      Into Assurance section starting on p 366
      The requirement that owners and operators surrender allowances under the assurance provisions will be triggered only if two criteria are met: (1) the group of sources and units with a common DR are located in a state where the total state EGU emissions for a control period exceed the state assurance level; and (2) that group with the common DR had emissions exceeding the respective DR's share of the state assurance level.  The share of the assurance penalty borne by the owners and operators will be based on the amount by which the total emissions for the units in the group exceed the common DR's share of the state assurance level as a percentage of the total calculated for all such groups of sources and units in the state.  Thus, the owners and operators of each such group of sources and units must surrender an amount of allowances equal to the excess of state EGU emissions over the state assurance level multiplied by the owners' and operators' percentage and multiplied by two (to reflect the penalty of two allowances for each ton of the state's excess EGU emissions).  See Table VII.E-1 below for an illustrative example.
      This approach in the final rule of implementing the assurance provisions on a common designated representative basis contrasts with the approach in the proposed rule of implementing the assurance provisions on an owner basis.  In the January 7, 2011 NODA, EPA requested comment on the alternative of basing the assurance provision penalty using common designated representatives, and some commenters supported this alternative.  The common designated representative approach is simpler and avoids the need to collect information on percentage ownership (which information is not used in any other provisions of the Transport Rule trading programs).

      In addition, the common designated representative approach provides additional flexibility to owners and operators who have only one or a few units in a given state but have the option of selecting a common designated representative with owners and operators of other units in the state.  EPA expects companies in various states will readily be able to manage their emissions to stay collectively below their state's assurance levels as they track emissions quarterly throughout the year and manage their generation units and pollution control efforts accordingly.  However, if the state appears to be approaching its assurance level, this final rule also gives companies the ability to further ensure that they will not have excess emissions by combining multiple units under a common DR.  This flexibility allows utilities to re-balance allowances and emissions to mitigate penalty risk if the state violates its assurance level. In a state that does not appear to risk violating its assurance level in a given period, utilities would not need to consider the assurance aspect of selecting DRs.  However, EPA anticipates that in the event utilities desire additional certainty or mitigation of assurance penalty risk, they will take advantage of this common DR provision or pursue similar private arrangements with each other to cover their emissions at the lowest possible cost.
      This new feature in the final rule, in conjunction with the simplifications to the final rule's variability limits described in section VI.E, will give companies under the air quality-assured trading program greater flexibility in each state to determine the most cost-effective pattern of emission reductions while EPA ensures each state meets its assurance level needed to address the significant contribution in each state


[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)]
[Notices]
[Page 77392]
[FR Doc No: 2015-31359]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension: Form T-6.
OMB Control No. 3235-0391, SEC File No. 270-344.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Form T-6 (17 CFR 269.9) is an application for eligibility and
qualification for a foreign person or corporation under the Trust
Indenture Act of 1939 (15 U.S.C. 77aaa et seq.). Form T-6 provides the
basis for determining whether a foreign person or corporation is
eligible to serve as a trustee for qualified indenture. Form T-6 is
filed on occasion. The information collected must be filed with the
Commission and is publicly available. Form T-6 takes approximately 17
burden hours per response and is filed by approximately 1 respondent
annually. We estimate that 25% of the 17 hours (4.25 hours) is prepared
by the filer for an annual reporting burden of 4.25 hours (4.25 hours
per response x 1 response).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: December 8, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-31359 Filed 12-11-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38658-38659]
[DOCID:fr04au09-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0258; FDA-2008-E-0260; and FDA-2008-E-0261]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for RECOTHROM and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of three applications to the Director of
Patents and Trademarks, Department of Commerce, for the extension of
patents which claim that human biological product.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the human biological product becomes effective and
runs until the approval phase begins. The approval phase starts with
the initial submission of an application to market the human biological
product and continues until FDA grants permission to market the human
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of Patents and Trademarks may award (for example, half the
testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human biological product
will include

all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA recently approved for marketing the human biological product
RECOTHROM (Thrombin, topical (Recombinant)). RECOTHROM is indicated as
an aid to hemostasis whenever oozing blood and minor bleeding from
capillaries and small venules is accessible and control of bleeding by
standard surgical techniques is ineffective or impractical. Subsequent
to this approval, the Patent and Trademark Office received patent term
restoration applications for RECOTHROM (U.S. Patent Nos. 5,476,777,
5,502,034, and 5,527,692) from ZymoGenetics, Inc., and the Patent and
Trademark Office requested FDA's assistance in determining the patents'
eligibilities for patent term restoration. In a letter dated February
26, 2009, FDA advised the Patent and Trademark Office that this human
biological product had undergone a regulatory review period and that
the approval of RECOTHROM represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
RECOTHROM is 1,511 days. Of this time, 1,115 days occurred during the
testing phase of the regulatory review period, while 396 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
November 30, 2003. FDA has verified the applicant's claims that the
date the investigational new drug application became effective was on
November 30, 2003.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 18, 2006. FDA has verified the
applicant's claims that the biologics license application (BLA) for
RECOTHROM (BLA 125248/0) was initially submitted on December 18, 2006.
    3. The date the application was approved: January 17, 2008. FDA has
verified the applicant's claims that BLA 125248/0 was approved on
January 17, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 952 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by October 5, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by February 1,
2010. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document.
    Comments and petitions may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-18528 Filed 8-3-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 155 (Monday, August 12, 2013)]
[Proposed Rules]
[Pages 48826-48828]
[FR Doc No: 2013-19458]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0672; Directorate Identifier 2013-NM-058-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 767-200, -300, -300F, and -400ER
airplanes. This proposed AD was prompted by reports indicating that a
standard access door was located where an impact-resistant access door
was required, and stencils were missing from some impact-resistant
access doors. This proposed AD would require an inspection of the left-
and right-hand wing fuel tank access doors to determine that impact-
resistant access doors are installed in the correct locations, and to
replace any door with an impact-resistant access door if necessary.
This proposed AD also would require an inspection for stencils and
index markers on impact-resistant access doors, and application of new
stencils or index markers if necessary. This proposed AD would also
require revising the maintenance program to incorporate changes to the
airworthiness limitations section. We are proposing this AD to prevent
foreign object penetration of the fuel tank, which could cause a fuel
leak near an ignition source (e.g., hot brakes or engine exhaust
nozzle), consequently leading to a fuel-fed fire.

DATES: We must receive comments on this proposed AD by September 26,
2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Suzanne Lucier, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6438; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2013-0672;
Directorate Identifier 2013-NM-058-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy

aspects of this proposed AD. We will consider all comments received by
the closing date and may amend this proposed AD because of those
comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We received reports of a standard access door located where an
impact-resistant access door is required, and stencils were missing
from some spare impact-resistant access doors. This condition, if not
corrected, could result in foreign object penetration of the fuel tank,
which could cause a fuel leak near an ignition source (e.g., hot brakes
or engine nozzle), consequently leading to a fuel-fed fire.

Relevant Service Information

    We reviewed Boeing Service Bulletin 767-28-0105, dated January 12,
2012; and critical design configuration control limitation (CDCCL) Task
57-AWL-01, ``Impact-Resistant Fuel Tank Access Door,'' of Section 9,
Airworthiness Limitations (AWLs) and Certification Maintenance
Requirements (CMRs) of Boeing 767 Maintenance Planning Data Document
D622T001-9, Revision October 2012. For information on the procedures
and compliance times, see this service information at http://www.regulations.gov by searching for Docket No. FAA-2013-0672.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs.

Proposed AD Requirements

    The FAA issued section 121.316 of the Federal Aviation Regulations
(14 CFR 121.316) requiring that each turbine powered transport category
airplane meet the requirements of section 25.963(e) of the Federal
Aviation Regulations (14 CFR 25.963(e)). Section 25.963(e) outlines the
certification requirements for fuel tank access covers on turbine
powered transport category airplanes.
    This proposed AD would require inspecting fuel tank access doors to
determine that impact-resistant access doors are installed in the
correct locations and replacing any door with an impact-resistant
access door if necessary; inspecting application of stencils and index
markers of impact-resistant access doors and application of new
stencils or index markers if necessary; and revising the maintenance
program.
    This proposed AD requires revisions to certain operator maintenance
documents to include a new CDCCL. Compliance with CDCCLs is required by
section 91.403(c) of the Federal Aviation Regulations (14 CFR
91.403(c)). For airplanes that have been previously modified, altered,
or repaired in the areas addressed by this proposed AD, the operator
might not be able to accomplish the actions described in the revisions.
In this situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according to
the procedures specified in paragraph (j) of this proposed AD. The
request should include a description of changes to the required actions
that will ensure the continued damage tolerance of the affected
structure.
    After accomplishing the revision required by paragraph (h) of this
AD, no alternative actions (e.g., inspections), intervals, and/or
CDCCLs may be used unless the actions, intervals, and/or CDCCLs are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (j) of this AD.

Costs of Compliance

    We estimate that this proposed AD affects 425 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Inspection..........................  Up to 7 work-hours x                 $0             $595         $252,875
                                       $85 per hour = $595.
Maintenance program revision........  1 work-hour x $85 per                 0               85           36,125
                                       hour = $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of aircraft that might need
these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                   Action                               Labor cost               Parts cost     Cost per product
----------------------------------------------------------------------------------------------------------------
Replacement per door........................  3 work-hours x $85 per hour =             $8,000            $8,255
                                               $255.
Stencil and index marker....................  9 work-hours x $85 per hour =                  0               765
                                               $765.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 proposed regulation is
within the scope of that

authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

The Boeing Company: Docket No. FAA-2013-0672; Directorate Identifier
2013-NM-058-AD.

(a) Comments Due Date

    We must receive comments by September 26, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 767-200, -300, -
300F, and -400ER series airplanes; certificated in any category; as
identified in Boeing Service Bulletin 767-28-0105, dated January 12,
2012.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports indicating that a standard
access door was located where an impact-resistant access door was
required, and stencils were missing from some impact-resistant
access doors. We are issuing this AD to prevent foreign object
penetration of the fuel tank, which could cause a fuel leak near an
ignition source (e.g., hot brakes or engine nozzle), consequently
leading to a fuel-fed fire.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspections

    Within 72 months after the effective date of this AD, do the
actions specified in paragraphs (g)(1) and (g)(2) of this AD, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 767-28-0105, dated January 12, 2012.
    (1) Do either a general visual inspection or ultrasonic non-
destructive test of the left- and right-hand wing fuel tank access
doors to determine whether impact-resistant access doors are
installed in the correct locations. If any standard access door is
found, before further flight, replace with an impact-resistant
access door, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 767-28-0105, dated January 12, 2012.
    (2) Do a general visual inspection of the left- and right-hand
wing fuel tank impact-resistant access doors to verify stencils and
index markers are applied. If a stencil or index marker is missing,
before further flight, apply stencil or index marker, as applicable,
in accordance with the Accomplishment Instructions of Boeing Service
Bulletin 767-28-0105, dated January 12, 2012.

(h) Maintenance Program Revision

    Within 60 days after the effective date of this AD, revise the
maintenance program to incorporate critical design configuration
control limitation (CDCCL) Task 57-AWL-01, ``Impact-Resistant Fuel
Tank Access Door,'' of Section 9, Airworthiness Limitations (AWLs)
and Certification Maintenance Requirements (CMRs) of Boeing 767
Maintenance Planning Data Document D622T001-9, Revision October
2012.

(i) No Alternative Actions, Intervals, and/or CDCCLs

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative actions (e.g., inspections), intervals, and/
or CDCCLs may be used unless the actions, intervals, and/or CDCCLs
are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in paragraph (j) of this
AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    (1) For more information about this AD, contact Suzanne Lucier,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 2, 2013.
Ross Landes,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-19458 Filed 8-9-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 24049-24053]
[FR Doc No: 2014-09675]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72001; File No. SR-EDGA-2014-09]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGA Exchange, Inc. Fee Schedule

April 23, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 9, 2014, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III 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\ 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 its fees and rebates applicable to
Members \3\ of the Exchange pursuant to EDGA Rule 15.1(a) and (c)
(``Fee Schedule'') to harmonize the definitions of Average Daily
Trading Volume (``ADV'') and Total Consolidated Volume (``TCV'') with
those contained in the BATS Exchange, Inc. (``BATS'') and BATS-Y
Exchange, Inc. (``BYX'') fee schedules by: (i) Modifying the way that,
for purposes of tiered pricing, the Exchange calculates ADV and average
daily TCV; and (ii) clarify the manner in which Members may aggregate
their ADV with other affiliated Members. The text of the proposed rule
change is available on the Exchange's Internet Web site at
www.directedge.com, at the Exchange's principal office, and at the
Public Reference Room of the Commission.
---------------------------------------------------------------------------

    \3\ The term ``Member'' is defined as ``any registered broker or
dealer, or any person associated with a registered broker or dealer,
that has been admitted to membership in the Exchange. A Member will
have the status of a ``member'' of the Exchange as that term is
defined in Section 3(a)(3) of the Act.'' See Exchange Rule 1.5(n).
---------------------------------------------------------------------------

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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

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

1. Purpose
    On January 31, 2014, Direct Edge Holdings LLC (``DE Holdings''),
the former parent company of the Exchange, completed its business
combination with BATS Global Markets, Inc., the parent company of BATS
and BYX.\4\ As part of its effort to reduce regulatory duplication and
relieve firms that are members of the Exchange, BATS, and BYX of
conflicting or unnecessary regulatory burdens, the Exchange is now
engaged in the process of reviewing and amending certain Exchange,
BATS, and BYX Rules. To conform to comparable BATS and BYX rules for
purposes of its harmonization efforts due to its business combination,
the Exchange proposes to amend the definitions of ADV and TCV to make
each definition similar to those contained in the BATS and BYX fee
schedules by modifying the way that, for purposes of tiered pricing:
(i) The Exchange calculates ADV and average daily TCV; and (ii) the
manner in which Members may aggregate their ADV with other affiliated
Members. The Exchange notes that it is not proposing to modify any of
the existing rebates or the percentage thresholds at which a Member may
qualify for certain rebates pursuant to the tiered pricing structure.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 71449 (January 30,
2014), 79 FR 6961 (February 5, 2014) (SR-EDGA-2013-34). Upon
completion of the Combination, DE Holdings and BATS Global Markets,
Inc. each became intermediate holding companies, held under a single
new holding company. The new holding company, formerly named ``BATS
Global Markets Holdings, Inc.,'' changed its name to ``BATS Global
Markets, Inc.''
---------------------------------------------------------------------------

ADV and TCV
    Currently, the Exchange determines the liquidity adding reduced
fees that it will provide to Members based on the Exchange's tiered
pricing structure based on the calculation of ADV,\5\ and/or average
daily TCV.\6\ Unlike on BATS and BYX, the Exchange does not currently
exclude any trading days from its calculation of ADV and TCV.
Therefore, to harmonize the calculation of ADV and TCV with BATS and
BYX, the Exchange proposes to amend the definitions of ADV and TCV to
exclude shares on: (i) Any day that the Exchange's system experiences a
disruption that lasts for more than 60 minutes during Regular Trading
Hours \7\ (``Exchange System Disruption''); and (ii) the last Friday in
June (the ``Russell Reconstitution Day''). The Exchange also proposes
to amend the definition of ADV to clarify that routed shares are not
included in ADV calculation.
---------------------------------------------------------------------------

    \5\ As provided in the Fee Schedule, ``ADV'' is currently
defined as the average daily volume of shares that a Member executed
on the Exchange for the month in which the fees are calculated.
    \6\ As provided in the Fee Schedule, ``TCV'' is currently
defined as the volume reported by all exchanges and trade reporting
facilities to the consolidated transaction reporting plans for Tapes
A, B and C securities for the month in which the fees are
calculated.
    \7\ ``Regular Trading Hours'' is defined as ``the time between
9:30 a.m. and 4:00 p.m. Eastern Time.'' See Exchange Rule 1.5(y).
---------------------------------------------------------------------------

    First, the Exchange proposes to modify the definitions of ADV and
TCV to exclude trading days where the Exchange experiences a systems
disruption that lasts for more than 60 minutes during Regular Trading
Hours and define it as an Exchange System Disruption.\8\ As an example,
an Exchange System Disruption may occur where a certain group of
securities (i.e., securities in a select symbol range such as A through
C) traded on the Exchange are unavailable for trading due to an
Exchange system issue. Similarly, the Exchange may be able to perform
certain functions with respect to accepting and processing orders, but
may have a failure to another significant process, such as routing to
other market centers, that would lead Members that rely on such process
to avoid utilizing the Exchange until the Exchange's entire system was
operational.
---------------------------------------------------------------------------

    \8\ See SR-BATS-2014-010 and SR-BYX-2014-006 (proposing to
exclude Exchange System Disruptions from the definition of ADV).
---------------------------------------------------------------------------

    The Exchange believes that this modification is reasonable because
it avoids penalizing Members that might otherwise qualify for certain
tiered pricing but that, because of a significant Exchange system
problem, did not participate on the Exchange to the extent that they
might have otherwise participated. The Exchange believes that certain
systems disruptions could preclude some Members from submitting orders
to the Exchange even if such issue is not actually a complete systems
outage. Therefore, the Exchange is proposing to modify its Fee Schedule
to exclude trading activity occurring on any day that the Exchange
experiences an Exchange System Disruption.
    Second, the Exchange proposes to exclude the last Friday of June
each year from the definition of ADV and TCV because the last Friday of
June is the day that Russell Investments reconstitutes its family of
indexes (``Russell Rebalance''), resulting in particularly high trading
volumes, much of which the Exchange believes derives from market
participants who are not generally as active entering the market to
rebalance their holdings in-line with the Russell Rebalance.\9\ The
Exchange believes that trading occurring as a result of the Russell
Rebalance can significantly skew the calculation of ADV and TCV. For
example, since 2008, on the last Friday in June, the TCV has exceeded
the average daily TCV for the preceding trading days in June by
approximately 43% on average. The chart below reflects the TCV on the
last Friday of June for each year dating to 2008 and compares it to the
average daily TCV for the preceding trading days in the month of June.
---------------------------------------------------------------------------

    \9\ Securities Exchange Act Release No. 69793 (July 18, 2013),
78 FR 37865 (July 24, 2013) (SR-BATS-2013-034) (excluding the
Russell Reconstitution Day from the definition of ADV).

----------------------------------------------------------------------------------------------------------------
                                                                 MTD average TCV as of
  Russell reconstitution date (RCD)           TCV on RCD             day before RCD            % Difference
----------------------------------------------------------------------------------------------------------------
6/28/2013............................           10,211,508,622            6,954,840,047                    46.83
6/29/2012............................            7,924,340,355            6,833,486,672                    15.96
6/24/2011............................           10,472,502,657            7,237,593,514                    44.70
6/25/2010............................           14,482,717,113            8,981,067,278                    61.26
6/26/2009............................           13,024,518,377            9,597,498,903                    35.71
6/27/2008............................           12,010,692,402            7,835,813,201                    53.28
----------------------------------------------------------------------------------------------------------------

Because of the extremely high volume numbers and abnormally distributed
daily volume or percentage of the TCV on this day, it stands that the
ADV or percentage of average daily TCV can be significantly impacted.
    As such, the Exchange believes that eliminating the last Friday of
June from the definition of ADV and TCV, and thereby eliminating that
day from the calculation as it relates to reduced fees for adding
liquidity to the Exchange, will help to eliminate significant
uncertainty faced by Members as to their monthly ADV or percentage of
average daily TCV and the reduced fees that this percentage will
qualify for, providing Members with an increased certainty as to their
monthly cost for trades executed on the Exchange. The Exchange further
believes that removing this uncertainty will encourage Members to
participate in trading on the Exchange during the remaining trading
days in June in a manner intended to be incented by the Exchange's Fee
Schedule.
    Lastly, the Exchange proposes to clarify within the definition of
ADV that ADV does not include shares that are routed to other trading
centers. ADV is defined as the average daily volume of shares executed
on the Exchange for the month in which the fees are calculated.
Clarifying that routed orders are not included in the definition of ADV
is designed to add further clarity and harmonize the definition with
BATS and BYX.
ADV Aggregation
    The Exchange also proposes to amend when a Member may aggregate
share volumes with other affiliated Members. Currently, under the
``General Notes'' section of the Fee Schedule, the Exchange will
aggregate share volume calculations for wholly owned affiliates on a
prospective basis upon a Member's request. The Exchange proposes to
relocate this provision to the definition of ADV and amend the language
to allow a Member to aggregate ADV with other Members that control, are
controlled by, or are under common control with such Member (as
evidenced on such Member's Form BD).\10\ To the extent two or more
affiliated companies maintain separate Exchange memberships and can
demonstrate their affiliation by showing they control, are controlled
by, or are under common control with each other, the Exchange will
permit such Members to count overall volume of the affiliates in
calculating ADV.
---------------------------------------------------------------------------

    \10\ Securities Exchange Act Release No. 64211 (April 6, 2011),
76 FR 20414 (April 12, 2014 [sic]) (SR-BATS-2011-012) (permitting
Members to aggregate shares volumes with affiliated entities).
---------------------------------------------------------------------------

Implementation Date
    The Exchange proposes to implement these amendments to its Fee
Schedule on May 1, 2014.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\11\ in general, and
furthers the objectives of Section 6(b)(4),\12\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee structures at a particular venue to
be unreasonable and/or excessive.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    Members who are also members of BATS or BYX are subject to
different definitions of ADV and TCV as well as differing standards for
aggregating ADV with affiliated Members when seeking to qualify for
certain tiered pricing. The Exchange believes that the proposed rule
change will provide greater harmonization between similar Exchange,
BATS and BYX rules, resulting in greater uniformity and less burdensome
and more efficient regulatory compliance for common members. As such,
the proposed rule change would foster cooperation and coordination with
persons engaged in facilitating transactions in securities and would
remove impediments to and perfect the mechanism of a free and open
market and a national market system. Lastly, the Exchange believes that
the proposed change is non-discriminatory because it applies uniformly
to all Members.
    Volume-based tiers such as the liquidity adding tiers maintained by
the Exchange have been widely adopted, and are equitable and not
unfairly discriminatory. They are open to all Members on an equal basis
and provide higher rebates or lower fees that are reasonably related to
the value to an exchange's market quality associated with higher levels
of market activity, such as higher levels of liquidity provision and
introduction of higher volumes of orders into the price and volume
discovery process. Accordingly, the Exchange believes that the proposal
is equitably allocated and not unfairly discriminatory because it is
consistent with the overall goals of enhancing market quality. Further,
the Exchange believes that a tiered pricing model not significantly
altered by a day of atypical trading behavior which allows Members to
predictably calculate what their costs associated with trading activity
on the Exchange will be is reasonable, fair and equitable and not
unreasonably discriminatory as it is uniform in application amongst
Members and should enable such participants to operate their business
without concern of unpredictable and potentially significant changes in
expenses.
ADV and TCV
    The Exchange believes that its proposed amendments to the
definitions of ADV and TCV to exclude shares on the day of an Exchange
System Disruption are reasonable because, as explained above, they will
help provide Members with a greater level of certainty as to their
level of costs for trading in any month where the Exchange experiences
an Exchange System Disruption on one or more trading days. The Exchange
is not proposing to amend the thresholds a Member must achieve to
become eligible for, or the dollar value associated with, the tiered
pricing. By eliminating the inclusion of a trading day on which an
Exchange System Disruption occurs the Exchange would almost certainly
be excluding a day that would otherwise lower a Member's ADV

or percentage of average daily TCV. Thus, the proposed change will make
the majority of Members more likely to meet the minimum or higher tier
thresholds, incentivizing Members to increase their participation on
the Exchange in order to meet the next highest tier. In addition, the
Exchange believes that the proposed changes to its Fee Schedule are
equitably allocated among Exchange constituents and not unfairly
discriminatory as the methodology for calculating ADV and TCV will
apply equally to all Members. While, although unlikely, certain Members
may have a higher ADV or percentage of average daily TCV with their
activity included from days where the Exchange experiences an Exchange
System Disruption, the proposal will make all Members' cost of trading
on the Exchange more predictable, regardless of how the proposal
affects their ADV or percentage of average daily TCV.
    The Exchange believes that its proposed amendments to the
definitions of ADV and TCV to exclude shares on the Russell
Reconstitution Day are reasonable because, as explained above, it will
help provide Members with a greater level of certainty as to their
level of fees for trading in the month of June. The Exchange also
believes that its proposal is reasonable because it is not changing the
thresholds to become eligible or the dollar value associated with the
reduced fees. Moreover, by eliminating the inclusion of a trading day
that would almost certainly lower a Member's ADV or percentage of
average daily TCV, it will make the majority of Members more likely to
meet the minimum or higher tier thresholds, which will provide
additional incentive to Members to increase their participation on the
Exchange in order to meet the next tier. In addition, the Exchange
believes that the proposed changes are equitably allocated among
Exchange constituents as the methodology for calculating ADV and TCV
will apply equally to all Members. While, although unlikely, certain
Members may have a higher ADV or percentage of average daily TCV with
the day included, the proposal will make June trading fees more similar
to other months. Moreover, all Members' cost of trading on the Exchange
will become more predictable, regardless of how the proposal affects
their ADV or percentage of average daily TCV, which in turn will
preserve Members' incentives to participate in trading on the Exchange
in a manner intended to be incented by the Exchange's Fee Schedule.
    Lastly, the Exchange proposes to clarify within the definition of
ADV that ADV does not include shares that are routed to other trading
centers. Clarifying that routed orders are not included in the
calculation of ADV will promote just and equitable principles of trade
and remove impediments to a free and open market by providing greater
transparency concerning the operation of the Exchange and a Member's
share volumes that are included in their ADV.
ADV Aggregation
    The proposed language permitting aggregation of volume amongst
Members that share common control for purposes of the ADV calculation
is intended to avoid disparate treatment of Members that have divided
their various business activities between separate corporate entities
as compared to Members that operate those business activities within a
single corporate entity. By way of example, subject to appropriate
information barriers, many firms that are Members of the Exchange
operate both a market making desk and a public customer business within
the same corporate entity. In contrast, other Members may be part of a
corporate structure that separates those business lines into different
corporate affiliates, either for business, compliance or historical
reasons, and those affiliates are not also considered wholly owned
affiliates. Those corporate affiliates, in turn, are required to
maintain separate memberships with the Exchange. Absent the proposed
change, such corporate affiliates that cannot be considered wholly
owned but are under common control would not receive the same treatment
as Members who are considered wholly owned affiliates. Current Members
who aggregate share volumes on the Exchange with wholly owned
affiliates will be considered as being under common control and
continue to be able to aggregate share volumes. Accordingly, the
Exchange believes that its proposed policy is fair and equitable, and
not unreasonably discriminatory. In addition to ensuring fair and equal
treatment of its Members, the Exchange does not want to create
incentives for its Members to restructure their business operations or
compliance functions simply due to the Exchange's pricing structure.

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

    The Exchange believes its proposed amendments to its Fee Schedule
would not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
does not believe that the proposed change represents a significant
departure from previous pricing offered by the Exchange or pricing
offered by the Exchange's competitors. Additionally, Members may opt to
disfavor EDGA's pricing if they believe that alternatives offer them
better value. Accordingly, the Exchange does not believe that the
proposed change will impair the ability of Members or competing venues
to maintain their competitive standing in the financial markets.
    The proposed change will help to promote intramarket competition by
avoiding a penalty to Members for days when trading on the Exchange is
disrupted for a significant portion of the day. In addition, excluding
the Russell Rebalance Day from the definition of ADV and TCV will help
the Exchange to continue to incentivize higher levels of liquidity at a
tighter spread while providing more stable and predictable costs to its
Members. Lastly, easing Member's ability to aggregate volumes with
Members who are under common control would increase competition because
it would incentivize Members that could not previously aggregate their
volumes to send higher volume to the Exchange in an effort to achieve
tier-based pricing. As stated above, the Exchange notes that it
operates in a highly competitive market in which market participants
can readily direct order flow to competing venues if they deem fee
structures to be unreasonable or excessive.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \13\ and Rule 19b-4(f)(2) \14\ thereunder. At
any time within 60 days of the filing of such proposed rule change, the
Commission summarily may temporarily suspend such 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..
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(2).

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

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 email to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2014-09 on the subject line.
    Paper Comments
     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGA-2014-09. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for 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
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGA-2014-09, and should be
submitted on or before May 20, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-09675 Filed 4-28-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18830-18831]
[FR Doc No: 2012-7455]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0121]

Small Entity Compliance Guide: Further Amendments to General
Regulations of the Food and Drug Administration To Incorporate Tobacco
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Further Amendments
to General Regulations of the Food and Drug Administration to
Incorporate Tobacco Products--Small Entity Compliance Guide'' for a
final rule published in the Federal Register of February 2, 2012. This
small entity compliance guide (SECG) is intended to set forth in plain
language the requirements of the regulation and to help small
businesses understand and comply with the regulation.

DATES: Submit either electronic or written comments on the SECG at any
time.

ADDRESSES: Submit written requests for single copies of the SECG
entitled ``Further Amendments to General Regulations of the Food and
Drug Administration to Incorporate Tobacco Products--Small Entity
Compliance Guide'' to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive label to assist that office in processing
your request or include a fax number to which the guidance document may
be sent. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 2, 2012 (77 FR 5171), FDA
issued a final rule regarding further amendments to the general
regulations of the FDA to incorporate tobacco products. FDA examined
the economic implications of the final rule as required by the
Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the
rule would have a significant economic impact on a substantial number
of small entities. In compliance with section 212 of the Small Business
Regulatory Enforcement Fairness Act (Pub. L. 104-121), FDA is making
available this SECG stating in plain language the legal requirements of
the February 2, 2012, final rule, set forth in 21 CFR parts 1, 7, and
16, amending the FDA's general regulations to ensure that tobacco
products are subject to the same general requirements that apply to
other FDA-regulated products.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
represents the Agency's current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulation.gov.

    Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7455 Filed 3-27-12; 8:45 am]
BILLING CODE 4160-01-P


Page 1 of 3 October 2, 2003 Questions for the Panel I. Performance Standards The Agency plans to adopt the Performance Standards developed by the Interagency Coordinating Committee on the Validation of Alternative Methods ( ICCVAM) as a means of communicating the basis by which each of three validated in vitro test methods, Corrositex ® , EPISKIN   / EpiDerm   , and Transcutaneous Electrical Resistance ( TER), are deemed acceptable for providing dermal corrosivity data. Performance Standards consist of descriptions of ( 1) essential test method components, which are the essential structural, functional, and procedural elements of a validated test method that should be included in the protocol of a proposed mechanistically and functionally similar test method; ( 2) a minimum list of Reference Chemicals, which is used to assess the accuracy and reliability of the similar test method; and ( 3) comparable accuracy and reliability values that should be achieved by the proposed test method when evaluated using the minimum set of Reference Chemicals.

Question 1. Please comment on the provisions in the Performance Standards for each of the three methods to demonstrate mechanistic similarity of " me too" methods. Do the essential test method components for each method adequately describe the unique characteristics of the method necessary to determine whether a test is mechanistically and functionally similar.

Question 2. In its evaluation of any mechanistically similar test system, the Agency plans to use the generic criteria used by ICCVAM for selecting subsets of the Reference Chemicals for all three ICCVAM Performance Standards documents. The criteria specify that chemicals should be selected in such a way that the subset: includes representatives of applicable chemical classes, measures a range of corrosive strengths, includes well defined chemicals that are currently available commercially, and has unequivocal animal or other in vivo evidence. Please comment on the strengths or weaknesses of this approach and identify and discuss any modifications to the criteria that should be considered.

Question 3. The ICCVAM approach for demonstrating functional similarity of " me too" test methods to validated methods includes the use of wellcharacterized Reference Chemicals and specifies the accuracy and reliability that should be achieved by " me too" test systems when tested in intra and inter laboratory studies. Please comment on whether " me too" test systems should be demonstrated to be effective for evaluating the testing Page 2 of 3 endpoint for all of the chemicals in the Performance Standard. Please comment on the value of including chemicals with range of potencies in the Performance Standard. Under what circumstances might testing of " metoo systems within one laboratory ever be sufficient to demonstrate functional equivalence?

II. Quality Control The Agency is proposing quality control measures that should be considered when evaluating the reliability of test kits for regulatory purposes. Please address the following specific issues.

Question 4. Subsets of the Reference Chemicals used in test method validation may be used as training or calibration sets by testing laboratories using in vitro systems. Please discuss the utility of and necessity for training or calibration sets in assuring data quality. Please comment on the chemicals selected by ICCVAM for use as a calibration set for TER for this purpose. Please comment on the ranges of chemical classes and potencies of these chemicals. How might other chemicals be selected for possible use in the calibration sets? Please comment on the value of identifying chemicals that might be used by laboratories as training sets to demonstrate proficiency in performing the test.

Question 5. Anticipating the use of systems using tissue constructs, ex vivo systems, microarrays or genetically modified cells, please discuss aspects of the quality control criteria that are necessary for assuring the integrity of such systems over time and from lot to lot. Please comment on whether and how the type of system  tissue constructs, ex vivo systems, or genetically modified cells or animals  should affect the criteria for quality control for assuring the integrity of such systems, both over time and from lot to lot.

Question 6. Please comment on the advantages and disadvantages of including concurrent positive and negative controls with in vitro assays when used as alternatives to animal testing. What are the important characteristics of positive and negative controls for in vitro studies? What aspects of positive control characteristics allow them to be used as part of the quality control process? When might confirmation that positive controls are performing within expected or historical limits be sufficient to demonstrate that the Proprietary Test Method or non proprietary assay system is functioning properly? When might additional quality control measures be needed?

Question 7. Does the Panel agree that the benchmark controls serve a useful purpose to Page 3 of 3 demonstrate the level of response that can be expected for each chemical class for each lot of Proprietary Test Method assays? Can the Panel suggest criteria for choice of appropriate benchmark controls?

sapquestions10/ 02/ 03. wpd


[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45487-45489]
[FR Doc No: 2019-18710]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-1002-001.

    Applicants: Crossroads Pipeline Company.
    Description: Compliance filing NAESB 3.1 Compliance to be effective
8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5078.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1015-001.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Compliance filing NAESB 3.1 Compliance to be effective
8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5077.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1071-001.
    Applicants: Portland General Electric Company.
    Description: Compliance filing NAESB V3.1 Standards Compliance
Refile to be effective 8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5153.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1081-001.
    Applicants: Bluewater Gas Storage, LLC.
    Description: Compliance filing Order No. 587-Y Compliance Filing to
be effective 8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5037.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1090-002.
    Applicants: American Midstream (AlaTenn), LLC.
    Description: Compliance filing Compliance to 724 to be effective 8/
1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5012.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1091-003.
    Applicants: American Midstream (Midla), LLC.
    Description: Compliance filing Compliance to 10008 to be effective
8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5013.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1092-002.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Compliance filing Compliance to 113026 to be effective
8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5014.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1093-002.
    Applicants: High Point Gas Transmission, LLC.
    Description: Compliance filing Compliance to 110521 to be effective
8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5189.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1094-002.
    Applicants: Trans-Union Interstate Pipeline, L.P.
    Description: Compliance filing Compliance to 713 to be effective 8/
1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5018.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-1477-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Cleanup to Remove NC Agreement
K870271 to be effective 9/16/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5002.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-898-001.
    Applicants: Greylock Pipeline, LLC.
    Description: Compliance filing Compliance to 207 to be effective 8/
1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5015.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-908-001.
    Applicants: High Island Offshore System, L.L.C.
    Description: Compliance filing Order No. 587-Y Compliance Filing
Part 2 to be effective 8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5020.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-927-001.
    Applicants: Bison Pipeline LLC.
    Description: Compliance filing NAESB 3.1 Compliance Filing to be
effective 8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5070.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-932-001.
    Applicants: Northern Border Pipeline Company.
    Description: Compliance filing NAESB 3.1 Compliance to be effective
8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5074.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP19-941-001.
    Applicants: Gas Transmission Northwest LLC.
    Description: Compliance filing Compliance to Docket No. RP19-941-
000 to be effective 8/1/2019.
    Filed Date: 8/16/19.
    Accession Number: 20190816-5071.
    Comments Due: 5 p.m. ET 8/28/19.

    Docket Numbers: RP15-1158-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Report Filing: FTS-A Activity Report in compliance.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5045.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-1041-001.
    Applicants: B-R Pipeline Company.
    Description: Compliance filing Order No. 587-Y Second Compliance
Filing to be effective 8/1/2019.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5047.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-1042-001.
    Applicants: USG Pipeline Company, LLC.
    Description: Compliance filing Order No. 587-Y Second Complaince
Filing to be effective 8/1/2019.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5046.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-1044-002.
    Applicants: Cheniere Corpus Christi Pipeline, LP.
    Description: Compliance filing NAESB 3.1 Compliance--Extension of
Time to be effective 8/1/2019.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5001.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-1045-002.
    Applicants: Cheniere Creole Trail Pipeline, L.P.
    Description: Compliance filing NAESB 3.1--Extension of Time to be
effective 8/1/2019.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5000.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-1213-001.
    Applicants: Total Peaking Services, L.L.C.
    Description: Compliance filing TPS Order No. 587-Y Compliance
Filing Changes Update to be effective 8/1/2019.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5042.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-1478-000.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Stingray Gas Quality Filing to
be effective 9/18/2019.
    Filed Date: 8/19/19.
    Accession Number: 20190819-5027.
    Comments Due: 5 p.m. ET 9/3/19.

    Docket Numbers: RP19-926-002.
    Applicants: Rendezvous Pipeline Company, LLC.
    Description: Compliance filing Revised NAESB Compliance Filing--
Order No. 587-Y to be effective 8/1/2019.
    Filed Date: 8/19/19.

    Accession Number: 20190819-5120.
    Comments Due: 5 p.m. ET 9/3/19.

    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 20, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-18710 Filed 8-28-19; 8:45 am]
 BILLING CODE 6717-01-P