[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Rules and Regulations]
[Pages 75689-75692]
[FR Doc No: 2016-26310]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73 and 74

[Docket No. FDA-2016-F-0821]

Listing of Color Additives Exempt From Certification; Titanium
Dioxide and Listing of Color Additives Subject to Certification;
[Phthalocyaninato (2-)] Copper

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of titanium
dioxide and [phthalocyaninato (2-)] copper to color orientation marks
for intraocular lenses. This action is in response to a petition filed
by Milton W. Chu, M.D.

DATES: This rule is effective December 2, 2016. See section IX for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by December
1, 2016.

ADDRESSES: You may submit objections and requests for a hearing as
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection 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 objection, that information will be
posted on http://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Division of
Dockets Management, FDA will post your objection, 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-2016-F-0821 for ``Listing of Color Additives Exempt From
Certification; Titanium Dioxide and Listing of Color Additives Subject
to Certification; [Phthalocyaninato (2-)] Copper.'' Received objections
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections 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 http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Laura A. Dye, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a document published in the Federal Register of March 22, 2016
(81 FR 15173), we announced that we had filed a color additive petition
(CAP 6C0305), submitted by Milton W. Chu, M.D. (petitioner), 5800 Santa
Rosa Rd., Suite 111, Camarillo, CA 93012. The petition proposed to
amend the color additive regulations in Sec.  73.3126 (21 CFR 73.3126)
and Sec.  74.3045 (21 CFR 74.3045) to provide for the safe use of
titanium dioxide and [phthalocyaninato (2-)] copper to color
orientation marks for intraocular lenses (IOLs). IOLs are devices made
of materials such as glass or plastic and are intended to be implanted
to replace the natural lens of an eye (21 CFR 886.3600). The
orientation marks are intended to aid the surgeon in visualization and
placement of IOLs during lens implantation surgery. Because IOLs are
permanently implanted, titanium dioxide and [phthalocyaninato (2-)]
copper, in the colored orientation marks, will come into direct contact
with a patient's eye for a significant amount of time. These color
additives are, therefore, subject to section 721 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e).

II. Background

    Titanium dioxide is already approved as a color additive for foods
(Sec.  73.575), drugs (Sec.  73.1575), cosmetics (Sec.  73.2575), and
medical devices (Sec.  73.3126). Regarding its use in medical devices,
titanium dioxide (CAS Reg. No. 13463-67-7, Color Index No. 77891) is
currently approved under Sec.  73.3126(b)(1) for use as a color
additive in contact lenses in amounts not to exceed the minimum
reasonably required to accomplish the intended coloring effect and must
meet the identity and specification requirements in Sec.  73.575(a)(1)
and (b). Titanium dioxide is exempt from certification under section
721(c) of the FD&C Act because we previously determined that
certification was not necessary for the protection of public health (51
FR 24815, July 9, 1986).
    [Phthalocyaninato (2-)] copper (CAS Reg. No. 147-14-8, Color Index
No. 74160) is currently approved as a color additive under Sec.
74.3045(c)(1) for use in coloring certain non-absorbable sutures for
general and ophthalmic surgery, and for use in coloring specific
monofilaments used as supporting side struts (haptics) that hold the
IOLs in place in the eye, at a level up to 0.5 percent by weight of the
suture or haptic material. In addition, it is currently approved as a
color additive under Sec.  74.3045(c)(2) for use in coloring contact
lenses in amounts not to exceed the minimum amount reasonably required
to accomplish the intended coloring effect. We previously determined
that batch certification was necessary to ensure the safety of
[phthalocyaninato (2-)] copper (34 FR 6777, April 23, 1969).

III. Safety Evaluation

A. Determination of Safety

    Under section 721(b)(4) of the FD&C Act, a color additive may not
be listed for a particular use unless the data and information
available to FDA establish that the color additive is safe for that
use. Our color additive regulations at 21 CFR 70.3(i) define ``safe''
to mean that there is convincing evidence that establishes with
reasonable certainty that no harm will result from the intended use of
the color additive. To establish with reasonable certainty that these
color additives intended to color IOL orientation marks are not harmful
under their intended conditions of use, we considered exposure to the
additives and their impurities, each additive's toxicological data, and
other relevant information (such as published literature) available to
us.

B. Safety of Petitioned Use of the Color Additives

    Regarding the petitioned use, titanium dioxide and
[phthalocyaninato (2-)] copper are intended to color orientation marks
for IOL materials (polymers) to create white and translucent or opaque
blue marks that are typically 100-250 microns ([mu]m) in diameter and
80-150 [mu]m in depth. Titanium dioxide will be used in amounts not to
exceed the minimum reasonably required to accomplish the intended
coloring effect of the orientation marks. [Phthalocyaninato (2-)]
copper will be used at levels not to exceed 0.5 percent by weight of
the orientation marks.
    To assess safety, we compared an individual's estimated exposure to
these two color additives for the petitioned use to color IOL
orientation marks to the approved uses of these color additives,
including in IOL haptics and opaque contact lenses, because these uses
are similar. As part of our previous approval for titanium dioxide used
to color contact lenses, we estimated exposure to titanium dioxide from
this use to be 270 nanograms per person per day (ng/p/d) over the lens
lifetime (51 FR 24815), which does not significantly contribute to the
cumulative exposure when compared to the exposure to titanium dioxide
from the approved uses of mica-based pearlescent pigments (of which
titanium dioxide is a component) in food and pharmaceuticals (Ref. 1).
Similarly, we previously estimated exposure to [phthalocyaninato (2-)]
copper from the use of surgical sutures, contact lenses, and specific
monofilaments used as supporting haptics for IOLs to be 310 ng/p/d, 280
ng/p/d, and 0.3 ng/p/d, respectively (64 FR 23185, April 30, 1999; 51
FR 39370, October 28, 1986; and 52 FR 15944, May 1, 1987). With respect
to the petitioned use, we estimated that the worst-case lifetime
exposure to titanium dioxide and [phthalocyaninato (2-)] copper used to
color orientation marks would be no greater than 0.06 ng/p/d and 0.004
ng/

p/d, respectively, over a 70-year lifetime (Ref. 2). This exposure
estimate is conservative as it assumes 100 percent migration of the
color additives from the IOLs into the ocular fluid of the eye over a
lifespan of 70 years following lens implantation. However, we expect
that the color additives in the orientation marks will most likely be
either chemically bound or otherwise integrated into the lens material,
which would limit migration of the color additives into the ocular
fluid of the eye. This means that the actual exposures to titanium
dioxide and [phthalocyaninato (2-)] copper to color IOL orientation
marks are expected to be far less than the worst-case exposure
estimates for these color additives and insignificant in comparison to
the cumulative exposures from the other approved uses of these color
additives that we have already established to be safe (Ref. 2).
    In assessing biocompatibility and toxicity of IOLs, we consider the
International Standard for intraocular lens testing for
biocompatibility (ISO 11979-5) as an appropriate standard. In general,
ISO 11979-5 recommends investigations on the following biological
endpoints: Cytotoxicity, genotoxicity, local effects after
implantation, and sensitization potential, in the context of
physicochemical properties.
    The petitioner conducted a cytotoxicity study in which cultured
cells were exposed to a mixture of titanium dioxide and
[phthalocyaninato (2-)] copper in direct contact for at least 24 hours.
Both color additives were found to be noncytotoxic in this study.
Cytotoxicity studies of [phthalocyaninato (2-)] copper in previous
petitions also indicated no cytotoxicity (Ref. 3). Additionally, the
toxicology data for [phthalocyaninato (2-)] copper from previous
petitions, as well as relevant data found in the Organization for
Economic Cooperation and Development's Screening Information Dataset
(OECD's SIDS) database, all indicated negative results for
genotoxicity, carcinogenicity, implantation safety, and sensitization
potential (Ref. 3). Similarly, data on titanium dioxide in OECD's SIDS
database reported negative results for genotoxicity and sensitization
potential. We conclude that the available toxicology data are
sufficient to support the safety of the proposed expanded uses of
titanium dioxide and [phthalocyaninato (2-)] copper.

IV. Conclusion

    Based on the data and information in the petition and other
relevant material, we conclude that the petitioned use of titanium
dioxide and [phthalocyaninato (2-)] copper to color orientation marks
for IOLs is safe. We further conclude that these additives will achieve
their intended technical effect and are suitable for the petitioned
use. Consequently, we are amending the color additive regulations in
parts 73 and 74 as set forth in this document. In addition, based upon
the factors listed in 21 CFR 71.20(b), we conclude that certification
of titanium dioxide remains unnecessary for the protection of the
public health. We also conclude that batch certification of
[phthalocyaninato (2-)] copper continues to be necessary to protect the
public health.

V. Public Disclosure and Confidentiality of Data and Information in a
Color Additive Rule

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we
will delete from the documents any materials that are not available for
public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the March 22, 2016, notice of petition for CAP 6C0305 (81 FR
15173). We stated that we had determined, under 21 CFR 25.32(l), that
this action ``is of a type that does not individually or cumulatively
have a significant effect on the human environment'' such that neither
an environmental assessment nor an environmental impact statement is
required. We have not received any new information or comments that
would affect our previous determination.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VIII. Objections

    This rule is effective as shown in the DATES section except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) of the regulation to which
you object and the grounds for your objection. Within each numbered
objection, you must specifically state whether you are requesting a
hearing on the particular provision that you specify in that numbered
objection. If you do not request a hearing for any particular
objection, you waive the right to a hearing on that objection. If you
request a hearing, your objection must include a detailed description
and analysis of the specific factual information you intend to present
in support of the objection in the event that a hearing is held. If you
do not include such a description and analysis for any particular
objection, you waive the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.

IX. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov.

1. Memorandum from H. Lee, Division of Petition Review, Chemistry
Review Team, to P. DeLeo, Division of Petition Review, Regulatory
Group I, FDA, March 1, 2005.
2. Memorandum from H. Lee, Division of Petition Review, Chemistry
Review Team, to L. Dye, Division of Petition Review, Regulatory
Group I, FDA, April 20, 2016.
3. Memorandum from Y. Zang, Division of Petition Review, Toxicology
Review Team, to L. Dye, Division of Petition Review, Regulatory
Group I, FDA, June 30, 2016.

List of Subjects

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

21 CFR Part 74

    Color additives, Cosmetics, Drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and re-
delegated to the Director, Center for Food Safety and

Applied Nutrition, 21 CFR parts 73 and 74 are amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. In Sec.  73.3126, revise paragraph (b)(1) to read as follows:

Sec.  73.3126  Titanium dioxide.

* * * * *
    (b) * * * (1) The substance listed in paragraph (a) of this section
may be used as a color additive in contact lenses and intraocular lens
orientation marks in amounts not to exceed the minimum reasonably
required to accomplish the intended coloring effect.
* * * * *

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

0
3. The authority citation for part 74 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
4. In Sec.  74.3045, revise paragraphs (c)(1) introductory text and
(c)(1)(i) to read as follows:

Sec.  74.3045   [Phthalocyaninato (2-)] copper.

* * * * *
    (c) * * * (1) The color additive [phthalocyaninato(2-)] copper may
be safely used to color polypropylene sutures, polybutester (the
generic designation for the suture fabricated from 1,4-
benzenedicarboxylic acid, polymer with 1,4-butanediol and alpha-hydro-
omega-hydroxypoly(oxy-1,4-butanediyl), CAS Reg. No. 37282-12-5)
nonabsorbable sutures for use in general and ophthalmic surgery,
polybutylene terephthalate nonabsorbable monofilament sutures for
general and ophthalmic surgery, nonabsorbable sutures made from
poly(vinylidene fluoride) and poly(vinylidene fluoride-co-
hexafluoropropylene) for general and ophthalmic surgery,
polymethylmethacrylate monofilament used as supporting haptics for
intraocular lenses, and polymers used in orientation marks for
intraocular lenses, subject to the following restrictions:
    (i) The quantity of the color additive does not exceed 0.5 percent
by weight of the suture, haptic material, or orientation mark.
* * * * *

    Dated: October 25, 2016.
Susan Bernard,
Director, Office of Regulations, Policy and Social Science, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2016-26310 Filed 10-31-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Rules and Regulations]
[Pages 30151-30152]
[FR Doc No: 2015-12753]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310, 314, 329, and 600

[Docket No. FDA-2008-N-0334]
RIN 0910-AF96

Postmarketing Safety Reports for Human Drug and Biological
Products; Electronic Submission Requirements; Delay of Compliance Date;
Safety Reporting Portal of Electronic Submission of Postmarketing
Safety Reports for Human Drugs and Nonvaccine Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of compliance date.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is delaying
the compliance date for the final rule for the electronic submission of
postmarketing safety reports for human drugs and biological products
that published in the Federal Register of June 10, 2014. The rule
amended FDA's postmarketing safety reporting regulations for human
drugs and biological products to require that persons subject to
mandatory reporting requirements submit safety reports in an electronic
format that FDA can process, review, and archive. FDA is also
announcing the availability of the Safety

Reporting Portal (SRP), a Web-based electronic submission system, for
the electronic submission of postmarketing individual case safety
reports (ICSRs) of adverse events for human drug and nonvaccine
biological products. The SRP is intended to facilitate the secure
electronic submission of postmarketing ICSRs and ICSR attachments to
the FDA Adverse Event Reporting System (FAERS) database. The SRP
creates a simple and efficient mechanism for electronic reporting of
ICSRs that does not require an internal database that is compatible
with the International Conference on Harmonisation-based direct
submission system. FDA is delaying the compliance date for the final
rule because FDA understands that not all persons subject to mandatory
postmarketing reporting requirements who wish to use the newly
available Safety Reporting Portal (SRP) will have the opportunity to
register for an account and test the submission process prior to June
10, 2015, the effective date of the final rule.

DATES: Effective Date: This final rule is effective June 10, 2015.
Compliance Date: The compliance date for the final rule published at 79
FR 33072 on June 10, 2014, is delayed until September 8, 2015.

FOR FURTHER INFORMATION CONTACT: Suranjan De, Office of Surveillance
and Epidemiology, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4307,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA published in the Federal Register of June 10, 2014 (79 FR
33072), a final rule requiring electronic submission of certain
postmarketing submissions (the final rule) and also published an
accompanying revised draft guidance for industry ``Providing
Submissions in Electronic Format--Postmarketing Safety Reports'' (79 FR
33200) (June 2014 revised draft guidance).\1\ The final rule becomes
effective June 10, 2015. Under the final rule, persons subject to
mandatory postmarketing reporting requirements are required to submit
postmarketing ICSRs to FDA in an electronic format that the Agency can
process, review, and archive. Postmarketing ICSRs and ICSR attachments
sent to FDA for human drug and nonvaccine biological products are
processed into the FAERS database. As discussed in the preamble to the
final rule, FDA provides two options for electronic submission of ICSRs
to FAERS to satisfy the requirement in the final rule that persons
subject to mandatory postmarketing reporting requirements submit
postmarketing ICSRs to FDA in an electronic format that the Agency can
process, review, and archive: (1) Direct submission through the
Electronic Submissions Gateway, and (2) submission through the SRP.
Persons subject to mandatory postmarketing reporting requirements can
choose to use these options to meet the requirements of the final rule
to electronically submit postmarketing ICSRs to FAERS.
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    \1\ The June 2014 revised draft guidance is available on the
Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and on
the FAERS Electronic Submissions Web page at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm115894.htm.
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    At this time, FDA is announcing the availability of the SRP, a Web-
based electronic submission system, for the electronic submission of
postmarketing ICSRs of adverse events for human drug and nonvaccine
biological products.
    To use the SRP, the ICSR information is entered manually into a
Web-based form and then submitted to FDA to be uploaded into the FAERS
database. The SRP may be used by any persons subject to mandatory
postmarketing safety reporting requirements, including manufacturers,
packers, and distributors, and applicants with approved new drug
applications (NDAs), abbreviated new drug applications (ANDAs), and
biologics license applications (BLAs), those that market prescription
drugs for human use without an approved application including entities
that are registered with FDA as outsourcing facilities under section
503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 353b), and those subject to the reporting requirements in
section 760 of the FD&C Act (21 U.S.C. 379aa).

II. Discussion of Rationale for Delay

    The Agency believes that the SRP may be particularly useful for
those entities that submit a small volume of ICSRs because the SRP does
not require an internal database that is compatible with the ICH-based
direct transmission system. FDA understands that not all persons
subject to mandatory postmarketing reporting requirements who wish to
use the SRP will have the opportunity to register for an account and
test the submission process prior to June 10, 2015, the effective date
of the final rule. Therefore, while persons subject to mandatory
postmarketing reporting requirements are going through the registration
process, FDA is delaying the compliance date of the final rule until
September 8, 2015. FDA will continue to accept postmarketing ICSRs
submitted on paper Forms FDA 3500A for 90 calendar days from the June
10, 2015, effective date of the final rule. FDA expects full compliance
with the final rule by Tuesday, September 8, 2015. FDA is delaying the
compliance date for this rule directly, without issuing notice of
proposed rulemaking or taking comments on this action, for good cause.
Because not all persons who want to use the SRP will be able to do so
prior to the June 10, 2015, effective date for this rule, and because
this effective date is now imminent, we find that issuing notice and
taking comments are impracticable, unnecessary, and contrary to the
public interest with respect to this action.

III. Overview of the SRP

    The SRP originated as a collaborative initiative developed by a
multi-agency Federal Adverse Event Task Force, which included FDA as
part of the Agency's MedWatch Plus strategic effort, starting in 2004.
Submission of safety reports through the SRP is described on the FDA
SRP Web page (the SRP is available on the SRP Web page at https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=0AA0751AD2587A59D28B14D5C764AC7CA68678FE). The SRP is intended to create greater harmonization among Federal
Agencies for adverse event and product problem reporting by
streamlining and coordinating the currently diverse Federal
requirements for the reporting and the review of adverse events.\2\
Further information on submitting ICSRs through the SRP is included in
FDA's June 2014 revised draft guidance.
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    \2\ The origins and purpose of the SRP are discussed on the SRP
Web page at https://www.safetyreporting.hhs.gov/fpsr/About.aspx.

    Dated: May 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12753 Filed 5-26-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Pages 67033-67036]
[FR Doc No: 2016-23496]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78918; File No. SR-NASDAQ-2016-104]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Granting Approval of a Proposed Rule Change To Amend Nasdaq Rule 5735
To Adopt Generic Listing Standards for Managed Fund Shares

September 23, 2016.

I. Introduction

    On August 16, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend Nasdaq Rule 5735 to,
among other things, adopt generic listing standards for Managed Fund
Shares. The proposed rule change was published for comment in the
Federal Register on August 24, 2016.\3\ The Commission has received no
comments on the proposed rule change. This order grants approval of the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78616 (Aug. 18,
2016), 81 FR 57968 (``Notice'').
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II. Description of the Proposal

    Nasdaq Rule 5735 governs the listing and trading of Managed Fund
Shares on the Exchange. Managed Fund Shares are issued by actively
managed exchange-traded funds (``ETFs'') that do not seek to replicate
the performance of a specified index of securities.
    Under its current rules, the Exchange must file separate proposals
under Section 19(b) of the Act before listing a new series of Managed
Fund Shares.\4\ The Exchange proposes to adopt ``generic'' listing
standards so that the Exchange may list Managed Fund Shares that
satisfy the applicable criteria by submitting notice pursuant to Rule
19b-4(e) under the Act, rather than by filing a proposed rule change
under Section 19(b) of the Act.\5\
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    \4\ See Nasdaq Rule 5735(b)(1).
    \5\ See 17 CFR 240.19b-4(e). Rule 19b-4(e) permits self-
regulatory organizations (``SROs'') to list and trade new derivative
securities products that comply with existing SRO trading rules,
procedures, surveillance programs, and listing standards, without
submitting a proposed rule change under Section 19(b). See
Securities Exchange Act Release No. 40761 (Dec. 8, 1998), 63 FR
70952 (Dec. 22, 1998).
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A. Description of the Generic Listing Standards

    The Exchange's listing standards establish requirements for the
various types of assets that may be held in the portfolio of a
generically listed, actively managed ETF (``Portfolio'').
1. Equity Portfolio Components
    Nasdaq Rule 5735(b)(1)(A) establishes the criteria applicable to
the equity securities included in a Portfolio. Equity securities
include the following securities: U.S. Component Stocks, which are
defined in Nasdaq Rule 5705; Non-U.S. Component Stocks, which are
defined in Nasdaq Rule 5705; Exchange Traded Derivative Securities,
which are defined in Nasdaq Rule 5735(c)(6); \6\ Linked Securities,
which are defined in Nasdaq Rule 5710, and each of the equivalent
security types listed on another national securities exchange.
Additionally, Nasdaq Rule 5735(b)(1)(A) provides that no more than 25%
of the equity weight of the Portfolio can include leveraged or inverse-
leveraged Exchange Traded Derivative Securities or Linked Securities
and that, to the extent a Portfolio includes convertible securities,
the equity securities into which such securities are converted must
meet the criteria of Nasdaq Rule 5735(b)(1)(A) after converting.
---------------------------------------------------------------------------

    \6\ Nasdaq Rule 5735(c)(6) defines ``Exchange Traded Derivative
Securities'' as: ``the securities described in Nasdaq Rules 5705(a)
(Portfolio Depository Receipts); 5705(b) (Index Fund Shares); 5720
(Trust Issued Receipts); 5711(d) (Commodity-Based Trust Shares);
5711(e) (Currency Trust Shares); 5711(f) (Commodity Index Trust
Shares); 5711(g) (Commodity Futures Trust Shares); 5711(h)
(Partnership Units); 5711(i) (Trust Units); 5735 (Managed Fund
Shares); and 5711(j) (Managed Trust Securities).''
---------------------------------------------------------------------------

    Nasdaq Rule 5735(b)(1)(A)(i) would require that U.S. Component
Stocks (except as mentioned below) meet the following criteria
initially and on a continuing basis:
    (1) Component stocks (excluding Exchange Traded Derivative
Securities and Linked Securities) that in the aggregate account for at
least 90% of the equity weight of the Portfolio (excluding Exchange
Traded Derivative Securities and Linked Securities) each shall have a
minimum market value of at least $75 million;

    (2) Component stocks (excluding Exchange Traded Derivative
Securities and Linked Securities) that in the aggregate account for at
least 70% of the equity weight of the Portfolio (excluding Exchange
Traded Derivative Securities and Linked Securities) each shall have a
minimum monthly trading volume of 250,000 shares, or minimum notional
volume traded per month of $25,000,000, averaged over the previous six
months;
    (3) The most heavily weighted component stock (excluding Exchange
Traded Derivative Securities and Linked Securities) must not exceed 30%
of the equity weight of the Portfolio, and, to the extent applicable,
the five most heavily weighted component stocks (excluding Exchange
Traded Derivative Securities and Linked Securities) must not exceed 65%
of the equity weight of the Portfolio;
    (4) Where the equity portion of the Portfolio does not include Non-
U.S. Component Stocks, the equity portion of the Portfolio shall
include a minimum of 13 component stocks; provided, however, that there
would be no minimum number of component stocks if (a) one or more
series of Exchange Traded Derivative Securities or Linked Securities
constitute, at least in part, components underlying a series of Managed
Fund Shares, or (b) one or more series of Exchange Traded Derivative
Securities or Linked Securities account for 100% of the equity weight
of the Portfolio of a series of Managed Fund Shares;
    (5) Except as provided in Nasdaq Rule 5735(b)(1)(A)(i), equity
securities in the Portfolio must be U.S. Component Stocks listed on a
national securities exchange and must be NMS Stocks as defined in Rule
600 of Regulation NMS; and
    (6) American Depositary Receipts (``ADRs'') may be exchange traded
or non-exchange traded, but no more than 10% of the equity weight of
the Portfolio shall consist of non-exchange traded ADRs.
    Nasdaq Rule 5735(b)(1)(A)(ii) requires that Non-U.S. Component
Stocks must meet the following criteria initially and on a continuing
basis:
    (1) Non-U.S. Component Stocks each shall have a minimum market
value of at least $100 million;
    (2) Non-U.S. Component Stocks each shall have a minimum global
monthly trading volume of 250,000 shares, or minimum global notional
volume traded per month of $25,000,000, averaged over the last six
months;
    (3) The most heavily weighted Non-U.S. Component Stock shall not
exceed 25% of the equity weight of the Portfolio, and, to the extent
applicable, the five most heavily weighted Non-U.S. Component Stocks
shall not exceed 60% of the equity weight of the Portfolio;
    (4) Where the equity portion of the Portfolio includes Non-U.S.
Component Stocks, the equity portion of the Portfolio shall include a
minimum of 20 component stocks; provided, however, that there shall be
no minimum number of component stocks if (a) one or more series of
Exchange Traded Derivative Securities or Linked Securities constitute,
at least in part, components underlying a series of Managed Fund
Shares, or (b) one or more series of Exchange Traded Derivative
Securities or Linked Securities account for 100% of the equity weight
of the Portfolio of a series of Managed Fund Shares; and
    (5) Each Non-U.S. Component Stock shall be listed and traded on an
exchange that has last-sale reporting.
2. Fixed Income Portfolio Components
    Nasdaq Rule 5735(b)(1)(B) establishes criteria for fixed income
securities that are included in a Portfolio. Fixed income securities
are debt securities \7\ that are notes, bonds, debentures, or evidence
of indebtedness that include, but are not limited to, U.S. Department
of Treasury securities (``Treasury Securities''), government-sponsored
entity securities (``GSE Securities''), municipal securities, trust
preferred securities, supranational debt and debt of a foreign country
or a subdivision thereof, investment grade and high yield corporate
debt, bank loans, mortgage and asset backed securities, and commercial
paper.\8\ To the extent that a Portfolio includes convertible
securities, the fixed income securities into which such securities are
converted shall meet the criteria of Nasdaq Rule 5735(b)(1)(B) after
converting.\9\
---------------------------------------------------------------------------

    \7\ Debt securities include a variety of fixed income
obligations, including, but not limited to, corporate debt
securities, government securities, municipal securities, convertible
securities, and mortgage-backed securities. Debt securities include
investment-grade securities, non-investment-grade securities, and
unrated securities. Debt securities also include variable and
floating rate securities. See Notice, supra note 3, 81 FR at 57971,
n.29.
    \8\ See Nasdaq Rule 5735(b)(1)(B).
    \9\ See id.
---------------------------------------------------------------------------

    Under Nasdaq Rule 5735(b)(1)(B), fixed income securities that are
part of a Portfolio must satisfy the following criteria initially and
on a continuing basis:
    (1) Components that in the aggregate account for at least 75% of
the fixed income weight of the Portfolio must each have a minimum
original principal amount outstanding of $100 million or more;
    (2) No component fixed-income security (excluding Treasury
Securities and GSE Securities) shall represent more than 30% of the
fixed income weight of the Portfolio, and the five most heavily
weighted fixed income securities in the Portfolio (excluding Treasury
Securities and GSE Securities) shall not in the aggregate account for
more than 65% of the fixed income weight of the Portfolio;
    (3) A Portfolio that includes fixed income securities (excluding
exempted securities) shall include a minimum of 13 non-affiliated
issuers, provided, however, that there shall be no minimum number of
non-affiliated issuers required for fixed income securities if at least
70% of the weight of the Portfolio consists of equity securities as
described in Nasdaq Rule 5735(b)(1)(A);
    (4) Component securities that in aggregate account for at least 90%
of the fixed income weight of the Portfolio must be: (a) From issuers
that are required to file reports pursuant to Sections 13 and 15(d) of
the Act; (b) from issuers each of which has a worldwide market value of
its outstanding common equity held by non-affiliates of $700 million or
more; (c) from issuers each of which has outstanding securities that
are notes, bonds, debentures, or evidence of indebtedness having a
total remaining principal amount of at least $1 billion; (d) exempted
securities as defined in Section 3(a)(12) of the Act; or (e) from
issuers that are a government of a foreign country or a political
subdivision of a foreign country; and
    (5) Non-agency, non-GSE, and privately issued mortgage-related and
other asset-backed securities shall not account, in the aggregate, for
more than 20% of the weight of the fixed income portion of the
Portfolio.
3. Cash and Cash Equivalent Portfolio Components
    Nasdaq Rule 5735(b)(1)(C) provides that a Portfolio may include
cash and cash equivalents. Cash equivalents are defined as short-term
instruments with maturities of less than three months.\10\ The Exchange
defines short-term instruments to include the following: (1) U.S.
Government securities, including bills, notes, and bonds differing as
to maturity and rates of interest, which are either issued or
guaranteed by the U.S. Treasury or by U.S. Government agencies or
instrumentalities; (2) certificates of deposit issued against funds
deposited in a bank or savings and loan association; (3) bankers'

acceptances, which are short-term credit instruments used to finance
commercial transactions; (4) repurchase agreements and reverse
repurchase agreements; (5) bank time deposits, which are monies kept on
deposit with banks or savings and loan associations for a stated period
of time at a fixed rate of interest; (6) commercial paper, which are
short-term unsecured promissory notes; and (7) money market funds.\11\
The Exchange does not propose to limit to the amount of cash or cash
equivalents that may be held in a Portfolio.\12\
---------------------------------------------------------------------------

    \10\ See Nasdaq Rule 5735(b)(1)(C).
    \11\ See Nasdaq Rule 5735(b)(1)(C)(ii).
    \12\ See Nasdaq Rule 5735(b)(1)(C)(i).
---------------------------------------------------------------------------

4. Derivatives in the Portfolio
    Nasdaq Rule 5735(b)(1)(D) establishes listing criteria for the
portion of a Portfolio that consists of listed derivatives such as
futures, options, and swaps overlying commodities, currencies,
financial instruments (e.g., stocks, fixed income securities, interest
rates, and volatility), or a basket or index of any of the foregoing.
The Exchange does not propose to limit the percentage of a Portfolio
that may be composed of such holdings, provided that, in the aggregate,
at least 90% of the weight of holdings in listed derivatives
(calculated using the aggregate gross notional value) must, on both an
initial and continuing basis, consist of futures, options, and swaps
for which the Exchange may obtain information via the ISG from other
members or affiliates or for which the principal market is a market
with which the Exchange has a comprehensive surveillance sharing
agreement (``CSSA'').\13\ Additionally, the aggregate gross notional
value of listed derivatives based on any five or fewer underlying
reference assets shall not exceed 65% of the weight of the Portfolio
(including gross notional exposures), and the aggregate gross notional
value of listed derivatives based on any single underlying reference
asset shall not exceed 30% of the weight of the Portfolio (including
gross notional exposures).\14\
---------------------------------------------------------------------------

    \13\ See Nasdaq Rule 5735(b)(1)(D)(i).
    \14\ See Nasdaq Rule 5735(b)(1)(D)(ii).
---------------------------------------------------------------------------

    Nasdaq Rule 5735(b)(1)(E) establishes a limit on over-the-counter
(``OTC'') derivatives: No more than 20% of the weight of the Portfolio
may be invested in OTC derivatives.\15\ The Exchange notes that, for
purposes of calculating this limitation, a Portfolio's investment in
OTC derivatives will be calculated as the aggregate gross notional
value of the OTC derivatives.
---------------------------------------------------------------------------

    \15\ OTC derivatives include: Forwards, options, and swaps
overlying commodities, currencies, financial instruments (e.g.,
stocks, fixed income securities, interest rates, and volatility), or
a basket or index of any of the foregoing. See Nasdaq Rule
5735(b)(1)(E).
---------------------------------------------------------------------------

    Nasdaq Rule 5735(b)(1)(E) provides that, to the extent that listed
or OTC derivatives are used to gain exposure to individual equities
and/or fixed income securities, or to indexes of equities and/or fixed
income securities, the aggregate gross notional value of such exposure
shall meet the criteria set forth in Nasdaq Rules 5735(b)(1)(A) and
5735(b)(1)(B), respectively.

B. Other Aspects of the Proposal

1. Disclosed Portfolio
    The daily dissemination of a Disclosed Portfolio \16\ is required
under current Nasdaq Rule 5735(d)(2)(B)(i), but its contents are not
specified. The Exchange proposes to amend the definition of ``Disclosed
Portfolio'' to require that the Web site for each series of Managed
Fund Shares listed on the Exchange, including all Managed Fund Shares
currently listed and traded on the Exchange, disclose the following
information in the Disclosed Portfolio, to the extent applicable:
Ticker symbol, CUSIP or other identifier, a description of the holding,
identity of the asset upon which the derivative is based, the strike
price for any options, the quantity of each security or other asset
held as measured by select metrics, maturity date, coupon rate,
effective date, market value, and percentage weight of the holding in
the portfolio.
---------------------------------------------------------------------------

    \16\ Nasdaq defines ``Disclosed Portfolio'' for purposes of its
Managed Fund Shares listing rule as the identities and quantities of
the securities and other assets held by the Investment Company that
will form the basis for the Investment Company's calculation of net
asset value at the end of the business day. See Nasdaq Rule
5735(c)(2).
---------------------------------------------------------------------------

2. Investment Objective
    The Exchange proposes to add as an initial listing criterion
applicable to all Managed Fund Shares (including those that are
generically listed) the requirement that Managed Fund Shares have a
stated investment objective, which shall be adhered to under ``Normal
Market Conditions.'' \17\ The Exchange would define ``Normal Market
Conditions'' as circumstances including, but not limited to, the
absence of: Trading halts in the applicable financial markets
generally; operational issues causing dissemination of inaccurate
market information or systems failure; or force majeure type events
such as natural or man-made disaster, act of God, armed conflict, act
of terrorism, riot or labor disruption, or any similar intervening
circumstance.\18\
---------------------------------------------------------------------------

    \17\ See Nasdaq Rule 5735(d)(1)(C).
    \18\ See Nasdaq Rule 5735(c)(5).
---------------------------------------------------------------------------

3. Intraday Indicative Value (``IIV'')
    The Exchange proposes to modify a continued listing criterion for
all Managed Fund Shares to require that the IIV be widely disseminated
by one or more major market data vendors at least every 15 seconds
during its Regular Market Session, as defined in Nasdaq Rule
4120(b),\19\ rather than during all times that Managed Fund Shares
trade on the Exchange.
---------------------------------------------------------------------------

    \19\ See Nasdaq Rule 5735(d)(2)(A).
---------------------------------------------------------------------------

C. Additional Representations of the Exchange Applicable to the Listing
and Trading of Managed Fund Shares

    In support of the proposed rule change, the Exchange represents
that:
    (1) Managed Fund Shares will conform to the initial and continued
listing criteria under Nasdaq Rule 5735.\20\
---------------------------------------------------------------------------

    \20\ See Notice, supra note 3, 81 FR at 57973.
---------------------------------------------------------------------------

    (2) The Exchange's surveillance procedures are adequate to continue
to properly monitor the trading of the Managed Fund Shares in all
trading sessions and to deter and detect violations of Exchange rules.
Specifically, the Exchange intends to utilize its existing surveillance
procedures applicable to derivative products, which will include
Managed Fund Shares, to monitor trading in the Managed Fund Shares.\21\
---------------------------------------------------------------------------

    \21\ See id.
---------------------------------------------------------------------------

    (3) Prior to the commencement of trading of a particular series of
Managed Fund Shares, the Exchange will inform its Members in an
information circular of the special characteristics and risks
associated with trading the Managed Fund Shares, including procedures
for purchases and redemptions of Managed Fund Shares, suitability
requirements under Nasdaq Rules 2090A and 2111A, the risks involved in
trading the Managed Fund Shares during the Pre-Market and Post-Market
Sessions when an updated IIV will not be calculated or publicly
disseminated, information regarding the IIV and Disclosed Portfolio,
prospectus delivery requirements, and other trading information. In
addition, the information circular will disclose that the Managed Fund
Shares are subject to various fees and expenses, as described in the
registration statement, and will discuss any exemptive, no-action, and
interpretive relief granted by the Commission from any rules under the
Act. Finally, the information circular will disclose that the NAV for
the Managed Fund Shares will be calculated

after 4:00 p.m. Eastern Time each trading day.\22\
---------------------------------------------------------------------------

    \22\ See id.
---------------------------------------------------------------------------

    (4) The issuer of a series of Managed Fund Shares will be required
to comply with Rule 10A-3 under the Act for the initial and continued
listing of Managed Fund Shares, as provided under the Nasdaq Rule 5600
Series.\23\
---------------------------------------------------------------------------

    \23\ See id.
---------------------------------------------------------------------------

    (5) On a periodic basis, and no less than annually, the Exchange
will review the Managed Fund Shares generically listed and traded on
the Exchange under Nasdaq Rule 5735 for compliance with that rule and
will provide a report to its Regulatory Oversight Committee presenting
the findings of its review.
    (6) On a quarterly basis, the Exchange will provide a report to the
Commission staff that contains, for each ETF whose shares are
generically listed and traded under Nasdaq Rule 5735(b)(1): (a) Symbol
and date of listing; (b) the number of active authorized participants
(``APs'') and a description of any failure by either a fund or an AP to
deliver promised baskets of shares, cash, or cash and instruments in
connection with creation or redemption orders; and (c) a description of
any failure by a fund to comply with Nasdaq Rule 5735.\24\
---------------------------------------------------------------------------

    \24\ See id.
---------------------------------------------------------------------------

    (7) Prior to listing pursuant to amended Rule 5735(b)(1), an issuer
would be required to represent to the Exchange that it will advise the
Exchange of any failure by a series of Managed Fund Shares to comply
with the continued listing requirements, and, pursuant to its
obligations under Section 19(g)(1) of the Exchange Act, the Exchange
will surveil for compliance with the continued listing requirements. If
a series of Managed Fund Shares is not in compliance with the
applicable listing requirements, the Exchange will commence delisting
procedures under the Nasdaq Rule 5800 Series.\25\
---------------------------------------------------------------------------

    \25\ See id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to amend Nasdaq Rule 5735 to, among other things, adopt
generic listing criteria, is consistent with the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\26\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\27\ which
requires, among other things, that the Exchange's rules be designed to
prevent fraudulent and manipulative acts and practices, 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.
---------------------------------------------------------------------------

    \26\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \27\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission notes that Nasdaq's proposal is substantively
identical to proposals that the Commission recently approved.\28\
Accordingly, for the reasons discussed in the Prior MFS Generics
Orders, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act \29\ and the rules and
regulations thereunder applicable to a national securities exchange.
---------------------------------------------------------------------------

    \28\ See Securities Exchange Act Release Nos. 78396 (Jul. 22,
2016), 81 FR 49698 (Jul. 28, 2016) (SR-BATS-2015-100); and 78397
(Jul. 22, 2016), 81 FR 49320 (Jul. 27, 2016) (SR-NYSEArca-2015-110).
These releases are referred to collectively as the ``Prior MFS
Generics Orders.''
    \29\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\30\ that the proposed rule change (SR-NASDAQ-2016-104) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-23496 Filed 9-28-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Rules and Regulations]
[Pages 8396-8398]
[FR Doc No: 2016-03368]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31060; Amdt. No. 3681]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective February 19, 2016. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of February 19, 2016.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff

Minimums and/or ODPs as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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); and
(3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97:

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on January 29, 2016.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 3 MARCH 2016

Benton Harbor, MI, Southwest Michigan Rgnl, VOR RWY 10, Amdt 10B,
CANCELED
East Hampton, NY, East Hampton, Takeoff Minimums and Obstacle DP,
Amdt 3A
Lebanon, OH, Warren County/John Lane Field, RNAV (GPS) RWY 19, Amdt
4
Oklahoma City, OK, Will Rogers World, RNAV (GPS) RWY 13, Amdt 3A
Walterboro, SC, Lowcountry Rgnl, ILS Y OR LOC Y RWY 23, Amdt 2
Walterboro, SC, Lowcountry Rgnl, ILS Z OR LOC Z RWY 23, Orig
Walterboro, SC, Lowcountry Rgnl, RNAV (GPS) RWY 17, Orig-A
Walterboro, SC, Lowcountry Rgnl, RNAV (GPS) RWY 23, Amdt 2
Walterboro, SC, Lowcountry Rgnl, RNAV (GPS) RWY 35, Orig-A
Baraboo, WI, Baraboo Wisconsin Dells, LOC/DME RWY 1, Amdt 2
Baraboo, WI, Baraboo Wisconsin Dells, RNAV (GPS) RWY 19, Amdt 2
Hayward, WI, Sawyer County, RNAV (GPS) RWY 3, Orig-C
Hayward, WI, Sawyer County, RNAV (GPS) RWY 21, Amdt 1A

Effective 31 MARCH 2016

McGrath, AK, McGrath, VOR-A, Amdt 8, CANCELED
Quinhagak, AK, Quinhagak, RNAV (GPS) RWY 12, Amdt 1
Quinhagak, AK, Quinhagak, RNAV (GPS) RWY 30, Amdt 1
Quinhagak, AK, Quinhagak, Takeoff Minimums and Obstacle DP, Amdt 1
Stuttgart, AR, Stuttgart Muni, VOR/DME-A, Amdt 1B, CANCELED
Bakersfield, CA, Meadows Field, VOR/DME RWY 30R, Amdt 9, CANCELED
San Francisco, CA, San Francisco Intl, VOR RWY 19L, Amdt 11,
CANCELED
Santa Rosa, CA, Charles M Schulz--Sonoma County, VOR/DME RWY 32,
Amdt 20, CANCELED
Fort Lauderdale, FL, Fort Lauderdale/Hollywood Intl, VOR RWY 28R,
Amdt 13A, CANCELED
Orlando, FL, Orlando Intl, VOR/DME RWY 36L, Amdt 5A, CANCELED
Orlando, FL, Orlando Intl, VOR/DME RWY 36R, Amdt 10A, CANCELED
Albany, GA, Southwest Georgia Rgnl, NDB RWY 4, Amdt 13B, CANCELED
Atlanta, GA, Fulton County Airport-Brown Field, RNAV (GPS) Y RWY 8,
Amdt 1A
Clinton, IA, Clinton Muni, VOR RWY 3, Amdt 15A, CANCELED
Newton, IA, Newton Muni-Earl Johnson Field, VOR RWY 32, Amdt 9A,
CANCELED
Ottumwa, IA, Ottumwa Rgnl, VOR RWY 31, Amdt 15, CANCELED
Sioux City, IA, Sioux Gateway/Col Bud Day Field, VOR OR TACAN RWY
31, Amdt 26D, CANCELED
Waterloo, IA, Waterloo Rgnl, VOR RWY 36, Amdt 17A, CANCELED
Coeur D'Alene, ID, Coeur D'Alene--Pappy Boyington Field, VOR RWY 6,
Orig-D, CANCELED
Idaho Falls, ID, Idaho Falls Rgnl, NDB RWY 20, Amdt 10D, CANCELED
Lewiston, ID, Lewiston-Nez Perce County, VOR RWY 26, Amdt 13,
CANCELED
Salmon, ID, Lemhi County, Takeoff Minimums and Obstacle DP, Amdt 3
Chicago/Romeoville, IL, Lewis University, VOR RWY 9, Amdt 3,
CANCELED
Chicago/West Chicago, IL, Dupage, VOR RWY 2L, Amdt 1B, CANCELED
Danville, IL, Vermilion Regional, VOR RWY 21, Amdt 14A, CANCELED
Galesburg, IL, Galesburg Muni, VOR RWY 3, Amdt 7A, CANCELED
Lawrenceville, IL, Lawrenceville-Vincennes Intl, VOR RWY 18, Amdt
1A, CANCELED
Mattoon/Charleston, IL, Coles County Memorial, ILS OR LOC RWY 29,
Amdt 6C
Mattoon/Charleston, IL, Coles County Memorial, NDB RWY 29, Amdt 5B
Mattoon/Charleston, IL, Coles County Memorial, RNAV (GPS) RWY 6,
Orig
Mattoon/Charleston, IL, Coles County Memorial, RNAV (GPS) RWY 11,
Orig
Mattoon/Charleston, IL, Coles County Memorial, RNAV (GPS) RWY 24,
Amdt 1
Mattoon/Charleston, IL, Coles County Memorial, RNAV (GPS) RWY 29,
Amdt 1
Quincy, IL, Quincy Rgnl-Baldwin Field, VOR RWY 4, Amdt 12, CANCELED
Auburn, IN, De Kalb County, VOR RWY 9, Amdt 7D, CANCELED
Goshen, IN, Goshen Muni, VOR RWY 27, Amdt 7A, CANCELED
Muncie, IN, Delaware County Rgnl, VOR RWY 32, Amdt 15, CANCELED
Richmond, IN, Richmond Muni, VOR RWY 24, Amdt 13, CANCELED
Richmond, IN, Richmond Muni, VOR RWY 33, Amdt 2, CANCELED
Liberal, KS, Liberal Mid-America Rgnl, VOR RWY 35, Amdt 12, CANCELED
Ashland, KY, Ashland Rgnl, VOR/DME RWY 10, Amdt 12
Hopkinsville, KY, Hopkinsville-Christian County, RNAV (GPS) RWY 26,
Amdt 2
Tompkinsville, KY, Tompkinsville-Monroe County, RNAV (GPS) RWY 4,
Amdt 1B

Tompkinsville, KY, Tompkinsville-Monroe County, RNAV (GPS) RWY 22,
Amdt 1B
Orange, MA, Orange Muni, NDB RWY 1, Amdt 1A, CANCELED
Orange, MA, Orange Muni, NDB RWY 32, Amdt 1A, CANCELED
Vineyard Haven, MA, Martha's Vineyard, VOR RWY 24, Amdt 2A, CANCELED
Baltimore, MD, Baltimore/Washington Intl Thurgood Marshall, VOR RWY
10, Amdt 17B, CANCELED
Baltimore, MD, Baltimore/Washington Intl Thurgood Marshall, VOR/DME
RWY 33L, Amdt 3A, CANCELED
Eliot, ME, Littlebrook Air Park, NDB-B, Amdt 1, CANCELED
Sanford, ME, Sanford Seacoast Rgnl, VOR RWY 7, Amdt 4C, CANCELED
Alpena, MI, Alpena County Rgnl, VOR RWY 1, Amdt 14D, CANCELED
Hancock, MI, Houghton County Memorial, VOR RWY 13, Amdt 16, CANCELED
Fairmont, MN, Fairmont Muni, VOR RWY 13, Amdt 5, CANCELED
Fairmont, MN, Fairmont Muni, VOR RWY 31, Amdt 8, CANCELED
Hibbing, MN, Range Rgnl, VOR RWY 13, Amdt 13A, CANCELED
Hibbing, MN, Range Rgnl, VOR RWY 31, Amdt 17, CANCELED
Willmar, MN, Willmar Muni-John L Rice Field, VOR RWY 13, Orig,
CANCELED
Glasgow, MT, Wokal Field/Glasgow Intl, NDB RWY 30, Amdt 2A, CANCELED
Beaufort, NC, Michael J Smith Field, NDB RWY 21, Amdt 2, CANCELED
Tarboro, NC, Tarboro-Edgecombe, NDB RWY 27, Orig, CANCELED
Berlin, NH, Berlin Rgnl, VOR-B, AMDT 3A, CANCELED
Manchester, NH, Manchester, VOR RWY 35, Amdt 15E, CANCELED
Portsmouth, NH, Portsmouth Intl at Pease, VOR RWY 16, Amdt 5B,
CANCELED
Portsmouth, NH, Portsmouth Intl at Pease, VOR RWY 34, Orig-D,
CANCELED
Newark, NJ, Newark Liberty Intl, VOR/DME RWY 22L, Orig-D, CANCELED
Newark, NJ, Newark Liberty Intl, VOR/DME RWY 22R, Amdt 4D, CANCELED
Hudson, NY, Columbia County, Takeoff Minimums and Obstacle DP, Amdt
1
White Plains, NY, Westchester County, VOR/DME-A, Amdt 4B, CANCELED
Knoxville, TN, Mc Ghee Tyson, Takeoff Minimums and Obstacle DP, Amdt
8

    RESCINDED: On December 7, 2015 (80 FR 75923), the FAA published
an Amendment in Docket No. 31049, Amdt No. 3671, to Part 97 of the
Federal Aviation Regulations, under section 97.20. The following
entry for Port Angeles, WA, effective February 4, 2016, is hereby
rescinded in its entirety:

Port Angeles, WA, William R Fairchild Intl, WATTR SIX, Graphic DP

    RESCINDED: On January 26, 2016 (81 FR 4174), the FAA published
an Amendment in Docket No. 31051, Amdt No. 3673, to Part 97 of the
Federal Aviation Regulations, under sections 97.29 and 97.33. The
following entries for Port Angeles, WA, effective February 4, 2016,
are hereby rescinded in their entirety:

Port Angeles, WA, William R Fairchild Intl, ILS OR LOC RWY 8, Amdt 3
Port Angeles, WA, William R Fairchild Intl, RNAV (GPS) RWY 8, Amdt 1
Port Angeles, WA, William R Fairchild Intl, RNAV (GPS) RWY 26, Amdt
1

[FR Doc. 2016-03368 Filed 2-18-16; 8:45 am]
 BILLING CODE 4910-13-P


NIVALIS

FOR USE BY COMMERCIAL APPLICATORS ONLY

A Bio-fungicide for use on turf

ACTIVE INGREDIENT:

Typhula phacorrhiza strain # 94671
…………………………………………………..……….
4.00% (by weight)

OTHER INGREDIENTS:
……………………………………………………………..
…………96.00% (by weight)

TOTAL:
……..................................................................
.................................................... 100.00%

Contains a minimum of 181,600 colony forming units (CFU)/pound.

(One product granule is equivalent to one CFU)

KEEP OUT OF REACH OF CHILDREN

Si usted no entiende la etiquette, busque a alguien para que se la
explique a usted en detalle

(If you do not understand the label, find someone to explain it to you
in detail)

POTENTIAL SENSITIZER

CAUTION

Causes moderate eye irritation

FIRST AID:

IF INHALED:	Move to fresh air.

If person is not breathing, call 911 or an ambulance, and then give
artificial respiration preferably mouth to mouth if possible.

Call a poison control center or doctor for further treatment advice.

IF IN EYES:	Hold eye open and rinse slowly and gently with water for
15-20 minutes.  Remove contact lenses, if present, after the first 5
minutes, then continue rinsing eye.

	Call a poison control center or doctor for treatment advice.

GENERAL:	Have the product container or label with you when calling a
poison control center or doctor, or going for treatment.

	For emergency information on product call the National Pesticide
Information Center at 1-800-858-7378, 6:30 AM to 4:30 PM Pacific time
(PT), seven days a week.  During other times, call poison control center
1-800-222-1222

PRECAUTIONARY STATEMENT

Hazards to Humans and Domestic Animals

CAUTION Causes moderate eye irritation

Causes moderate eye irritation.  Avoid contact with eyes or clothing.
Wear protective eye goggles.  Wash thoroughly with soap and water after
handling and before eating, drinking, and chewing gum, using tobacco or
using the toilet. Prolonged or frequently repeated skin contact may
cause allergic reactions in some individuals.

ENVIRONMENTAL HAZARDS

For terrestrial use, do not apply directly to water, or to areas where
surface water is present; or to inter-tidal areas below the mean high
water mark.  Do not contaminate water when disposing of equipment wash
water or rinsate.

NET CONTENT: ________lbs

PERSONAL PROTECTIVE EQUIPMENT (PPE)

Wear a long sleeved shirt, long pants, and shoes plus socks when
handling, mixing/loading or applying the product and during all
clean-up/repair activities.  Follow manufacturer’s instructions for
cleaning/maintaining PPE. If no such instructions for washables exist,
use detergent and hot water. Keep and wash PPE separately from other
laundry.

ENGINEERING CONTROLS: When handlers use closed systems, enclosed cabs,
or aircraft in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240
(d) (4-6), the handler PPE requirement may be reduced or modified as
specified in the WPS.

USER SAFETY RECOMMENDATION

Wash hands before eating, drinking, chewing gum, using tobacco, or using
the toilet.

Remove clothing/PPE immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing.

Remove PPE immediately after handling this product. Wash the outside of
gloves before removing. As soon as possible, wash thoroughly and change
into clean clothing.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner
inconsistent with its labeling. Do not apply this product in a way that
will contact workers or other persons, either directly or through drift.
Only protected handlers may be in the area during application. For any
requirements specific to your State or Tribe, consult the agency
responsible for pesticide regulation.

AGRICULTURAL USE REQUIREMENTS

Use this product only in accordance with its labeling and with the
Worker Protection Standard, 40 CFR Part 170

This standard contains requirements for the protection of agricultural
workers on farms, forests, nurseries, and greenhouses, and handlers of
agricultural pesticides. It contains requirements for training,
decontamination, notification, and emergency assistance. It also
contains specific instructions and exceptions pertaining to the
statements on the label about personal protective equipment,
restricted-entry interval, and notification to workers (as applicable).
Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application. Do not enter or allow worker entry
into treated areas during the restricted-entry interval (REI) of 4
hours. For early entry into treated areas that is permitted under the
Worker Protection Standard and that involves contact with anything that
has been treated, such as plants, soil, or water, wear long sleeved
shirt, long pants, and shoes plus sock.

NON - AGRICULTURAL USE REQUIREMENTS

The requirements in this box apply to uses of this product that are NOT
within the scope of the Worker Protection Standard for agricultural
pesticides (40 CFR Part 170). The WPS applies when this product is used
to produce agricultural plants on farms, forests, nurseries, or
greenhouses.

Professional applicators to golf courses are not within the scope of the
Worker Protection Standards.

GENERAL USE INFORMATION

NIVALIS contains dried mycelium and sclerotia of the fungus Typhula
phacorrhiza.  The fungus competes with other low temperature fungi under
snow cover and controls the development of pink and grey snow mould
disease on turfgrass.

DO NOT APPLY BY AIR.

Failure to follow label directions may result in erratic control of snow
mould disease of turfgrass.  Read all information and directions
carefully before using NIVALIS.

NIVALIS is for use on turf where continuous snow cover persists for 90
days or more. NIVALIS is safe for use on creeping bentgrass, Kentucky
bluegrass, annual bluegrass, perennial ryegrass and other common species
of turfgrass.

USE DIRECTIONS:

Method of Application:  21 lbs/1000 ft2 of NIVALIS to golf course
fairways and 103 lbs/1000 ft2 for golf course greens and tees. Do not
use water or equipment contaminated with chemicals likely to be harmful
to the active ingredient fungus in this product.

Application Timing:  NIVALIS should be applied after the last mowing and
before snowfall.  Do not apply within 2 weeks of fungicide applications.

Integrated Pest Management:  The use of turf fungicides does not
interfere with the efficacy of NIVALIS. However, NIVALIS should not be
applied in combination with any pesticides or within 2 weeks of
fungicide application.

STORAGE AND DISPOSAL

DO NOT contaminate water, food, or feed by storage, disposal, or
cleaning of application equipment.

PESTICIDE STORAGE: Keep pesticide in original container. Store in a
cool, dry place below 390F (40C). DO NOT contaminate food or foodstuffs.
DO NOT store or transport near feed or food.

PESTICIDE DISPOSAL: Do not contaminate water, food, of feed by storage
and disposal. Wastes resulting from the use of this product may be
disposed of on-site or at an approved waste disposal facility.

CONTAINER DISPOSAL: DO NOT reuse bags, completely empty bag into
application equipment. Dispose of empty bag in a sanitary landfill or by
incineration, or if allowed by State and local authorities, by burning.
If burned, stay out of smoke.

Spill Clean/Decontamination: Contact the manufacturer in case of a
spill, and for clean-up of spills.

CONDITIONS OF SALE AND WARRANTY

Read the entire label of this product before its application and use.

LIMITATION OF WARRANTY AND LIABILITY

Read the entire Directions for Use, Conditions of Warranties and
Limitations of Liability before using this product. If terms are not
acceptable, return the unopened product container at once.

By using this product, user or buyer accepts the following Conditions,
Disclaimer of Warranties and Limitations of Liability.

CONDITIONS: The directions for use of this product are believed to be
adequate and must be followed carefully. However, it is impossible to
eliminate all risks associated with the use of this product. Crop
injury, ineffectiveness or other unintended consequences may result
because of such factors as weather conditions, presence of other
materials, or the manner of use or application, all of which are beyond
the control of Agrium Advanced Technologies. All such risks shall be
assumed by the user or buyer.

DISCLAIMER OF WARRANTIES: To the extent consistent with applicable law,
Agrium Advanced Technologies, Inc. makes no other warranties, express or
implied, of merchantability or of fitness for a particular purpose or
otherwise, that extend beyond the statements made on this label. No
agent of Agrium Advanced Technologies is authorized to make any
warranties beyond those contained herein or to modify the warranties
contained herein. To the extent consistent with applicable law, Agrium
Advanced Technologies disclaims any liability whatsoever for special,
incidental or consequential damages resulting from the use or handling
of this product.

LIMITATIONS OF LIABILITY: To the extent consistent with applicable law,
the exclusive remedy of the user or buyer for any and all losses,
injuries or damages resulting from the use or handling of this product,
whether in contract, warranty, tort, negligence, strict liability or
otherwise, shall not exceed the purchase price paid or at Agrium
Advanced Technologies’ election, the replacement of product.

MANUFACTURER:

SYLVAN INC.

198 NOLTE DRIVE,

KITTANNING, PA

16201, USA

Always check with your State to verify State registration status

PRODUCT NAME: NIVALIS

EPA REGISTRATION NO: XXXXX

SUBMISSION NUMBER: NEW PRODUCT APPLICATION

DISTRIBUTED BY:

AGRIUM ADVANCED TECHNOLOGIES

10 CRAIG STREET

BRANTFORD, ONTARIO

CANADA

N3R 7J1

EPA REGISTRATION NUMBER:  XXXXXXXX

MANUFACTURER’S EPA ESTABLISHMENT NUMBERS:

070002-PA-002, 070002-PA-003, 0700002-PA-004


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30684-30685]
[FR Doc No: 2014-12217]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-32]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before June 17, 2014.

ADDRESSES: You may send comments identified by docket number FAA-2012-
1146 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mark Forseth, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>; or Sandra Long, ARM-
201, Office of Rulemaking, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591, email
<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 21, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2012-1146.
    Petitioner: Bombardier Aerospace.
    Section of 14 CFR Affected: Sec.  25.841(a)(2)(i) and (a)(2)(ii) at
Amendment 25-87.
    Description of Relief Sought: Petitioner seeks relief from the
cabin altitude limits following an uncontained engine failure (UEF),
and from additional considerations for a UEF which punctures and/or
tears the fuselage creating a very large hole for the Bombardier Models
BD-500-1A10 (CS100) and BD-500-1A11 (CS300) airplanes operating above
40,000 feet pressure altitude.

[FR Doc. 2014-12217 Filed 5-27-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 56979-56980]
[FR Doc No: 2015-23529]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC15-197-000.
    Applicants: Joliet Battery Storage LLC, West Chicago Battery
Storage LLC.
    Description: Joint Application of Joliet Battery Storage LLC and
West Chicago Battery Storage LLC for Authorization Under Section 203 of
the Federal Power Act and Request for Waivers, Confidential Treatment,
Expedited Action and Shortened Comment Period.
    Filed Date: 8/28/15.
    Accession Number: 20150828-5292.
    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: EC15-198-000.
    Applicants: NRG Chalk Point LLC, NRG Chalk Point CT LLC.
    Description: Joint Application of NRG Chalk Point LLC and NRG Chalk
Point CT LLC for Approval under Section 203 of the Federal Power Act
and Request for Expedited Action.
    Filed Date: 8/28/15.
    Accession Number: 20150828-5294.
    Comments Due: 5 p.m. ET 9/18/15.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER15-861-004.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2015-08-28 EIM Readiness Compliance
to be effective 3/16/2015.
    Filed Date: 8/28/15.
    Accession Number: 20150828-5271.
    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2453-000.
    Applicants: Passadumkeag Windpark, LLC.
    Description: Supplement to August 14, 2015 Passadumkeag Windpark,
LLC.
    Filed Date: 8/28/15.
    Accession Number: 20150828-5233.
    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2564-000.
    Applicants: Southern Power Company.
    Description: Section 205(d) Rate Filing: Decatur Parkway PPA Filing
to be effective 10/12/2015.
    Filed Date: 8/28/15.
    Accession Number: 20150828-5272.
    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2565-000.
    Applicants: California Independent System Operator Corporation.
    Description: Section 205(d) Rate Filing: 2015-08-28 EIM Transition
Period Amendment to be effective 11/1/2015.
    Filed Date: 8/28/15.
    Accession Number: 20150828-5291.
    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2566-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Section 205(d) Rate Filing: 6th Amendment to Extend
the PGE-SVP Interconnection Agreement to be effective 10/31/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5025.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2567-000.
    Applicants: Duke Energy Progress, LLC, Duke Energy Florida, LLC,
Duke Energy Carolinas, LLC.
    Description: Section 205(d) Rate Filing: Tariff Name Change Filing
to be effective 11/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5170.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2568-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Section 205(d) Rate Filing: Tariff Name Change Filing
to be effective 11/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5173.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2569-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Section 205(d) Rate Filing: Tariff Name Change Filing
to be effective 11/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5175.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2570-000.
    Applicants: Potomac Electric Power Company.

    Description: Section 205(d) Rate Filing: Construction Agreement
Between PEPCO and SMECO to be effective 9/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5200.
    Comments Due: 5 p.m. ET 9/21/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 31, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-23529 Filed 9-18-15; 8:45 am]
 BILLING CODE 6717-01-P