Armstrong Pharmaceuticals Inc.’s response to EPA’s January 7, 2009 letter

This information is classified as Confidential Business Information (CBI).

CBI is located at EPA headquarters 1310 L St NW.

 PAGE

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[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Rules and Regulations]
[Page 49121]
[FR Doc No: 2013-19506]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0103]

Safety Zone; Luna Pier Fireworks, Luna Pier, MI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the Luna Pier
Fireworks Show, Luna Pier, MI, from 9:25 p.m. until 10:25 p.m. on
August 24, 2013. Enforcement of this zone is necessary to ensure the
safety of life on the navigable waters of the United States immediately
prior to, during, and immediately after the associated marine event.
During the aforementioned period, the Coast Guard will enforce
restrictions upon, and control movement of, vessels on those waters of
Lake Erie within a 300-yard radius of the fireworks launch site at the
Clyde E. Evens Municipal Pier, located at position 41[deg]48'32'' N,
83[deg]26'23'' W (NAD 83) immediately prior to, during, and immediately
after the fireworks event.

DATES: The regulation in 33 CFR 165.941(a)(16) will be enforced from
9:25 p.m. until 10:25 p.m. on August 24, 2013.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email MST1 Ian Fallon, Response Department, Marine Safety Unit
Toledo, 420 Madison Ave., Suite 700, Toledo, OH 43604; telephone (419)
418-6036, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
listed in 33 CFR 165.941(a)(16) Luna Pier Fireworks Show, Luna Pier, MI
from 9:25 p.m. to 10:35 p.m. on August 24, 2013.
    Under the provisions of 33 CFR 165.23, entry into, transiting, or
anchoring within this safety zone during the enforcement period is
prohibited unless authorized by the Captain of the Port Detroit or his
designated representative. Vessels that wish to transit through the
safety zone may request permission from the Captain of the Port Detroit
or his designated representative. Requests must be made in advance and
approved by the Captain of Port before transits will be authorized.
Approvals will be granted on a case by case basis. The Captain of the
Port may be contacted via U.S. Coast Guard Sector Detroit on channel
16, VHF-FM. The Coast Guard will give notice to the public via Local
Notice to Mariners and VHF radio broadcasts that the regulation is
being enforced.
    This notice is issued under authority of 33 CFR 165.941(a)(16) and
5 U.S.C. 552(a). If the Captain of the Port determines that the safety
zone need not be enforced for the full duration stated in this notice,
he or she may suspend such enforcement and notify the public of the
suspension via a Broadcast Notice to Mariners.

    Dated: July 29, 2013.
J. E. Ogden,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2013-19506 Filed 8-12-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Proposed Rules]
[Pages 52371-52377]
[FR Doc No: 2016-18533]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]

Refuse To Accept Procedures for Premarket Tobacco Product
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
rule describing when FDA would refuse to accept a tobacco product
submission (or application) because the application has not met a
minimum threshold for acceptability for FDA review. Under the proposed
rule, FDA would refuse to accept a tobacco product submission, for
example, that is not in English, does not pertain to a tobacco product,
or does not identify the

type of submission. By refusing to accept submissions that have the
deficiencies identified in the proposed rule, FDA would be able to
focus our review resources on submissions that meet a threshold of
acceptability and encourage quality submissions. If we receive any
significant adverse comments that warrant terminating the direct final
rule, we will consider such comments on the proposed rule in developing
the final rule.

DATES: Submit either electronic or written comments on the proposed
rule by October 24, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-1555 for ``Refuse to Accept Procedures for Premarket Tobacco
Product Submissions.'' Received comments 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 a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on 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: Annette Marthaler or Paul Hart, Office
of Regulations, Center for Tobacco Products (CTP), Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing this refuse to accept rule as a companion to the
direct final rule issued elsewhere in this issue of the Federal
Register. The proposed rule would identify deficiencies that would
result in FDA's refusal to accept certain tobacco product submissions
under sections 905, 910, and 911 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (21 U.S.C.
387e, 387j, and 387k).\1\ Because these submissions would be refused
before they enter FDA's review queue, more resources would be available
for submissions that are ready for further review. This proposed rule
would establish a refuse to accept process for premarket tobacco
product submissions, including premarket tobacco product applications
(PMTAs), modified risk tobacco product applications (MRTPAs),
substantial equivalence (SE) applications (also called SE reports), and
exemption requests (including subsequent abbreviated reports).
---------------------------------------------------------------------------

    \1\ FDA has published a final rule extending the Agency's
``tobacco product'' authorities in the FD&C Act to all categories of
products that meet the statutory definition of ``tobacco product''
in the FD&C Act, except accessories of such newly deemed tobacco
products (Final Rule Deeming Tobacco Products To Be Subject to the
Federal Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Restrictions on the Sale
and Distribution of Tobacco Products and Required Warning Statements
for Tobacco Products (81 FR 28974, May 10, 2016)). This proposed
rule would apply to all tobacco products FDA regulates under Chapter
IX of the FD&C Act.
---------------------------------------------------------------------------

B. Summary of the Major Provisions of the Regulatory Action

    The proposed rule explains when FDA would refuse to accept a
premarket submission, including PMTAs, MRTPAs, SE applications, and
exemption requests (including subsequent abbreviated reports). The
proposal is based on FDA's experience in reviewing these submissions.
Under the proposed rule, FDA would refuse to accept a premarket
submission that: (1) Does not pertain to a tobacco product; (2) is not
in English (or does not include a complete translation); (3) is
submitted in an electronic format that FDA cannot process, read,
review, or archive; (4) does not include the applicant's contact
information; (5) is from a foreign applicant and does not include the
name and contact information of an authorized U.S. agent (authorized to
act on behalf of the applicant for the submission); (6) does not
include a

required form(s); (7) does not identify the tobacco product; (8) does
not identify the type of submission; (9) does not include the signature
of a responsible official authorized to represent the applicant; or
(10) does not include an environmental assessment or claim of a
categorical exclusion, if applicable. Under the proposed rule, if FDA
refuses to accept the submission, FDA would send the contact (if
available) a notification. If the submission is accepted for further
review, FDA would send an acknowledgement letter.

II. Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule with the
same codified language published in the final rules section of this
issue of the Federal Register. This companion proposed rule provides
the procedural framework to finalize the rule in the event that the
direct final rule receives any adverse comment and is withdrawn. The
comment period for this companion proposed rule runs concurrently with
the comment period for the direct final rule. We are publishing the
direct final rule because the rule is noncontroversial, and we do not
anticipate that it will receive any significant adverse comments.
    An adverse comment is defined as a comment that explains why the
rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice and comment process. Comments that
are frivolous, insubstantial, or outside the scope of the rule will not
be considered significant or adverse under this procedure. A comment
recommending a rule change in addition to the rule would not be
considered a significant adverse comment unless the comment provides a
reasonable explanation for why the rule would be ineffective without
additional change. In addition, if a significant adverse comment
applies to an amendment, paragraph, or section of this rule, and that
provision can be severed from the remainder of the rule, we may adopt
as final those provisions of the rule that are not subjects of
significant adverse comment.
    If no significant adverse comment is received in response to the
direct final rule, no further action will be taken related to this
proposed rule. Instead, we will publish a confirmation document, before
the effective date of the direct final rule, confirming that the direct
final rule will go into effect on December 21, 2016. In the Federal
Register of November 21, 1997 (62 FR 62466), you can find additional
information about direct rulemaking procedures in the guidance document
entitled ``Guidance for FDA and Industry: Direct Final Rule
Procedures.'' This guidance may be accessed at http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.

III. Purpose and Legal Authority

A. Purpose

    FDA is proposing this refuse to accept rule as a means of
efficiently handling submissions that do not meet a threshold of
acceptability for FDA review, e.g., the submission lacks certain
information FDA needs for substantive review of the submission.
Currently, FDA often expends extensive time and resources in attempts
to obtain information and resolve the deficiencies identified in the
proposed rule simply to begin substantively processing the submission.
FDA expects that this proposed rule would enhance the quality of the
submissions and that submissions would move expeditiously through the
review process. In addition, this rule would help submitters better
understand the common hurdles FDA encounters in conducting a
substantive review of submissions.
    The proposed rule identifies deficiencies that FDA has seen across
types of premarket submissions and would result in FDA refusing to
accept the submission. This proposed rule applies to all tobacco
product applications; we note that there are additional deficiencies
that are not covered in this rule that may arise for specific types of
premarket submissions that would also result in FDA's refusal to accept
that specific type of premarket submission (e.g., a PMTA fails to
contain specimens of the labeling proposed to be used for such tobacco
product under section 910(b)(1)(F) of the FD&C Act).
    FDA's refusal to accept a tobacco product submission would not
preclude an applicant from resubmitting a new submission that addresses
the deficiencies. In addition, acceptance of a submission would not
mean that FDA has determined that the submission is complete, but
rather only that the submission has met the basic, minimum threshold
for acceptance. Substantive review of the submission would begin once
FDA accepts the submission, and for submissions with filing
requirements (i.e., PMTAs and MRPTAs), once filed. This proposed rule
would establish a general process for refusing to accept submissions
for premarket tobacco review, including PMTAs, MRTPAs, SE applications,
and exemption requests (including subsequent abbreviated reports).
Because administratively incomplete submissions would be refused before
FDA begins substantive review, we would be able to use our resources on
submissions that are more complete and better prepared for further
review. In addition, FDA intends to determine, as soon as practicable,
whether the submission will be accepted. We expect the amount of time
it takes FDA to make this determination to be relatively quick,
however, it may vary depending on the volume of submissions received at
any one time. FDA remains committed to an efficient product review
process and intends to establish and implement performance goals for
this action once it has experience with the volume of submissions it
will receive after the deeming rule becomes effective. FDA expects the
performance goals to be generally similar to other Agency performance
goals, i.e. a certain percentage of RTA determinations made within a
defined period of time, and with the percentage rising over time.

B. Legal Authority

    Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) provides FDA with
the authority to issue regulations for the efficient enforcement of the
FD&C Act. This proposed rule would allow FDA to more efficiently use
our resources to review premarket submissions under sections 905, 910,
and 911 of the FD&C Act. FDA has processed and reviewed many
submissions since the enactment of the Tobacco Control Act, and
submissions with the deficiencies identified in the proposed rule have
been repeatedly identified by FDA as reflecting submissions that are
incomplete and not prepared for further review.

IV. Description of Proposed Regulation

    We are proposing to add part 1105 (21 CFR part 1105) to title 21,
specifically Sec.  1105.10. Proposed Sec.  1105.10(a) would provide
that FDA would refuse to accept, as soon as practicable, PMTAs, MRTPAs,
SE applications, and exemption requests (including subsequent
abbreviated reports) for the reasons listed in paragraphs (a)(1)
through (a)(10), if applicable.
     Proposed Sec.  1105.10(a)(1) states that FDA would refuse
to accept a submission that does not pertain to a tobacco product. This
provision would

address a submission that refers to a product that does not meet the
definition of a ``tobacco product'' under section 201(rr) of the FD&C
Act (21 U.S.C. 321(rr)) and, therefore, would not be subject to FDA's
tobacco product authorities.
     Proposed Sec.  1105.10(a)(2) states that FDA would refuse
to accept a submission that is not in the English language or does not
contain complete English translations of any information included with
the submission. FDA is unable to read and process such submissions.
     Proposed Sec.  1105.10(a)(3) provides that FDA would
refuse to accept a submission if it is provided in an electronic format
that FDA cannot process, read, review, and archive. As with submissions
that are not in English (or fail to include an English translation),
FDA is unable to read and process such a submission. FDA provides
information on the electronic formats that it can read, process,
review, and archive at http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/manufacturing/default.htm.
     Proposed Sec.  1105.10(a)(4) provides that FDA would
refuse to accept any submission that does not contain contact
information, including the applicant's name and address. If a
submission omits the contact information, FDA would not be able to
contact the applicant regarding the submission, e.g., with questions or
followup related to the submission. In this instance, FDA also would
likely be unable to provide notice of the Agency's refusal to accept
the submission under Sec.  1105.10(c).
     Proposed Sec.  1105.10(a)(5) provides that FDA would
refuse to accept a submission from a foreign applicant if it does not
list an authorized U.S. agent for the submission, including the agent's
U.S. address. FDA is proposing to require identification of a U.S.
agent for two reasons: First, a U.S. agent is important to help CTP
ensure adequate notice is provided to applicants for official Agency
communications. FDA may be unable to confirm that adequate notice of
Agency action or correspondence concerning premarket submissions is
provided to foreign applicants as FDA cannot necessarily confirm
receipt of correspondence sent internationally. Accordingly, the
designation of a U.S. agent provides an official contact to the Agency
who can receive the information or documentation on behalf of the
applicant. Providing notice regarding that application to the U.S.
agent would constitute notice to the foreign applicant. Second, FDA
requires identification of a U.S. agent to assist FDA in communication
with the foreign applicant and help the Agency to efficiently process
applications and avoid delays. In many instances during the application
review process, FDA has reached out numerous times to foreign
applicants and has either been unable to speak with the applicant or
unable to directly communicate questions and/or concerns. This
impediment, which occurs more for foreign applicants than domestic
applicants, has resulted in delays or terminations in the review of
specific applications and a slowdown of the premarket application
process as a whole. A U.S. agent would act as a communications link
between FDA and the applicant and would facilitate timely
correspondence between FDA and foreign applicants, including responding
to questions concerning pending applications and, if needed, assisting
FDA in scheduling meetings with the foreign applicants to resolve
outstanding issues before Agency action is taken. Additionally, the
identified U.S. agent would be authorized to act on behalf of the
foreign applicant for that specific application.
     Proposed Sec.  1105.10(a)(6) provides that FDA would
refuse to accept the submission if it does not include any required FDA
form(s). At the time of this proposed rule, FDA has not yet issued any
forms to accompany premarket submissions. In the event that FDA does
issue such a form(s), the Agency will give interested parties notice
and opportunity to comment on such forms in accordance with rulemaking
procedures and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).
     Proposed Sec.  1105.10(a)(7) provides that FDA would
refuse to accept a submission that does not contain the following
product-identifying information (for the product that is the subject of
the submission and, if applicable, for the predicate): The manufacturer
of the tobacco product; the product name, including brand and subbrand;
product category (e.g., cigarette) and subcategory (e.g., combusted,
filtered); package type (e.g., box) and package quantity (e.g., 20 per
box); and characterizing flavor (i.e., applicants must state the
characterizing flavor, such as menthol, or state that there is no
characterizing flavor present in the tobacco product). For example, in
table 1, FDA has supplied a list of recommended categories and
subcategories of some tobacco products to assist applicants in
providing product-identifying information in their submissions. Note
that there may be other information FDA needs to identify a particular
product, e.g., descriptors (such as ``premium'') that are separate from
the product name. If this is the case, such information should be
provided by the applicant in the initial submission to facilitate FDA's
efficient review.

                             Table 1--Tobacco Products Categories and Subcategories
----------------------------------------------------------------------------------------------------------------
           Tobacco product category                               Tobacco product subcategory
----------------------------------------------------------------------------------------------------------------
Cigarettes...................................  Combusted, Filtered.
                                               Combusted, Non-Filtered.
                                               Combusted, Other.
                                               Non-Combusted.
Roll-Your-Own Tobacco Products...............  Roll-Your-Own Tobacco Filler.
                                               Rolling Paper.
                                               Filtered Cigarette Tube.
                                               Non-Filtered Cigarette Tube.
                                               Filter.
                                               Paper Tip.
                                               Roll-Your-Own Co-Package.
                                               Other.
Smokeless Tobacco Products...................  Loose Moist Snuff.
                                               Portioned Moist Snuff.

                                               Loose Snus.
                                               Portioned Snus.
                                               Loose Dry Snuff.
                                               Dissolvable.
                                               Loose Chewing Tobacco.
                                               Portioned Chewing Tobacco.
                                               Smokeless Co-Package.
                                               Other.
ENDS (Electronic Nicotine Delivery System)...  Open E-Liquid.
                                               Closed E-Liquid.
                                               Closed E-Cigarette.
                                               Open E-Cigarette.
                                               ENDS Component.
                                               ENDS Co-Package.
                                               ENDS Other.
Cigars.......................................  Filtered, Sheet-Wrapped Cigar.
                                               Unfiltered, Sheet-Wrapped Cigar.
                                               Leaf-Wrapped Cigar.
                                               Cigar Component.
                                               Cigar Tobacco Filler.
                                               Cigar Co-Package.
                                               Other.
Pipe Tobacco Products........................  Pipe.
                                               Pipe Tobacco Filler.
                                               Pipe Component.
                                               Pipe Co-Package.
                                               Other.
----------------------------------------------------------------------------------------------------------------

    This product-specific information helps ensure that the product is
within CTP's purview and enables FDA to appropriately identify the
specific product that is the subject of the submission. Specifically,
this information is necessary to both review the submission itself and
to issue an order that appropriately identifies the tobacco product
that is subject to the order. For example, an SE submission contains a
comparison between the predicate and new products. If FDA does not know
the exact products that are being compared, FDA would be unable to
sufficiently understand and evaluate the comparison to determine
whether the products are substantially equivalent. As another example,
if an applicant does not specify whether its proposed new product
contains a characterizing flavor, FDA would not be able to issue an
order as it will not know the specific product for which the applicant
is seeking an order (e.g., product X menthol or product X cinnamon.)
     Proposed Sec.  1105.10(a)(8) provides that FDA would
refuse to accept a submission if the applicant fails to indicate the
type of submission (i.e., PMTA, MRTPA, SE application, or exemption
request or subsequent abbreviated report), because that information is
necessary to enable FDA to begin an appropriate review of the
submission.
     Proposed Sec.  1105.10(a)(9) provides that FDA would
refuse to accept a submission if it does not contain a signature of a
responsible official, authorized to represent the applicant who either
resides in or has a place of business in the United States. A signature
provides assurance to FDA that the submission is both intended by the
applicant and ready for review. Responsible officials also should be
aware that under 18 U.S.C. 1001, it is illegal to knowingly and
willingly submit false information to the U.S. Government.
     Proposed Sec.  1105.10(a)(10) would apply only to PMTAs,
MRTPAs, SE applications, and exemption requests (this subsection does
not apply to the subsequent abbreviated report). For these submissions,
this proposed paragraph provides that FDA would refuse to accept the
submission if it does not include an environmental assessment (EA) or a
valid claim of categorical exclusion prepared in accordance with 21 CFR
25.40. Under Sec.  25.15(a) (21 CFR 25.15), all submissions requesting
FDA action require the submission of either a claim of categorical
exclusion or an EA. Because an EA is required for an initial exemption
request, it is not also required for an abbreviated report, and thus
would not be a basis for FDA to refuse to accept an abbreviated report.
In addition, Sec.  25.15(a) provides that FDA may refuse to file a
submission if the included EA fails to address ``the relevant
environmental issues.'' Because the SE and SE Exemption pathways do not
include a filing stage, FDA intends to determine such adequacy at the
acceptance stage for those pathways.\2\ The EA or claim of categorical
exclusion must be made for the Agency action being proposed (e.g.,
issuance of an SE order for introduction of such new tobacco product
into interstate commerce for commercial distribution in the United
States.). For information on preparing an EA, refer to Sec.  25.40.
---------------------------------------------------------------------------

    \2\ The PMTA and MRTPA pathways, by contrast, have a filing
stage.
---------------------------------------------------------------------------

    Proposed Sec.  1105.10(b) provides that if FDA does not identify a
reason under paragraph (a) for refusing to accept a premarket review
submission, then the Agency may accept it for processing and further
review. If FDA does accept the submission, the Agency intends to send
the submitter an acknowledgement letter stating that FDA has accepted
the submission for processing and further review. This letter would
also include a premarket submission tracking number.
    Proposed Sec.  1105.10(c) provides that if FDA identifies a reason
under paragraph (a) for refusing to accept a premarket review
submission, we would notify the applicant in writing of the reason(s)
and that FDA has not accepted the submission for processing and further
review. However, FDA would not be able to provide this information when

the contact information has not been provided or is not legible. If FDA
would refuse to accept the submission for one or more of the reasons
stated in Sec.  1105.10, the submitter may revise the submission to
correct the deficiencies and resubmit it to FDA as a new submission.

V. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed 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.

VI. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

VII. Tribal Consultation

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have determined that
the rule does not contain policies that would have substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order;
consequently, a tribal summary impact statement is not required.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule would establish a procedure that
FDA would be responsible for implementing and would have the effect of
providing all entities useful feedback on the readiness of a
submission, we certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in expenditure in any year that meets or exceeds this
amount.
    This proposed rule identifies 10 significant and common
deficiencies in premarket tobacco submissions that will cause FDA to
refuse to accept them. Encouraging submissions that are free of the
deficiencies listed in this rule does not represent a change in Agency
expectations. One of the 10 deficiencies is required by statute (i.e.,
must be a tobacco product). One of the deficiencies is required by
another regulation (i.e., must comply with environmental
considerations). The remaining eight deficiencies are basic
expectations for an application to enter the review process. Therefore,
this proposed rule would clarify these expectations. This clarification
would result in cost savings for both the applicant and FDA as less
time is spent by FDA working with applicants to address these
significant deficiencies. Applicants would have clarity about basic
expectations of the requirements needed for acceptance of premarket
applications. In addition, refusing to accept submissions with these
deficiencies would allow Agency staff to more efficiently process
submissions and quickly move those submissions without these
deficiencies into review of substantial scientific issues.

List of Subjects in 21 CFR Part 1105

    Administrative practices and procedures, Tobacco, Tobacco products.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is proposed to be amended by adding part 1105.

PART 1105--GENERAL

Sec.
1105.10 Refusal to accept a premarket submission

    Authority:  21 U.S.C. 371(a), 387e, 387j, and 387k.

Subpart A--General Submission Requirements

Sec.  1105.10   Refusal to accept a premarket submission.

    (a) FDA will refuse to accept for review, as soon as practicable, a
premarket tobacco product application, modified risk tobacco product
application, substantial equivalence application, or exemption request
or subsequent abbreviated report for the following reasons, if
applicable:
    (1) The submission does not pertain to a tobacco product as defined
in 21 U.S.C. 321(rr).
    (2) The submission is not in English or does not contain complete
English translations of any information submitted within.
    (3) If submitted in an electronic format, the submission is in a
format that FDA cannot process, read, review, and archive.
    (4) The submission does not contain contact information, including
the applicant's name and address.
    (5) The submission is from a foreign applicant and does not
identify an authorized U.S. agent, including the agent's name and
address, for the submission.
    (6) The submission does not contain a required FDA form(s).
    (7) The submission does not contain the following product-
identifying information: The manufacturer of the tobacco product; the
product name, including the brand and subbrand; the product category
and subcategory; package type and package quantity; and characterizing
flavor.

    (8) The type of submission is not specified.
    (9) The submission does not contain a signature of a responsible
official, authorized to represent the applicant, who either resides in
or has a place of business in the United States.
    (10) For premarket tobacco applications, modified risk tobacco
product applications, substantial equivalence applications, and
exemption requests only: The submission does not include an
environmental assessment, or a valid claim of categorical exclusion in
accordance with part 25 of this chapter.
    (b) If FDA finds that none of the reasons in paragraph (a) of this
section exists for refusing to accept a premarket submission, FDA may
accept the submission for processing and further review. FDA will send
to the submitter an acknowledgement letter stating the submission has
been accepted for processing and further review and will provide the
premarket submission tracking number.
    (c) If FDA finds that any of the reasons in paragraph (a) of this
section exist for refusing to accept the submission, FDA will notify
the submitter in writing of the reason(s) and that the submission has
not been accepted, unless insufficient contact information was
provided.

    Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18533 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Notices]
[Page 46278-46279]
[DOCID:fr08se09-145]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60602; File No. SR-OCC-2009-14]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Proposed Rule Change To Clear Options Based on
Index-Linked Securities

September 1, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on August 12, 2009, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change described in Items I, II, and III below, which
items have been prepared primarily by OCC. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested parties.
---------------------------------------------------------------------------

    \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 proposed rule change seeks to permit OCC to clear options based
on index-linked securities (``Index-Linked Securities'').

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified the text of the summaries
prepared by OCC.
---------------------------------------------------------------------------

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

    Index-Linked Securities are non-convertible debt of a major
financial institution that typically have a term of at least one year
but not greater than thirty years and that provide for payment at
maturity based upon the performance of an index or indices of equity
securities or futures contracts, one or more physical commodities,

currencies or debt securities, or a combination of any of the
foregoing. Index-Linked Securities are traded on national securities
exchanges and meet the definition of ``NMS Stock'' under regulation
NMS.\4\ The options exchanges will treat options on Index-Linked
Securities (``Index-Linked Security Options'') as standardized equity
options for listing and trading purposes and will generally govern
their trading by the same rules that are applicable to trading in other
equity options. Exercises of Index-Linked Security Options will be
settled by delivery of the underlying securities in the same manner as
exercises of equity options.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 51808 (Jun. 9, 2005), 70
FR 37496 (Jun. 29, 2005). ``NMS Stock'' is defined in Rule
600(b)(47) of Regulation NMS as ``any NMS security other than an
option.'' The definition of ``NMS Security'' in Rule 600(b)(46) of
Regulation NMS includes any security for which transaction reports
are collected and disseminated under an effective national market
system plan. Because Index-Linked Securities are exchange traded,
they fall within this definition.
---------------------------------------------------------------------------

    OCC is proposing to amend its By-Laws and Rules to accommodate
Index-Linked Security Options. OCC is proposing to add a definition of
``index-linked security'' to Article I of its By-Laws, to amend the
definition of ``stock option contract'' in Article I of its By-Laws to
include Index-Linked Security Options, and to amend the definition of
``non-equity securities option contract'' in Article I of its By-Laws
to clarify that Index-Linked Security Options are excluded from the
definition. OCC also is proposing to amend Interpretation and Policy
.05 to Article VI, Section 11A of its By-Laws to clarify that call of
an entire class of Index-Linked Securities will result in an adjustment
of Index-Linked Security Options in the event of a cash merger, but
that a partial call will not result in an adjustment. OCC also is
proposing to add Interpretation and Policy .10 to Article VI, Section
11A of the By-Laws that would state that interest payments on Index-
Linked Securities generally will be considered ``ordinary cash
dividends or distributions'' within the meaning of paragraph (c)
Article VI, Section 11A. In addition, OCC is proposing to add language
to Rule 604(b)(4)(iii) stating that for the purposes of Rule 604,
Index-Linked Securities will be treated as stock, assuming they meet
the basic listing requirement applicable to stocks. Finally, OCC is
proposing to amend Rule 604(b)(4) to conform to its practice of
limiting the value of securities with the same CUSIP number, as opposed
to securities of the same issuer, to 10% of the margin requirement of
an account, and proposing to add Interpretation and Policy .14 to Rule
604(b)(4) stating that OCC may disapprove for margin credit a security
that otherwise meets the Rule 604(b) criteria if other factors warrant
such a disapproval.
    OCC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act \5\ and the rules and
regulations thereunder because the proposed change will promote the
prompt and accurate clearance and settlement of transaction in Index-
Linked Security Options by providing that such options will be cleared
and settled subject to the same rules and procedures that have been
used successfully by OCC to clear and settle stock options.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. OCC will notify the Commission of any written
comments received by OCC.

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

    Within thirty-five days of the date of publication of this notice
in the Federal Register or within such longer period: (i) As the
Commission may designate up to ninety days of such date if it finds
such longer period to be appropriate and publishes its reasons for so
finding or (ii) as to which the self-regulatory organization consents,
the Commission will:
    (A) By order approve such proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml) or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2009-14 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2009-14. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filings also will be available for
inspection and copying at the principal office of OCC and on OCC's Web
site at http://www.optionsclearing.com/publications/rules/proposed_
changes/sr_occ_09_14.pdf. 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-OCC-2009-14 and should be submitted on or before
September 23, 2009.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-21638 Filed 9-4-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 179 (Thursday, September 15, 2016)]
[Proposed Rules]
[Pages 63433-63435]
[FR Doc No: 2016-22101]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9075; Directorate Identifier 2016-NM-082-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 787-8 and 787-9 airplanes. This
proposed AD was prompted by a report indicating that a portion of the
sealant above the engine pylon between the wing skin and the vapor
barrier may have been omitted. This proposed AD would require an
inspection for missing sealant in the seam on the outside and inside of
the engine struts, and corrective actions if necessary. We are
proposing this AD to detect and correct missing sealant above the
engine pylon between the wing skin and the vapor barrier, which can
create an unintended leak path for fuel, potentially draining onto the
aft fairing heat shield above the engine and onto hot engine parts or
brakes, which could lead to a major ground fire.

DATES: We must receive comments on this proposed AD by October 31,
2016.

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 NPRM, 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 view this 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>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-9075.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9075; 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: Sherry Vevea, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6514; 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-2016-9075; Directorate
Identifier 2016-NM-082-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 have received a report indicating that a portion of the sealant
above the engine pylon between the wing skin and the vapor barrier may
have been omitted due to a manufacturing sequencing issue. This
condition, if not corrected, can create an unintended leak path for
fuel, potentially draining onto the aft fairing heat shield above the
engine and onto hot engine parts or brakes, which could lead to a major
ground fire.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin B787-81205-SB570029-00,
Issue 001, dated February 23, 2016. The service information describes
procedures for doing an inspection for missing sealant in the seam on
the outside and inside of the engine struts, and installing missing
sealant. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

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 the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously. For information on the
procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9075.
    The phrase ``corrective actions'' is used in this proposed AD.
Corrective actions correct or address any condition found. Corrective
actions in an AD could include, for example, repairs.

Costs of Compliance

    We estimate that this proposed AD affects 32 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............................  3 work-hours x $85 per                $0            $255          $8,160
                                         hour = $255.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs 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
repairs:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Repair.....................................  Up to 3 work-hours x $85 per hour =           (\1\)           (\1\)
                                              $255.
----------------------------------------------------------------------------------------------------------------
\1\ We have received no definitive data that would enable us to provide cost estimates for the on-condition
  material costs specified in this proposed AD.

    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 available 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 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-2016-9075; Directorate Identifier
2016-NM-082-AD.

(a) Comments Due Date

    We must receive comments by October 31, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 787-8 and 787-9
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin B787-81205-SB570029-00, Issue 001, dated
February 23, 2016.

(d) Subject

    Air Transport Association (ATA) of America Code 57; Wings.

(e) Unsafe Condition

    This AD was prompted by a report indicating that a portion of
the sealant above the engine pylon between the wing skin and the
vapor barrier may have been omitted. We are issuing this AD to
detect and correct missing sealant above the engine pylon between
the wing skin and the vapor barrier, which can create an unintended
leak path for fuel, potentially draining onto the aft fairing heat
shield and onto hot engine parts or brakes, which could lead to a
major ground fire.

(f) Compliance

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

(g) Inspection and Corrective Actions

    Within 60 months after the effective date of this AD: Do a
general visual inspection for missing sealant in the seam on the
outside and inside of the engine struts; and do all applicable
corrective actions; in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin B787-81205-SB570029-
00, Issue 001, dated February 23, 2016. Do all applicable corrective
actions before further flight.

(h) 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 paragraph (i)(1) 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, modification, or alteration 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. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(h)(4)(i) and (h)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or sub-step is labeled ``RC Exempt,'' then
the RC requirement is removed from that step or sub-step. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(i) Related Information

    (1) For more information about this AD, contact Sherry Vevea,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office (ACO), 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 view this 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 September 6, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-22101 Filed 9-14-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18227-18228]
[FR Doc No: 2020-06709]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ- OAR-2019-0333; FRL-10007-19-OAR]

Alternative Methods for Calculating Off-Cycle Credits Under the
Light-Duty Vehicle Greenhouse Gas Emissions Program: Applications From
Toyota Motor North America

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is requesting
comment on applications from Toyota Motor North America (``Toyota'')
for off-cycle carbon dioxide (CO2) credits under EPA's
light-duty vehicle greenhouse gas emissions standards. ``Off-cycle''
emission reductions can be achieved by employing technologies that
result in real-world benefits, but where that benefit is not adequately
captured on the test procedures used by manufacturers to demonstrate
compliance with emission standards. EPA's light-duty vehicle greenhouse
gas program acknowledges these benefits by giving automobile
manufacturers several options for generating ``off-cycle''
CO2 credits. Under the regulations, a manufacturer may apply
for CO2 credits for off-cycle technologies that result in
off-cycle benefits. In these cases, a manufacturer must provide EPA
with a proposed methodology for determining the real-world off-cycle
benefit. Toyota has submitted applications that describe methodologies
for determining off-cycle credits from technologies described in their
applications. Pursuant to applicable regulations, EPA is making these
off-cycle credit calculation methodologies available for public
comment.

DATES: Comments must be received on or before May 1, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2019-0333, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Linc Wehrly, Director, Light Duty
Vehicle Center, Compliance Division, Office of Transportation and Air
Quality, U.S. Environmental Protection Agency, 2000 Traverwood Drive,
Ann Arbor, MI 48105. Telephone:<PHONE_NUMBER>. Fax:<PHONE_NUMBER>.
Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    EPA's light-duty vehicle greenhouse gas (GHG) program provides
three pathways by which a manufacturer may accrue off-cycle carbon
dioxide (CO2) credits for those technologies that achieve
CO2 reductions in the real world but where those reductions
are not adequately captured on the test used to determine compliance
with the CO2 standards, and which are not otherwise
reflected in the standards' stringency. The first pathway is a
predetermined list of credit values for specific off-cycle technologies
that may be used beginning in model year 2014.\1\ This pathway allows
manufacturers to use conservative credit values established by EPA for
a wide range of technologies, with minimal data submittal or testing
requirements, if the technologies meet EPA regulatory definitions. In
cases where the off-cycle technology is not on the menu but additional
laboratory testing can demonstrate emission benefits, a second pathway
allows manufacturers to use a broader array of emission tests (known as
``5-cycle'' testing because the methodology uses five different testing
procedures) to demonstrate and justify off-cycle CO2
credits.\2\ The additional emission tests allow emission benefits to be
demonstrated over some elements of real-world driving not adequately
captured by the GHG compliance tests, including high speeds, hard
accelerations, and cold temperatures. These first two methodologies
were completely defined through notice and comment rulemaking and
therefore no additional process is necessary for manufacturers to use
these methods. The third and last pathway allows manufacturers to seek
EPA approval to use an alternative methodology for determining the off-
cycle CO2 credits.\3\ This option is only available if the
benefit of the technology cannot be adequately demonstrated using the
5-cycle methodology. Manufacturers may also use this option to
demonstrate reductions that exceed those available via use of the
predetermined list.
---------------------------------------------------------------------------

    \1\ See 40 CFR 86.1869-12(b).
    \2\ See 40 CFR 86.1869-12(c).
    \3\ See 40 CFR 86.1869-12(d).
---------------------------------------------------------------------------

    Under the regulations, a manufacturer seeking to demonstrate off-
cycle credits with an alternative methodology (i.e., under the third
pathway described above) must describe a methodology that meets the
following criteria:
     Use modeling, on-road testing, on-road data collection, or
other approved analytical or engineering methods;
     Be robust, verifiable, and capable of demonstrating the
real-world emissions benefit with strong statistical significance;
     Result in a demonstration of baseline and controlled
emissions over a wide range of driving conditions and number of
vehicles such that issues of data uncertainty are minimized;
     Result in data on a model type basis unless the
manufacturer demonstrates that another basis is appropriate and
adequate.
    Further, the regulations specify the following requirements
regarding an application for off-cycle CO2 credits:
     A manufacturer requesting off-cycle credits must develop a
methodology for demonstrating and determining the benefit of the off-
cycle technology and

carry out any necessary testing and analysis required to support that
methodology.
     A manufacturer requesting off-cycle credits must conduct
testing and/or prepare engineering analyses that demonstrate the in-use
durability of the technology for the full useful life of the vehicle.
     The application must contain a detailed description of the
off-cycle technology and how it functions to reduce CO2
emissions under conditions not represented on the compliance tests.
     The application must contain a list of the vehicle
model(s) which will be equipped with the technology.
     The application must contain a detailed description of the
test vehicles selected and an engineering analysis that supports the
selection of those vehicles for testing.
     The application must contain all testing and/or simulation
data required under the regulations, plus any other data the
manufacturer has considered in the analysis.
    Finally, the alternative methodology must be approved by EPA prior
to the manufacturer using it to generate credits. As part of the review
process defined by regulation, the alternative methodology submitted to
EPA for consideration must be made available for public comment.\4\ EPA
will consider public comments as part of its final decision to approve
or deny the request for off-cycle credits.
---------------------------------------------------------------------------

    \4\ See 40 CFR 86.1869-12(d)(2).
---------------------------------------------------------------------------

II. Off-Cycle Credit Applications

A. Denso Electric Scroll Air Conditioning Compressor

    Toyota is applying for off-cycle GHG credits for the use of the
Denso Electric Scroll Air Conditioning Compressor Variation B (ESB)
with pressure adjusting valve technology. This technology improves the
efficiency of the electric scroll compressor using a pressure adjusting
valve to optimize back pressure on the fixed scroll and reduce
mechanical losses. This is similar to the off cycle alternative method
technology for the belt driven Denso SES/SAS compressor, for which
credits were granted to Toyota in June 2018.\5\ The requested credit
amount was confirmed by Toyota through bench testing, following the
method in the Society of Automotive Engineers (SAE) procedure J2765, to
confirm air conditioning system power reduction of the technology
resulting from the reduced mechanical losses in the compressor. The SAE
J2766 standard (using the GREEN MAC Life Cycle Climate Performance
Model) was used to calculate the normalized grams CO2 per
mile improvement of the technology for the U.S. market. The
CO2 grams per mile improvement was derived from the bench
test results.
---------------------------------------------------------------------------

    \5\ ``EPA Decision Document: Off-cycle Credits for General
Motors and Toyota Motor Corporation.'' Compliance Division, Office
of Transportation and Air Quality, U.S. Environmental Protection
Agency. EPA-420-R-18-014, June 2018.
---------------------------------------------------------------------------

    Toyota is applying for a credit of 1.9 grams/mile for 2016 and
later model years for vehicles sold in the U.S. and equipped with the
Denso ESB air conditioning compressor. EPA considers this compressor
technology to be a technology that, if approved, will be subject to the
maximum limits for an A/C system of 5.0 g/mi for passenger automobiles
and 7.2 g/mi for light trucks specified in the regulations.\6\ Details
of the testing and analysis can be found in the manufacturer's
applications.
---------------------------------------------------------------------------

    \6\ See 40 CFR 86.1868-12 (b).
---------------------------------------------------------------------------

B. Dual Layer HVAC Technology

    Toyota is applying for off-cycle GHG credits for the use of a dual
layer (or 2-layer) HVAC technology. Ventilation and heat transfer
losses between the cabin and outside ambient are the key HVAC thermal
losses during warmup. Ventilation losses can be reduced by
recirculating the cabin air, but this has the adverse effect of
building up cabin humidity, which can then become a safety hazard due
to increased windshield fogging. Dual layer HVAC uses two separate
``layers'' of airflow within the vehicle and a two[hyphen]stage fan
that can recirculate air through the lower outlets while flowing fresh,
low humidity air through the upper ducts (includes the windshield
defroster). The module has a door that selects full fresh, full
recirculate, or dual layer mode based on logic parameters. Low humidity
air is needed to better defog the windshield and recirculated air
improves warm up performance. With the use of recirculated air less
engine heat is needed to warm the cabin, and both the cabin and the
engine warm up faster. Faster engine warmup improves vehicle
efficiency.
    Toyota is applying for a credit of 0.6 grams/mile for 2016 and
later model years for vehicles sold in the U.S. and equipped with the
dual layer HVAC technology. Details of the testing and analysis can be
found in the manufacturer's applications.

III. EPA Decision Process

    EPA has reviewed the applications for completeness and is now
making the applications available for public review and comment as
required by the regulations. The off-cycle credit applications
submitted by the manufacturers (with confidential business information
redacted) have been placed in the public docket (see ADDRESSES section
above) and on EPA's website at https://www.epa.gov/vehicle-and-engine-certification/compliance-information-light-duty-greenhouse-gas-ghg-standards.
    EPA is providing a 30-day comment period on the applications for
off-cycle credits described in this document, as specified by the
regulations. The manufacturers may submit a written rebuttal of
comments for EPA's consideration, or may revise an application in
response to comments. After reviewing any public comments and any
rebuttal of comments submitted by manufacturers, EPA will make a final
decision regarding the credit requests. EPA will make its decision
available to the public by placing a decision document (or multiple
decision documents) in the docket and on EPA's website at the same
manufacturer-specific pages shown above. While the broad methodologies
used by these manufacturers could potentially be used for other
vehicles and by other manufacturers, the vehicle specific data needed
to demonstrate the off-cycle emissions reductions would likely be
different. In such cases, a new application would be required,
including an opportunity for public comment.

    Dated: March 25, 2020.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2020-06709 Filed 3-31-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 4, 2007 (Volume 72, Number 86)]
[Notices]
[Page 25299-25300]
[DOCID:fr04my07-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12769-000]

Ice House Partners, Inc.; Notice of Application Accepted for
Filing and Soliciting Motions To Intervene and Protests

April 27, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption from Licensing.
    b. Project No.: 12769-000.
    c. Date filed: January 22, 2007.
    d. Applicant: Ice House Partners, Inc.
    e. Name of Project: Ice House Power Project.
    f. Location: On the Nashua River, in the Town of Ayer, Middlesex
County, Massachusetts. The project would use Federal land.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. sections 2705 and 2708.
    h. Applicant Contact: Liisa Dowd, Ice House Partners, Inc., 323
West Main Street, Ayer, MA 01432,<PHONE_NUMBER>.
    i. FERC Contact: Tom Dean,<PHONE_NUMBER>.
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Motions to intervene and protests may be filed electronically via
the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the

``eFiling'' link.
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. Description of Project: The Ice House Power Project would
consist of the following existing facilities: (1) The 300-foot-long,
10-foot-high Ice House Dam consisting of a 210-foot-long spillway
topped with flashboards; (2) a 137-acre reservoir with a normal full
pond elevation of 215 feet National Geodetic Vertical Datum; (3) a 50-
foot-wide, 600-foot-long power canal; (4) a restored powerhouse
containing two generating units with a total installed capacity of 270
kilowatts; and (5) appurtenant facilities. The project would have an
average annual generation of 2,500 megawatt-hours.
    m. A copy of the filing is available for review at the Commission
in the Public Reference Room or may be viewed on the Commission's Web
site at http://www.ferc.gov using the ``eLibrary'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must: (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4)

otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. Agencies may obtain copies of the application directly from
the applicant. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified in the
particular application.
    o. Procedural schedule: The application will be processed according
to the following revised hydro licensing schedule.
    Notice of application is ready for environmental analysis September
2007.
    Notice of the availability of the EA February 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-8521 Filed 5-3-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39307-39308]
[FR Doc No: 2016-14204]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78032; File No. SR-BatsBZX-2016-23]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Extend
the Penny Pilot Program

June 10, 2016.
    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 June 3, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal for the BZX Options Market (``BZX
Options'' f/k/a ``BATS Options'') to extend through December 31, 2016,
the Penny Pilot Program (``Penny Pilot'') in options classes in certain
issues (``Pilot Program'') previously approved by the Commission.\5\
---------------------------------------------------------------------------

    \5\ The rules of BZX Options, including rules applicable to BZX
Options' participation in the Penny Pilot, were approved on January
26, 2010. See Securities Exchange Act Release No. 61419 (January 26,
2010), 75 FR 5157 (February 1, 2010) (SR-BATS-2009-031). BZX Options
commenced operations on February 26, 2010. The Penny Pilot was most
recently extended for BZX Options through June 30, 2016. See
Securities Exchange Act Release No. 75388 (June 30, 2015), 80 FR
38793 (July 7, 2015) (SR-BATS-2015-50).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com/, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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 Exchange 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 Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The purpose of this filing is to extend the Penny Pilot, which was
previously approved by the Commission, through December 31, 2016, and
to provide revised dates for adding replacement issues to the Pilot
Program. The Exchange proposes that any Pilot Program issues that have
been delisted may be replaced on the second trading day following July
1, 2016. The replacement issues will be selected based on trading
activity for the most recent six month period excluding the month
immediately preceding the replacement (i.e., beginning December 1,
2015, and ending May 31, 2016).
    The Exchange represents that the Exchange has the necessary system
capacity to continue to support operation of the Penny Pilot. The
Exchange believes the benefits to public customers and other market
participants who will be able to express their true prices to buy and
sell options have been demonstrated to outweigh the increase in quote
traffic.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\6\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act,\7\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system. The Exchange believes that the Pilot
Program promotes just and equitable principles of trade by enabling
public customers and other market participants to express their true
prices to buy and sell options. Accordingly, the Exchange believes that
the proposal is consistent with the Act because it will allow the
Exchange to extend the Pilot Program prior to its expiration on June
30, 2016. The Exchange notes that this proposal does not propose any
new policies or provisions that are unique or unproven, but instead
relates to the continuation of an existing program that operates on a
pilot basis.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. In this regard, the Exchange
notes that the rule change is being proposed in order to continue the
Pilot Program, which is a competitive response to analogous programs
offered by other options exchanges. The Exchange believes this proposed
rule change is necessary to permit fair competition among the options
exchanges.

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 written comments from members or other interested parties.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\11\
However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because doing so will
allow the Pilot Program to continue without interruption in a manner
that is consistent with the Commission's prior approval of the
extension and expansion of the Pilot Program and will allow the
Exchange and the Commission additional time to analyze the impact of
the Pilot Program.\13\ Accordingly, the Commission designates the
proposed rule change as operative upon filing with the Commission.\14\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this pre-filing requirement.
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ See Securities Exchange Act Release No. 61061 (November 24,
2009), 74 FR 62857 (December 1, 2009) (SR-NYSEArca-2009-44). See
also supra note 5.
    \14\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \15\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

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

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-BatsBZX-2016-23 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-BatsBZX-2016-23. 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-BatsBZX-2016-23 and should
be submitted on or before July 7, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-14204 Filed 6-15-16; 8:45 am]
 BILLING CODE 8011-01-P