[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Notices]
[Page 57385-57387]
[DOCID:fr05no09-107]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0171]

2010-2015 Strategic Planning

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice and request for comment.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA) is
currently seeking public comment on emerging or potential traffic
safety problems. Public feedback will assist the agency in preparing to
meet the challenges it faces in the next 5 years on improving motor
vehicle and traffic safety in the United States. This foundational work
will assist the agency in shaping its 2010-2015 strategic plan.
    This notice invites comments, suggestions and recommendations from
all individuals and organizations that have an interest in motor
vehicle and highway safety, consumer programs (e.g., fuel economy,
vehicle theft, odometer fraud, tire performance) administered by the
agency, and/or other NHTSA activities. Respondents can choose to answer
any number of questions proposed in this notice. The agency values any
comments received and would also like input on the strategic planning
process in general. Please include any elements believed important for
NHTSA to consider in shaping its vision and building its 2010-2015
strategic plan.

DATES: Comments must be received no later than January 4, 2010.

ADDRESSES: You may submit comments identified by Long Range Strategic
Planning DOT DMS Docket Number [XXX] by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays. Telephone:
1-800-647-5527.
    Instructions: All submissions must include the agency name and
docket number. It is suggested that comment submissions be limited to
ten (10) pages with unlimited attachments. Note that all comments
received will be posted without change to http://www.regulations.gov,
including any personal information provided. Please see the Privacy Act
heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70, pp. 19477-78) or you may visit
http://www.dot.gov/privacy.html.
    Docket: For access to the docket to read background documents or
comments received, go to http://regulations.gov and follow the online
instructions, or visit the Docket Management Facility at the street
address listed above.

FOR FURTHER INFORMATION CONTACT: Dee Williams, Acting Director, Office
of Strategic Planning, National Highway Traffic Safety Administration,
Room W40-311, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Telephone:<PHONE_NUMBER>. E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: NHTSA was established as the successor to
the National Highway Safety Bureau in 1970, to carry out safety
programs under the National Traffic and Motor Vehicle Safety Act of
1966 (Chapter 301 of Title 49, United States Code) and the Highway
Safety Act of 1966 (Chapter 4 of Title 23, United States Code). The
agency also administers consumer programs established by the Motor
Vehicle Information and Cost Saving Act of 1972 (Part C of Subtitle VI
(Chapters 321, 323, 325, 327, 329 and 331) of Title 49, United States
Code).
    NHTSA's mission is to save lives, prevent injuries, and reduce
traffic-related health care and other economic costs due to road
traffic crashes through education, research, safety standards, and
enforcement activity. Motor vehicle crashes are responsible for 95
percent of all transportation-related fatalities and are the leading
cause of death for people in the United States of every age from age 3
through 34 (based on 2006 data).
    The economic costs associated with these crashes also seriously
impact the Nation's fiscal health. The cost to our economy of all motor
vehicle crashes was approximately $230 billion in 2000, or 2.3 percent
of the U.S. gross domestic product. Alcohol-involved crashes cost over
$50 billion, accounting for 22 percent of all crash costs. In 2003,
failure to wear safety belts cost $18 billion. Twenty-six percent of
overall crash costs are paid by those individuals directly involved in
these crashes. The remaining 74 percent of overall crash costs is paid
by the public through insurance premiums, taxes, and higher health care
costs.
    In order to address these public health issues and economic costs
of highway crashes, the agency seeks to improve public health by
helping to make highway travel safer. The agency develops, promotes and
implements educational, regulatory, enforcement and emergency medical
service programs aimed at ending preventable tragedies and reducing the
economic costs associated with motor vehicle use and highway travel. A
multi-disciplinary approach that draws upon diverse fields such as
epidemiology, engineering, biomechanics, emergency medicine, the social
sciences, human factors, economics, education, law enforcement, and
communication science to address one of the most complex and
challenging public health problems facing our society.
    NHTSA is a leader in collecting and analyzing motor vehicle crash
data, in conducting research, and in developing countermeasures
designed to prevent and mitigate vehicle crashes, thereby reducing
associated fatalities and traumatic injury. The agency improves traffic
safety through its regulation and enforcement of motor vehicle and
motor vehicle equipment; develops evidence-based education and
enforcement programs and promotes their use by States, localities, and
other safety partners; sponsors critical research; conducts innovative
projects to improve traffic and motor vehicle safety;

provides leadership in understanding and assessing the safety impact of
advanced technologies; and, works to develop harmonized international
safety standards. All aspects of engineering, education, enforcement
and evaluation are incorporated into programs to address the challenges
of crash and injury prevention involving people, vehicles, and the
roadway environment.
    Over the last 43 years, the agency has had a solid record of
achievement in reducing traffic crash fatalities and resulting
injuries. Since 1966, the crash fatality rate has dropped from 5.5
deaths per 100 million vehicle miles of travel (VMT) to a historic low
of 1.27 in 2008. While the recent reductions in total fatalities may be
due in part to a decrease in vehicle miles traveled, additional factors
that may be attributed to the decline include more crashworthy vehicles
in the fleet, improvements in roadway infrastructure, increases in
safety belt use, and decreases in impaired driving. While the reduction
in the fatality rate shows progress, much work still needs to be done
to reduce the number of deaths and serious injuries that take place
every year on our Nation's highways. Moreover, as new technology
continues to develop and evolve, it will be essential to address
emerging risks in addition to seeking ways to harness the potential of
technology to an even greater extent to help reduce crashes.
    In an attempt to anticipate and meet the challenges on the horizon,
NHTSA is embarking upon a long-range strategic planning initiative. The
initiative will have two phases. Phase I begins with this solicitation
of comments from individuals and public and private organizations
interested in the nation's motor vehicle and highway safety programs,
consumer programs (e.g., fuel economy, vehicle theft and odometer
fraud, tire performance) administered by the agency, and other NHTSA
activities. The information gathered during Phase I will serve as the
foundation for Phase II: the development of NHTSA's Strategic Plan
2010-2015. The information and data generated from Phase I will assist
the agency at shaping its future vision, program plans, and safety
goals.
    NHTSA requests comments, suggestions and recommendations that will
assist the agency in assessing and understanding the potential effects
and implications that changes in demographic, economic, environmental,
institutional, and technological factors will have on motor vehicle and
highway traffic safety.
    The following are some of the key issues that the agency would like
public comments to address. In addition to general comments, the agency
seeks documents, studies, or references relevant to the issues. The
agency is particularly interested in learning about emerging or
potential safety problems, gaps in current strategies and approaches,
and in receiving recommendations for addressing traffic safety problems
effectively. While the strategic plan under development will cover
2010-2015, the agency is interested in the public's views on issues and
trends beyond 2015. The public may respond to all or some of the
questions below. NHTSA will consider all comments received but may not
necessarily include all comments into the strategic plan due to
inconsistency with NHTSA's mission, budget constraints, and data driven
priority areas. Stakeholder meetings and listening sessions will be
held at a later date to obtain feedback on the questions below.

A. Factors and Issues

    (A1) What are critical, highway safety issues facing the nation
today?
    (A2) What will future key demographic and social influences be on
highway safety (e.g. novice and older drivers, gender, obesity,
cultural diversity, immigration, geographic distribution, alcohol and
drug consumption, shifts in economic development, etc.)?
    (A3) In general, how might driving behaviors change in the United
States in the future? How might demographic and social influences
change driving behaviors and impact highway safety?
    (A4) What changes in the auto fleet, including size and mix, will
impact highway safety?
    (A5) What changes in commercial vehicle use will impact highway
safety?
    (A6) What international trends and technologies will influence
future developments in American automotive industry?
    (A7) What changes in energy and environmental issues will impact
public policy and highway safety? How will these changes impact vehicle
use?
    (A8) What change in the highway or energy distribution
infrastructures will either affect or be needed for improved highway
safety?
    (A9) What changes in auto and medical insurance might affect
highway safety?
    (A10) What changes in the national, State, and local economies will
impact public policy and highway safety? Will these changes require
modification in Federal funding programs or delivery systems for
highway safety?
    (A11) How might changes in vehicle theft and odometer fraud impact
NHTSA's future program efforts in these areas?
    (A12) What are new and emerging areas of automotive safety research
(e.g., injury prevention, passive safety, active safety, advanced crash
notification, etc.) that would enable NHTSA and the auto industry to
improve motor vehicle safety?
    (A13) What are new and emerging areas of behavioral safety research
that would enable NHTSA to improve highway safety countermeasures?
    (A14) What additional analytical data need to be collected with
respect to motor vehicle and highway safety? How might data and
information be combined for more effective and valuable results? How
might these data be collected, linked, analyzed and made available in a
more efficient and cost-effective manner?
    (A15) What are critical data elements that NHTSA does not collect
that should be collected to identify areas to target to reduce traffic
fatalities and injuries?
    (A16) How can crash avoidance data be gathered?
    (A17) What role will public education and consumer information play
in the future of highway safety? What other cost effective tools should
NHTSA use to promote motor vehicle and highway safety programs?
    (A18) What changes in the area of Federal, State, and local
legislation are appropriate and how might that legislation affect
traffic safety in the future? What changes are likely?
    (A19) How might homeland security affect traffic safety in the
future?
    (A20) What changes are imminent in State politics, and the
relationship between the States and agency? What changes would help the
agency achieve its safety goals?
    (A21) How will ``Smart Growth'' or livable community concepts
impact traffic safety? What is NHTSA's role within these growing inter-
disciplinary fields?

B. Technology

    (B1) How will advanced vehicle technologies (i.e., crash avoidance)
impact the future of motor vehicles and highway safety?
    (B2) What future technologies should be researched and encouraged
to enhance highway safety?
    (B3) What technological changes are necessary in other modes of
passenger and freight transportation to positively impact motor vehicle
and highway safety?
    (B4) What changes in medical technology and emergency medical

services will impact motor vehicle and highway safety and health
outcomes?
    (B5) How can the development and implementation of crash
notification technologies (i.e., automatic advanced crash notification)
and crash victim triage protocols impact health outcomes related to
motor vehicle crashes?
    (B6) What changes do you envision in automation, information
management, and workplace alternatives (e.g., telecommuting)? How will
these activities impact highway safety and commuting and travel
behaviors?
    (B7) What changes in law enforcement practices and technologies
might impact highway safety?
    (B8) How will technology affect driving behavior? What issues
related to vehicle/driver interaction could affect safety? What issues
should NHTSA research?

C. Institutional Relationships

    (C1) How do you and/or your organization (include organization's
name) interact with NHTSA? Please explain the dynamics of this
relationship.
    (C2) How could NHTSA strengthen its relationship with your
organization and with other organizations and institutions engaged in
traffic safety programs?

D. NHTSA's Role and Mission

    (D1) In your view, should there be major changes in NHTSA's role/
mission in the future?
    (D2) What are NHTSA's strengths and weaknesses?
    (D3) How can NHTSA have a greater impact in the reduction of injury
and loss of life on the nation's highways?
    (D4) What is NHTSA doing well and not well? How can NHTSA improve
the way it does business or provides customer service? Please identify
possible improvements or ideas for doing better.
    (D5) What should NHTSA's role in international highway safety be?
How should NHTSA be involved in international global road safety
efforts? What opportunities exist for NHTSA to learn from highway
safety initiatives in other countries?
    (D6) What mechanisms should NHTSA consider using for communication
with the public?

Request for Comments

How Do I Prepare and Submit Comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the Docket
number of this document (2010-2015 Strategic Planning, XXXX) in your
comments.
    Please send two paper copies of your comments to Docket Management
or submit them electronically. The mailing address is Docket Management
Facility; U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590. If
you submit your comments electronically, log onto the Federal
eRulemaking Portal: Go to http://www.regulations.gov. Follow the online
instructions for submitting comments.

How Can I Be Sure That My Comments Were Received?

    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will return the postcard by mail.

How Do I Submit Confidential Business Information?

    If you wish to submit any information under a claim of
confidentiality, send three copies of your complete submission,
including the information you claim to be confidential business
information, to the Chief Counsel, NCC-01, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC
20590. Include a cover letter supplying the information specified in
our confidential business information regulation (49 CFR Part 512).
    In addition, send two copies from which you have deleted the
claimed confidential business information to Docket Management
Facility; U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590.

Will the Agency Consider Late Comments?

    NHTSA will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent possible, we will also consider
comments that Docket Management receives after that date.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Some people may submit late comments. Accordingly, we
recommend that you periodically check the Docket for new material.

How Can I Read the Comments Submitted by Other People?

    You may read the comments by visiting Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC from 9 a.m. and 5
p.m., Monday through Friday, except Federal Holidays. You may also see
the comments on the Internet by taking the following steps:
    (1) Go to http://www.regulations.gov.
    (2) On that page, in the field marked ``search,'' type in the
docket number provided at the top of this document.
    (3) The next page will contain results for that docket number; it
may help you to sort by ``Date Posted: Oldest to Recent.''
    (4) On the results page, click on the desired comments. You may
download the comments. However, since the comments are imaged documents
instead of word processing documents, the downloaded comments may not
be word searchable.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.dot.gov/privacy.html.

Gregory Walter,
Senior Associate Administrator for Policy and Operations.
[FR Doc. E9-26658 Filed 11-4-09; 8:45 am]

BILLING CODE 4910-59-P


<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

(7/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: Shanaz
Bacchus,<PHONE_NUMBER>.>

<>

<TEMPLATE: Company submission>

<Circle One Global, Inc.>

<Pesticide Petition 7F7302>

<	EPA has received a pesticide petition 7F7302 from Circle One Global,
Inc. (Circle One), P.O. Box 28, Shellman, GA 39886-0028, proposing,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.1254 to establish
an amendment/expansion of an existing tolerance exemption for the
microbial pesticide Aspergillus flavus NRRL 21882 for its use on the
food/feed commodity corn.>

<	Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Circle One
has submitted the following summary of information, data, and arguments
in support of their pesticide petition. This summary was prepared by
Circle One and EPA has not fully evaluated the merits of the pesticide
petition. The summary may have been edited by EPA if the terminology
used was unclear, the summary contained extraneous material, or the
summary unintentionally made the reader conclude that the findings
reflected EPA’s position and not the position of the petitioner.>

<I. Circle One Petition Summary>

<	Pesticide Petition 7F7302>

<A. Product Name and Proposed Use Practices>

<	Circle One proposes to expand the registration for afla-guard®, which
is formulated with Aspergillus flavus NRRL 21882, to include use on
corn.  The product will be applied aerially at 20 pounds per acre, the
rate currently approved for use on peanuts.  The application to corn
will be once per season at the first sign of corn tasseling.>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. Aspergillus
flavus NRRL 21882 is a naturally-occurring non-aflatoxin-producing
fungal active ingredient that will be used to displace the ubiquitous A.
flavus group of microbes, many of which can produce aflatoxins, which
are potent carcinogens.  The residues resulting from treatment on corn
are Aspergillus flavus NRRL 21882.  The active ingredient is cultured
from spores originally obtained from the U.S. Department of
Agriculture’s (USDA) Agricultural Research Service (ARS) Patent
Culture Collection in Peoria, Illinois.  It is cultured on a selective
isolation medium and can be identified by vegetative compatibility group
(VCG) assays and characterized as non-aflatoxin-producing by standard
thin layer chromatography (TLC) and high performance liquid
chromatography (HPLC) procedures.  Product characterization previously
submitted confirmed the absence of aflatoxins (B1, B2, G1, and G2), and
cyclopiazonic acid (CPA) (see Aspergillus flavus NRRL 21882
Biopesticides Registration Action Document (BRAD), May 24, 2004, pp.
15-16).  Additionally, the manufacturer of the technical grade active
ingredient routinely conducts standard microbiological assays on
Aspergillus flavus NRRL 21882 conidia to assay for potential aflatoxins,
metabolites, CPA, bacterial contaminants, and bacterial pathogens. >

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue.   It is expected that the percent toxic strains
of total A. flavus found in corn grain will be reduced as a result of
treatment with the registered product.  A dilution plating method has
been used to quantify the A. flavus colonization in both corn and
peanuts, as well as the aflatoxin  contamination (J.W. Dorner (2002)
Simultaneous Quantification of Aspergillus flavus/A. parasiticus and
Aflatoxins in Peanuts, J. of AOAC International, 85(4): 911-916).>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. A petition for
exemption from the requirement of tolerance is being submitted with
applications to add the corn use to both the manufacturing-use label for
Aspergillus flavus NRRL 21882 and the end-use label for afla-guard®.
EPA previously has determined that an exemption from tolerance is
supported when the product is used on peanuts (see 69 FR 39341, June 30,
2004, codified at 40 C.F.R. § 180.1254) and temporarily when used on
corn (see 72 FR 27460, May 16, 2007) in association with an Experimental
Use Permit (EPA File Symbol 75624-EUP-2).  In reaching these
conclusions, EPA noted that Aspergillus flavus NRRL 21882 occurs
naturally in the environment and beneficially displaces toxigenic
strains of naturally-occurring A. flavus.  EPA also noted that there is
no indication of toxicity, infectivity, or pathogenicity in mammalian
acute oral and pulmonary studies using Aspergillus flavus NRRL 21882 as
the test material.  Accordingly, a numerical tolerance and an analytical
method to measure pesticide residues are not needed.>

<C. Mammalian Toxicological Profile>

<	The toxicological profile previously has been summarized and published
in the final rule to create a tolerance exemption for use on peanuts, 69
Fed. Reg. 39341 (Jun. 30, 2004) as well as in the May 24, 2004, BRAD.>
The pesticide is classified as Toxicity Category IV   on the basis of
acute oral toxicity/pathogenicity tests submitted for the exemption from
tolerance for its use on peanuts.  EPA also noted that there is no
indication of toxicity, infectivity, or pathogenicity in mammalian acute
oral, pulmonary and intravenous studies using Aspergillus flavus NRRL
21882 as the test material.  Aspergillus flavus NRRL 21882 cleared all
tissues examined during those tests (see 69 FR 39341, June 30, 2004).
Those studies also supported the temporary exemption from tolerance for
corn (see 72 FR 27460, May 16, 2007).

<D. Aggregate Exposure>

<	1. Dietary exposure. The total dietary exposure consists of the
potential exposure in food and drinking water, which are discussed
below.  Aspergillus flavus NRRL 21882 is neither toxic nor infective as
determined by submitted studies (see May 24, 2004, BRAD).  A tolerance
exemption has been granted for use on peanuts (69 Fed. Reg. 39341, Jun.
30, 2004).  >

<	i. Food. The product is proposed for use for treatment of corn at the
same rate as approved for use on peanuts.  Levels of Aspergillus flavus
NRRL 21882 are not expected to exceed total levels of
naturally-occurring Aspergillus fungi on corn and thus would not
increase dietary exposure.  Aspergillus flavus NRRL 21882 is a
naturally-occurring strain that does not produce aflatoxins, CPA, or
other known intermediates in the aflatoxin biosynthetic pathway, some of
which are toxic.  The use of the product reduces the aflatoxin content
of treated corn when compared with untreated controls, as demonstrated
by efficacy data submitted with the registration amendment application
for afla-guard®.  In the United States, aflatoxin levels in corn are
monitored to verify they do not exceed the regulatory action levels
(limits) set by the U.S. Food and Drug Administration (FDA). >

<	ii. Drinking water. Exposure to Aspergillus flavus NRRL 21882 in
drinking water is not expected to be greater than existing exposures to
A. flavus strains generally.  Potential risks via exposure to drinking
water or runoff are mitigated adequately by, among other things,
percolation through soil.  The product is not applied to crops grown in
water and is not likely to accumulate in drinking water if used as
directed on the label.  Accordingly, exposure by drinking water will not
increase as a result of the proposed use on corn.>

<	2. Non-dietary exposure. The product currently is registered for use
on peanuts only.  EPA has evaluated occupational, residential,
ecological, and environmental exposure with the peanut use.  Based on
these evaluations, the only mitigation required was with respect to the
exposure by pesticide handlers.  To mitigate this exposure, EPA requires
the use of personal protective equipment.  This requirement is triggered
by the properties of the A. flavus species, not the specific registered
strain, which has had no hypersensitivity incidents reported during the
12 years handled by workers in the laboratory and in field trials.
There are no residential or non-crop uses.  Non-occupational exposure is
not likely to be greater than that which normally exists to the
naturally-occurring A. flavus species.  This issue is discussed in
further detail at 69 FR 39347 and in the May 24, 2004, BRAD.>

<E. Cumulative Effects>

<	Completed toxicology studies indicate that Aspergillus flavus NRRL
21882 is not toxic or pathogenic to humans.  It currently is registered
for use on peanuts only.  Another strain of Aspergillus flavus, A.
flavus AF36, is registered under Section 3(c)(5) for use on cotton.  A.
flavus AF36 is also temporarily exempt from the requirement of a
tolerance on corn in accordance with an EUP (EPA File Symbol
71693-EUP-2).  Other A. flavus strains abound naturally in the
environment.  The displacement of aflatoxin-producing strains of A.
flavus by Aspergillus flavus NRRL 21882 is expected to reduce aflatoxin
contamination in corn, as demonstrated by the efficacy data submitted
with the registration amendment for afla-guard®.  As Aspergillus flavus
NRRL 21882 is naturally occurring, in toxicity Category IV, and
atoxigenic, no cumulative incremental effect from its use on corn is
expected.>

<F. Safety Determination>

<	1. U.S. population. There is a reasonable certainty that no harm will
result to the U.S. population from aggregate exposures to residues of
Aspergillus flavus NRRL 21882 as a result of its use on corn.  EPA has
already concluded that the organism is non-toxic and non-pathogenic to
animals and humans.  The additional exposure to this organism from use
on corn should not increase the overall exposure to A. flavus, and the
use is expected to reduce potential exposure to potent mycotoxins.
Accordingly, use of the product on corn should not change the conclusion
concerning the safety of the product already reached by EPA in the
context of its use on peanuts.>

<	2. Infants and children. EPA previously has concluded that Aspergillus
flavus NRRL 21882 is non-toxic to mammals, including human infants and
children.  As there are no threshold effects of concern for infants,
children, and adults, no additional margin of safety was added in
EPA’s assessment of the product’s use on peanuts.  As Aspergillus
flavus NRRL 21882 is naturally occurring, in toxicity Category IV, and
atoxigenic, it can be concluded that no additional safety factor is
needed.>

<G. Effects on the Immune and Endocrine Systems>

<	EPA has not required submission of information on the endocrine
effects of the active ingredient, Aspergillus flavus NRRL 21882.  There
is no known metabolite produced by this microorganism that acts as an
endocrine disruptor.  The submitted toxicity/infectivity and/or
pathogenicity studies in the rodent indicate that, following oral and
pulmonary routes of exposure, the immune system is intact and able to
process and clear the active ingredient.  Additionally, based on the low
potential exposure associated with the proposed, single application per
season use, no adverse effects to the endocrine or immune system are
expected.  >

<H. Existing Tolerances>

<	An exemption from the requirement of a tolerance currently exists for
residues of Aspergillus flavus NRRL 21882 in/on peanuts, which is
published in 40 C.F.R. § 180.1254.  There also is a temporary tolerance
exemption for residues of Aspergillus flavus NRRL 21882 in/on corn when
used in accordance with Experimental Use Permit 75624-EUP-2, which will
expire on May 2, 2009.>

<I. International Tolerances>

<	There is no Codex maximum residue level for residues of Aspergillus
flavus NRRL 21882.>

 PAGE

 PAGE   4


[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Page 3865]
[FR Doc No: 2022-01326]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94000; File No. SR-EMERALD-2021-38]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Amend Exchange Rule 531 To Provide for a New Service Called
the ``High Precision Network Time Signal Service''

January 19, 2022.
    On November 19, 2021, MIAX Emerald, LLC (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend Exchange
Rule 531 to provide for a new service called the ``High Precision
Network Time Signal Service.'' The proposed rule change was published
for comment in the Federal Register on December 7, 2021.\3\ The
Commission has not received any comment letters on the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 93698 (December 1,
2021), 86 FR 69301 (December 7, 2021).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is January 21, 2022.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider the
proposed rule change. Accordingly, pursuant to Section 19(b)(2) of the
Act,\5\ the Commission designates March 7, 2022, as the date by which
the Commission shall either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-EMERALD-2021-38).
---------------------------------------------------------------------------

    \5\ Id.

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

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-01326 Filed 1-24-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 11, 2007 (Volume 72, Number 7)]
[Proposed Rules]
[Page 1301]
[DOCID:fr11ja07-23]

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

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 270

[Release No. IC-27600A; File No. S7-03-04]
RIN 3235-AJ62

Investment Company Governance; Correction

AGENCY: Securities and Exchange Commission.

ACTION: Proposed rule.

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

    In document E6-21903 beginning on page 76618 in the issue of
Thursday, December 21, 2006, make the following correction:
    On page 76618, in the first column, the RIN number should read as
set forth above.

    Dated: January 4, 2007.
Nancy M. Morris,
Secretary.
[FR Doc. E7-210 Filed 1-10-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6683-6685]
[DOCID:fr10fe09-129]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59348; File No. SR-NYSEALTR-2009-08]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Alternext US, LLC
Amending Rule 916 To Eliminate the $3 Market Price Per Share
Requirement

February 3, 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 February 2, 2009, NYSE Alternext US, LLC (``NYSE Amex'' or the
``Exchange'') 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. NYSE Amex has
designated the proposed rule change as constituting a non-controversial
rule change under Rule 19b-4(f)(6) under the Act,\3\ 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 916, Withdrawal of Approval of
Underlying Securities, to eliminate the $3 market price per share
requirement from the Exchange's requirements for continued approval for
an underlying security and eliminate the prohibition against listing
additional series of options on an underlying security at any time when
the price per share of such underlying security is less than $3.
Changes to the rule text are shown in the attached Exhibit 5. Changes
to the rule text are shown in the attached Exhibit 5.\4\ A copy of this
filing is available on the Exchange's Web site at http://www.nyse.com,
at the Exchange's principal office and at the Commission's Public
Reference Room.
---------------------------------------------------------------------------

    \4\ The Commission notes that while provided in Exhibit 5 to the
filing, the text of the proposed rule change is not attached to this
notice but is available at the Exchange, the Commission's Public
Reference Room, and at http://www.nyse.com.
---------------------------------------------------------------------------

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

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

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

1. Purpose
    The purpose of this proposed rule change is to eliminate the $3
market price per share requirement from the Exchange's requirements for
continued approval for an underlying security from Rule 916. In
addition, the rule filing would further amend Rule 916 by eliminating
the prohibition against listing additional series of options on an
underlying security at any time when the price per share of such
underlying security is less than $3.
    The Exchange believes that the $3 market price per share
requirement is no longer necessary or appropriate, and states that only
those underlying securities meeting the remaining maintenance listing
criteria set forth in Rule 5.4 will be eligible for continued listing
and the listing of additional option series. The Exchange believes that
the current $3 market price per share requirement could have a negative
effect on investors. For example, in the current volatile market
environment, the Exchange is currently unable to list new series on
underlying securities trading below $3. If there is market demand for
series while the underlying is below $3, the Exchange would be unable
to accommodate such requests and investors would be unable to hedge
their positions with new options series.
    As of January 2, 2009, the Exchange had 161 underlying issues that
closed below $3 per share, and an additional 114 that closed between $3
and $5 per share, out of a total of 1646 underlying classes.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
and furthers the objectives of Section 6(b)(5) of the Act, in that it
is designed to promote just and equitable principles of trade, remove
impediments to and perfect the mechanisms of a free and open market and
a national market system and, in general, to protect investors and the
public interest, as it provides for the continued listing of options
overlying securities that meet all requirements except for share price.
By continuing the listing, investors will be able to continue managing
risk in these securities.

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

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

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

    No written comments were either solicited or received.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \5\ and Rule 19b-
4(f)(6) thereunder.\6\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.
NYSE Amex has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \7\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \8\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. NYSE Amex requests
that the Commission waive the 30-day operative delay. The Commission
notes that this proposed rule change is substantially identical to a
proposed rule change that was approved by the Commission after an
opportunity for public comment,\9\ and does not raise any new
substantive issues. The Exchange requests the waiver of the 30-day
operative delay so that the proposed rule change may become effective
and operative on or near the date that the CBOE proposal is operative.
For these reasons, the Commission believes that waiving the 30-day
operative delay \10\ is consistent with the protection of investors and
the public interest and designates the proposal operative upon filing.
---------------------------------------------------------------------------

    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ NYSE Amex's proposed rule change is substantially identical
to a proposed rule change by the Chicago Board Options Exchange
(``CBOE'') recently approved by the Commission. See Securities
Exchange Act Release No. 59336 (February 2, 2009) (SR-CBOE-2008-
127).
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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-NYSEALTR-2009-08 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-NYSEALTR-2009-08. 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 Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of 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 publicly available. All
submissions should refer to File Number SR-NYSEALTR-2009-08 and should
be submitted on or before March 3, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-2656 Filed 2-9-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Pages 71033-71036]
[FR Doc No: 2013-28450]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2013-0084]

Pipeline Safety: Information Collection Activities, Revisions to
Incident and Annual Reports for Gas Pipeline Operators

AGENCY: Pipeline and Hazardous Materials Safety Administration, DOT.

ACTION: Notice and request for comments.

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

SUMMARY: On June 27, 2013, in accordance with the Paperwork Reduction
Act of 1995, PHMSA published a notice in the Federal Register of its
intent to revise six forms under OMB Control Number 2137-0522. These
forms include: PHMSA F 7100.1 Incident Report--Gas Distribution System;
PHMSA F 7100.1-2 Mechanical Fitting Failure Report Form for Calendar
Year 20xx for Distribution Operators; PHMSA F 7100.2 Incident Report--
Natural and Other Gas Transmission and Gathering Pipeline Systems;
PHMSA F 7100.2-1 Annual Report for Calendar Year 20xx Natural and Other
Gas Transmission and Gathering Pipeline Systems; PHMSA F 7100.3
Incident Report--Liquefied Natural Gas Facilities; and PHMSA F 7100.3-1
Annual Report for Calendar Year 20xx Liquefied Natural Gas Facilities.
    In response to that notice, PHMSA received comments from three
organizations on the proposed revisions. PHMSA is publishing this
notice to respond to the comments, to provide the public with an
additional 30 days to comment on the proposed revisions to the forms
and instructions, and to announce that this revised Information
Collection request will be submitted to the Office of Management and
Budget (OMB) for approval.

DATES: Comments on this notice must be received by December 27, 2013 to
be assured of consideration.

FOR FURTHER INFORMATION CONTACT: Angela Dow by telephone at 202-366-
1246, by fax at<PHONE_NUMBER>, by email at<EMAIL_ADDRESS>
ADDRESSES: You may submit comments identified by the docket number
PHMSA-2013-0084 by any of the following methods:
     Fax: 1-202-395-5806.
     Mail: Office of Information and Regulatory Affairs (OIRA),
Records Management Center, Room 10102 NEOB, 725 17th Street NW.,
Washington, DC 20503, ATTN: Desk Officer for the U.S. Department of
Transportation\PHMSA.
     Email: OIRA, OMB, at the following email address<EMAIL_ADDRESS>    Requests for a copy of the Information Collection should be
directed to Angela Dow by telephone at<PHONE_NUMBER>, by fax at 202-366-
4566, by email at<EMAIL_ADDRESS>or by mail at U.S. Department of
Transportation, PHMSA, 1200 New Jersey Avenue SE., PHP-30, Washington,
DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8 (d), Title 5, Code of Federal
Regulations, requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies a revised
information collection request that PHMSA will be submitting to OMB for
approval.

I. Summary of Topic Comments/Responses

    During the 60-day comment period, PHMSA received comments from the
following stakeholders:
     Norton McMurray Manufacturing Company (NORMAC)
     Interstate Natural Gas Association of America (INGAA)
     Pipeline Safety Trust (PST)
    The comments from these stakeholders are available at http://www.regulations.gov, under docket number ``PHMSA-2013-0084.'' The
docket also contains the forms and instructions as amended in response
to the comments. The responses to these comments are detailed below.

II. NORMAC's Comments/PHMSA's Responses

    NORMAC submitted comments on both the PHMSA F 7100.1 Incident
Report--Gas Distribution System (Incident Report) and PHMSA F 7100.1-2
Mechanical Fitting Failure (MFF) Report Form for Calendar Year 20xx for
Distribution Operators (MFF Report).
    1. NORMAC proposes that PHMSA consistently apply to both the
Incident Report and the MFF Report the exemption in the MFF Report
instructions against categorizing leaks in gasketed joints found on
main or service pipe as ``Equipment Failure.''
    Response: PHMSA has proposed changes to the MFF Report and Incident
Report instructions to improve clarity. Significant differences exist
in the scope of data collected on each form; therefore, PHMSA is not
accepting NORMAC's proposal. The Incident Report collects data for all
gas distribution pipeline facility failures, regardless of the location
of the failure within the facility. The MFF Report only collects data
on mechanical fitting failures. The Incident Report does not exempt
incidents on mains and services from being categorized as ``Equipment
Failures.'' The instructions direct these leaks to either ``Equipment
Failure'' or ``Pipe, Weld, or Joint Failures.'' The proposed causes on
the Incident Report allow PHMSA to identify failures caused by
incorrect installation separately from manufacturing flaws. On the MFF
Report, every failure reported is a joint failure and PHMSA provides a
different set of cause categories for these failures. The proposed
causes on the MFF Report allow PHMSA to identify failures caused by
incorrect installation separately from manufacturing flaws.
    2. NORMAC asserts that because PHMSA's reports ask the wrong
questions, the data collected and stored in PHMSA's database is flawed.
NORMAC suggests that PHMSA should delete, redact or similarly account
for this flawed data. Further, PHMSA should issue corrections to prior
reports and publications that have included remarks based on such
flawed data.
    Response: PHMSA believes that data being collected is critical to
its safety mission and there is no need to delete, redact, or correct
its database. PHMSA does not believe it needs to revisit its prior
reports and publications on this topic.
    3. NORMAC proposes that PHMSA create a bright line separation
between equipment failure and improper joining procedures, joint
installation, or joint design in the MFF Report and all related PHMSA
forms and programs, specifying the precise regulation that applies.
    Response: PHMSA has proposed changes to the MFF Report, Incident
Report, and the Gas Distribution Annual Report (see docket PHMSA-2013-
0004) to improve clarity in the instructions and consistency in the
data collected. PHMSA issued an Advisory Bulletin (ADB-2012-07) titled:
``Pipeline Safety: Mechanical Fitting Failure Reports'' communicating,
among other things, that hazardous mechanical fitting failures
resulting from an installation defect be reported under ``Incorrect
Operation''. Through these information collections, PHMSA seeks to
implement the separation proposed by NORMAC.
    4. NORMAC proposes that PHMSA use the same definition of ``Cause''
in both the Incident Report and the MFF Report.
    Response: As mentioned earlier, the scope of data collection under
the Incident Report and the MFF Report are very different. The Incident
Report collects data for all gas distribution pipeline facility
failures regardless of the location of the failure within the facility.
The MFF Report only collects data on mechanical fitting failures. These
differing scopes preclude applying the same definitions and exemptions
to both the Incident Report and MFF Report.
    5. NORMAC proposed that PHMSA eliminate the titles and intent of 49
CFR 191.12 and 192.1009 for Mechanical Fitting Failure Reporting.
    Response: NORMAC's proposal would require rulemaking, which is
beyond the scope of this information collection renewal.
    6. NORMAC asserts that the forms do not tie the likely causes of
failure to whether such actions, inactions or decisions are compliant
with Subpart F, the manufacturer's instructions, or ASME B31.8, as
applicable. NORMAC proposes that PHMSA reform the MFF Report to relate
each apparent cause of leaks to specific actions or inactions in
compliance with PHMSA's applicable regulations.
    Response: The MFF Report form and instructions provide numerous
apparent leak cause categories and there is no bias toward selecting
``Equipment Failure.''
    7. NORMAC proposes that PHMSA remove the note in Part G1 of the
Incident Report instructions because the note assumes that the failure
of a piece of equipment is always due to a flaw in the equipment and
never due to a failure to properly install the equipment.
    Response: PHMSA has revised the note in Part G1 of the instructions
of the Incident Report to clarify that non-corrosion bonnet, packing,
or other gasket failures could be reported under ``Incorrect
Operations'' or under ``Equipment Failure.''
    8. NORMAC proposes that PHMSA clarify language in both the Incident
Report and MFF report instructions for Incorrect Operations.

    Response: PHMSA has modified the instructions for Incorrect
Operations and Equipment Failure in both the Incident Report and MFF
Report in response to NORMAC's proposal.

III. INGAA's Comments/PHMSA's Responses

    INGAA submitted comments on PHMSA F 7100.2 Incident Report--Natural
and Other Gas Transmission and Gathering Pipeline Systems.
    1. INGAA contends that PHMSA did not explain the reason for
amending the instructions for item 19, time sequence, and that these
changes should not be adopted without discussion with the pipeline
safety community.
    Response: In a report titled, ``PIPELINE SAFETY Better Data and
Guidance Needed to Improve Pipeline Operator Incident Response'' (GAO-
13-168) the Government Accountability Office recommends that PHMSA
improve the reliability of incident response data. PHMSA concurs with
the GAO recommendation and has proposed this change to collect more
meaningful data from which to calculate operator response time. PHMSA
will calculate response time as ``arrival on-site'' minus ``failure
awareness.''
    2. INGAA believes there is significant potential value in
collecting C3(a) through C3(h) data for welds other than girth welds.
    Response: The current data structure of the form allows the
collection of one set of C3(a) through C3(h) data for each report.
These data elements are required for pipe girth weld failures with the
assumption that each data element is the same on each side of the girth
weld. The other weld configurations would almost certainly have
different C3(a) through C3(h) values on each side of the weld. PHMSA
lacks the resources to change the data structure to accommodate
multiple C3(a) through C3(h) data per report and there is no compelling
reason to do so.
    3. INGAA urges PHMSA to ensure that the database is able to accept
onshore reports without a valid value for County/Parish.
    Response: PHMSA has modified the instructions accordingly and will
ensure the database is appropriately configured.

IV. Annual Report Gas Transmission and Gathering Pipeline Systems
Comments/PHMSA Responses

    PHMSA received comments regarding the proposed changes to the
Annual Report for Gas Transmission and Gas Gathering Systems--PHMSA
F.7100.2-1 from INGAA and the PST. The following is a summary of the
comments PHMSA received regarding the proposed changes to PHMSA F.
7100.2-1. A complete record of the comments received is available at
http://www.regulations.gov, at docket number ``PHMSA-2013-0084.''

1. Remove Part C-Volume Transported by Transmission Lines

    Comment: The PST commented that it was unable to access this data
on the Federal Energy Regulatory Commission (FERC) Web site and does
not support removing Part C from the PHMSA report.
    Response: PHMSA proposed removing Part C under the assumption that
volume transported data would be available from the FERC. PHMSA concurs
that the data is not readily available from FERC. However, simply
keeping the current instructions for Part C is not an attractive
alternative. Under the current instructions, Part C data is not
required for ``Transmission Lines of Gas Distribution Systems.'' If
PHMSA collects volume transported from any gas transmission operator,
the data should be collected from all gas transmission operators. To
make fair comparisons of operator performance, PHMSA needs to know not
just miles of pipe, but also the volume delivered by the pipelines
included in each annual report. PHMSA has modified the instructions so
that all gas transmission operators are required to submit volume
transported data. We expect that operators with both gas transmission
and gas distribution assets have the volume transported data readily
available, so the reporting burden increase is minimal.

2. Instructions for Parts Q and R

    Comment: INGAA has no comments regarding the proposed changes to
Parts Q and R of the annual report form, but urges PHMSA to change the
instructions for Parts Q and Part R to:
    (1) Recognize the distinction between MAOP determination and MAOP
verification. According to INGAA, MAOP determination, based on the
reporting operator's internal procedures and the best information
available, determines the Part Q ``Total'' column where specific
mileage will be placed. MAOP verification, which occurs after MAOP
determination, determines how much of the reported ``Total'' mileage
should be reported in the corresponding ``Incomplete Records'' column.
    (2) recognize that an ``Incomplete Records'' entry refers
exclusively to the status of the records for the corresponding
determination method but does not indicate anything regarding the
quality or existence of the operator's records for any of the other
MAOP determination methods.
    (3) eliminate the phrase ``traceable, verifiable, and complete'' to
describe the MAOP records because it appears to impose a standard for
records though instructions for completing an annual report.
    (4) expand the instructions for Part Q to specify how and where
entries should be made when two of the methods specified in subsection
192.619(a) result in the same MAOP.
    (5) specify that consistency is required between the ``Total''
columns in Part Q and mileage entered in other parts of the Annual
Report. No consistency is expected between the ``Incomplete Records''
columns and other parts of the Annual Report.
    (6) provide that if an elevation analysis shows some of a tested
segment did not achieve a specified test pressure, (e.g., a 1.25 x
MAOP) because of elevation differences, the operator should report the
miles that did not achieve the specified test pressure in the pressure
test range actually achieved.
    Response: PHMSA has revised the instructions to implement the
changes listed above except for suggested revision (3). PHMSA is using
the data submitted in Parts Q and R as one of many inputs into
potential regulation changes. These instruction clarifications should
provide more accurate data to inform the rulemaking process. PHMSA has
chosen not to change the exisiting instructions for records. PHMSA's
use of the phrase ``traceable, verifiable, and complete'' provides
guidance for operators to meet the requirements of 49 U.S.C. 60139.

3. Effective Date

    Comment: INGAA suggested improvements in the ``General
Instructions'' section of the instructions to clarify the effective
date for the form.
    Response: PHMSA has implemented the suggestion.

4. Filing Supplemental Reports to Amend Part Q

    Comment: INGAA expressed concern that the ``General Instructions''
require operators to supplement an annual report if any length of pipe,
regardless of how short, changes record status from incomplete to
complete.
    Response: PHMSA has modified the ``General Instructions'' to
clarify that supplemental reports to change the record status are
optional.

5. Consistency Among Parts

    Comment: INGAA asked for the details behind the consistency

requirements among various parts of the form.
    Response: Some of the details already exist in the Parts H through
R introductory instructions. PHMSA has expanded these details in
accordance with INGAA's request.

6. Categories for Leaks and Failures

    After the publication of the 60-day notice, PHMSA found an error in
the instructions for leak and failure categories in Part M of the
instructions. Under the heading titled ``Third Party Damage/Mechanical
Damage,'' operators are instructed to report first, second, and third
party excavation damage. Only third party excavation damage should be
reported under this heading. First and second party excavation damage
leaks and failures represent an error by either the operator (first
party) or a contractor working for the operator (second party) and
should be reported in the ``Incorrect Operations'' category. PHMSA has
revised the instructions accordingly.

V. Proposed Information Collection Revisions and Request for Comments

    The following information is provided for each revised information
collection: (1) Title of the information collection; (2) OMB control
number; (3) Type of request; (4) Abstract of the information collection
activity; (5) Description of affected public; (6) Estimate of total
annual reporting and recordkeeping burden; and (7) Frequency of
collection. PHMSA will request a three-year term of approval for each
information collection activity. PHMSA is only focusing on the
revisions detailed in this notice and will request revisions to the
following information collection activities.
    Title: Incident and Annual Reports for Gas Pipeline Operators.
    OMB Control Number: 2137-0522.
    Current Expiration Date: 02/28/2014.
    Type of Request: Revision.
    Abstract: PHMSA is looking to revise several reporting forms for
gas pipeline operators to improve the granularity of the data collected
in several areas.
    Affected Public: Gas pipeline operators.
    Annual Reporting and Recordkeeping Burden:
Total Annual Responses: 12,164.
Total Annual Burden Hours: 92,321.
Frequency of Collection: On occasion.
    Comments are invited on:
    (a) The need for the proposed collection of information for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
    (b) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques.

    Issued in Washington, DC on November 22, 2013.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2013-28450 Filed 11-26-13; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Page 35194]
[FR Doc No: 2017-15915]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-473-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on July 14, 2017, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221, filed a prior notice application pursuant to sections 157.205
and 157.216 of the Federal Energy Regulatory Commission's (Commission)
regulations under the Natural Gas Act (NGA), and National Fuel's
blanket certificate issued in Docket No. CP83-4-000. National Fuel
requests authorization to abandon one injection/withdrawal (I/W)
storage well in its Henderson Storage Field (Henderson), and remove a
portion of the associated well line, all located in Irwin Township,
Venango County, Pennsylvania, all as more fully set forth in the
request, which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web 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 at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Specifically National Fuel proposes to abandon Well 3168 in
Henderson and removal of approximately 30 feet of 4-inch-diameter well
line NW-3168 that connects Well 3168 to branch line N14SB1, which is
connected to N36S, an 8-inch storage line looping around the field, all
located in Irwin Township, Venango County, Pennsylvania.
    Any questions regarding this application should be directed to
Alice A. Curtiss Deputy General Counsel, National Fuel Gas Supply
Corporation, 6363 Main Street, Williamsville, New York 14221-5887 or
phone<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenter will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.

    Dated: July 24, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-15915 Filed 7-27-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7054-7056]
[FR Doc No: 2018-03218]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2512 and FDA-2016-E-2511]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has

determined the regulatory review period for COTELLIC and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
17, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 15, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 17, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2016-E-2512 and FDA-2016-E-2511 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; COTELLIC.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product COTELLIC
(cobimetinib). COTELLIC is indicated for treatment of patients with
unresectable or metastatic melanoma with a BRAF V600E or V600K
mutation,

in combination with vemurafenib. Subsequent to this approval, the USPTO
received patent term restoration applications for COTELLIC (U.S. Patent
Nos. 7,803,839 and 8,362,002) from Exelixis, Inc., and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated September 26, 2016, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of COTELLIC represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
COTELLIC is 3,219 days. Of this time, 2,884 days occurred during the
testing phase of the regulatory review period, while 335 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 19, 2007. FDA has verified the Exelixis, Inc. claim that
January 19, 2007, is the date the investigational new drug application
became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 11,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for COTELLIC (NDA 206192) was initially submitted on
December 11, 2014.
    3. The date the application was approved: November 10, 2015. FDA
has verified the applicant's claim that NDA 206192 was approved on
November 10, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,013 days or 676 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03218 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Rules and Regulations]
[Page 56655]
[FR Doc No: 2014-22591]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0829]

Drawbridge Operation Regulation; Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Burlington Northern Santa Fe
Railway Bridge, also known as the St. Johns RR Bridge, across the
Willamette River, mile 6.9, at Portland, OR. The deviation is necessary
to facilitate installation of new rail joints. This deviation allows
the bridge to remain in the closed position during maintenance
activities.

DATES: This deviation is effective from 7 a.m. on September 23, 2014 to
5 p.m. on October 2, 2014, and will be enforced from 7 a.m. to 5 p.m.
on September 23, 2014; from 7 a.m. to 5 p.m. on September 25, 2014;
from 7 a.m. to 5 p.m. on September 30, 2014; and from 7 a.m. to 5 p.m.
on October 2, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0829] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Coast Guard Thirteenth District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Burlington Northern Santa Fe (BNSF) Railway
requested this deviation to facilitate the installation of new rail
joints on the bridge. The bridge, also known as the St. Johns RR
Bridge, crosses the Willamette River at mile 6.9 and provides 54 feet
of vertical clearance above Columbia River Datum 0.0 while in the
closed position. Under normal operations, this bridge opens on signal
as required by 33 CFR 117.5. The deviation period is from 7 a.m. to 5
p.m. on September 23, 2014; from 7 a.m. to 5 p.m. on September 25,
2014; from 7 a.m. to 5 p.m. on September 30, 2014; and from 7 a.m. to 5
p.m. on October 2, 2014. This deviation allows the lift span of the
BNSF Railway Bridge across the Willamette River, mile 6.9, to remain in
the closed position and need not open for maritime traffic during the
periods listed above The bridge shall operate in accordance to 33 CFR
Sec.  117.5 at all other times. BNSF will entertain requests from
mariners to change the above listed schedule for emergent vessel
arrivals or departures that are dependent on water level, given 72
hours advanced notice. The BNSF contact is Ron Berry, who can be
reached at<PHONE_NUMBER>. Waterway usage on this stretch of the
Willamette River includes vessels ranging from commercial tug and barge
to small pleasure craft.
    Vessels able to pass through the bridge in the closed positions may
do so at any time. Barring coordination with BNSF, the bridge will not
be able to open for emergencies, and there is no immediate alternate
route for vessels to pass. The Coast Guard will also inform the users
of the waterways through our Local and Broadcast Notices to Mariners of
the change in operating schedule for the bridge so that vessels can
arrange their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: September 9, 2014.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2014-22591 Filed 9-22-14; 8:45 am]
BILLING CODE 9110-04-P