[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Notices]
[Pages 20214-20215]
[FR Doc No: 2014-08148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1515]

Determination That ZOVIRAX (Acyclovir Sodium) Injection,
Equivalent to 250 Milligrams Base/Vial, 500 Milligrams Base/Vial, and 1
Gram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
ZOVIRAX (acyclovir sodium) Injection, equivalent to (EQ) 250 milligrams
(mg) base/vial, 500 mg base/vial, and 1gram (g) base/vial, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for ZOVIRAX (acyclovir sodium) Injection, EQ 250
mg base/vial, 500 mg base/vial, and 1 g base/vial, if all other legal
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg
base/vial, and 1g base/vial, is the subject of NDA 18-603, held by
GlaxoSmithKline and initially approved on October 22, 1982. ZOVIRAX
(acyclovir sodium) is indicated for the treatment of herpes and
varicella-zoster (shingles) in immunocompromised patients.
    In a letter dated June 20, 2005, GlaxoSmithKline notified FDA that
ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/
vial, and 1g base/vial, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book.
    Lachman Consultant Services, Inc., submitted a citizen petition
dated November 15, 2013 (Docket No. FDA-2013-P-1515), under 21 CFR
10.30, requesting that the Agency determine whether ZOVIRAX (acyclovir
sodium) Injection, EQ 1 g base/vial, was withdrawn from sale for
reasons of safety or effectiveness. Although the citizen petition did
not address the 250 mg and 500 mg strengths, those strengths have also
been discontinued. On our own initiative, we have also determined
whether those strengths were withdrawn for safety or effectiveness
reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ZOVIRAX (acyclovir sodium) Injection, EQ 250
mg base/vial, 500 mg base/vial, and 1g base/vial, was

not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that ZOVIRAX
(acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial,
and 1 g base/vial, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ZOVIRAX (acyclovir sodium) Injection, EQ
250 mg base/vial, 500 mg base/vial, and 1g base/vial, from sale. We
have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that these products were not withdrawn from
sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ZOVIRAX (acyclovir
sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial, and 1g base/
vial, in the ``Discontinued Drug Product List'' section of the Orange
Book. The ``Discontinued Drug Product List'' delineates, among other
items, drug products that have been discontinued from marketing for
reasons other than safety or effectiveness. ANDAs that refer to ZOVIRAX
(acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial,
and 1g base/vial, may be approved by the Agency as long as they meet
all other legal and regulatory requirements for the approval of ANDAs.
If FDA determines that labeling for this drug product should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: April 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08148 Filed 4-10-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Rules and Regulations]
[Pages 13524-13526]
[FR Doc No: 2014-04697]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0573; Directorate Identifier 2012-SW-042-AD;
Amendment 39-17781; AD 2014-05-08]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters (Type Certificate
Previously Held by Eurocopter France) (Airbus Helicopters)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Helicopters Model AS332L1 helicopters. This AD requires
replacing the rivets on the left-hand (LH) and right-hand (RH) Y350
longitudinal beams (longitudinal beams Y350). This AD was prompted by a
report that non-conforming rivets had been installed on an AS332
helicopter during a production modification. The actions of this AD are
intended to prevent failure of the longitudinal beams Y350 and
subsequent loss of control of the helicopter.

DATES: This AD is effective April 15, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of April 15, 2014.

ADDRESSES: For service information identified in this AD, contact
Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.airbushelicopters.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the foreign authority's AD,
any incorporated-by-reference service information, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S.
Department of Transportation, Docket Operations Office, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On July 3, 2013 at 78 FR 40072, the Federal Register published our
notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR
part 39 by adding an AD that would apply to certain serial-numbered
Eurocopter (now Airbus Helicopters) Model AS332C1 and AS332L1
helicopters. The NPRM proposed to require replacing the non-conforming
3.2 mm rivets, part-number (P/N) 212 15DC 3200J, on the longitudinal
beams Y350 with airworthy 4.8 mm rivets, P/N 212 15DC 4800J. The
proposed requirements were intended to prevent failure of the
longitudinal beams Y350 and subsequent loss of control of the
helicopter.
    The NPRM was prompted by AD No. 2012-0046-E, dated March 21, 2012
(EAD 2012-0046-E), issued by the European Aviation Safety Agency
(EASA), which is the Technical Agent for the Member States of the
European Union, to correct an unsafe condition for Model AS332C1 and
AS332L1 helicopters. EASA advises that an AS332 helicopter was found on
the production line with non-conforming rivets installed on the RH and
LH longitudinal beams Y350 of the bottom structure of the fuselage,
between sections X4780 and X5295. According to EASA, the investigation
revealed that a limited number of helicopters were documented as
receiving a production modification requiring the replacement of
certain 3.2 mm rivets with 4.8 mm rivets, but the actual replacement of
the rivets had not been performed. EASA states that this condition
leads to significant reduction in the safety margins during sling
operations and may cause failure of the web/flange assembly connections
of the longitudinal beams Y350, possibly resulting in loss of control
of the helicopter. For these reasons, EASA issued EAD 2012-0046-E,
which, pending inspection of the helicopter beams Y350 and replacement
of the affected rivets, prohibits sling operations or limits the 3-ton
sling to external loads of 2.28 tons or less.

    Since the NPRM was published, we have determined that the
applicability requirements of the proposed AD should not apply to Model
AS332C1 helicopters, because that model is not type certificated in the
United States. We have removed that model and its corresponding serial
numbers from this AD. Also, Eurocopter France has changed its name to
Airbus Helicopters. This AD reflects that change and updates to contact
information to obtain service information.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM (78 FR 40072,
July 3, 2013).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed, except that we have removed
Eurocopter Model AS332C1 helicopters from the Applicability paragraph
and changed Eurocopter France to Airbus Helicopters. These changes are
consistent with the intent of the proposals in the NPRM (78 FR 40072,
July 3, 2013) and will not increase the economic burden on any operator
nor increase the scope of the AD.

Differences Between This AD and the EASA AD

    The EASA AD requires limiting the use of the 3-ton sling,
inspecting the longitudinal beams Y350 for loose or missing rivets,
black marks around the rivets, and cracks, and, depending on the
accumulated sling operation cycles, replacing the rivets within a
period of up to 24 months. This AD does not require the inspections as
it would require replacing the rivets within 10 hours time-in-service,
regardless of accumulated sling operation cycles. The EASA AD applies
to Model AS332C1 helicopters, and this AD does not because that model
is not type certificated in the United States.

Related Service Information

    We reviewed Eurocopter Emergency Alert Service Bulletin No.
01.00.81 Revision 0, dated March 19, 2012 (EASB 01.00.81) for Model
AS332 helicopters. The EASB describes procedures for temporarily
prohibiting sling operations or limiting the use of the 3-ton sling to
2.28 tons until the 3.2 mm diameter rivets are replaced with 4.8 mm
diameter rivets.
    We have subsequently reviewed Eurocopter EASB 01.00.81 Revision 1,
dated July 6, 2012 (EASB 01.00.81 Revision 1). EASB 01.00.81 Revision 1
deletes from the applicability of the EASB helicopters with
Modification (MOD) 07 26082 installed. MOD 07 26082 provides for
installation of the correct 4.8 mm diameter rivets on Eurocopter's
production line.

Costs of Compliance

    We estimate that this AD will affect 1 helicopter of U.S. Registry.
We estimate that operators will incur the following costs in order to
comply with this AD. Modifying the longitudinal beams Y350 with 4.8 mm
rivets requires about 24 work-hours at an average labor rate of $85 per
hour and required parts cost about $110, for a total cost per
helicopter of $2,150. Thus, the total cost to U.S. operators to comply
with this AD is about $2,150.

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 helicopters identified in this
rulemaking action.

Regulatory Findings

    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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; 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.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

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 airworthiness
directive (AD):

2014-05-08 Airbus Helicopters (Type Certificate Previously Held by
Eurocopter France): Amendment 39-17781; Docket No. FAA-2013-0573;
Directorate Identifier 2012-SW-042-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model AS332L1 helicopters
with the following serial numbers, certificated in any category:
2635, 2641, 2644, 9007, 9008, and 9009.

(b) Unsafe Condition

    This AD defines the unsafe condition as non-conforming rivets
installed on the left-hand (LH) and right-hand (RH) Y350
longitudinal beams (longitudinal beams Y350) of the bottom
structure. This condition could result in failure of the web/flange
assembly connections of the longitudinal beams Y350 and subsequent
loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective April 15, 2014.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 10 hours time-in-service, replace the 3.2 mm rivets,
part-number (P/N) 21215DC3200J, of the RH and LH longitudinal beams
Y350 of the bottom structure with 4.8 mm rivets, P/N 21215DC4800J,
as shown in Figures 2 and 3 of Eurocopter Emergency Alert Service
Bulletin No. 01.00.81, Revision 0, dated March 19, 2012.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Gary Roach, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) Emergency AD No. 2012-0046-E, dated March 21, 2012.
You may view the EASA AD on the Internet at www.regulations.gov in
Docket No. FAA-2013-0573.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5314: Fuselage
Main, Keel.

(i) 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) Eurocopter Emergency Alert Service Bulletin No. 01.00.81,
Revision 0, dated March 19, 2012.
    Note 1 to paragraph (i)(2): Eurocopter Emergency Alert Service
Bulletin No. 01.00.81, Revision 0, dated March 19, 2012, is co-
published as one document along with Eurocopter Emergency Alert
Service Bulletin No. 01.00.46, Revision 0, dated March 19, 2012,
which is not incorporated by reference in this AD.
    (ii) Reserved.
    (3) For Eurocopter service information identified in this AD,
contact Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at http://www.airbushelicopters.com/techpub.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (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 Fort Worth, Texas, on February 26, 2014.
Bruce E. Cain,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-04697 Filed 3-10-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26482-26483]
[FR Doc No: 2018-12223]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1774]

Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission Program;
Draft Guidance for Industry and Food and Drug Administration Staff.''
This draft guidance document provides an overview of the mechanisms
available to applicants through which they can request feedback from or
a meeting with FDA regarding potential or planned medical device
investigational device exemption (IDE) applications, premarket approval
(PMA) applications, humanitarian device exemption (HDE) applications,
evaluation of automatic class III designations (de novo requests),
premarket notification (510(k)) submissions, Clinical Laboratory
Improvement Amendments (CLIA) Waiver by Application, Accessory
Classification Requests, and certain investigational new drug (IND)
applications and biologics license applications (BLAs). This draft
guidance, when finalized, is intended to supersede the document
entitled ``Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug Administration
Staff'' issued on September 29, 2017. This draft guidance is not final
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by August 6, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-1774 for ``Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program; Draft Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for

information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program; Draft Guidance for Industry and Food and Drug
Administration Staff'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002 or the Office of Communication,
Outreach, and Development, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: J. Allen Hill, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5627, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The pre-IDE program was established in 1995, to provide applicants
a mechanism to obtain FDA feedback on future IDE applications prior to
their submission. Over time, the pre-IDE program evolved to include
feedback on PMA applications, HDE applications, de novo requests, and
510(k) submissions, as well as to address whether a clinical study
requires submission of an IDE.
    To capture this evolution, the Secretary of Health and Human
Services' 2012 Commitment Letter to Congress regarding the Medical
Device User Fee Amendments of 2012 (MDUFA III) included FDA's
commitment to institute a structured process for managing these
interactions, referring to them as ``Pre-Submissions.'' The Pre-
Submission Guidance, published February 18, 2014, implemented the
broader Q-Submission (Q-Sub) Program, which includes Pre-Submissions
(Pre-Subs), as well as additional opportunities to engage with FDA.
    As part of the Medical Device User Fee Amendments of 2017 (MDUFA
IV), industry and the Agency agreed to refine the Q-Sub Program with
changes related to the scheduling of Pre-Sub meetings and a new
performance goal on the timing of FDA feedback on Pre-Subs. This
guidance reflects those changes and clarifies other elements of the Q-
Sub program.
    This draft guidance document provides an overview of the mechanisms
available to applicants through which they can request feedback from or
a meeting with FDA regarding potential or planned medical device IDE
applications, PMA applications, HDE applications, de novo requests,
510(k) Submissions, CLIA Waiver by Application, Accessory
Classification Requests, and certain INDs and BLAs.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Requests for
Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program; Draft Guidance for Industry and Food and Drug Administration
Staff.'' 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.
This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft
guidance is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program; Draft Guidance for
Industry and Food and Drug Administration Staff'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1677 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance also refers to previously approved information
collections found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; the collections of information in 21 CFR part
807, subpart E are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 812 are approved under OMB
control number 0910-0078; the collections of information in 21 CFR part
814 are approved under OMB control number 0910-0231; and the
collections of information for ``Request for Feedback on Medical Device
Submissions'' are approved under OMB control number 0910-0756.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12223 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P


D 33 Appendix D 1. Calculations for Ionic Composition of Standard Laboratory Reconstituted Water Molecular Weights Atomic Weights NaHCO3 = 84.03 CaSO4.2H2 O = 172.12 MgSO4= 120.37 KCl = 74.55 SO4 = 96.06 Na = 22.98 Ca = 40.08 Mg = 24.31 K = 39.10 Cl = 35.45 Example Calculation [ Na] in very soft water: 12 mg NaHCO3/ L x 1 mmol NaHCO3/ 84.03 mg NaHCO3 = 0.143 mmol NaHCO3/ L. 0.143 mmol NaHCO3/ L x ( 1 mmol Na/ 1 mmol NaHCO3) x 22.98 mg Na/ 1 mmol Na = 3.3 mg Na/ L.

[ Ca] in very soft water: 7.5 mg CaSO4.2H2O/ L x 1 mmol CaSO4.2H2O/ 172.12 mg CaSO4.2H2O = 0.044 mmol CaSO4.2H2O/ L. 0.044 mmol CaSO4.2H2O/ L x ( 1 mmol Ca/ 1 mmol CaSO4.2H2O) x 40.08 mg Ca/ 1 mmol Ca = 1.8 mg Ca/ L.

[ Mg] in very soft water: 7.5 mg MgSO4/ L x 1 mmol MgSO4/ 120.37 mg MgSO4 = 0.062 mmol MgSO4/ L. 0.062 mmol MgSO4/ L x ( 1 mmol Mg/ 1 mmol MgSO4) x 24.31 mg Mg/ 1 mmol Mg = 1.5 mg Mg/ L.

[ K] in very soft water: 0.5 mg KCl/ L x 1 mmol KCl/ 74.55 mg KCl = 0.0067 mmol KCl/ L. 0.0067 mmol KCl/ L x ( 1 mmol K/ 1 mmolKCl) x 39.102 mg K/ 1 mmol K = 0.26 mg K/ L.

[ Cl] in very soft water: 0.5 mg KCl/ L x 1 mmol KCl/ 74.55 mg KCl = 0.0067 mmol KCl/ L. 0.0067 mmol KCl/ L x ( 1 mmol Cl/ 1 mmolKCl) x 35.453 mg Cl/ 1 mmol K = 0.24 mg Cl/ L.

[ SO4] in very soft water: 7.5 mg CaSO4.2H2O/ L x 1 mmol CaSO4.2H2 O/ 172.12 mg CaSO4.2H2O = 0.044 mmol CaSO4.2H2O/ L. 0.044 mmol CaSO4.2H2O/ L x ( 1 mmol SO4/ 1 mmol CaSO4.2H2O) x 96.064 mg Ca/ 1 mmol Ca = 4.2 mg Ca/ L.

[ SO4] in very soft water: 7.5 mg MgSO4/ L x 1 mmol MgSO4/ 120.37 mg MgSO4 = 0.062 mmol MgSO4/ L. 0.062 mmol MgSO4/ L x ( 1 mmol SO4/ 1 mmol MgSO4) x 96.064 mg Mg/ 1 mmol Mg = 6.0 mg Mg/ L.

Total SO 4 = 10.2 mg/ L Conversion Factors to calculate water hardness ( as CaCO3) from [ Ca] and [ Mg]:

[ Ca] x 2.497 [ Mg] x 4.116


[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Page 36607]
[FR Doc No: 2012-14696]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety Notice of Application for
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of Applications for Special Permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before July 19, 2012.

ADDRESSES: Address Comments to: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC, or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on June 12, 2012.
Donald Burger,
Chief, General Approvals and Permits.

                                               New Special Permits
----------------------------------------------------------------------------------------------------------------
                                                                     Regulation(s)      Nature of special permit
   Application  No.        Docket  No.          Applicant              affected                 thereof
----------------------------------------------------------------------------------------------------------------
15617-N...............  ................  Veolia ES Technical    49 CFR 173.192,       To authorize the
                                           Solutions, L.L.C.      177.848.              transportation in
                                           Flanders, NJ.                                commerce of waste
                                                                                phosgene in alternative
                                                                                packaging being
                                                                                transported to a
                                                                                disposal facility
                                                                                without meeting the
                                                                                segregation requirements
                                                                                for Division 2.3 gas
                                                                                Zone A materials within
                                                                                the transport vehicle.
                                                                                (mode 1)
15638-N...............  ................  Lantis Productions     49 CFR 172.101,       Authorizes the
                                           Inc. dba Lantis        172.204(c)(3),        transportation of
                                           Fireworks & Lasers     173.27,;              Fireworks, Division
                                           Draper, UT.            175.30(a)(1),         1.3G, UNO335 by cargo
                                                                  175.320.              aircraft only, which is
                                                                                otherwise forbidden for
                                                                                air transportation.
                                                                                (mode 3)
15642-N...............  ................  Praxair Distribution,  49 CFR 180.205 and    To authorize the
                                           Inc. Danbury, CT.      180.209(a)(b),        transportation in
                                                                  180.213(b), and       commerce of DOT
                                                                  180.213(f)(2).        Specification 3AL
                                                                                cylinders, cylinders
                                                                                manufactured under DOT-
                                                                                SP 12440, and ISO 7866
                                                                                cylinders containing
                                                                                certain compressed gases
                                                                                when retested by a 100%
                                                                                ultrasonic examination
                                                                                in lieu of the internal
                                                                                visual and the
                                                                                hydrostatic retest.
                                                                                (modes 1, 2, 3, 4, 5)
15650-N JL............  ................  Shepherd & Associates  49 CFR 173.416......  To authorize the
                                           San Fernando, CA.                            continued transportation
                                                                                in commerce of certain
                                                                                DOT Specification 20WC
                                                                                radioactive material
                                                                                packagings after October
                                                                                1, 2008. (mode 1)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-14696 Filed 6-18-12; 8:45 am]
BILLING CODE 4909-60-M


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on May 10, 2001

   NOTICE OF ACTION TAKEN -- DOCKET OST-97-2591

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of      Atlas Air, Inc.    filed  4/16/01 to:

XX  Renew for two years exemption under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of property and mail between New
York, Chicago, Los Angeles, Anchorage, and Honolulu, on the one hand,
and Hong Kong, on the other, via intermediate points in Taiwan and Korea
(without local traffic rights between Taiwan and Korea, on the one hand,
and Hong Kong on the other).

Applicant rep:  William C. Evans,<PHONE_NUMBER>    DOT Analyst:  Sylvia
Moore,<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted

The above action was effective when taken:   May 10, 2001, through   May
10,  2003

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreements
between the United States and Hong Kong, the United States and Korea,
and the aviation agreement governing air services between the United
States and Taiwan.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) grant of the
exemption authority was consistent with the public interest; and (3)
grant of the authority would not constitute a major federal action under
the Energy, Policy and Conservation Act of 1975.  To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within ten (10) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with the applicable requirements of the Federal Aviation
Administration Regulations, including all FAA requirements concerning
security; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.


4500 S. Laspina * Suite 214 * Tulare, CA  93274

October 24, 2008

Ms. Debbie Edwards, Director

Office of Pesticide Program

United States Environmental Protection Agency (EPA)

One Potomac Yard

Arlington, VA

Dear Ms. Edwards:

We are writing to acknowledge the professionalism and hospitality of
your staff at the October 14, 2008 meeting between your office and the
California Specialty Crops Council.  Last week nine members of the
California Specialty Crops Council participated in dialogue with a
variety of staff including Ms. Lois Rossi, Mr. Rick Keigwin, and Ms
Margaret Rice.  One of the issues discussed was EPA’s Fumigant
Reregistration Eligibility Decision (RED) - Risk Mitigation Measures to
Address Inhalation Exposures from Soil Fumigant Applications (Docket ID:
EPA-HQ-OPP-2007-0350).  Based upon that discussion we request that you
extend the comment period for 30 days and conduct a workshop in
California.

During our discussion about the Fumigant RED we learned that EPA has
offered to conduct workshops to help inform the regulated community
about the new requirements of the RED.  We were advised that workshops
have been conducted in the Northwest and in Florida, but that no such
workshops have been conducted in California.  EPA’s proposed
mitigation measures will affect thousands of farmers in California and
millions of acres.  These changes will have a significant impact on
fumigation practices in California.  We would be pleased to organize a
workshop immediately and invite your staff to present the proposed
Fumigant RED.  We request that the comment period be extended to allow
time for such a workshop to be conducted.

During our discussion we also learned for the first time that EPA is
considering case studies as part of the public comment process.  Ms.
Margaret Rice explained that EPA is learning that the proposed Fumigant
RED will affect different commodities and regions in ways that were not
expected and that EPA is considering case studies to better understand
these impacts.  The request for case studies was not included in the
public notice for comment.  We would like the opportunity to submit a
case study to describe how the proposed Fumigant RED will impact
California.  We request that the comment period be extended to allow
more time for us to prepare and submit such case studies.

During our discussions we were also told that EPA will be considering
input beyond the October 30, 2008 deadline for public comments.  Given
this statement, we would appreciate EPA extending the public comment
period so that our comments can be formally included into the record.

Thank you for considering our request.  If you or your staff has any
questions, please do not hesitate to contact us at<PHONE_NUMBER>.

Sincerely,

Jim Culbertson

Jim Culbertson,

Chairman of the Board


[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Rules and Regulations]
[Pages 41895-41899]
[FR Doc No: 2017-18623]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0621; FRL-9965-89-Region 9]

Revisions to the California State Implementation Plan; Imperial
County Air Pollution Control District; Stationary Sources Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing action
on a revision to the Imperial County Air Pollution Control District
(ICAPCD or District) portion of the California State Implementation
Plan (SIP). We are finalizing a conditional approval of one rule. This
rule updates and revises the District's New Source Review (NSR)
permitting program for new and modified sources of air pollution.

DATES: This rule is effective on October 5, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket No. EPA-R09-OAR-2015-0621. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although it may be
listed in the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through http://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Thien Khoi Nguyen, EPA Region IX,
(415) 947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Definitions

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

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The word or initials CAA mean or refer to the Clean Air Act,
unless the context indicates otherwise.

    (ii) The initials CARB mean or refer to the California Air
Resources Board.
    (iii) The initials CFR mean or refer to Code of Federal
Regulations.
    (iv) The initials or words EPA, we, us or our mean or refer to the
United States Environmental Protection Agency.
    (v) The initials FIP mean or refer to Federal Implementation Plan.
    (vi) The word or initials ICAPCD or District mean or refer to the
Imperial County Air Pollution Control District, the agency with
jurisdiction over stationary sources within Imperial County.
    (vii) The initials NSR mean or refer to New Source Review.
    (viii) The initials SIP mean or refer to State Implementation Plan.
    (ix) The initials TSD mean or refer to Technical Support Document.

I. Proposed Action

    On June 12, 2017, the EPA proposed a conditional approval of Rule
207 (New and Modified Stationary Source Review; as noted in Table 1)
submitted by CARB for incorporation into the ICAPCD portion of the
California SIP. 82 FR 26883.\1\ Table 1 also lists the dates the rule
was adopted by ICAPCD and submitted by CARB, which is the governor's
designee for California SIP submittals.
---------------------------------------------------------------------------

    \1\ Previously, the EPA proposed a limited approval and limited
disapproval of Rule 207. 81 FR 91895. (December 19, 2016)

                                           Table 1--Submitted NSR Rule
----------------------------------------------------------------------------------------------------------------
         Rule No.             Rule title        Adopted/revised       Submitted            Proposed action
----------------------------------------------------------------------------------------------------------------
207......................  New and Modified             10/22/13          1/21/14   Conditional Approval.
                            Stationary
                            Source Review.
----------------------------------------------------------------------------------------------------------------

    Rule 207 satisfies the statutory and regulatory requirements for a
general NSR permit program as set forth in CAA section 110(a)(2)(c) and
40 CFR 51.160--51.164, and the statutory and regulatory requirements
for a nonattainment NSR permit program for moderate ozone and serious
PM10, nonattainment areas as set forth in the applicable
provisions of part D of title I of the Act (sections 172 and 173), in
40 CFR 51.165 and 40 CFR 51.307. For a moderate PM2.5
nonattainment area, Rule 207 mostly satisfies these requirements;
however, we have determined that it does not satisfy the requirements
of 40 CFR 51.165(a)(13), which requires ammonia to be regulated as a
PM2.5 precursor. The state committed to revise the rule to
correct this deficiency in Rule 207, and, based on those assertions,
EPA proposed conditional approval of the rule.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period we received two comments, one posted anonymously and
one from the Center for Biological Diversity (CBD). Copies of each
comment letter have been added to the docket for this action and are
accessible at www.regulations.gov. We have summarized the comments
received and provided a response to the comments below.
    Comment 1: ``keep standards in place. we all want clean air to
breathe.''
    Response 1: The EPA did not propose to remove any standards.
Instead, as explained in our proposed rulemaking, our action concerns
ICAPCD Rule 207. Rule 207 implements a federal preconstruction permit
program for new and modified minor sources of regulated NSR pollutants,
and new and modified major sources of regulated NSR pollutants for
which the area is designated nonattainment. This action will not remove
or alter the National Ambient Air Quality Standards, which are the
federal standards promulgated by the EPA to protect air quality. As
explained in our technical support document (TSD), dated November 28,
2016, in the rulemaking docket,\2\ this action will update ICAPCD's
SIP-approved preconstruction permitting program, including lower
emission thresholds at which projects will trigger requirements for
Lowest Achievable Emission Reductions and offsets. TSD at 20. These
updates to ICAPCD's preconstruction permitting program will promote air
quality protection, consistent with current federal requirements.
---------------------------------------------------------------------------

    \2\ We included the November 28, 2016 TSD in the rulemaking
docket in connection with our previous proposed limited approval and
limited disapproval of Rule 207. See 81 FR 91895 (December 19,
2016).
---------------------------------------------------------------------------

    Comment 2: CBD stated that, ``the EPA's conditional approval of the
proposed Rule 207 is not valid because the commitment letter submitted
by the District does not provide for specific enforceable measures to
regulate ammonia as a PM2.5 precursor as required by 40 CFR
51.165(a)(13).'' CBD stated that the District's commitment letter is
neither specific nor enforceable but merely commits to revise the
definitions of the terms ``precursor'' and ``significant.'' CBD stated
that the District's commitment lacks information on what the revision
will entail, how the revision will satisfy the mandatory requirement to
include ammonia as a PM2.5 precursor, how the revision will
create enforceable mechanisms to control ammonia, and how the revision
will meet CAA section 110(l) requirements to not interfere with
attainment and reasonable further progress of the NAAQS. CBD proposed
certain specific measures and controls technologies, and stated that
because the District's commitment letter did not include these measures
or any other measures, the commitment measures cannot be properly
enforced. CBD stated that the unspecified commitment puts the public at
risk because the public cannot fully inform themselves as to whether
the District is meeting its legal duties to protect public health. CBD
stated that because the EPA must deny the District's Rule 207 proposal,
the EPA is obligated to implement a Federal Implementation Plan (FIP)
that will mandate ammonia as a PM2.5 precursor and cure the
Rule 207 deficiency within two years.
    Response 2: The EPA disagrees with the comment. As explained
further below, the EPA believes the record supports conditional
approval of Rule 207 because the State has committed to correct the
deficiency in Rule 207 identified by EPA in the November 2016 TSD
within one year of this final action.
    As explained in our proposed action, Rule 207 implements a federal
preconstruction permit program for new and modified minor sources of
regulated NSR pollutants, and new and modified major sources of
regulated NSR pollutants for which the area is designated
nonattainment. Rule 207 authorizes ICAPCD to issue permits that will
contain emission limits, and associated monitoring, reporting, and
recordkeeping requirements, consistent with the EPA's requirements for
such programs as set forth in CAA sections 110(a)(2), 172 and 173, and
applicable

regulatory provisions such as 40 CFR 51.160-51.165 and 40 CFR 51.307.
    The EPA's proposed conditional approval of Rule 207 explained our
determination that Rule 207 largely satisfies the statutory and
regulatory requirements for an NSR permit program. We noted, however,
one area in which Rule 207 was deficient. Specifically, our proposed
action noted that Rule 207 does not adequately regulate ammonia as a
PM2.5 precursor as required by 40 CFR 51.165(a)(13).\3\ Our
proposed action explained that additional information on this issue
could be found in our TSD.\4\
---------------------------------------------------------------------------

    \3\ 40 CFR 51.165(a)(13) provides: ``The plan shall require that
the control requirements of this section applicable to major
stationary sources and major modifications of PM2.5 shall
also apply to major stationary sources and major modifications of
PM2.5 precursors in a PM2.5 nonattainment
area, except that a reviewing authority may exempt new major
stationary sources and major modifications of a particular precursor
from the requirements of this section for PM2.5 if the
NNSR precursor demonstration submitted to and approved by the
Administrator shows that such sources do not contribute
significantly to PM2.5 levels that exceed the standard in
the area. Any demonstration submitted for the Administrator's review
must meet the conditions for a NNSR precursor demonstration as set
forth in Sec.  51.1006(a)(3).''
    \4\ See also, 82 FR 91897.
---------------------------------------------------------------------------

    Our TSD explains that Rule 207, section B, contains various
definitions necessary to implement the preconstruction permitting
program set forth in the rule. TSD at 4. The TSD states that Rule 207's
definition of the term ``precursor'' explicitly applies to two of four
PM2.5 precursors, NOX and SOx, and
indirectly applies to a third PM2.5 precursor, VOCs. Id. at
10. With respect to the fourth PM2.5 precursor, ammonia, the
TSD states that the Rule 207 definition of ``precursor'' does not
satisfy regulatory requirements. Id. at 10-11. The TSD notes that
ICAPCD adopted Rule 207 in October 2013, prior to EPA's revisions to
our PM2.5 regulations, including revisions relevant to the
regulation of PM2.5 precursors.\5\ In particular, the TSD
notes that Rule 207 requires regulation of ammonia as a
PM2.5 precursor ``if ammonia is determined to be a necessary
part of the PM2.5 control strategy in the attainment
demonstration approved by USEPA in the SIP.'' Id. In other words, Rule
207 in its current form does not regulate ammonia as a PM2.5
precursor absent a finding by EPA that regulation of ammonia is a
necessary component of ICAPCD's strategy to attain the PM2.5
NAAQS. This presumption against regulating ammonia as a precursor
absent a determination that regulation is necessary for attainment was
rejected by the Court of Appeals for District of Columbia Circuit in
Natural Resources Defense Council (NRDC) v. EPA, 706 F.3d 428 (D.C.
Cir. 2013). Following the NRDC decision, EPA revised its regulatory
requirements, (specifically, by promulgating 40 CFR 51.165(a)(13)), to
require regulation of ammonia as a PM2.5 precursor unless
EPA determines that such regulation is not necessary.\6\
---------------------------------------------------------------------------

    \5\ See FN 3; see also, ``Fine Particulate Matter National
Ambient Air Quality Standard: State Implementation Plan
Requirements.'' 81 FR 58010, 58151 (August 24, 2016).
    \6\ Id.
---------------------------------------------------------------------------

    As explained above, our proposed conditional approval of Rule 207
applies the correct standard pertaining to ammonia as a
PM2.5 precursor and appropriately identifies Rule 207's
definition of precursor as deficient on the basis that it does not meet
the requirements of 40 CFR 51.165(a)(13). As stated in our TSD, the
remedy for Rule 207's deficient definition of ``precursor'' is either a
revision to the definition of ``precursor'' or a demonstration that
regulation of ammonia is not necessary to attain the PM2.5
NAAQS, consistent with the EPA's requirements for such demonstrations
at 40 CFR 51.1006(a)(3). TSD at 10-11. Similarly, our proposed
conditional approval of Rule 207 identified our authority under CAA
section 110(k)(4) to conditionally approve a plan revision based on a
commitment by the State to adopt specific enforceable measures by a
date certain but no later than one year after the effective date of
final action. We also explained that the enforceable measures that the
State must submit are revisions that regulate ammonia as a
PM2.5 precursor and that the District had in fact submitted
such a letter.\7\
---------------------------------------------------------------------------

    \7\ The rulemaking docket for our proposed action includes the
following documents relevant to the State's commitment pursuant to
CAA section 110(k)(4): (1) a letter dated May 17, 2017 from Karen
Magliano, Chief of the Air Quality Planning and Science Division,
California Air Resources Board (CARB) to Alexis Strauss, Acting
Regional Administrator, EPA Region 9; (2) a letter dated May 16,
2017 from Matt Dessert, Air Pollution Control Officer (APCO), ICAPCD
to Carol Sutkus, Manager, CARB; and (3) a letter dated May 16, 2017
from Matt Dessert APCO ICAPCD to Alexis Strauss, Acting Regional
Administrator, EPA Region 9. CARB is the state agency responsible
for adopting and revising the California SIP and for submitting SIP
revisions to the EPA. We are clarifying that the State's commitment
``to adopt specific enforceable measures by a date certain''
pursuant to CAA section 110(k)(4) is comprised of all three
documents.
---------------------------------------------------------------------------

    As noted by the commenter, ICAPCD's letter commits to submit a
revised Rule 207 that will revise the definitions of the terms
``precursor'' and ``significant''.\8\ The record for this action
demonstrates that EPA identified a deficiency in Rule 207 based on the
definition of ``precursor'' not properly regulating ammonia as far back
as December 19, 2016, when EPA proposed a limited approval/limited
disapproval of Rule 207 and included the TSD in the publicly available
rulemaking docket.\9\ As explained above and in our TSD, the only
reason that Rule 207 is deficient with respect to federal requirements
for NSR permit programs (specifically, 40 CFR 51.165(a)(13)) is that
certain definitions in Rule 207 mean that the rule does not properly
regulate ammonia as a PM2.5 precursor. Therefore, the most
logical approach to remedy the identified deficiency is to revise the
definitions for these terms as the TSD advises. The State and the
District committed to implement the changes necessary to correct the
deficiency.
---------------------------------------------------------------------------

    \8\ The District also indicated its intent to revise Rule 207's
definition of the term ``significant.'' Rule 207's definition of
``significant'' also fails to include ammonia, and therefore
requires revision for reasons similar to those necessitating a
revision to the definition of ``precursor.''
    \9\ By the time CARB and the District submitted their commitment
letters to the EPA, in mid-May 2017, the EPA's TSD for Rule 207,
which explained Rule 207's deficiency as linked to the rule's
definitions, was in the rulemaking docket for several months (since
December 2016). See FN 2.
---------------------------------------------------------------------------

    We do not agree with the commenter that ICAPCD's commitment to
remedy the deficiencies in Rule 207's definitions of ``precursor'' or
``significant'' are insufficiently specific or are unenforceable. The
EPA's TSD explains that Rule 207's definition of ``precursor'' fails to
include ammonia; therefore, the State and the District reasonably
committed to address the deficiency by revising certain
definitions.\10\ In addition, the District must solicit input from the
public regarding the revisions to the definitions, and, as part of the
public participation process for the revisions to Rule 207, interested
members of the public will have the opportunity to provide input
regarding the District's revised definitions and whether they meet the
requirements of 40 CFR 51.165(a)(13). In addition, the public will be
able to provide input as to whether the revisions provide an
enforceable mechanism for regulating ammonia as a PM2.5
precursor.\11\
---------------------------------------------------------------------------

    \10\ We also note that ICAPCD's letter states that EPA had
``informed'' it that Rule 207 ``contains a deficiency regarding the
treatment of ammonia as a PM2.5 precursor'' and that it
was committing to submit a revised rule with revised definitions of
these terms ``to address this deficiency.''
    \11\ We also note that if the District does not fulfill its
commitment, the conditional approval will convert to a disapproval
and start an 18-month clock for sanctions under CAA section
179(a)(2). Such a failure would also trigger a two-year clock for a
federal implementation plan (FIP) under CAA section 110(c)(1).
---------------------------------------------------------------------------

    EPA also disagrees with the commenter that the District's

commitment lacks specificity because it does not explain how the
revisions to Rule 207 will comply with CAA section 110(l). Once the EPA
receives ICAPCD's revisions to Rule 207, the EPA will review the
revised rule pursuant to CAA section 110(l) to ensure that the
revisions do not interfere with any applicable requirements concerning
attainment and reasonable further progress, or any other applicable
requirements of the Act, and will take public comment on our
determination regarding CAA section 110(l) along with other aspects of
our action. It is therefore unnecessary for the District to provide
this analysis in its commitment letter to EPA.
    CBD also provided several suggestions for measures to control and
monitor ammonia emissions and concluded that the failure to commit to
implement such measures in the area puts the public at risk and
deprives the public of its ability to assess compliance with the
statute. The EPA disagrees that the State and the District are required
to commit to implement specific control measures in order to obtain
this conditional approval or that the public will be deprived of the
right to review the state revisions to Rule 207 or any permits issued
thereunder. When the District proposes revisions to Rule 207 or is
actively issuing permits pursuant to that rule, CBD and other parties
may comment as part of the public participation processes for those
future actions. Thus, the comments are not within the scope of our
current action, and the comments do not demonstrate a flaw in the EPA's
identification of the Rule 207 deficiency and revisions necessary to
address it.
    Finally, because the EPA believes that the commitment of the State
and the District to remedy the deficiencies identified in Rule 207 to
regulate ammonia as a precursor to PM2.5 is sufficient, we
disagree that EPA is obligated to implement a FIP. Our proposed action
to conditionally approve Rule 207 is based on a commitment from the
State and the District to submit specific, enforceable measures in the
form of revised definitions for the terms ``precursor'' and
``significant'' within twelve months from the effective date of our
final action. Because the State and the District provided the necessary
commitments, EPA reasonably proposed to conditionally approve Rule 207
pursuant to CAA section 110(k)(4).\12\
---------------------------------------------------------------------------

    \12\ See NRDC v. EPA, 22 F3d 1125, 1134-1135 (D.C. Cir. 1994)
(concluding that the conditional approval mechanism under CAA
section 110(k)(4) ``is intended to provide EPA with an alternative
to disapproving substantive, but not entirely satisfactory, SIPs
submitted by the statutory deadlines.'')
---------------------------------------------------------------------------

III. EPA Action

    As authorized by CAA section 110(k)(4), EPA is finalizing
conditional approval of Rule 207--New and Modified Stationary Source
Review into the ICAPCD portion of the California SIP.
    Section 110(k)(4) authorizes the EPA to conditionally approve a
plan revision based on a commitment by the State to adopt specific
enforceable measures by a date certain, but not later than one year
after the effective date of the plan approval. In this instance, the
enforceable measures that the State must submit are revisions to
regulate ammonia as a PM2.5 precursor. On May 17, 2017, CARB
submitted a letter dated May 16, 2017 from the District committing to
submit a SIP revision that regulates ammonia as a PM2.5
precursor no later than one year from the effective date of this final
action. Under a conditional approval, the state must adopt and submit
the specific revisions it has committed to within one year. If the
State does not comply with this commitment, the EPA's conditional
approval will convert to a disapproval and start an 18-month clock for
sanctions under CAA section 179(a)(2) and a two-year clock for a
federal implementation plan (FIP) under CAA section 110(c)(1).
    In today's action we are also making a technical correction to our
previous action approving Rule 206 into the ICAPCD portion of the
California SIP.\13\ In that action, we provided incorrect regulatory
text to effect that change. This final action includes the corrected
regulatory text to approve the revised Rule 206 in the California SIP.
We did not seek public comment on this technical correction because
public participation requirements were satisfied as part of our action
approving Rule 206 into the SIP.
---------------------------------------------------------------------------

    \13\ 82 FR 27125 (June 14, 2017).
---------------------------------------------------------------------------

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
ICAPCD rules listed in Table 1 of this notice. The EPA has made, and
will continue to make, these rules generally available electronically
through www.regulations.gov and in hard copy at the U.S. Environmental
Protection Agency, Region IX (Air -3), 75 Hawthorne Street, San
Francisco, CA, 94105-3901.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law.

Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    The EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 6, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: July 31, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(56)(i)(B),
(c)(442)(i)(A)(5), and (c)(490) to read as follows:

Sec.  52.220  Identification of plan--in part.

* * * * *
    (c) * * *
    (56) * * *
    (i) * * *
    (B) Previously approved on November 10, 1980 in paragraph
(c)(56)(i)(A) of this section and now deleted with replacement in
paragraph (c)(490)(i)(A)(1) of this section: Rule 207 and Rule 209.
* * * * *
    (442) * * *
    (i) * * *
    (A) * * *
    (5) Rule 206, ``Processing of Applications,'' revised on October
22, 2013.
* * * * *
    (490) An amended regulation was submitted on January 21, 2014 by
the Governor's designee.
    (i) Incorporation by reference.
    (A) Imperial County Air Pollution Control District.
    (1) Rule 207, ``Federal New Source Review,'' revised on October 22,
2013.

Sec.  52.232  [Amended]

0
3. Section 52.232 is amended by removing and reserving paragraph
(a)(1).

Sec.  52.233   [Amended]

0
4. Section 52.233 is amended by removing and reserving paragraph
(a)(1).

[FR Doc. 2017-18623 Filed 9-1-17; 8:45 am]
 BILLING CODE 6560-50-P


ANALYSIS OF EMISSIONS REDUCTION OPTIONS FOR THE ELECTRIC POWER INDUSTRY Office of Air and Radiation U. S. Environmental Protection Agency March 1999


[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Rules and Regulations]
[Page 54758]
[FR Doc No: 2013-21712]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2012-C-0224]

Listing of Color Additives Exempt From Certification; Mica-Based
Pearlescent Pigments; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is confirming the
effective date of July 15, 2013, for the final rule that appeared in
the Federal Register of June 12, 2013 (78 FR 35115). The final rule
amended the color additive regulations to provide for the safe use of
mica-based pearlescent pigments prepared from titanium dioxide and mica
as color additives in distilled spirits containing not less than 18
percent and not more than 23 percent alcohol by volume but not
including distilled spirits mixtures containing more than 5 percent
wine on a proof gallon basis.

DATES: Effective date confirmed: July 15, 2013.

FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 12, 2013 (78
FR 35115), we amended the color additive regulations in Sec.  73.350
(21 CFR 73.350) to provide for the safe use of mica-based pearlescent
pigments prepared from titanium dioxide and mica as color additives in
distilled spirits containing not less than 18 percent and not more than
23 percent alcohol by volume but not including distilled spirits
mixtures containing more than 5 percent wine on a proof gallon basis.
    We gave interested persons until July 12, 2013, to file objections
or requests for a hearing. We received no objections or requests for a
hearing on the final rule. Therefore, we find that the effective date
of the final rule that published in the Federal Register of June 12,
2013, should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and
under authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director, Office of Food Additive Safety, we are
giving notice that no objections or requests for a hearing were filed
in response to the June 12, 2013, final rule. Accordingly, the
amendments issued thereby became effective July 15, 2013.

    Dated: August 28, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-21712 Filed 9-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Page 28861]
[FR Doc No: 2016-10905]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-56-000]

Consumer Energy Company; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On April 28, 2016, the Commission issued an order in Docket No.
EL16-56-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into the justness and
reasonableness of Consumer Energy Company's proposed rate reduction.
Consumer Energy Company, 155 FERC ] 61, 104 (2016).
    The refund effective date in Docket No. EL16-56-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: April 28, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-10905 Filed 5-9-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: June 15, 2010 (Volume 75, Number 114)]
[Notices]
[Page 33872-33874]
[DOCID:fr15jn10-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62231; File No. SR-NYSE-2010-42]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC
Amending NYSE Rule 123C(9)(a)(1) To Extend the Operation of a Pilot
Operating Pursuant to the Rule Until December 1, 2010

June 4, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on May 27, 2010, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Rule 123C(9)(a)(1) to extend
the operation of a pilot operating pursuant the Rule until December 1,
2010. The text of the proposed rule change is available at the
Exchange, on the Commission's Web site at http://www.sec.gov, the
Commission's Public Reference Room, and http://www.nyse.com.

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

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

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

1. Purpose
    The New York Stock Exchange (``NYSE'' or the ``Exchange'') proposes
to amend NYSE Rule 123C(9)(a)(1) to extend the operation of a pilot
that allows the Exchange to temporarily suspend certain rule
requirements at the close when extreme order imbalances may cause
significant dislocation to the closing price (``Extreme Order
Imbalances Pilot'' or ``Pilot'') \4\ until December 1, 2010.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 59755 (April 13,
2009) 74 FR 18009 (April 20, 2009) (SR-NYSE-2009-18); see also,
Securities and Exchange Act Release No. 61264 (December 31, 2009) 75
FR 1107 (January 8, 2010) (SR-NYSE-2009-131) (extending the
operation of the pilot from December 31, 2009 to March 1, 2010);
Securities Exchange Act Release No. 61612, (March 1, 2010), (SR-
NYSE-2010-11) (extending the operation of the pilot from March 1,
2010 to June 1, 2010).
    \5\ The Exchange notes that parallel changes are proposed to be
made to the rules of NYSE Amex LLC. See SR-NYSEAmex-2010-50.
---------------------------------------------------------------------------

    Background
    Pursuant to NYSE Rule 123C(9)(a)(1), the Exchange may suspend NYSE
Rule 52 (Hours of Operation) to resolve an extreme order imbalance that
may result in a price dislocation at the close as a result of an order
entered into Exchange systems or represented to a DMM orally at or near
the close. The provisions of NYSE Rule 123C(9)(a)(1) operate as the
Extreme Order Imbalance Pilot.
    As a condition of the approval to operate the Pilot, the Exchange
committed to provide the Commission with information regarding: (i) how
often a Rule 52 temporary suspension pursuant to the Pilot was invoked
during the six months following its approval; and (ii) the Exchange's
determination as to how to proceed with technical modifications to
reconfigure Exchange systems to accept orders electronically after 4
p.m.
    During the operation of the Pilot, the Exchange believed that the
systems modifications to allow Exchange systems to accept orders
electronically after 4 p.m. would not be as onerous as previously
believed when the Pilot was initially commenced. The Exchange completed
the system modifications necessary to accept orders electronically
after 4 p.m. and began the process of testing the modifications. The
Exchange therefore filed to extend the Extreme Order Imbalance Pilot
until the earlier of SEC approval to make such Pilot permanent or June
1, 2010.\6\ At the time,

the Exchange anticipated that its quality assurance review process
would be completed by June 1, 2010 and it would be able to operate
under the new system. The quality assurance review determined that
additional testing was required in order to assure the optimal
functioning of the system modifications. Given unanticipated market
wide initiatives that were [sic] (i.e., short sale and stock-by-stock
circuit breakers), which require systemic modifications and a
significant allocation of quality assurance resources, additional
testing is not feasible at this time.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 61612, (March 1,
2010), (SR-NYSE-2010-11) (extending the operation of the pilot from
March 1, 2010 to June 1, 2010).
---------------------------------------------------------------------------

Proposal To Extend the Operation of the Extreme Order Imbalance Pilot
    The Exchange established the Extreme Order Imbalance Pilot to
create a mechanism for ensuring a fair and orderly close when interest
is received at or near the close that could negatively affect the
closing transaction. The Exchange believes that this tool has proved
very useful to resolve an extreme order imbalance that may result in a
closing price dislocation at the close as a result of an order entered
into Exchange systems, or represented to a DMM orally at or near the
close.
    NYSE Rule 123C(9) was intended to be and has been invoked to
attract offsetting interest in rare circumstances where there exists an
extreme imbalance at the close such that a DMM is unable to close the
security without significantly dislocating the price. This is evidenced
by the fact that since the inception of the pilot in April 2009, the
Exchange has invoked the provisions of NYSE Rule 123C(9)(a)(1) on only
four occasions.
    Given the infrequency of these situations, the Exchange proposes to
extend the operation of the Pilot for a six-month period to allow the
Exchange to complete systemic modifications required to implement the
short sale and stock-by-stock circuit breakers, as well as to upgrade
server capacity and an upcoming initiative to incorporate odd-lot
orders into the round lot market and decommission its Odd-lot System.
During the six-month period, the Exchange will continue to monitor and
provide to the Commission information on how often it suspends NYSE
Rule 52 (Hours of Operation) to resolve an extreme order imbalance that
may result in a price dislocation at the close as a result of an order
entered into Exchange systems, or represented to a DMM orally at or
near the close. At the end of that period, the Exchange will be in a
better position to determine the efficacy of providing any additional
functionality under this Pilot rule. The Exchange therefore requests an
extension from the current expiration date of June 1, 2010, until
December 1, 2010.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \7\ that an Exchange have rules that
are designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes that the
instant filing is consistent with these principles. Specifically an
extension will allow the Exchange to determine the efficacy of
providing any additional functionality under this Pilot rule. The rule
operates to protect investors and the public interest by ensuring that
the closing price at the Exchange is not significantly dislocated from
the last sale price by virtue of an extreme order imbalance at or near
the close.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

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

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

    Because the proposed rule change: (i) Does not significantly affect
the protection of investors or the public interest; (ii) does not
impose any significant burden on competition; and (iii) does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest, the proposed rule change has
become effective pursuant to Section 19(b)(3)(A) of the Act \8\ and
Rule 19b-4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). Pursuant to Rule 19b-4(f)(6)(iii)
under the Act, the Exchange is required to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \10\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \11\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiver of the operative delay is
consistent with the protection of investors and the public interest.
The Commission notes that because the pilot program was scheduled to
expire on June 1, 2010, waiver of the operative delay is necessary so
that no interruption of the pilot program will occur. In addition, the
Commission notes that the Exchange has requested the extension to allow
the Exchange time to fully evaluate the Extreme Order Imbalance Pilot.
Therefore, the Commission designates the proposed rule change operative
upon filing.\12\
---------------------------------------------------------------------------

    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NYSE-2010-42 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 No. SR-NYSE-2010-42. 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,\13\ 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 Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of NYSE.
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 No. SR-NYSE-2010-42 and
should be submitted on or before July 6, 2010.
---------------------------------------------------------------------------

    \13\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-14368 Filed 6-14-10; 8:45 am]
BILLING CODE 8011-01-P