; email:
[email protected]; internet: http://www.embraer.com.br/en-US/Pages/home.aspx. You may view this referenced service information
at the FAA, Policy and Innovation Division, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>. It is also available on the internet at
http://www.regulations.gov by searching for Docket No. FAA-2017-1119.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to Embraer S.A. Models EMB-500
and EMB-505 airplanes. The NPRM was published in the Federal Register
on December 4, 2017 (82 FR 57172). The NPRM proposed to correct an
unsafe condition for the specified products and was based on mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country. The MCAI states:

    This [ANAC] AD results of a report of one airplane having
improperly tied castle nut on the aileron, rudder and elevator trim
tab (or autotab) attachment bolts. A disconnected surface may cause
an increase in dynamic loads and probable flutter, which may cause
structural failure and possible loss of control of the airplane.
    Since this condition may occur in other airplanes of the same
type and affects flight safety, a corrective action is required.
Thus, sufficient reason exists to request compliance with this
[ANAC] AD in the indicated time limit without prior notice.

The MCAI can be found in the AD docket on the internet at: https://www.regulations.gov/document?D=FAA-2017-1119-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Request To Withdraw NPRM

    Eduardo Cerdeira and Ricardo Hollerbach, both from Embraer S.A.,
commented that all of the affected airplanes have been inspected with
no faults found; therefore, there is no need for the proposed AD. They
state that, since the issuance of the original versions of the service
information for the two affected fleets, Embraer S.A. has been in
direct contact with all the applicable operators in the world to
encourage them to accomplish the required inspections as soon as
possible. Since the start of the inspections, the commenters state that
the completion status has been provided to the FAA, as well as the
aviation authorities of Europe (EASA), and Brazil (ANAC). As of
December 6, 2017, they stated that all affected airplanes, as defined
in the current service information, have been inspected with no faults
found. Finally, the commenters provided tables showing each of the
affected airplane serial numbers and the date on which the applicable
service information was accomplished.
    We don't agree with this comment. The FAA contacted Embraer. S.A.
to obtain records to show that all airplanes were in compliance with
the actions in this AD. Embraer S.A. informed the FAA that they were
unable to provide such information. While the FAA appreciates the
effort that the commenters went to in order to assure that the unsafe
condition was addressed on the affected airplanes, our policy of not
accepting assurance from a design approval holder that all products are
in compliance as a reason to not issue an AD action requires us to move
forward with the issuance of the final rule AD. Please note that the
Action and Compliance paragraph within the FAA AD begins with the
phrase ``unless already done'', which may apply in this case.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed except for minor editorial changes. We have determined
that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Embraer S.A. has issued PHENOM by Embraer Alert Service Bulletin
500-27-A026, Revision 1, dated October 6, 2017; and PHENOM by Embraer
Alert Service Bulletin 505-27-A028, Revision 2, dated October 6, 2017.
For the applicable models, the service information describes procedures
for inspection of the aileron trim tab, rudder trim tab, and elevator
trim tab, and, if required, application of torque and installation of a
cotter pin. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section of this
AD.

Costs of Compliance

    We estimate that this AD will affect 114 products of U.S. registry.
We also estimate that it would take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $9,690, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 3 work-hours and require parts costing $50, for a cost of
$305 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1119; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2018-07-10 Embraer S.A.: Amendment 39-19241; Docket No. FAA-2017-
1119; Product Identifier 2017-CE-037-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 15,
2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Embraer S.A. Models EMB-500 and EMB-505
airplanes, serial numbers 50000246, 50000267, 50000286, 50000289,
50000291, 50000299, 50000304, 50000305, 50000306, 50000310,
50000348, 50000359, 50000368, 50000370, 50000372, 50000376,
50000377, 50000378, 50000379, 50000380, 50500118, 50500122,
50500148, 50500151, 50500167, 50500176, 50500179, 50500185,
50500188, 50500191, 50500197, 50500203, 50500207, 50500209,
50500212, 50500214, 50500215, 50500219, 50500225, 50500226,
50500231, 50500242, 50500244, 50500246, 50500248, 50500250,
50500256, 50500260, 50500266, 50500273, 50500275, 50500277,
50500280, 50500282, 50500285, 50500287, 50500288, 50500289,
50500292, 50500293, 50500294, 50500296, 50500297, 50500298,
50500300, 50500302, 50500304, 50500306, 50500309, 50500311,
50500317, 50500318, 50500323, 50500328, 50500331, 50500333,
50500335, 50500338, 50500340, 50500344, 50500345, 50500348,
50500351, 50500357, 50500361, 50500362, 50500363, 50500364,
50500365, 50500367, 50500368, 50500371, 50500372, 50500379,
50500381, 50500382, 50500385, 50500386, 50500390, 50500391,
50500394, 50500395, 50500397, 50500398, 50500399, 50500400,
50500402, 50500403, 50500404, 50500407, 50500410, 50500415,
50500418, and 50500424, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as improperly tied
castle nuts on the aileron, rudder and elevator trim tab (or
autotab) attachment bolts. We are issuing this AD to inspect the
aileron trim tab, rudder trim tab and elevator trim tab (or
autotab), and correct any discrepancy, which if not corrected, may
cause an increase in dynamic loads and possible flutter, leading to
structural failure and loss of control.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (2) of this AD following the Accomplishment Instructions
in PHENOM by Embraer Alert Service Bulletin (SB) No.: 500-27-A026,
Revision 1, dated October 6, 2017; or PHENOM by Embraer Alert SB
No.: 505-27-A028, Revision 2, dated October 6, 2017, as applicable:
    (1) Within the next 25 hours time in service (TIS) after May 15,
2018 (the effective date of this AD) or within the next 12 months
after May 15, 2018 (the effective date of this AD), whichever occurs
first, inspect the aileron trim tab, rudder trim tab, and elevator
trim tab attachment points to make sure the cotter pin is installed
on the castle nut of the attaching bolts.
    (2) If any discrepancy is found during the inspection required
in paragraph (f)(1) of this AD, before further flight, correct the
discrepancy.

(g) Credit for Actions Accomplished in Accordance With Previous Service
Information

    This AD allows credit for the actions required in paragraph (f)
of this AD if done before the effective date of this AD following
PHENOM by Embraer Alert SB No. 500-27-A026, original issue, dated
September 29, 2017; PHENOM by Embraer Alert SB No. 505-27-A028,
original issue, dated September 28, 2017; or PHENOM by Embraer Alert
SB 505-27-A028, Revision 01, dated September 29, 2017; as
applicable.

(h) No Reporting Requirement

    Although PHENOM by Embraer Alert SB No.: 500-27-A026, Revision
1, dated October 6, 2017; and PHENOM by Embraer Alert SB No.: 505-
27-A028, Revision 2, dated October 6, 2017; specify to submit
certain information to the manufacturer, this AD does not require
that action.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Small Airplane Standards Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816) 329-
4090; email: [email protected]. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, Small Airplane
Standards Branch, FAA; or Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC), which is the aviation authority
for Brazil.

(j) Related Information

    Refer to MCAI Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o
Civil (ANAC), which is the aviation authority for Brazil, AD No.:
2017-11-01, dated November 10, 2017. You may examine the MCAI on the
internet at: https://www.regulations.gov/document?D=FAA-2017-1119-0002.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) PHENOM by Embraer Alert Service Bulletin No.: 500-27-A026,
Revision 1, dated October 6, 2017.
    (ii) PHENOM by Embraer Alert Service Bulletin No.: 505-27-A028,
Revision 2, dated October 6, 2017.
    (3) For Embraer S.A. service information identified in this AD,
contact Embraer S.A., Phenom Maintenance Support, Avenida Brigadeiro
Faria Lima, 2170, S[atilde]o Jos[eacute] dos Campos--SP-12227-901,
P.O. Box 36/2, Brasil; phone: +55 12 3927 1000; fax: +55 12 3927-
2619; email: [email protected]; internet: http://www.embraer.com.br/en-US/Pages/home.aspx.
    (4) You may view this service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-1119.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on March 28, 2018.
William Schinstock,
Acting Deputy Director, Policy & Innovation Division, Aircraft
Certification Service.
[FR Doc. 2018-06821 Filed 4-9-18; 8:45 am]
 BILLING CODE 4910-13-P


United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-017
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.3040:

Field Testing for Pollinators

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  NOTICE
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  This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).  To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number.  Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in their title.
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  	The OCSPP harmonized test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice.  At places in this guidance, the Agency uses the word "should."  In this guidance, the use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.
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  	For additional information about these test guidelines and to access these guidelines electronically, please go to http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.
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OCSPP 850.3040: Field testing for pollinators.
(a) Scope --
      (1) Applicability.  This guideline is intended to be used to help develop data to submit to EPA under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).
      (2) Background.  The source materials used in developing this harmonized OCSPP test guideline include OPP 141-5 Field Testing for Pollinators (Pesticide Assessment Guidelines Subdivision L), and the Field Testing for Pollinators Standard Evaluation Procedure.
(b) Purpose.  This guideline is intended for use in developing data on hazards to bees, under actual field conditions, of chemical substances and mixtures ("test chemicals" or "test substances") subject to environmental effects test regulations.  The Environmental Protection Agency will use data from this test in assessing the hazard to bees that a test substance may present in the environment.
(c) Definitions.  The definitions in OCSPP 850.3000 apply to this guideline.
(d) General Considerations.  As this field test will be required only on a case-by-case basis and will be conducted in response to some specific problem, it may be designed to answer any number of questions concerning the hazard of the test substance to bees.  These questions will be determined during consultation between the submitter and the Agency.
(e) Test standards--
      (1) Test substance.  The substance to be tested is the specific form of a chemical or mixture of chemicals that is used to develop the data.  For pesticides, the substance to be tested is the end-use product.  OCSPP 850.3000 lists the type of information that should be known about the test substance before testing, and discusses methods for preparation of test substances.
      (2) Test organism.  Testing will be conducted on the species of concern.  Pollinators of economic importance in the United States include the honey bee (Apis mellifera), alfalfa leafcutting bee (Megachile rotundata), and alkali bee (Nomia melanderi).
      (3) Test conditions.  The test conditions for conducting an actual field test should resemble the conditions likely to be encountered under actual use of the product.  Specifically, the test substance should be applied to the site at the rate, frequency, and method specified on the label.  Information useful in developing a test protocol may be obtained from paragraphs (i)(1), (i)(2), and (i)(3) of this guideline.  It should be noted, however, that any testing conducted to satisfy the field test pollinator data in Part 158 should be preceded by consultation with the Agency.
(f) Tabular summary of test conditions.  Test conditions, data quality objectives, and statistical study design will vary from field study to field study.  Depending on the type of problem being addressed, the field test may take any one of a number of forms.  As such, this area does not lend itself to a detailed list of test conditions.
(g) Test validity elements.  Test conditions, data quality objectives, and study design will vary from field study to field study.  Depending on the type of problem being addressed, the field test may take any one of a number of forms.  As such, this area does not lend itself to a detailed treatment of test validity elements.
(h) Reporting--
      (1) Background information.  Background information to be supplied in the report consists at a minimum of those background information items listed in paragraph (j)(1) of OCSPP 850.3000.
      (2) Test protocol deviations.  Objectives and procedures stated in the EPA-approved protocol, developed based upon consultation with the Agency.  Include a description of any deviations from the agreed upon test protocol or any occurrences which may have influenced the results of the test.
      (3) Test substance.
            (i) End-use product (name, state or form, source), its purity (for pesticides, the identity (common name, IUPAC and CAS names, CAS number) and concentration of active ingredient(s)), and known physical and chemical properties that are pertinent to the test.
		(ii) Storage conditions of the test substance.
            (iii) Methods of preparation of test substance, including any carrier used to dissolve or dilute the test substance, and the amount of test substance (per acre, per colony, etc.), method of administration, and rationale for selection of method, route, or frequency.
	(4) Test organisms.
      (i) Scientific name, strain, and source.
		(ii) Culture method and conditions.
            (iii) Health status of colonies used or used for collection of test bees (e.g., any adult diseases, use and application date(s) of any prophylactic or preventative treatments).
		(iv) Collection method and date of collection.
		(v) Holding period.
		(vi) Approximate age at test initiation.
      (5) Test system and conditions.  Description of the test system and conditions of the field test.
            (i) Size of colonies or description of housing conditions: type, size, and material of test cages.
		(ii) Source and availability of food and water.
		(iii) Common and scientific name of treated crop.
            (iv) Field plot size, and method and time of administration of test substance on the field plot(s).
		(v) Type of controls.
            (vi) Number of treatment levels and controls and the method used to determine treatment levels.
		(vii) Number of bees per cage or colony.
		(viii) Number of bees per treatment level.
		(ix) Number of replicates.
            (x) Method of assigning bees or colonies to treatment and control groups and method of assigning field plots.
		(xi) Method and time of administration.
		(xii) Duration of the study and length of total observation period.
            (xiii) Types and frequency of effects to be observed and duration of each observation.
            (xiv) Methods and frequency of environmental monitoring performed on treated plots during administration of test substance and throughout observation period for temperature, precipitation, humidity, wind speed, cloud cover and any other conditions that would impact initial concentration or stability of residue levels on treated plots.
		(xv) A description of cropping practices during the test.
            (xvi) Description of the frequency and type of analytical samples, if any.  All analytical procedures and preservation methods should be described.  The accuracy of the method, method detection limit, and limit of quantification should be given.

	(6) Results.
            (i) Field site environmental monitoring data results (temperature, precipitation, wind speed, relative humidity, cloud cover) in tabular form (provide raw data for measurements not made on a continuous basis), and descriptive statistics (mean, standard deviation, minimum, maximum).
      	(ii) The reported results should include the results of range-finding tests, if conducted.
      	(iii) Effects data in tabular form (provide raw data) and descriptive statistics.
      	(iv) A summary and analysis of the data with a statement of the conclusions drawn from the analysis of the effects data.
      	(v) Statistical methods employed for analyzing the data, including any software used, a description of the transformations, calculations, or operations performed on the data.
(i) References.  The references in this paragraph should be consulted for additional background material on this test guideline.
	(1)  Atkins, E.L. et al., 1976.  Protecting Honeybees from Pesticides, University of California, Division of Agricultural Sciences, Leaflet 2883, 14 pp.
	(2)  Robinson, W.S. and C.A. Johansen, 1978. Effects of Control Chemicals for Douglas Fir Tussock Moth Orgyia pseudotsugata (McDonnough) on Forest Pollination (Lepidoptera: Lymantriidae), Washington State Entomological Society Melanderia 30:9-56.
	(3)  U.S. Environmental Protection Agency, 1986.  Hazard Evaluation Division Standard Evaluation Procedure, Field Testing for Pollinators.  Office of Pesticides Programs, Washington, D.C., EPA-540/9-86-140.
	(4)  U.S. Environmental Protection Agency, 1982.  Pesticide Assessment Guidelines Subdivision L Hazard Evaluation: Nontarget Insects. Office of Pesticides and Toxic Substances, Washington, D.C., EPA-540/9-82-019.


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18563-18564]
[FR Doc No: 2014-07336]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0677 and FDA-2011-E-0678]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ONSIOR and is publishing this notice of
that determination as required by law. FDA has made the determination

because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that animal drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For animal drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the animal drug product and
continues until FDA grants permission to market the animal drug
product. Although only a portion of a regulatory review period may
count toward the actual amount of extension that the Director of
Patents and Trademarks may award (for example, half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for an animal drug product will include all of
the testing phase and approval phase as specified in 35 U.S.C.
156(g)(4)(B).
    FDA has approved for marketing the animal drug product ONSIOR
(robenacoxib). ONSIOR is indicated for control of postoperative pain
associated with orthopedic surgery, ovariohysterectomy and castration
in cats >= 5.5 pounds and > 6 months of age; for up to a maximum of 3
days. Subsequent to this approval, the Patent and Trademark Office
received patent term restoration applications for ONSIOR (U.S. Patent
Nos. 6,291,523 and 7,115,662) from Novartis Animal Health US, Inc., and
the Patent and Trademark Office requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated July 9, 2012, FDA advised the Patent and Trademark Office
that this animal drug product had undergone a regulatory review period
and that the approval of ONSIOR represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
ONSIOR is 1,704 days. Of this time, 1,650 days occurred during the
testing phase of the regulatory review period, while 54 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(j)) became
effective: July 10, 2006. The applicant claims March 2, 2004, as the
date the investigational new animal drug application (INAD) became
effective. However, FDA records indicate that the INAD effective date
was July 10, 2006, which was the received date of the first submission
that includes a study with substantial data (submission of a major
health test) or the first submission containing a Notice of Claimed
Investigational Exemption.
    2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act: January 14,
2011. The applicant claims January 13, 2011, as the date the new animal
drug application (NADA) for ONSIOR (NADA 141-320) was initially
submitted. However, FDA records indicate that NADA 141-320 was
submitted on January 14, 2011.
    3. The date the application was approved: March 8, 2011. FDA has
verified the applicant's claim that NADA 141-320 was approved on March
8, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,308 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 2, 2014. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by September 29, 2014. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket numbers found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA 2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07336 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P