[Federal Register Volume 81, Number 54 (Monday, March 21, 2016)]
[Proposed Rules]
[Pages 15000-15002]
[FR Doc No: 2016-06294]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0138]
RIN 1625-AA00

Safety Zone; Cocos Lagoon, Merizo, GU

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a safety zone for Coco's
Crossing swim event in the waters of Coco's Lagoon, Guam. This event is
scheduled to take place from 6 a.m. to 1 p.m. on May 29, 2015. This
safety zone is necessary to protect all persons and vessels
participating in this marine event from potential safety hazards
associated with vessel traffic in the area. Race participants, chase
boats and organizers of the event will be exempt from the safety zone.
Entry of persons or vessels into this safety zone is prohibited unless
authorized by the Captain of the Port (COTP). We invite your comments
on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 20, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0138 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Chief Kristina Gauthier, U.S. Coast
Guard Sector Guam at<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On February 16, 2016, the Coast Guard was notified of the intent of
the Manukai Athletic Club and The Manhoben Swim Club to hold the Coco's
Crossing swimming race on May 29, 2016 from 6 a.m. to 1 p.m. in Merizo.
The race will be from the Merizo pier to Coco's Island and back. This
safety zone is necessary to protect all persons and vessels
participating in this marine event from potential safety hazards
associated with vessel traffic in the area. The Captain of the Port
Guam has determined that potential hazards associated with vessels in
the area would be a safety concern for participants; therefore, a 100-
yard radius is established around all participants.
    The purpose of this rulemaking is to ensure the safety of race
participants in the navigable waters within a 100-yard radius before,
during, and after the scheduled event. The Coast Guard proposes this
rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 6 a.m. to 1 p.m.
on May 29, 2016. The safety zone would cover all navigable waters
within a 100-yard radius of race participants in Merizo and Coco's
Lagoon. The duration of the zone is intended to ensure the safety of
participants before, during, and after the scheduled 6 a.m. to 1 p.m.
race. No vessel or person would be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. Race participants, chase boats and organizers of the
event are exempt from the safety zone. The regulatory text we are
proposing appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
would be able to safely transit around this safety zone which would
impact a small designated area of the Merizo and Coco's Lagoon for 7
hours in the morning when vessel traffic in the area is low and mainly
constitutes excursions to Coco's Island. Moreover, the Coast Guard
would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the zone, and the rule would allow vessels to seek permission to
enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121),

we want to assist small entities in understanding this proposed rule.
If the rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact the person listed
in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will
not retaliate against small entities that question or complain about
this proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting less than 7 hours that would prohibit entry within 200
yards of race participants. Normally such actions are categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of
Commandant Instruction M16475.lD. A preliminary environmental analysis
checklist and Categorical Exclusion Determination are available in the
docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record-
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--SAFETY ZONE; COCOS LAGOON, MERIZO, GU

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T14-0138 to read as follows:

165. T14-0138  Safety Zone; Cocos Lagoon, Merizo, Guam.

    (a) Location. The following area, within the Guam Captain of the
Port (COTP) Zone (See 33 CFR 3.70-15), all navigable waters within a
100-yard radius of race participants in Merizo and Coco's Lagoon. Race
participants, chase boats and organizers of the event will be exempt
from the safety zone.
    (b) Effective Dates. This rule is effective from 6 a.m. through 1
p.m. on May 29, 2016 through 1 p.m.
    (c) Enforcement. Any Coast Guard commissioned, warrant, or petty
officer, and any other COTP representative permitted by law, may
enforce this temporary safety zone.
    (d) Waiver. The COPT may waive any of the requirements of this rule
for any person, vessel or class of vessel upon finding that application
of the safety zone is unnecessary or impractical for the purpose of
maritime security,
    (g) Penalties. Vessels or persons violating this rule are subject
to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: March 2, 2016.
James B. Pruett,
Captain, U.S. Coast Guard, Captain of the Port Guam.
[FR Doc. 2016-06294 Filed 3-18-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44881-44883]
[FR Doc No: 2016-16361]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1309]

Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.'' To qualify for exemptions under section
503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug
product must be compounded by a licensed pharmacist or physician who
does not compound regularly or in inordinate amounts any drug products
that are essentially copies of a commercially available drug product.
This guidance sets forth FDA policies regarding this provision of
section 503A, including the terms ``commercially available,''
``essentially a copy of a commercially available drug,'' and
``regularly or in inordinate amounts.''

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work to finalize the guidance, submit
either electronic or written comments on this draft guidance by October
11, 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-D-1309 for ``Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic Act.'' 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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.'' Section 503A (21 U.S.C. 353a), added to
the FD&C Act by the Food and Drug Administration Modernization Act in
1997, describes the conditions that must be satisfied for human drug
products compounded by a licensed pharmacist in a State-licensed
pharmacy or Federal facility, or by a licensed physician, to be exempt
from the following three sections of the FD&C Act:
     Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice requirements);
     section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate directions for use); and
     section 505 (21 U.S.C. 355) (concerning the approval of
drugs under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)).
    One of the conditions that must be met for a compounded drug
product to qualify for the exemptions under section 503A of the FD&C
Act is that it must be compounded by a licensed pharmacist or a
licensed physician that does not compound regularly or in inordinate
amounts (as defined by the Secretary) any drug products that are
essentially copies of a commercially available drug product (see
section 503A(b)(1)(D)).
    The statute further states that the term ``essentially a copy of a
commercially available drug product'' does not include a drug product
in which there is a change, made for an identified individual patient,
which produces for that patient a significant difference, as determined
by the prescribing practitioner, between the compounded drug and the
comparable commercially available drug (see section 503A(b)(2)).
    This draft guidance sets forth the FDA's proposed policies
regarding this provision of section 503A, including the terms
``commercially available,'' ``essentially a copy of a commercially
available drug,'' and ``regularly or in inordinate amounts.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the compounded
drug products that are essentially copies of a commercially available
drug product under section 503A of the FD&C Act. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Under the draft guidance, pursuant to section 503A(b)(2) of the
FD&C Act, a compounded drug product is not essentially a copy of a
commercially available drug product if a change is made for an
identified individual patient, and the prescribing practitioner has
determined that the change will produce a significant difference for
that patient. If a compounder intends to rely on such a determination
to establish that a compounded drug is not essentially a copy of a
commercially available drug product, the compounder should ensure that
the determination is documented on a prescription.
    If a prescription does not make clear that the prescriber made the
determination required by section 503A(b)(2), or a compounded drug is
substituted for the commercially available product at the pharmacy, the
compounder may contact the prescriber and if the prescriber confirms
it, make a notation on the prescription that the compounded product
contains a change that makes a significant difference for the patient.
The notations should be as specific as those described in this
document, and the date of the conversation with the prescriber should
be included on the prescription.
    We estimate that annually a total of approximately 3,444
compounders (``number of respondents'' in table 1, line 1) will consult
a prescriber to determine whether he or she has made a determination
that the compounded drug has a change that produces a significant
difference for a patient as compared to the comparable commercially
available drug, and that the compounders will document this
determination on approximately

172,200 prescription orders for compounded drugs (``total annual
disclosures'' in table 1, line 1). We estimate that the consultation
between the compounder and the prescriber and adding a notation to each
prescription that does not already document this determination will
take approximately 3 minutes per prescription order.
    In addition, if the drug was compounded because the approved
product was not commercially available because it was on the FDA drug
shortage list, the prescription or a notation on the prescription
should note that it was on the drug shortage list and the date the list
was checked. We estimate that a total of approximately 6,888
compounders (``number of respondents'' in table 1, line 2) will
document this information on approximately 344,400 prescription orders
for compounded drugs (``total annual disclosures'' in table 1, line 2).
We estimate that checking FDA's drug shortage list and documenting this
information will take approximately 2 minutes per prescription order.
    Compounders under section 503A should maintain records of the
frequency in which they have compounded drug products that are
essentially copies of commercially available drug products and the
number of prescriptions that they have filled for compounded drug
products that are essentially copies of commercially available drug
products to document that such compounding has not been done
``regularly'' or in ``inordinate amounts.'' We estimate that a total of
approximately 3,444 compounders (``number of recordkeepers'' in table
1) will keep approximately 165,312 records (``total annual records'').
We estimate that maintaining the records will take approximately 2
minutes per record.
    A licensed pharmacist or physician seeking to compound a drug
product under section 503A should also maintain records of
prescriptions for identified individual patients including notations
that a prescriber has determined that the compounded drug has a change
that produces a significant difference for the identified patient.
Because the time, effort, and financial resources necessary to comply
with this collection of information would be incurred by licensed
pharmacists and licensed physicians in the normal course of their
activities, it is excluded from the definition of ``burden'' under 5
CFR 1320.3(b)(2). FDA understands that maintaining records of
prescriptions for compounded drug products is part of the usual course
of the practice of compounding and selling drugs and is required by
States' pharmacy laws and other state laws governing recordkeeping by
health care professionals and health care facilities.
    FDA estimates the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
      Type of reporting          Number of      disclosures    Total annual   Average burden per    Total hours
                                respondents   per respondent    disclosures       disclosure
----------------------------------------------------------------------------------------------------------------
Consultation between the               6,888              50         344,400  3 minutes.........          17,220
 compounder and prescriber
 and the notation on the
 prescription documenting
 the prescriber's
 determination of
 significant difference.
Checking FDA's drug shortage           6,888              50         344,400  2 minutes.........          11,480
 list and documenting on the
 prescription that the drug
 is in shortage.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
    Type of recordkeeping        Number of      records per    Total annual   Average burden per    Total hours
                               recordkeepers   recordkeeper       records        recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of frequency and               3,444              48         165,312  2 minutes.........           5,510
 number of prescriptions
 filled for compounded drugs
 that are essentially a copy.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16361 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 2, 2006 (Volume 71, Number 41)]
[Notices]
[Page 10736-10738]
[DOCID:fr02mr06-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53359; File No. SR-NYSE-2006-09]

Self-Regulatory Organizations; New York Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Automatic Conversion of CAP-DI Orders

February 24, 2006.
    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 February 21, 2006, the New York Stock Exchange, Inc. (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. NYSE
filed the proposed rule change as effecting a change in an existing
order-entry or trading system pursuant to section 19(b)(3)(A) of the
Act \3\ and Rule 19b-4(f)(5) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \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)(5).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE is proposing to amend Exchange Rule 123A.30(a)(iv)(P), which
was part of the pilot (``Pilot'') \5\ which put into operation Phase 1
of the NYSE HYBRID MARKET SM (``Hybrid Market'') initiative,
as proposed in SR-NYSE-2004-05 \6\ and amendments thereto (``Hybrid
Market filings'') and certain system changes discussed in SR-NYSE-2005-
57.\7\ The text of the proposed rule change is available on the
Exchange's Web site (http://www.nyse.com), at the principal office of

the Exchange, and at the Commission's Public Reference Room.
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    \5\ See Securities Exchange Act Release No. 52954 (December 14,
2005), 70 FR 75519 (December 20, 2005).
    \6\ See Securities Exchange Act Release Nos. 50173 (August 10,
2004), 69 FR 50407 (August 16, 2004); 50667 (November 15, 2004) 69
FR 67980 (November 22, 2004); and 51906 (June 22, 2005), 70 FR 37463
(June 29, 2005) See also Amendment No. 6, filed on September 16,
2005, and Amendment No. 7, filed on October 11, 2005.
    \7\ See Securities Exchange Act Release No. 52362 (August 30,
2005), 70 FR 53701 (September 9, 2005). While submitted as effective
upon filing, the Exchange intended to implement these changes upon
approval of the Hybrid Market filings by the Commission, if such
approval is granted.
---------------------------------------------------------------------------

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 aspects of such
statements.

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

I. Purpose
    The Exchange proposed a Pilot to put into operation Phase 1 of the
Hybrid Market initiative with respect to a group of securities, known
as Phase 1 \8\ Pilot securities (``Pilot securities''). Following
Commission approval, the Pilot commenced during the week of December
12, 2005 and will terminate the earlier of: (1) March 14, 2006, or (2)
Commission approval of the Exchange's Hybrid Market proposal, if
granted.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 51906 (June 22,
2005), 70 FR 37463 (June 29, 2005).
---------------------------------------------------------------------------

    Commencing with the Pilot; the Exchange systemically ensures that
the specialist's participation when trading along with CAP-DI orders is
in accordance with the parity requirements of Exchange Rule 123A.30.
The system assigns the proper number of shares to the specialist and
CAP-DI orders. The Exchange filed SR-NYSE-2005-57 \9\ for immediate
effectiveness pursuant to section 19(b)(3)(A) of the Act \10\ and Rule
19b-4(f)(5) thereunder \11\ to effect this change.
---------------------------------------------------------------------------

    \9\ See supra note 7.
    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(5).
---------------------------------------------------------------------------

    Automatic Conversions of CAP-DI Orders. Current Exchange Rule
123A.30 provides that specialists have the ability, subject to certain
restrictions noted in the rule, to convert CAP-DI orders to participate
in transactions or to bid or offer, without an electing trade.
    Exchange Rule 123A.30(a)(P) \12\ provides in part that the elected
or converted portion of a ``percentage order that is convertible on a
destabilizing tick and designated immediate execution cancel election''
(``CAP-DI order'') may be automatically executed. An elected or
converted CAP-DI order on the same side of the market as an
automatically executed electing order may participate in a transaction
at the bid (offer) price if there is volume associated with the bid
(offer) remaining after the electing order is filled in its entirety.
An elected or converted CAP-DI order on the contra-side of the market
as an automatically executed electing order may participate in a
transaction at the bid (offer) price if there is volume remaining in
the electing order.
---------------------------------------------------------------------------

    \12\ This rule is parallel to amendments made to Rule 123A.30.
See Securities Exchange Act Release No. 51906 (June 22, 2005), 70 FR
37463 (June 29, 2005).
---------------------------------------------------------------------------

    In addition, the Exchange added new section (iv)(P) to proposed
Exchange Rule 123A.30(a)(P) to provide that when a specialist is
bidding or offering and an automatic execution occurs with such bid/
offer, marketable CAP-DI orders on the Display Book[reg] on the same
side as the specialist's interest will be automatically converted to
participate in this execution, with the system assigning the proper
number of shares to the specialist and auto-converted CAP-DI orders, as
discussed above. This will allow CAP-DI orders to better participate in
executions.
    However, in certain instances, an automatic conversion of
marketable CAP-DI orders will not occur even though the specialist is
trading for its own account. This will occur where the execution that
included automatically converted CAP-DI orders elects a contra-side
stop or stop limit order. In this situation, pursuant to current
Exchange Rule 123A.40, the specialist, as party to the election of the
stop order, owes such elected stop order an execution at the same price
as the specialist traded. The execution of such stop orders, in which
the specialist is the contra-party, may be manual \13\ or
automatic,\14\ depending upon whether

any specialist interest remains at the execution price. In either
situation, marketable CAP-DI interest at that price will not be
automatically converted to participate along with the specialist in the
execution of such elected stop order. The specialist is, however,
alerted to the fact that there are CAP-DI orders on the Display
Book[reg] capable of trading so that is can take appropriate action and
manually trade such CAP-DI interest.
---------------------------------------------------------------------------

    \13\ If there is no specialist interest remaining in the bid/
offer, and the specialist must guarantee an execution to the stop
order at the electing price pursuant to Exchange Rule 123A.40, the
specialist must do a manual transaction to guarantee that the stop
order receives the same price as the specialist.
    \14\ If there is specialist interest remaining in the bid/offer
and the specialist must guarantee an execution to the stop order at
the electing price pursuant to Exchange Rule 123A.40, the Display
Book system will automatically execute the remaining specialist
interest against the elected stop order at the same price the
specialist traded.
---------------------------------------------------------------------------

    Modification to the Pilot. The Exchange is proposing to modify
Exchange Rule 123A.30(a)(iv)(P) to clarify that when a specialist is
bidding, offering, or trading and an automatic execution occurs with
the specialist's proprietary interest, which elects contra-side stop or
stop limit orders, marketable CAP-DI orders on the Display Book[supreg]
on the same side as the specialist will be automatically converted to
participate in the execution of such contra-side stop or stop limit
orders with the system assigning the proper number of shares to the
specialist and CAP-DI orders. In other words, in all circumstances
where the specialist is trading for its own account and the specialist,
as party to the election of a stop order, owes an elected stop order an
execution at the same price as the specialist traded pursuant to
current Exchange Rule 123A.40, an automatic conversion of marketable
CAP-DI orders will occur. This modification, however, will not effect
the proper allocation of shares to CAP-DI orders.
     The Exchange believes that this modification is beneficial for the
market in that it reduces the chances for error by removing the
responsibility from the specialist to manually ensure the CAP-DI
interest trading is allocated correctly. This will allow CAP-DI orders
to better participate in executions. This modification is part of a
package of software corrections to the Pilot which the Exchange would
like to implement as quickly as possible. This modification will expire
upon the termination of the Pilot.
2. Statutory Basis
     The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\15\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\16\ in particular, in that it
is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system and, in general, to protect investors and the public interest.
The exchange believes that the proposed rule change is also designed to
support the principles of section 11A(a)(1) of the act \17\ in that it
seeks to assure economically efficient execution of securities
transactions, make it practicable for brokers to execute investors'
orders in the best market and provide an opportunity for investors'
orders to be executed without the participation of a dealer.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
    \17\ 15 U.S.C. 78K-1(a)(1).
---------------------------------------------------------------------------

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

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

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.\18\
---------------------------------------------------------------------------

    \18\ See telephone conversation between Jeffrey Rosenstrock,
Principal Rule Counsel, Market Surveillance, NYSE, and Kelly Riley,
Assistant Director, Division of Market Regulation, Commission, dated
February 23, 2006.
---------------------------------------------------------------------------

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

    Because the proposed rule change effects a change in an existing
order-entry or trading system of a self-regulatory organization that
does not:
    (i) significantly affect the protection of investors or the public
interest;
    (ii) impose any significant burden on competition; or
    (iii) have the effect of limiting access to or availability of the
system, it has become effective pursuant to section 19(b)(3)(A) of the
Act \19\ and paragraph (f)(5) of Rule 19b-4 thereunder.\20\ The
Exchange believes that this modification to the Pilot would allow the
Pilot to continue in effect and reduce the chance of error by the
specialist by allowing the system to automatically convert CAP-DI
orders and execute with the proper allocation.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 20 CFR 240.19b-4(f)(5).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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-NYSE-2006-09 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSE-2006-09. 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 Commissiona and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
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-NYSE-2006-09 and should be submitted on or before March
23, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. 06-1962 Filed 3-1-06; 8:45 am]

BILLING CODE 8010-01-M


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on September 20, 2006

   NOTICE OF ACTION TAKEN -- DOCKET OST-2004-19419

________________________________________________________________________
_________________________________

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

Application of ALASKA AIRLINES, INC. (ALASKA) filed 8/28/06 for:

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

Scheduled foreign air transportation of persons, property, and mail
between Los Angeles, California and Loreto, Mexico.

Applicant rep: Marshall S. Sinick<PHONE_NUMBER>     DOT Analyst: Thuy
H. Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: September 20, 2006, through
September 20, 2008.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX Holder’s certificates of public convenience and necessity

   	XX Standard exemption conditions (attached)

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.

________________________________________________________________________
_____________

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

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

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

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

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

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

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

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

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

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

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

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

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

										  05/2004


[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Rules and Regulations]
[Pages 30939-30941]
[FR Doc No: 2015-13029]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2014-0683, FRL-9928-39-Region 2]

Approval and Promulgation of Implementation Plans; New York;
Infrastructure SIP for the 2008 Lead NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving certain
elements of New York's State Implementation Plan (SIP) revision
submitted to demonstrate that the State meets the requirements of the
Clean Air Act (CAA) for the 2008 National Ambient Air Quality Standard
(NAAQS) for lead (Pb). The CAA requires that each state adopt and
submit a SIP for the implementation, maintenance and enforcement of
each NAAQS promulgated by the EPA and is commonly referred to as an
infrastructure SIP.

DATES: This rule is effective on July 1, 2015.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R02-OAR-2014-0683. All documents in the docket are listed on
the www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through
www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 2 Office, Air Programs Branch, 290 Broadway, 25th Floor,
New York, New York 10007-1866. The Air Programs Branch dockets are
available from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The Air Programs Branch telephone number is 212-637-
4249.

FOR FURTHER INFORMATION CONTACT: Kirk J. Wieber, Air Programs Branch,
Environmental Protection Agency, Region 2, 290 Broadway, 25th Floor,
New York, New York 10007-1866,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What is the background information?
II. What comments did EPA receive in response to its proposal?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is the background information?

    On November 12, 2008, EPA promulgated a new, rolling 3 month
average NAAQS for Pb, herein referred to as the 2008 Pb NAAQS. See 73
FR 66964.\1\ The 2008 Pb NAAQS is 0.15 micrograms per cubic meter of
air ([mu]g/m\3\) maximum (not-to-be-exceeded). In the same action EPA
revised the secondary Pb NAAQS to be identical in all respects to the
revised primary standard, i.e., 0.15 [mu]g/m\3\.
---------------------------------------------------------------------------

    \1\ Final rule signed October 15, 2008. The 1978 lead standard
(1.5 [mu]g/m\3\ as a quarterly average) remains in effect until one
year after an area is designated for the 2008 standard, except that
in areas designated nonattainment for the 1978 lead standard, the
1978 standard remains in effect until implementation plans to attain
or maintain the 2008 standard are approved.
---------------------------------------------------------------------------

    Section 110(a)(1) provides the procedural and timing requirements
for State Implementation Plans (SIPs). Section 110(a)(2) lists specific
elements that states must meet for SIP requirements related to a newly
established or revised NAAQS. Sections 110(a)(1) and (2) of the CAA
require, in part, that states submit to EPA plans to implement,
maintain and enforce each of the NAAQS promulgated by EPA. By statute,
SIPs meeting the requirements of section 110(a)(1) and (2) are to be
submitted by states within three years after promulgation of a new or
revised standard. These SIPs are commonly called infrastructure SIPs.
Based on the October 15, 2008 date of signature for the 2008 Pb NAAQS,
infrastructure SIPs for the 2008 Pb NAAQS were due on October 15, 2011.
    EPA is acting on New York's SIP submittal dated October 13, 2011,
as supplemented on February 24, 2012, which addresses the section 110
infrastructure requirements for the 2008 Pb NAAQS. Two elements
identified in section 110(a)(2) are not governed by the three year
submission deadline of section 110(a)(1) because SIPs incorporating
necessary local nonattainment area controls are not due within three
years after promulgation of a new or revised NAAQS, but rather due at
the time that the nonattainment area plan requirements are due pursuant
to CAA section 191. (See also CAA section 172 for general nonattainment
plan requirements). These requirements are: (1) Submissions required by
section 110(a)(2)(C) to the extent that subsection refers to a permit
program as required in part D Title I of the CAA, and (2) submissions
required by section 110(a)(2)(I) which pertain to the nonattainment
planning requirements of part D, Title I of the CAA.
    As a result, this action does not address the nonattainment area
plan requirements related to section 110(a)(2)(C) or 110(a)(2)(I).

II. What comments did EPA receive in response to its proposal?

    On December 15, 2014 (79 FR 74046), EPA proposed to approve New
York's SIP submittal addressing the section 110 infrastructure
requirements for the 2008 Pb NAAQS. EPA received one adverse comment on
the December 15, 2014 proposal. A synopsis of the adverse comment, as
well as EPA's response is discussed below.
    Comment: EPA must disapprove element C with regard to Prevention of
Significant Deterioration (PSD) unless New York has the
PM2.5 increments approved into its PSD SIP. As you may know,
EPA's position is the issue of PM2.5 increments is relevant
even if this is a lead infrastructure SIP.
    Response: Element C requires that each infrastructure SIP contain a
permitting program ``as required by part C.'' CAA title I part C is
applicable to all pollutants subject to regulation under the CAA. See,
e.g., CAA section 165(a)(4). After further review EPA agrees that
Element C is not restricted to only those provisions of CAA title I
part C that pertain to the particular new or revised NAAQS addressed by
the particular infrastructure SIP action. Because the scope of CAA
title I part C is comprehensive (covering all pollutants subject to
regulation under the CAA, including GHG), the EPA likewise reads the
unrestricted reference to CAA title I part C in Element C to mean that
this provision has the same scope as CAA title I part C itself. Thus, a
fully approved comprehensive PSD program addressing all regulated
pollutants is needed in order to approve the infrastructure SIP for any
one pollutant.
    NYSDEC has adopted and submitted to EPA for approval into its SIP,
a PSD program that includes PM2.5 increments. However, the
PM2.5 increments have not yet been approved by EPA. EPA will
defer taking final action approving New York's infrastructure SIP
submission with respect to the PSD program requirements in sections
110(a)(2)(C), (D)(i)(II) prong 3, and (J) until EPA has approved, or
simultaneously approves New York's adopted PSD program.

III. What action is EPA taking?

    EPA is approving New York's submittal as fully meeting the
infrastructure requirements for the 2008

primary Pb NAAQS for all section 110(a)(2) elements and sub-elements,
as follows: (A), (B), (D)(i)(I) prongs 1 and 2, D(i)(II) prong 4, (E),
(F), (G), (H), (K), (L), and (M). EPA is not finalizing action on
110(a)(2) elements and sub-elements, as follows: (C), (D)(i)(II) prong
3, and (J). EPA is not acting on New York's submittal as it relates to
nonattainment provisions, the NSR program required by part D in section
110(a)(2)(C) and the measures for attainment required by section
110(a)(2)(I), as part of the infrastructure SIPs because the State's
infrastructure SIP submittal does not include nonattainment
requirements and EPA will act on them when, if necessary, they are
submitted.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 31, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Particulate matter,
Reporting and recordkeeping requirements.

    Dated: May 8, 2015.
Judith A. Enck,
Regional Administrator, Region 2.

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

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATON PLANS

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

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

Subpart HH--New York

0
2. In Sec.  52.1670(e), the table titled ``EPA-Approved New York
Nonregulatory and Quasi-Regulatory Provisions'' is amended by adding
the entry ``Section 110(a)(2) Infrastructure Requirements for the 2008
Primary Pb NAAQS'' at the end of table, to read as follows:

Sec.  52.1670  Identification of plan.

* * * * *
    (e) * * *

                       EPA-APPROVED NEW YORK NONREGULATORY AND QUASI-REGULATORY PROVISIONS
----------------------------------------------------------------------------------------------------------------
                                     Applicable
                                   geographic or         New York
       Action/SIP element          nonattainment      submittal date   EPA approval date        Explanation
                                        area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2)                Statewide........  10/13/11, and      6/1/15,..........  This action addresses
 Infrastructure Requirements                         supplemented on   [Insert FR          the following CAA
 for the 2008 Primary Pb NAAQS.                      2/24/12.           citation].         elements:
                                                                                110(a)(2)(A), (B),
                                                                                (D)(i)(I) prongs 1
                                                                                and 2, D(i)(II) prong
                                                                                4, (E), (F), (G),
                                                                                (H), (K), (L), and
                                                                                (M).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-13029 Filed 5-29-15; 8:45 am]
 BILLING CODE 6560-50-P


44259101 Brill, F.; Bramble, F.; Norwood, G.; et al. (1997) Enforcement Analytical Method for the Determination of Hexazinone and Metabolites of Interest in Animal Tissues and Milk Using ESI LC/ MS: Lab Project Number: AMR 3783 96. Unpublished study prepared by E. I. du Pont de Nemours and Co. 100 p.

44259102 Xu, B. (1997) Independent Laboratory Validation of a Proposed Enforcement Analytical Method for the Determination of Hexazinone and Metabolites of Interest in Animal Tissue and Milk Using ESI LC/ MS: Lab Project Number: AMR 4366 97: 008 07. Unpublished study prepared by Centre Analytical Laboratories, Inc. 117 p. 55 45084101 Brill, F. (2000) Magnitude of Residues of Hexazinone in Rotational Crops Following Application of Velpar Herbicide at Maximum Label Rates to Alfalfa: Lab Project Number: AMR 4336 97. Unpublished study prepared by E. I. du Pont de Nemours and Co. 253 p.


[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]
[Page 78776]
[DOCID:fr23de08-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-56-007; Docket No. EL07-58-007]

Allegheny Electric Cooperative, Inc., et al. v. PJM
Interconnection, L.L.C.; Organization of PJM States, et al. v. PJM
Interconnection, L.L.C.; Notice of Filing

December 16, 2008.
    Take notice that on September 4, 2008, Public Utilities Commission
of Ohio filed a State Certification in which they make certain
representations and warranties regarding its legal obligations,
pursuant to section 18.17.4 of the Operating Agreement of the PJM
Interconnection, L.L.C.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 30, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-30397 Filed 12-22-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Page 17052]
[FR Doc No: 2012-6926]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0038; FRL-9339-2]

Environmental Protection Agency, Department of Health and Human
Services and Department of Agriculture; Memorandum of Understanding
Regarding Genetically Engineered Plants; Clarification and Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; clarification and correction.

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SUMMARY: EPA issued a notice in the Federal Register of February 1,
2012, concerning a Memorandum of Understanding between the
Environmental Protection Agency, Department of Health and Human
Services and the Department of Agriculture regarding genetically
engineered plants. This document is being issued to clarify and correct
the notice announcing the Memorandum of Understanding.

FOR FURTHER INFORMATION CONTACT: Mario Steadman, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    The Agency included in the notice a list of those who may be
potentially affected by this action. If you have questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0038. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What does this correction do?

    In the SUMMARY of the notice published on February 1, 2012, (77 FR
5012) (FRL-9328-7), announcing the Memorandum of Understanding, it was
stated that the Department of Health and Human Services' Centers for
Disease Control and Prevention and the Food and Drug Administration
would perform work for EPA's Office of Pesticide Programs. However,
under the Memorandum of Understanding neither the Centers for Disease
Control and Prevention nor the Food and Drug Administration will
perform any work for OPP; therefore EPA is correcting the SUMMARY to
the notice announcing the Memorandum of Understanding.
    FR Doc. 2012-2198, published in the Federal Register of February 1,
2012, at page 5012 is corrected as follows:
    On page 5012, in the third column, in EPA document ``EPA-HQ-OPP-
2011-0038,'' the SUMMARY for the Memorandum of Understanding is
corrected to read: SUMMARY: This notice announces that pesticide-
related information submitted to EPA's Office of Pesticide Programs
(OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA),
including information that may have been claimed as Confidential
Business Information (CBI) by submitters in accordance with 40 CFR
2.309(c) and 2.308(h)(2) will be shared with the Department of Health
and Human Services (HHS) and the U.S. Department of Agriculture (USDA).
The Memorandum of Understanding (MOU) will support and encourage
cooperation and communication between USDA, HHS' Food and Drug
Administration and Centers for Disease Control and Prevention, and EPA
in the regulatory oversight over genetically engineered plants and the
foods derived from such plants. Under the MOU, USDA's Office of Animal
and Plant Health Inspection Service/Biotechnology Regulatory Services
(APHIS/BRS) and EPA agree to share with each other information about
genetically engineered plants and the foods derived from such plants,
including non-public information exempt from public disclosure usually
referred to as ``confidential business information'' and/or ``trade
secrets.''

List of Subjects

    Environmental protection, Confidential business information,
Interagency agreements, Memorandum of Understanding, Pesticides and
pests.

    Dated: March 8, 2012.
Michael Hardy,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.
[FR Doc. 2012-6926 Filed 3-21-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 13, 2008 (Volume 73, Number 93)]
[Notices]
[Page 27534]
[DOCID:fr13my08-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2479-010]

Pacific Gas and Electric Company; Errata Notice

May 6, 2008.
    On March 25, 2008, the Commission issued a ``Notice of Intent to
File License Application, Filing of Pre-Application Document,
Commencement of Licensing Proceeding, Scoping, Solicitation of Comments
on the PAD and Scoping Document, and Identification of Issues and
Associated Study Requests'' in the above-referenced proceeding.
Paragraph (o) of the notice stated an incorrect due date and should
read as follows:
    o. With this notice, we are soliciting comments on the PAD and
Scoping Document 1 (SD1), as well as study requests. All comments on
the PAD and SD1, and study requests should be sent to the address above
in paragraph (h). In addition, all comments on the PAD and SD1, study
requests, requests for cooperating agency status, and all
communications to and from Commission staff related to the merits of
the potential application (an original and eight copies) must be filed
with the Commission at the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. All filings with the Commission must include on
the first page, the project name (French Meadows Transmission Line
Project) and number (P-2479-010), and bear the heading ``Comments on
Pre-Application Document,'' ``Study Requests,'' ``Comments on Scoping
Document 1,'' ``Request for Cooperating Agency Status,'' or
``Communications to and from Commission Staff.'' Any individual or
entity interested in submitting study requests, commenting on the PAD
or SD1, and any agency requesting cooperating status must do so by May
27, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-10615 Filed 5-12-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Pages 62792-62793]
[FR Doc No: 2016-21827]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0032]

Commercial Driver's License Standards: Application for Exemption;
Daimler Trucks North America (Daimler)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition; grant of application for
exemption.

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SUMMARY: FMCSA announces its decision to grant an exemption to Daimler
Trucks North America (Daimler) for one of its commercial motor vehicle
(CMV) drivers. Daimler requested an exemption from the Federal
requirement to hold a U.S. commercial driver's license (CDL) for Mr.
Henning Oeltjenbruns, a general manager of the Daimler Truck Plant in
Cleveland, NC. Mr. Oeltjenbruns wants to test drive Daimler vehicles on
U.S. roads to better understand product requirements in ``real world''
environments, and verify results. Daimler believes the requirements for
a German commercial license ensure that operation under the exemption
will likely achieve a level of safety equivalent to or greater than the
level that would be obtained in the absence of the exemption.

DATES: This exemption is effective September 12, 2016 through September
12, 2018.

ADDRESSES:
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information concerning this
notice, please contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier
Operations Division; Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>
If you have questions on viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, ``FMCSA-2012-0032'' in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the Internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from the Federal Motor Carrier Safety Regulations. FMCSA
must publish a notice of each exemption request in the Federal Register
(49 CFR 381.315(a)). The Agency must provide the public an opportunity
to inspect the information relevant to the application, including any
safety analyses that have been conducted. The Agency must also provide
an opportunity for public comment on the request.
    The Agency reviews the safety analyses and the public comments, and
determines whether granting the exemption would likely achieve a level
of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reason for the grant or denial, and, if granted,
the specific person or class of persons receiving the exemption, and
the regulatory provision or provisions from which exemption is granted.
The notice must also specify the effective period of the exemption (up
to 5 years), and explain its terms and conditions. The exemption may be
renewed (49 CFR 381.300(b)).
    Section 5206(a)(3) of the ``Fixing America's Surface Transportation
Act,'' (FAST Act) [Pub. L. 114-94, 129 Stat.

1312, 1537, Dec. 4, 2015], amended 49 U.S.C. 31315(b) by adding a new
paragraph (2) which permits exemptions for no longer than 5 years from
their dates of inception, instead of the previous 2 years. This
statutory provision will be codified in 49 CFR part 381 in a
forthcoming rulemaking.

III. Request for Exemption

    On behalf of Henning Oeltjenbruns, Daimler has applied for a 5-year
exemption from 49 CFR 383.23, which prescribes licensing requirements
for drivers operating CMVs in interstate or intrastate commerce. Mr.
Oeltjenbruns is unable to obtain a CDL in any of the States due to his
lack of residency in the United States. A copy of the application is in
Docket No. FMCSA-2012-0032.
    The exemption would allow Mr. Oeltjenbruns to operate CMVs in
interstate or intrastate commerce to support Daimler field tests
designed to meet future vehicle safety and environmental requirements
and to promote technological advancements in vehicle safety systems and
emissions reductions. Mr. Oeltjenbruns needs to drive Daimler vehicles
on public roads to better understand ``real world'' environments in the
U.S. market. According to Daimler, Mr. Oeltjenbruns will typically
drive for no more than 6 hours per day, and 10 percent of the test
driving will be on two-lane state highways, while 90 percent will be on
interstate highways. The driving will consist of no more than 200 miles
per day, during a two-day period on a quarterly basis. He will in all
cases be accompanied by a holder of a U.S. CDL who is familiar with the
routes to be traveled.
    Mr. Oeltjenbruns would be required to comply with all applicable
Federal Motor Carrier Safety Regulations (FMCSRs) (49 CFR parts 350-
399) except the CDL provisions described in this notice.
    Mr. Oeltjenbruns holds a valid German commercial license, and as
explained by Daimler in its exemption request, the requirements for
that license ensure that the same level of safety is met or exceeded as
if this driver had a U.S. CDL. Furthermore, according to Daimler, Mr.
Oeltjenbruns is familiar with the operation of CMVs worldwide.
    FMCSA has previously determined that the process for obtaining a
German commercial license is comparable to, or as effective as, the
requirements of part 383, and adequately assesses the driver's ability
to operate CMVs in the U.S. Since 2012, FMCSA has granted Daimler
drivers similar exemptions [May 25, 2012 (77 FR 31422); July 22, 2014
(79 FR 42626); March 27, 2015 (80 FR 16511); October 5, 2015 (80 FR
60220); December 7, 2015 (80 FR 76059); December 21, 2015 (80 FR
79410)].

Public Comments

    On May 4, 2016, FMCSA published notice of this application and
requested public comments (81 FR 26865). No comments were submitted.

FMCSA Decision

    Based upon the merits of this application, including Mr.
Oeltjenbruns' extensive driving experience and safety record, FMCSA
concluded that the exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption, in accordance with Sec.  381.305(a).

Terms and Conditions for the Exemption

    FMCSA grants Daimler and Henning Oeltjenbruns an exemption from the
CDL requirement in 49 CFR 383.23 to allow Mr. Oeltjenbruns to drive
CMVs in this country without a U.S. State-issued CDL, subject to the
following terms and conditions: (1) The driver and carrier must comply
with all other applicable provisions of the FMCSRs (49 CFR parts 350-
399); (2) the driver must be in possession of this notice or an
equivalent signed letter, and a valid German commercial license; (3)
the driver must be employed by and operate the CMV within the scope of
his duties for Daimler; (4) at all times while operating a CMV under
this exemption, the driver must be accompanied by a holder of a U.S.
CDL who is familiar with the routes traveled; (5) Daimler must notify
FMCSA in writing within 5 business days of any accident, as defined in
49 CFR 390.5, involving this driver; and (6) Daimler must notify FMCSA
in writing if this driver is convicted of a disqualifying offense under
Sec.  383.51 or Sec.  391.15 of the FMCSRs.
    In accordance with 49 U.S.C. 31315 and 31136(e), the exemption will
be valid for 2 years unless revoked earlier by the FMCSA. The exemption
will be revoked if: (1) Mr. Oeltjenbruns fails to comply with the terms
and conditions of the exemption; (2) the exemption results in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would be inconsistent with the goals and
objectives of 49 U.S.C. 31315 and 31136.

VIII. Preemption

    In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR
381.600, during the period this exemption is in effect, no State shall
enforce any law or regulation applicable to interstate or intrastate
commerce that conflicts with or is inconsistent with this exemption
with respect to a firm or person operating under the exemption.

    Issued on: August 31, 2016.
T.F. Scott Darling, III,
Administrator.
[FR Doc. 2016-21827 Filed 9-9-16; 8:45 am]
BILLING CODE 4910-EX-P