[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Page 60856]
[FR Doc No: 2014-24002]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Drug Safety and Risk Management Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Drug Safety and Risk Management (DSaRM) Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 18, 2014, from
9 a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Kristina Toliver, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss the Food and Drug Administration
Amendments Act of 2007 which requires FDA to bring, at least annually,
one or more drugs with Risk Evaluation and Mitigation Strategies (REMS)
with elements to assure safe use (ETASU) before the DSaRM Advisory
Committee. The Agency plans to discuss the risk management of
eculizumab (SOLIRIS). The Agency will seek public input whether the
REMS with ETASU for this drug assures safe use of the drug, is not
unduly burdensome on patient access to the drug, and to the extent
practicable, minimizes the burden on the health care delivery system.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 3, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 24, 2014. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 27, 2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristina Toliver at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 2, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-24002 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (11/11/2011)>

<EPA Registration Division contact: Kathryn Montague Product Manager 23
(703) 305- 1243>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline.  Please do not change
the margins, font, or format in your pesticide petition.  Simply replace
the instructions that appear in green and brackets, i.e., “[insert
company name],” with the information specific to your action.>

<TEMPLATE:>

<[Nichino America, Inc.]>

<[Pesticide Petition No. xxxxxx]>

<	EPA has received a pesticide petition (PP # xxxxxx) from Nichino
America, Inc. 4550 New Linden Hill Road Suite 501 Wilmington, DE 19808
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 180.585>

<>

<	1. by establishing a tolerance for residues of the herbicide,
pyraflufen-ethyl, ethyl
2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluor
ophenoxyacetate and its acid metabolite, E-1,
2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluor
ophenoxyacetic acid, expressed in terms of the parent, in or on the
following raw agricultural commodities: hop, dried cone at 0.01 parts
per million (ppm), peanut at 0.01 parts per million (ppm), peanut, hay
at 0.07 parts per million (ppm), peanut, meal at 0.01 parts per million
(ppm), and peanut, refined oil at 0.01 parts per million (ppm).

>

<	2. to establish an exemption from the requirement of a tolerance for
“NA-Remove”>

<EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
 Additional data may be needed before EPA rules on the petition.>

<A. Residue Chemistry>

<	1. Plant metabolism. The qualitative nature of the residues of

pyraflufen-ethyl (ET-751) in hops, peanuts, peanut hay, peanut meal, and
peanut refined oil are adequately understood.  The metabolism of
pyraflufen-ethyl has been studied in cotton, wheat, potato, and oranges.
 Metabolism in the plant involves ester hydrolysis, de-methylation on
the pyrazole ring and further degradation of the phenoyxyacetate moiety
to bound polar metabolites.  The nature of the residue is adequately
understood and the residues of concern are the parent, pyraflufen-ethyl,
and the acid metabolite, E-1, only.

>

<2. Analytical method. Aqueous organic solvent extraction, column clean
up, and quantitation by gas chromatography with mass spectrometry is
used to measure and evaluate the chemical residues.

>

<	3. Magnitude of residues. Residue trials were conducted in hops and
peanuts to satisfy the required EPA region locations.  Other than peanut
hay, there were no residues found in any hop, peanut, or peanut
processed samples above the limit of quantitation for the analytical
method established at 0.005 ppm.  Based on these data, it is proposed
that the Agency establish new tolerances in hop, dried cone at 0.01 ppm,
peanut at 0.01 ppm, peanut hay at 0.07 ppm, peanut meal at 0.01 ppm, and
peanut refined oil at 0.01 ppm.

>

    	4. Magnitude of the residue in animals.--i. Ruminants. The results
of the meat and milk 28-day feeding study conclude that no finite
residues of the parent, ET-751 or the metabolites E-9, and E-15 can be
detected in milk at a dose level of 10 ppm, and no residues of either
ET-751, E-5, or E-9, are detected in muscle, liver or fat tissues, and
low level residues of 0.0534 ppm were detected in kidney tissues.  These
results concur with those of an earlier ruminant metabolism study (MRID
45283005) at a dose of 10 ppm.  Although the results of this livestock
feeding study indicate that no finite residues are detected in meat and
milk commodities from the anticipated dietary burdens, we are using an
anticipated residue value in milk calculated to be of 0.007 ppm.

    ii. Poultry. The maximum poultry dietary burden from a diet
comprised of cotton meal, corn grain, corn milled byproducts, soybean
seed, soybean meal, soybean hulls, wheat grain, and wheat milled
byproducts results in a total dietary burden that is significantly lower
than the levels that would require tolerances in poultry and poultry
byproducts.

<B. Toxicological Profile>

<	1. Acute toxicity.  [Insert text.] “NA-Remove”>

<	2. Genotoxicty. [Insert text.] “NA-Remove”>

<	3. Reproductive and developmental toxicity. [Insert text.]
“NA-Remove”>

<	4. Subchronic toxicity. [Insert text.] “NA-Remove”

>

<	5. Chronic toxicity. [Insert text.] “NA-Remove”

	EPA has evaluated the available toxicity data on pyraflufen-ethyl and
considered its validity, completeness, and reliability as well as the
relationship of the results of the studies to human risk.  EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.  Specific information on the nature of the adverse
effects caused by pyraflufen-ethyl as well as the
no-observed-adverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
reviewed can be found at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  in the document “Pyraflufen-ethyl: Human
Health Risk Assessment for a Section 3 Registration of New Food Uses on
Tree Nuts (Crop Group 14), Pistachios, Pome Fruit (Crop Group 11-10),
and Stone Fruit (Crop Group 12), Hops, Grapes, Olives, and
Pomegranates,” at page 17 in docket ID number EPA-HQ-OPP-2010-0426.

>

<	6. Animal metabolism.  The qualitative nature of the residues of
pyraflufen-ethyl and its acid metabolite, E-1, in animals is adequately
understood. Pyraflufen-ethyl is rapidly absorbed, metabolized, and
excreted to feces and urine, with greater than 90% of the administered
dose excreted within 24 hours in rats. Based on metabolism studies with
goats, hens, and rats, there is no reasonable expectation that
measurable pyraflufen-ethyl-related residues will occur in meat, milk,
poultry, or eggs from the proposed use.

>

<	7. Metabolite toxicology. No toxicologically significant metabolites
were detected in animal metabolism studies or plant metabolism studies
on cotton, potatoes, and mandarin oranges.

>

<	8. Endocrine disruption. Chronic, lifespan, and multigenerational

bioassays in mammals and acute and subchronic studies on aquatic
organisms and wildlife did not reveal any endocrine effects for
pyraflufen-ethyl.  Any endocrine related effects would have been
detected in this comprehensive series of required tests.  The
probability of any such effect due to agricultural uses of pyraflufen-

ethyl is negligible.

>

<C. Aggregate Exposure>

<	1. Dietary exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring as
a result of a 1-day or single exposure.  No such effects attributable to
a single exposure (dose) were observed in oral toxicity studies,
including the developmental toxicity studies in rats and rabbits
conducted with pyraflufen-ethyl; therefore, a quantitative acute dietary
exposure assessment is not necessary.  Chronic dietary risk analyses
were conducted using Dietary Exposure Evaluation Model Software with the
Food Commodity Intake Database (DEEM-FCID).  These dietary exposure
assessments used the following assumptions:  100 percent crop treated
(PCT) and tolerance-level residues for pyraflufen-ethyl on all treated
crops except corn, cottonseed, potato, soybean, wheat, pome fruit, stone
fruit, pomegranate, olive, grape, tree nuts, pistachio, hops, and
peanuts for which one half of the combined Levels of Quantification
(LOQs) for the parent and the metabolite were used since all field trial
residue levels were less than the LOQ.  Exposure estimates to water were
based on modeling with FIRST, PRZM/EXAMS, and SCI-GROW.

>

<	i. Food. Using the exposure assumptions listed above, chronic exposure
to pyraflufen-ethyl from food including the proposed new uses on hops
and peanuts will incrementally utilize <1% of the cPAD of 0.172
mg/kg/day for all population groups.

>

<	ii. Drinking water. The residue of concern in drinking water was
determined to be pyraflufen-ethyl.  Based on the First Index Reservoir
Screening Tool (FIRST), Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS), and Screening Concentration in Ground
Water (SCI-GROW) models, the estimated drinking water concentrations
(EDWCs) of pyraflufen-ethyl for acute exposures are estimated to be
1,247 parts per trillion (ppt) for surface water and 1.8 ppt for ground
water.  For chronic exposures for non-cancer and cancer assessments, the
EDWCs are estimated to be 281 ppt for surface water and 1.8 ppt for
ground water.

	2. Non-dietary exposure. EPA calculated non-dietary exposure scenarios
as listed in the Federal Register May 12, 2004 (69 FR 26305)
(FRL-7358-2). Pyraflufen-ethyl is registered in several non-food sites,
including airports, commercial plants, nurseries and ornamental
plantings; established ornamental turf; railroad, roadside, and utility
rights-of-ways, and other similar non-crop areas.

>

<>

<D. Cumulative Effects>

<Pyraflufen-ethyl belongs to the protox inhibitor class of compounds,
and chemically is a 3-phenylpyrazole.  The herbicidal activity of protox
inhibitors is due to the inhibition of protoporphyrinogen IX oxidase.
Chemicals with a similar mode of action, i.e., the protox inhibitors,
have different chemical structures compared to pyraflufen-ethyl.
Although other protox inhibitors have a similar herbicidal mode of
action, there is no information available to suggest that these
compounds exhibit a similar toxicity profile in the mammalian system.
Current available data and information does not indicate or suggest that
pyraflufen-ethyl has a common mechanism of toxicity with other
substances.  Therefore, for the purposes of this Food Quality Protection
Act (FQPA) document, assessment of cumulative risk is not required.

>

<E. Safety Determination>

<U.S. population.

i.  Acute risk. No adverse effect attributable to a single exposure
(dose) of pyraflufen-ethyl was observed in the oral toxicity studies,
including the developmental toxicity studies in rats and rabbits.
Therefore, an acute reference dose was not established and no acute risk
is expected.

ii. Chronic Risk.  Based on the chronic toxicity data, the cPAD for
pyraflufen-ethyl is considered to be 0.172 mg/kg/day.  This value is
based on the NOAEL of 17.2 mg/kg/day observed in the chronic rat feeding
study and a safety (uncertainty) factor of 100.  A worse case estimate,
using proposed tolerance values, of chronic dietary exposure of
pyraflufen-ethyl from hops and peanuts will utilize less than 1% of the
cPAD for the general U.S. population.  EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will not
pose appreciable risks to human health.  The complete toxicity data set
and the conservative chronic exposure assumptions support the conclusion
that there is a reasonable certainty of no harm from dietary (food)
exposure to pyraflufen-ethyl and the acid metabolite residues.
Moreover, as exposure to residues of pyraflufen-ethyl and the acid
metabolite via water is negligible, there is a reasonable certainty of
no harm from aggregate exposure to pyraflufen-ethyl and the acid
metabolite residues.

iii.  Cancer Risk.  There is essentially no incremental cancer risk
associated with pyraflufen-ethyl treated hops and peanuts.  Cancer risk
was calculated by EPA as listed in the Federal Register May 12, 2004 (69
FR 26305) (FRL-7358-2) for both food and water.  This assessment
substantially overstates risk because it is based on the assumption that
all commodities covered by pyraflufen-ethyl tolerances contain tolerance
level residues.  The cancer risk estimate was in the range of 1 in 1
million and does not exceed the Agency’s level of concern for exposure
from either food or water sources.

>

<	2. Infants and children. The chronic dietary exposure of
pyraflufen-ethyl and the acid metabolite from hops and peanuts will
utilize < 1% of the cPAD for children (1-6 years).  Exposure to
potential residues in drinking water is expected to be negligible.  In
the Federal Register May 12, 2004 (69 FR 26305) (FRL-7358-2) after
calculating DWLOCs and comparing them to the EDWCs for surface and
ground water, it is not expected the aggregate exposure to children will
exceed the Agency’s level of concern.>

There is no evidence of increased susceptibility of rat or rabbit
fetuses following in utero exposure in the developmental studies with
pyraflufen-ethyl.  There is no evidence of increased susceptibility of
young rats in the reproduction study with pyraflufen-ethyl.  There are
no residual uncertainties for pre- and/or post-natal exposure.

<F. International Tolerances>

<	There are no Codex maximum residue levels (MRLs) established for
residues of pyraflufen-ethyl and the acid metabolite, E-1, expressed in
terms of parent on any crop.  Canada has not established MRLs for
pyraflufen-ethyl.

>

 PAGE

 PAGE   6


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Wednesday, February 17, 2016 3:01 PM
To:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
final drafts of enclosure 1&2 for coke ovens - facility lists

Hello. As promised, here are the final versions of the enclosures for the coke ICR. I've also included the facility lists. Unfortunately, because of the dual nature of the ICR for the by-product industry, in terms of extended coking standards vs normal operating standards, I don't have the flexibility to allow switching out one facility for another in the case of multiple facilities under one company. I believe this only applied to one company.

I know, David, you had said that the ACCCI had been working with a test consultant on getting additional comments on enclosure 2 to me by February 10[th]. I don't know if you all are delayed or maybe your issues were addressed in the comments I sent a few weeks ago in response to SunCoke's comments on enclosure 2. Regardless, it will take us about 2 weeks to get the packages together and the letters signed, so if I get comments in the next two weeks, I will still take a look at them. Since we have discussed all of the testing issues a number of time, I doubt if there would be any broad changes at this point to the test requests. But if there are facility=specific issues that are still a problem, we can discuss these on an individual facility basis even after the letters go out.

If either of you have any comments or see any errors with the two enclosures in the next 2 weeks, let me know. Again, not expecting to be able to make broad changes but interested in correcting errors and also adding any flexibility we can, as long as the integrity of the rule is not jeopardized.

_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< Final-Draft-Coke ICR Intro-Enclosure I-DLJ-02-16-16.docx >>
<< Final-Draft-Coke ICR-Enclosure 2-DLJ-02-16-16.doc >>
<< Coke-114-facilities-02-17-16.pdf >>


[Federal Register Volume 82, Number 164 (Friday, August 25, 2017)]
[Notices]
[Pages 40578-40579]
[FR Doc No: 2017-17985]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0316; FRL-9966-44-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Onshore Natural Gas Processing
Plants (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for Onshore Natural Gas
Processing Plants (Renewal)'' (EPA ICR No. 1086.11, OMB Control No.
2060-0120), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through
August 31, 2017. Public comments were previously requested via the
Federal Register (81 FR 26546) on May 3, 2016 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before September 25,
2017.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0316, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at http://www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 60, subpart A, and any changes,
or additions to the Provisions specified at 40 CFR part 60, subparts
KKK and LLL. Owners or operators of the affected facilities must submit
a one-time-only report of any physical or operational changes, initial
performance tests, and periodic reports and results. Owners or
operators are also required to maintain records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility, or any period during which the monitoring system
is inoperative. Reports are required semiannually at a minimum.
    Form Numbers: None.
    Respondents/affected entities: Owners or operators of onshore
natural gas processing plants.
    Respondent's obligation to respond: Mandatory (40 CFFR part 60,
subparts KKK and LLL).
    Estimated number of respondents: 484 (total).
    Frequency of response: Initially, semiannually, and occasionally.
    Total estimated burden: 102,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $10,800,000 (per year), includes $68,400
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an adjustment decrease in the
estimated labor hours and number of responses as currently identified
in the OMB Inventory of Approved Burdens. The decrease is due to a
projected decline in the number of sources subject to the regulation,
as new and modified sources will become subject to NSPS Subpart OOOO.
We expect on average 27 existing facilities under Subpart KKK and 3
facilities under Subpart LLL will undergo modifications each year such

that they will become subject to Subpart OOOO. The burden of NSPS
Subpart OOOO is accounted for under EPA ICR Number 2437.04 (OMB Control
Number 2060-0673).

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2017-17985 Filed 8-24-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 19, 2009 (Volume 74, Number 95)]
[Notices]
[Page 23466]
[DOCID:fr19my09-97]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the requirements of
49 CFR Part 236, as detailed below.

Docket Number FRA-2009-0040

    Applicant: Western New York & Pennsylvania Railroad, LLC, Mr. Carl
P. Belke, President and Chief Operating Officer, 3146 Constitution
Avenue, Olean, New York 14760.
    The Western New York & Pennsylvania Railroad, LLC (WNYP) seeks
approval of the proposed discontinuance and removal of signal systems
on three sections of the Buffalo Line between North Driftwood,
Pennsylvania, and Machias, New York. The three sections are:
    1. The discontinuance and removal of the Block Signal System,
Interlocking and Traffic Control System between Machias (MP BR44.5) and
CP North Olean (MP BR66.4).
    2. The discontinuance and removal of the Block Signal System,
Interlocking and Traffic Control System between CP-South Olean (MP BR
73.0 and CP-Kean (MP BR97.0).
    3. The discontinuance and removal of the Block Signal System,
Interlocking and Traffic Control System between CP-Kean (MP BR97.0) and
North Driftwood (MP BR 134.0).
    The reason given for the proposed changes is the low traffic
density on all three sections.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his or her position by written statements, an application may be set
for public hearing.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0040) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and 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).

    Issued in Washington, DC on May 13, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E9-11592 Filed 5-18-09; 8:45 am]

BILLING CODE 4910-06-P


1 Tobacco Products Processing Wastewater Characterization Sampling Telephone Interview Form Date July 11, 2005 Facility Name R. J. Reynolds Whitaker Park Facility Contacts Steve Curl, Myron Shore Facility Contact Information Steve Curl ( 336) 741 5146 curls@ rjrt. com EPA Contact Jan Matuszko, Carey Johnston ERG Contacts Kim Porter, TJ Finseth Interview Questions:

1. Does the facility have process wastewater treatment or pre treatment?

The facility discharges to Winston Salem POTW and does not have pre treatment.

Facilities without pre treatment or treatment 2. What process wastewaters are discharged from the facility?

The process wastewater includes discharges from the reconstituted tobacco operations and the flavor and adhesive operations.

Note that while this facility manufactures cigarettes, primary processing does not occur at this location. All cigarette manufacturing primary processing operations are performed at Tobaccoville. No process wastewater is generated from cigarette manufacturing.

3. Describe each process wastewater stream and other waste streams ( e. g., domestic or processing cooling water) that are discharged ( direct or indirect). How are the process wastewaters commingled? What processes or parts of the facility discharge to each waste stream?

Process wastewater from reconstituted tobacco operations is combined with wastewater from cigarette manufacturing ( which includes glue pot and tank washing and some domestic wastewater) and wastewater from the central flavoring and adhesives building.

4. What are the characteristics of each waste stream? Approximately what percent of the waste 2 stream is process wastewater?

All wastewaters are commingled and discharged via one single point to the Winston Salem POTW. Most of the hydraulic load and BOD are from wastewater resulting from reconstituted operations. It is not possible to collect a sample of the process wastewater only. However, RJ Reynolds the process wastewater should be similar to the process wastewater at their Chester facility.

General Sampling Questions 5. Where do you currently collect samples? What is your sample collection methodology ( sample tap on a pipe, automatic sampling machine)?

The facility currently collects samples from the flume only. The loads from each operation in the plant are unknown.

6. Briefly describe each sampling point. What waste streams comprise each sampling point. What are the typical flow and wastewater characteristics?

The flume sampling point is below surface level, accessable through two removable metal plates. The wastewater is about 10 ft below ground level. The wastewater will not be hot.

Sampling Logistics 7. How far apart are the sampling locations? If far apart, what is the best means of transporting sampling equipment to and from the sampling locations? ( Sampling equipment would include several coolers with ice and up to 46 sample bottles.)

There is only one sampling location for the outfall to the Winston Salem POTW.

8. Can you provide us with a staging area where we can perform sample preservation, field tests, and sample packaging? Where would this staging area be and how much room could you provide? Is it indoors? Air conditioned? Ventilated? Will it be far from the influent and effluent sampling locations?

A table will be provided at the sampling site.

9. Is your facility interested in collecting split samples?

Reynolds will not collect split samples.

Facility Health and Safety Information 10. Does the plant staff want to provide an on site health and safety briefing prior to the start of sampling? 3 No onsite health and safety briefing will be required.

11. Will we be escorted to and from the sampling locations? If not, what is the best way for communicating with facility personnel in case of an emergency?

Reynolds personnel will accompany the sampling team during all phases of the site visit and sampling.

14. What PPE is required by your facility, and specifically for the sampling/ site visit areas?

The required PPE includes boots, gloves and safety glasses or goggles when collecting samples, and hearing protection in some areas of the facility.


[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Notices]
[Pages 76153-76154]
[FR Doc No: 2011-31165]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14318-000]

Grand Coulee Project Hydroelectric Authority; Notice of
Preliminary Permit Application Accepted for Filing and Soliciting
Comments and Motions To Intervene

    On November 8, 2011, Grand Coulee Project Hydropower Authority
(Grand Coulee Authority) filed an application for a preliminary permit,
pursuant to section 4(f) of the Federal Power Act (FPA), proposing to
study the feasibility

of the Scooteney Inlet Drop Hydroelectric Project (Scooteney Inlet
Project or project) to be located on the Potholes East Canal, which is
an inlet structure to the Scooteney Reservoir, near Othello, Franklin
County, Washington. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of the following: (1) An
approximately 200-foot-long, 100-foot-wide canal leading to a 100-foot-
wide, 15-foot-high intake structure installed on the Potholes East
Canal to divert flow from the canal to the penstock; (2) an 80-foot-
long, 12-foot-diameter penstock from the intake structure to the
powerhouse; (3) an approximately 20-foot-long, 50-foot-wide powerhouse
containing a single S-turbine/generator unit rated at 1.7 megawatts at
an average head of 14 feet; (4) a 150-foot-long tailrace returning
flows from the powerhouse to the Potholes East Canal; (5) a substation
at the powerhouse; (6) a 2,500-foot-long, 13.8-kilovolt transmission
line which will connect with an existing distribution line; and (7)
appurtenant facilities. The project will be located on federal lands,
and would operate as run-of-release using irrigation flows provided by
the U.S. Bureau of Reclamation and the South Columbia Basin Irrigation
District. The estimated annual generation of the Scooteney Inlet
Project would be 5.2 gigawatt-hours.
    Applicant Contact: Mr. Ronald Rodewald, Secretary-Manager, Grand
Coulee Project Hydroelectric Authority, P.O. Box 219, Ephrata, WA
98823; phone:<PHONE_NUMBER>.
    FERC Contact: Jennifer Harper; phone:<PHONE_NUMBER>.
    Competing Application: This application competes with Project No.
14204-000 filed May 31, 2011, and with Project No. 14231, filed July
18, 2011. A notice was issued for both competing projects on August 10,
2011, and competing applications or notices of intent for competing
applications had to be filed on or before October 9, 2011. Grand Coulee
Authority filed a notice of intent to file a competing application for
a preliminary permit on October 7, 2011.
    Deadline for filing comments or motions to intervene: 60 days from
the issuance of this notice. Comments and motions to intervene may be
filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to
6,000 characters, without prior registration, using the eComment system
at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-(866) 208-3676, or for
TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14318-000) in the docket number field to
access the document. For assistance, call toll-free 1-(866) 208-3372.

    Dated: November 29, 2011.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2011-31165 Filed 12-5-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Notices]
[Page 30452-30453]
[DOCID:fr01jn10-122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62148; File No. SR-CBOE-2010-045]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to the Establishment of a Post-Demutualization
Trading Permit Application Fee

May 21, 2010.
    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 May 14, 2010, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or the ``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 CBOE. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    CBOE proposes to amend the CBOE and CBOE Stock Exchange (``CBSX'')
Fees Schedules to establish a Post-Demutualization Trading Permit
Application Fee. The text of the proposed rule change is available on
the Exchange's Web site (http://www.cboe.org/Legal/), at the Exchange's
Office of the Secretary, at the Commission's Public Reference Room, and
on the Commission's Web site at http://www.sec.gov.

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

    In its filing with the Commission, CBOE 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. CBOE 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

1. Purpose
    The purpose of this proposed rule change is to amend the CBOE and
CBSX Fees Schedules to establish a Post-Demutualization Trading Permit
Application Fee. Following CBOE's proposed demutualization,\3\ access
to CBOE and CBSX will be provided through the issuance of Trading
Permits. Issuance of these Trading Permits will require an application
process for all current members with trading privileges and related
functions on the Exchange (including member organizations, individual
members, temporary members, interim trading permit holders and CBSX
trading permit holders). To apply for trading permits, all such CBOE
members will be required to submit a Post-Demutualization Trading
Permit Application to request the type of access desired following
demutualization. The Post-Demutualization Trading Permit Application
will need to be submitted prior to the effectiveness of the
demutualization for trading access to CBOE and CBSX to continue without
interruption at demutualization. The Exchange will administer the
application process in the manner that has already been proposed to the
Commission, contingent upon the approval of that process by the
Commission.\4\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 58425 (August 26,
2008), 73 FR 51652 (September 4, 2008) (noticing for comment SR-
CBOE-2008-88), which sets forth a description of CBOE's proposed
demutualization.
    \4\ See Securities Exchange Act Release No. 58425 (August 26,
2008), 73 FR 51652 (September 4, 2008) (noticing for comment SR-
CBOE-2008-88), which sets forth a description of the post-
demutualization trading permit application process.
---------------------------------------------------------------------------

    Due to the significant amount of time required to process all of
the Post-Demutualization Trading Permit Applications, CBOE proposes to
establish a $1,000 Post-Demutualization Trading Permit Application Fee
that would be assessed to any member organization or individual member
that is not associated with a member organization that submits a Post-
Demutualization Trading Permit Application after May 21, 2010.
Specifically, the fee would only be assessed for Post-Demutualization
Trading Permit Applications received after the close of business on May
21, 2010 and prior to the close of business on the effective date of
demutualization.\5\
---------------------------------------------------------------------------

    \5\ The effective date of demutualization is the date that CBOE
completes its restructuring of the Exchange from a non-stock
corporation to a stock corporation and wholly-owned subsidiary of
CBOE Holdings, Inc. This should be distinguished from the date of
approval by the SEC of SR-CBOE-2008-088, as the filing may be
approved some period of time prior to the actual effectiveness of
the demutualization.
---------------------------------------------------------------------------

    The Post-Demutualization Trading Permit Application Fee would not
be assessed for Post-Demutualization Trading Permit Applications
received on or prior to May 21, 2010. The Post-Demutualization Trading
Permit Application Fee would also not be assessed to new CBOE members
that are not approved and active until after May 21, 2010. In addition,
the Post-Demutualization Trading Permit Application Fee would not be
assessed for any amendments submitted after May 21, 2010 to Post-
Demutualization

Trading Permit Applications where the initial application was submitted
prior to the close of business on May 21, 2010.
    The existing CBOE Membership application fees are set forth in
Section 11 of the CBOE Fees Schedule as well as in a regulatory
circular (``Membership Fees Circular''). The Exchange proposes to add
the Post-Demutualization Trading Permit Application Fee to Section 11
of the CBOE Fees Schedule and to revise the Membership Fees Circular.
The proposed changes to the CBOE Fees Schedule are included as part of
Exhibit 5 to the 19b-4. The proposed changes to the Membership Fees
Circular are included as Exhibit 2 to the 19b-4.
    CBOE proposes to add a new Section 8 to the CBSX Fees Schedule for
Membership Fees that includes the Post-Demutualization Trading Permit
Application Fee. The proposed changes to the CBSX Fees Schedule are
included as part of Exhibit 5 to the 19b-4.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Securities Exchange Act of 1934 (``Act'') \6\, in
general, and furthers the objectives of Section 6(b)(4) \7\ of the Act
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities. In particular, the
proposed fee would be assessed to all members in a consistent manner
and encourage the submission of Post-Demutualization Trading Permit
Applications with sufficient time to allow for the efficient processing
of these applications. CBOE believes this fee is reasonable as compared
to other application fees assessed by the Exchange and is reflective of
the amount of work necessary to process the applications.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    CBOE 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 solicited or received with respect to the
proposed rule change.

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

    Because the foregoing rule change establishes or changes a due,
fee, or other charge imposed by the Exchange, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and subparagraph (f)(2)
of Rule 19b-4 \9\ thereunder. 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.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2010-045 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-CBOE-2010-045. 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
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 available publicly. All
submissions should refer to File No. SR-CBOE-2010-045 and should be
submitted on or before June 22, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-13038 Filed 5-28-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Notices]
[Page 43746-43747]
[DOCID:fr28jy08-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-56-004; EL07-58-004]

Allegheny Electric Cooperative v. PJM Interconnection, LLC;
Notice of Filing

July 18, 2008.
    Take notice that on July 7, 2008, PJM Interconnection, LLC filed
revised Tariff and Operating Agreement sheets to reflect an August 1,
2008 effective date to correspond to the implementation date and on
July 8, 2008 filed an additional revision to section X of Attachment M
to also reflect the August 1, 2008 effective date.
    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 July 28, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-17171 Filed 7-25-08; 8:45 am]

BILLING CODE 6717-01-P


Placeholder for document 150; this document is titled " Response to Section 114 Request for Information Concerning Hendrix and Dail, Inc.' s Inventories of Methyl Bromide as of December 31, 2003, dated January 12, 2004" and contains Confidential Business Information.

Please contact Hodayah Finman at 202 343 9246 for more information.


[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45776-45778]
[FR Doc No: 2019-18805]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-0189]

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

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 MACI and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application 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
biological 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 October
29, 2019. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by February 26, 2020.
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 October 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 29, 2019. 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 No.
FDA-2018-E-0189 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; MACI.'' 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
Staff 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product MACI
(autologous cellularized scaffold). MACI is indicated for the repair of
symptomatic, single or multiple full-thickness cartilage defects of the
knee with or without bone involvement in adults. Subsequent to this
approval, the USPTO received a patent term restoration application for
MACI (U.S. Patent No. 8,029,992) from Vericel Corporation, and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated March 19,
2018, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of MACI
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
MACI is 345 days. Of this time, 0 days occurred during the testing
phase of the regulatory review period, while 345 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 (21 U.S.C. 355(i)) became effective: No
exemption under subsection 505(i) of the Federal Food, Drug, and
Cosmetic Act involving this biologic product became effective.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): January 4, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for MACI
(BLA 125603) was initially submitted on January 4, 2016.
    3. The date the application was approved: December 13, 2016. FDA
has verified the applicant's claim that BLA 125603 was approved on
December 13, 2016.
    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
application for patent extension, this applicant seeks 345 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: August 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18805 Filed 8-29-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33625-33627]
[FR Doc No: 2014-13557]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72327; File No. SR-NYSE-2014-27]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending the NYSE BBO Market Data Product Offering

June 5, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on May 23, 2014, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the NYSE BBO market data product
offering. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the NYSE BBO market data product

offering. In 2010, the Securities and Exchange Commission
(``Commission'') approved the NYSE BBO data feed and certain fees for
it.\4\ NYSE BBO is an NYSE-only market data feed that distributes on a
real-time basis the same best-bid-and-offer information that the
Exchange reports under the Consolidated Quotation (``CQ'') Plan for
inclusion in the CQ Plan's consolidated quotation information data
stream. The data feed includes the best bids and offers for all
securities that are traded on the Exchange and for which NYSE reports
quotes under the CQ Plan.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 62181 (May 26,
2010), 75 FR 31488 (June 3, 2010) (SR-NYSE-2010-30).
---------------------------------------------------------------------------

    The Exchange has determined to add information about security
status, such as whether a security is in a short sale restriction or
retail price improvement indications pursuant to NYSE Rule 107C(j), to
the NYSE BBO data feed. There will be no change to the fees for the
NYSE BBO feed in connection with this change.\5\
---------------------------------------------------------------------------

    \5\ When the security status information is added, NYSE BBO also
will be distributed in a new format, Exchange Data Protocol
(``XDP''). The feed will also include a symbol index mapping message
that will be sent once a day. These two changes do not affect the
real-time data content that is distributed.
---------------------------------------------------------------------------

    The Exchange expects to offer the current NYSE BBO data product and
the proposed NYSE BBO data product with the added security status
information at the same time for a limited transition period. After the
transition period, the Exchange will offer only the proposed NYSE BBO
with the added security status information. The Exchange will announce
the transition dates in advance.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \6\ of the
Act, in general, and furthers the objectives of Section 6(b)(5) \7\ of
the Act, in particular, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in 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, and it is not designed to permit unfair discrimination
among customers, brokers, or dealers.
---------------------------------------------------------------------------

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

    The Exchange believes that including the additional information in
NYSE BBO will provide vendors and subscribers with a more comprehensive
and higher quality market data product. The NYSE BBO data feed will
help to protect a free and open market by providing vendors and
subscribers with additional choices in receiving proprietary market
data, thus promoting competition and innovation. The Exchange believes
that NYSE BBO offers an alternative to consolidated data products and
proprietary data products offered by other exchanges.\8\ In addition,
the proposal would not permit unfair discrimination because the product
will be available to all of the Exchange's market data vendors and
customers on an equivalent basis.
---------------------------------------------------------------------------

    \8\ For example, NASDAQ Basic includes market status information
including Stock Directory, Emergency Market Condition event
messages, System Status and Trading Halt information for NASDAQ,
NYSE, NYSE MKT, NYSE Arca and other regional exchange listed issues.
See NASDAQ Rule 7047 and http://www.nasdaqtrader.com/Trader.aspx?id=NASDAQBasic.
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to consumers of such
data. It was believed that this authority would expand the amount of
data available to users and consumers of such data and also spur
innovation and competition for the provision of market data. The
Exchange believes that the data products proposed herein are precisely
the sort of market data products that the Commission envisioned when it
adopted Regulation NMS. The Commission concluded that Regulation NMS--
by lessening regulation of the market in proprietary data--would itself
further the Act's goals of facilitating efficiency and competition:

    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\9\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (File No. S7-10-04).

    By removing ``unnecessary regulatory restrictions'' on the ability
of exchanges to sell their own data, Regulation NMS advanced the goals
of the Act and the principles reflected in its legislative history. The
Exchange believes that offering NYSE BBO with the additional
information reflects innovation in its product offerings and promotes
competition for the provision of market data. The existence of
alternatives to the Exchange's products, including real-time
consolidated data and proprietary data from other exchanges, ensures
that the Exchange is not unreasonably discriminatory because vendors
and subscribers can elect these alternatives.

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. The market for proprietary
data products is currently competitive and inherently contestable
because there is fierce competition for the inputs necessary to the
creation of proprietary data. Numerous exchanges compete with each
other for listings, trades, and market data itself, providing virtually
limitless opportunities for entrepreneurs who wish to produce and
distribute their own market data. This proprietary data is produced by
each individual exchange, as well as other entities (such as
internalizing broker-dealers and various forms of alternative trading
systems, including dark pools and electronic communication networks),
in a vigorously competitive market. NYSE BBO offers an alternative to
similar products offered by other exchanges,\10\ thus promoting
competition. The existence of numerous alternatives to the Exchange's
products, including real-time consolidated data and proprietary data
from other sources, subjects the Exchange to vigorous competition.
Vendors and subscribers are free to elect these alternatives, purchase
some or all of the underlying data feeds, or choose not to purchase a
specific proprietary data product at all.
---------------------------------------------------------------------------

    \10\ See supra note 8.
---------------------------------------------------------------------------

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on

competition; and (iii) become operative prior to 30 days from the date
on which it was filed, or such shorter time as the Commission may
designate, if consistent with the protection of investors and the
public interest, provided that the self-regulatory organization has
given 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,\13\ the proposed rule change has become effective pursuant
to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \14\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2014-27 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2014-27. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of the filing will also be available
for Web site viewing and printing at the NYSE's principal office and on
its Internet Web site at www.nyse.com. 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-2014-27 and should be submitted on
or before July 2, 2014.

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

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-13557 Filed 6-10-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 2, 2009 (Volume 74, Number 62)]
[Notices]
[Page 14992]
[DOCID:fr02ap09-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0132]

Draft Guidance for Industry: Somatic Cell Therapy for Cardiac
Disease; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Somatic Cell Therapy for Cardiac Disease'' dated March 2009. The draft
guidance document provides sponsors of cellular therapies for the
treatment of cardiac disease with recommendations on the design of
preclinical and clinical studies, and information that should be
submitted about the product delivery system. This guidance also
provides recommendations on the chemistry, manufacturing and controls
information to include in an investigational new drug application (IND)
for cardiac cellular therapy.

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 on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 1, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448; or the Division of Small Manufacturers,
International, and Consumer Assistance (DSMICA), Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
    Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
    Brenda R. Friend, Center for Biologics Evaluation and Research
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448,<PHONE_NUMBER>; or
    Sabina Reilly, Center for Devices and Radiological Health (HFZ-
450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Somatic Cell Therapy for Cardiac Disease''
dated March 2009. This guidance provides to sponsors developing
cellular therapies for the treatment of cardiac disease with
recommendations including, but not limited to, the following: (1)
Design of preclinical and clinical studies; (2) information to submit
on the product delivery system; and (3) the chemistry, manufacturing
and controls information to include in an IND for cardiac cellular
therapy. This guidance also includes regulatory considerations for the
use of intravascular catheter delivery systems.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in the IND regulations (21 CFR part 312)
have been approved under OMB control number 0910-0014, and the Good
Laboratory Practice regulations (21 CFR part 58) have been approved
under OMB control number 0910-0119.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in the brackets in
the heading of this document. A copy of the draft guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7350 Filed 4-1-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Proposed Rules]
[Page 13413]
[FR Doc No: 2017-04782]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2016-0772; FRL-9958-18-Region 9]

Determination of Attainment and Approval of Base Year Emissions
Inventories for the Imperial County, California Fine Particulate Matter
Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is determining that
the Imperial County, California Moderate nonattainment area (``the
Imperial County NA'') has attained the 2006 24-hour fine particulate
matter (PM2.5) national ambient air quality standard
(NAAQS). The EPA is also approving a revision to California's state
implementation plan (SIP) consisting of the 2008 winter and annual base
year emissions inventories for the Imperial County NA submitted by
California Air Resources Board on January 9, 2015.

DATES: Any comments on this proposal must arrive by April 12, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2016-0772 at http://www.regulations.gov, or via email to Ginger
Vagenas, at<EMAIL_ADDRESS>For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be removed or edited from
Regulations.gov. For either manner of submission, the EPA may publish
any comment received to its public docket. Do not submit electronically
any information you consider to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Ginger Vagenas, EPA Region IX, (415)
972-3964<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA. This proposal pertains to the 2008 winter and
annual base year emissions inventories in a plan submitted by the
California Air Resources Board to address the attainment planning
requirements for the Imperial County NA. It also addresses our
determination (also referred to as a clean data determination or CDD)
that the Imperial County NA has attained the 2006 24-hour
PM2.5 NAAQS. In the Rules and Regulations section of this
issue of the Federal Register, we are approving the 2008 winter and
annual base year emissions inventories and making this CDD in a direct
final action without prior proposal because we believe this SIP
revision and CDD are not controversial. If, however, we receive adverse
comments we will publish a timely withdrawal of the direct final rule
and address the comments in subsequent action based on this proposed
rule. If we receive adverse comment on a distinct provision of this
rulemaking, we will publish a timely withdrawal in the Federal Register
indicating which provision we are withdrawing. The provision that is
not withdrawn will become effective on the date set out above,
notwithstanding adverse comment on the other provision.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: January 3, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-04782 Filed 3-10-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25726-25727]
[FR Doc No: 2023-08839]

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

Federal Railroad Administration

Regulations Governing Certain Positive Train Control System
Outages

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: The purpose of this notice is to inform the public about FRA's
regulations that currently govern certain outages of positive train
control (PTC) systems during, for example, infrastructure upgrades and
capital projects. This notice also contains information about the
process a railroad must follow to obtain FRA's approval before
temporarily disabling its PTC system for such purposes.

FOR FURTHER INFORMATION CONTACT: For technical questions, please
contact Gabe Neal, Staff Director, Signal, Train Control, and Crossings
Division, telephone:<PHONE_NUMBER>, email: [email protected]. For legal
questions, please contact Stephanie Anderson, Attorney Adviser,
telephone:<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION: By law, PTC systems must govern operations
on PTC-mandated main lines, which currently encompass approximately
58,000 route miles, and include Class I railroads' main lines over
which poison- or toxic-by-inhalation hazardous materials are
transported and any railroads' main lines over which intercity or
commuter rail passenger transportation is regularly provided.\1\
---------------------------------------------------------------------------

    \1\ Title 49 United States Code (U.S.C.) 20157; Title 49 Code of
Federal Regulations (CFR) 236.1005(b), 236.1006(a). This requirement
does not apply, however, to a railroad's controlling locomotives
that are subject to either a temporary or permanent exception under
49 U.S.C. 20157(j)-(k) or 49 CFR 236.1006(b).
---------------------------------------------------------------------------

    Previously, FRA's regulations permitted railroads to temporarily
disable PTC systems where necessary to perform PTC system repair or
maintenance.\2\ That temporary flexibility expired, by regulation, on
December 31, 2022.\3\ Under that temporary provision, railroads were
required only to notify to FRA; seeking FRA's approval was not
necessary.
---------------------------------------------------------------------------

    \2\ 49 CFR 236.1029(g)(3).
    \3\ Id.
---------------------------------------------------------------------------

    FRA appreciates that several types of PTC systems can be upgraded
seamlessly, without necessitating an interruption of PTC system
service. FRA also recognizes, however, that in limited cases, even
those types of PTC systems might experience temporary outages for a
short period during certain infrastructure upgrades.\4\ In addition,
FRA understands that the design of certain PTC systems, including the
Advanced Civil Speed Enforcement System II on the Northeast Corridor,
may require more extended periods of outages to facilitate ongoing
capital projects. FRA expects that, in such a case, a railroad would
schedule the temporary disabling of its PTC system for the time posing
the least risk to railroad safety and for the minimum time necessary to
complete the capital project and recommission its PTC system.\5\
---------------------------------------------------------------------------

    \4\ For example, FRA is aware of multiple railroads' electrical
infrastructure upgrade projects that involved disabling the PTC
system for a maximum period of four hours.
    \5\ See 49 CFR 236.1029(g)(3)(ii), 236.1033(f).
---------------------------------------------------------------------------

    As noted above, 49 CFR 236.1029(g)(3) previously permitted
railroads to temporarily disable their PTC systems, with just
notification to FRA; however, that provision expired on December 31,
2022, and is therefore no longer available for railroads to utilize.
Now, if a railroad needs to disable its PTC system temporarily for
maintenance or upgrade purposes, a railroad must obtain FRA's approval
under 49 CFR 236.1021, Discontinuances, material modifications, and
amendments, before temporarily disabling its PTC system or

initiating a PTC system service outage. To obtain FRA's approval in
this context, a railroad must submit a request to amend its FRA-
certified PTC system pursuant to 49 CFR 236.1021(m), which outlines the
process, content requirements, and FRA decision deadline (i.e., 45
days) for this specific type of request for amendment (RFA).
    Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will
publish a notice in the Federal Register and invite public comment, if
an RFA includes a request for approval of a material modification or
discontinuance of a PTC system. During FRA's review of a railroad's
RFA, FRA will consider any comments or data submitted within the
timeline specified in the notice and to the extent practicable, without
delaying implementation of valuable or necessary safety and functional
modifications to a PTC system. See 49 CFR 236.1021; see also 49 CFR
236.1011(e).
    In addition, 49 CFR 236.1021(f) specifies that FRA will review the
RFA, including the proposed temporary outage, and determine whether
granting the request is ``in the public interest and consistent with
railroad safety, taking into consideration all changes in the method of
operation and system functionalities, both within normal PTC system
availability and in the case of a system failed state (unavailable).''
If FRA approves the railroad's request to amend its FRA-certified PTC
system, involving a limited outage period, FRA may attach conditions to
that approval, which may include, for example, the following types of
conditions, among other reporting requirements:
    (1) The host railroad and its applicable tenant railroads must
comply with the operating rules specified in the host railroad's FRA-
approved PTCSP that would otherwise apply when a PTC system is
temporarily disabled;
    (2) The host railroad shall make reasonable efforts to schedule the
temporary disabling of its PTC system for times posing the least risk
to railroad safety;
    (3) The host railroad shall notify FRA (via
[email protected]) and each applicable tenant railroad at
least 7 days before the host railroad temporarily disables its PTC
system. In its notification, the host railroad must include the exact
date and period of time during which the PTC system will be disabled,
and explain how that date and period of time pose the least risk to
railroad safety;
    (4) The host railroad shall notify all applicable train crews,
including tenant railroads' train crews, about the PTC system outage,
including in accordance with the host railroad's operating rules and
practices, which may require, for example, such information to be
provided via track bulletins, dispatcher bulletins, or special
instructions;
    (5) The host railroad shall place its PTC system back into service
without undue delay, and the PTC system may not be disabled longer than
the approved timeframe; and
    (6) During the period in which the PTC system is temporarily
disabled, the host railroad and its tenant railroads must comply with
the operating restrictions under 49 CFR 236.1029(b), including the
applicable speed limitations.
    Please be advised that this notice focuses on outages resulting
from infrastructure upgrades or capital projects and does not address
all types of PTC system outages. Other provisions in FRA's PTC
regulations may instead apply and govern, depending on the exact
circumstances. For example, please see 49 CFR 236.1005(g) through (k)
for the requirements and procedures associated with temporary rerouting
for emergencies or planned maintenance. In addition, please see 49 CFR
236.1029(b), which outlines the requirements that apply when a
railroad's PTC system experiences an en route failure, including a cut
out or malfunction.
    FRA remains available to provide technical assistance to railroads
and other stakeholders and to advise about any railroad-specific
scenarios that may arise. FRA appreciates railroads' commitment to
operating their FRA-certified, interoperable PTC systems on PTC-
mandated main lines, as generally required by law, outside these
special, limited circumstances.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-08839 Filed 4-26-23; 8:45 am]
BILLING CODE 4910-06-P