( 2) What restrictions apply on the creditability of emission control measures for the RFP plans required under this section? Except as specifically provided in section 182( b)( 1)( C) and ( D) and section 182( c)( 2)( B) of the Act,

all emissions reductions that occur after the baseline emissions inventory year are creditable for purposes of the RFP requirements in this section, provided the reductions meet the requirements for creditability, including the need to be enforceable, permanent, quantifiable and surplus, as described for purposes of State economic incentive programs in the requirements of section 51.493 of this part.

( b) What are the general requirements for RFP for an area PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 490 subject only to subpart 1 pursuant to section 51.902( b)? An area subject only to subpart 1 pursuant to section 51.902( b)

shall meet the RFP requirements of section 172( c)( 2) of the Act as follows:

( 1) A subpart 1 area with an approved SIP pursuant to section 51.908( f) is considered to have met the RFP obligation under section 172( c)( 2) of the Act with the measures that will bring the area into attainment by the attainment date.

( 2) For each area subject to section 51.902( b) without an approved SIP pursuant to section 51.908( f), the State shall submit no later than 3 years following designation for the 8 hour NAAQS a SIP providing for RFP consistent with the following, as applicable:

( i) For each area with a requested attainment date of 5 years or less after designation for the 8 hour NAAQS,

the SIP revision shall show that all emissions reductions needed for attainment would be implemented by the beginning of the attainment year ozone season.

( ii) For each area with a requested attainment date more than 5 years after the designation for the 8 hour NAAQS, the RFP plan   ( A) Shall demonstrate increments of progress from the baseline emissions inventory year out to the PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 491 attainment date.

( B) Shall provide for a 15 percent emission reduction from the baseline year within 6 years after the baseline year.

( C) May use either NOx or VOC emission reductions ( or both) to achieve the 15 percent emission reduction requirement. Use of NOx emission reductions must meet the criteria in section 182( c)( 2)( C) of the Act.

( D) For each subsequent 3 year period out to the attainment date, shall provide for an additional increment of progress no less than the amount of emission reductions that would be proportional to the time between the end of the first increment and the attainment date.

( c) What method should a State use to calculate RFP targets?

In calculating RFP targets pursuant to this section, the State shall use the methods consistent with requirements of sections 182( b)( 1)( C) and ( D) and 182( c)( 2)( B) to properly account for the non creditable reductions when calculating RFP targets for the initial 6 year period and the subsequent 3 year periods.

( d) What is the baseline emissions inventory for RFP plans?

( 1) A baseline emissions inventory is required for the RFP plan required under this section. PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 492 ( 2) The baseline emissions inventory shall be determined at the time of designation for the 8 hour NAAQS and shall be the emissions inventory for the most recent calendar year for which a complete inventory is required to be submitted to EPA under the provisions of subpart A of this part.

( 3) For areas designated nonattainment for the 8 hour NAAQS with an effective date of June 15, 2004, the baseline emissions inventory shall be for calendar year 2002.

51.911 [ Reserved]

51.912 What requirements apply for reasonably available control technology ( RACT) and reasonably available control measures ( RACM) under the 8 hour NAAQS?

( a) What is the RACT requirement for areas subject to subpart 2 in accordance with section 51.903?

( 1) For each area subject to subpart 2 in accordance with section 51.903 of this part and classified moderate or higher, the State shall submit a SIP revision that meets the NOx and VOC RACT requirements in sections 182( b)( 2) and 182( f) of the Act.

( 2) The State shall submit the RACT SIP for each area no later than 2 years after designation for the 8 hour NAAQS.

( 3) The State shall provide for implementation of RACT as expeditiously as practicable but no later than the first PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 493 ozone season or portion thereof which occurs 30 months after the RACT SIP is due.

( b) How do the RACT provisions apply to areas required to submit a RACT?

( 1) VOC and NOx are to be considered separately for purposes of determining whether a source is a major stationary source as defined in section 302 of the Act.

( 2) States may use current EPA guidance to assist in making RACT determinations and certifications. As new or updated EPA RACT guidance becomes available, States shall consider the new information in their RACT determinations or certifications.

( c) What is the RACT requirement for areas subject only to subpart 1 pursuant to section 51.902( b)? Areas subject only to subpart 1 pursuant to section 51.902( b) are subject to the RACT requirement specified in section 172( c)( 1) of the Act.

( 1) For an area that requests an attainment date 5 years or less after designation for the 8 hour NAAQS, the State shall meet the RACT requirement by submitting an attainment demonstration SIP demonstrating that the area has adopted all control measures necessary to demonstrate attainment as expeditiously as practicable.

( 2) For an area that requests an attainment date more PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 494 than 5 years after designation for the 8 hour NAAQS, the State shall submit a SIP consistent with the requirements of section 51.912( a) and ( b) except the State shall submit the RACT SIP for each area with its attainment date extension request.

( d) What is the Reasonably Available Control Measures ( RACM) requirement for areas designated nonattainment for the 8 hour NAAQS? For each nonattainment area required to submit an attainment demonstration under section 51.908, the State shall submit with the attainment demonstration a SIP revision demonstrating that it has adopted all RACM necessary to demonstrate attainment as expeditiously as practicable and to meet any RFP requirements.

Sec. 51.913 How do the section 182( f) NOx exemption provisions apply for the 8 hour NAAQS?

( a) A person may petition the Administrator for an exemption from NOx NSR and/ or RACT requirement for any area designated nonattainment for the 8 hour ozone NAAQS and for any area in a section 184 ozone transport region.

( b) The petition must contain adequate documentation that the criteria in section 182( f) are met.

( c) A section 182( f) NOx exemption granted under the 1 hour ozone standard does not relieve the area from any requirements under the 8 hour ozone standard. PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 495 51.914 What new source review requirements apply for 8 hour ozone nonattainment area.

The requirements for a SIP's new source review provisions for the 8 hour ozone standard are located in section 51.165 of this part.

Sec. 51.915 What emissions inventory requirements apply under the 8 hour NAAQS?

For each nonattainment area subject to subpart 2 in accordance with section 51.903, the emissions inventory requirements in sections 182( a)( 1) and 182( a)( 3) of the Act shall apply, and for each nonattainment area subject only to subpart 1 in accordance with section 51.902( b), the emissions inventory requirement in section 172( c)( 3) of the Act shall apply. For purposes of meeting the emissions inventory requirements of the Act for these areas, the ozone relevant data requirements under 40 CFR 51 Subpart A apply.

51.916 What are the requirements for an Ozone Transport Region under the 8 hour NAAQS?

( a) In General. Sections 176A and 184 of the Act apply for purposes of the 8 hour NAAQS.

( b) RACT Requirements for Certain Portions of an Ozone Transport Region. The State must submit a SIP revision that meets the RACT requirements of section 184 of the Act for PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 496 each area designated as attainment or unclassifiable, or that may be classified as marginal, or that is covered under section 51.904 of this subpart, but which is located in an ozone transport region. A major stationary source for purposes of this paragraph is defined as a source which directly emits, or has the potential to emit, 100 tons per year or more of NOx or 50 tons per year or more of VOC.

The State shall submit the RACT revision no later than 2 years after the effective date of the nonattainment designation of any area in the OTR for the 8 hour NAAQS and shall provide for implementation of RACT as expeditiously as practicable but no later than 30 months after the RACT SIP is due.

PART 52  [ Amended]

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

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

Subpart A  [ Amended]

2. Section 52.21 is amended by:

a. Revising paragraph ( b)( 1)( ii).

b. Revising paragraph ( b)( 2)( ii).

c. Revising paragraph ( b)( 23)( i).

d. Revising paragraph ( b)( 50).

e. By revising the second sentence of footnote 1 to PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 497 paragraph ( i)( 5)( i)( e) to state: However, any net emissions increase of 100 tons per year or more of volatile organic compounds or nitrogen oxides subject to PSD would be required to perform an ambient impact analysis, including the gathering of ambient air quality data.

The revisions read as follows:

( b) * * *

( 1) * * *

( ii) A major source that is major for volatile organic compounds or NOx shall be considered major for ozone.

* * * * *

( 2) * * *

( ii) Any significant emissions increase ( as defined at paragraph ( b)( 40) of this section) from any emissions units or net emissions increase ( as defined in pargraph ( b)( 3) of this section) at a major stationary source that is significant for volatile organic compounds or NOx shall be considered significant for ozone.

( 23)

( i) * * *

Pollutant and Emissions Rate * * *

Ozone: 40 tpy of volatile organic compounds or NOx * * * * * PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 498 ( 50) * * *

( i) Any pollutant for which a national ambient air quality standard has been promulgated and any constituents or precursors for such pollutants identified by the Administrator ( e. g., volatile organic compounds and NOx are precursors for ozone);

3. Section 52.24 is revised to read as follows:

§ 52.24 Statutory restriction on new sources.

( a) Any area designated nonattainment pursuant to section 107( d) of the Act to which, immediately prior to the enactment of the Amendments to the Act of 1990 ( November 15,

1990), a prohibition of construction or modification of major stationary sources was applied, shall retain that prohibition if such prohibition was applied by virtue of a finding of the Administrator that the State containing such an area:

( 1) Failed to submit an implementation plan meeting the requirements of an approvable new source review permitting program; or ( 2) Failed to submit an implementation plan that provided for timely attainment of the national ambient air quality standard for sulfur dioxide by December 31, 1982.

This prohibition shall apply until the Administrator approves a plan for such area as meeting the applicable PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 499 requirements of part D of title I of the Act as amended ( NSR permitting requirements) or subpart 5 of part D of title I of the Act as amended ( relating to attainment of the national ambient air quality standards for sulfur dioxide),

as applicable.

( b) Permits to construct and operate as required by permit programs under section 172( c)( 5) of the Act may not be issued for new or modified major stationary sources proposing to locate in nonattainment areas or areas in a transport region where the Administrator has determined that the applicable implementation plan is not being adequately implemented for the nonattainment area or transport region in which the proposed source is to be constructed or modified in accordance with the requirements of part D of title I of the Act.

( c) Whenever, on the basis of any information, the Administrator finds that a State is not in compliance with any requirement or prohibition of the Act relating to the construction of new sources or the modification of existing sources, the Administrator may issue an order under section 113( a)( 5) of the Act prohibiting the construction or modification of any major stationary source in any area to which such requirement applies.

( d) The restrictions in paragraphs ( a) and ( b) of this PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 500 section apply only to major stationary sources of emissions that cause or contribute to concentrations of the pollutant ( or precursors, as applicable) for which the transport region or nonattainment area was designated such, and for which the applicable implementation plan is not being carried out in accordance with, or does not meet, the requirements of part D of title I of the Act.

( e) For any transport region or any area designated as nonattainment for any national ambient air quality standard,

the restrictions in paragraphs ( a) and ( b) of this section shall apply to any major stationary source or major modification that would be major for the pollutant ( or precursors, where applicable) for which the area is designated nonattainment or a transport region, if the stationary source or major modification would be constructed anywhere in the designated nonattainment area or transport region.

( f) The provisions in § 51.165 of this chapter shall apply in interpreting the terms under this section.

( g) At such time that a particular source or modification becomes a major stationary source or major modification solely by virtue of a relaxation in any enforceable limitation which was established after August 7,

1980, on the capacity of the source or modification PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 501 otherwise to emit a pollutant, such as a restriction on hours of operation, then:

( 1) If the construction moratorium imposed pursuant to this section is still in effect for the nonattainment area or transport region in which the source or modification is located, then the permit may not be so revised; or ( 2) If the construction moratorium is no longer in effect in that area, then the requirements of § 51.165 of this chapter shall apply to the source or modification as though construction had not yet commenced on the source or modification.

( h) This section does not apply to major stationary sources or major modifications locating in a clearly defined part of a nonattainment area or transport region ( such as a political subdivision of a State), where the EPA finds that a plan which meets the requirements of part D of title I of the Act is in effect and is being implemented in that part.

( i) [ Reserved]

( j) [ Reserved]

( k) For an area designated as nonattainment after July 1, 1979, the Emission Offset Interpretative Ruling, 40 CFR part 51, Appendix S shall govern permits to construct and operate applied for during the period between the date of designation as nonattainment and the date the part D plan is PREDECISIONAL DRAFT   DO NOT QUOTE, CITE OR DISTRIBUTE 2/ 6/ 05 502 approved.


[Federal Register Volume 86, Number 19 (Monday, February 1, 2021)]
[Notices]
[Page 7751]
[FR Doc No: 2021-02131]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting; Cancellation

Federal Register CITATION OF PREVIOUS ANNOUNCEMENT:  86 FR 6687,
January 22, 2021.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:  Wednesday, January
27, 2021 at 2:00 p.m.

CHANGES IN THE MEETING:  The Closed Meeting scheduled for Wednesday,
January 27, 2021 at 2:00 p.m., has been cancelled.

CONTACT PERSON FOR MORE INFORMATION:  For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

     Dated: January 27, 2021.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-02131 Filed 1-28-21; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Notices]
[Pages 22363-22364]
[FR Doc No: 2013-08745]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Environmental Impact Statement for the All Aboard Florida Miami--
Orlando Passenger Rail Project

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

ACTION: Notice of intent to prepare an Environmental Impact Statement
(EIS).

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SUMMARY: FRA is issuing this notice to advise the public that FRA will
prepare an Environmental Impact Statement (EIS) to evaluate the
potential environmental and related impacts of constructing and
operating an intercity passenger rail service proposed by the private
company, All Aboard Florida--Operations LLC (AAF), between Miami and
Orlando, Florida, with intermediate stops in Fort Lauderdale and West
Palm Beach, Florida (Proposed Action). FRA will evaluate alternatives
for construction and operation of the Proposed Action, which would
include infrastructure improvements to existing rail corridor right-of-
way between Miami and Cocoa, and the development of a new rail corridor
between Cocoa and Orlando. FRA will also evaluate a No Action (No
Build) Alternative. FRA is issuing this notice to solicit public and
agency input into the development of the scope of the EIS and to advise
the public that outreach activities conducted by FRA, AAF and its
representatives will be considered in the preparation of the EIS. To
ensure all significant issues are identified and considered, the public
is invited to comment on the scope of the EIS, including the purpose
and need, alternatives to be considered, impacts to be evaluated, and
methodologies to be used in the evaluation.

DATES: FRA invites the public, governmental agencies, and all other
interested parties to comment on the scope of the EIS. All such
comments should be provided to FRA, in writing, within thirty (30) days
of the publication of this notice, at the address listed below.
Comments may also be provided orally or in writing at the scoping
meetings for the Project. Scoping meeting dates, times and locations,
in addition to related Project information can be found online at
www.allaboardflorida.com or www.fra.dot.gov.

ADDRESSES: Written comments on the scope of the EIS may be mailed or
emailed within thirty (30) days of the publication of this notice to
Catherine Dobbs, Transportation Industry Analyst, Office of Railroad
Policy and Development, Federal Railroad Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590, or<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Ali Soule, Public Affairs Manager, All
Aboard Florida--Operations LLC, 2855 LeJeune Road, 4th Floor, Coral
Gables, FL 33134<EMAIL_ADDRESS>or Catherine Dobbs,
Transportation Industry Analyst, Office of Railroad Policy and
Development, Federal Railroad Administration, 1200 New Jersey Avenue
SE., Washington, DC 20590<EMAIL_ADDRESS>Information and
documents regarding the EIS process will also be made available through
the FRA Web site at www.fra.dot.gov and the AAF Web site at
www.allaboardflorida.com.

SUPPLEMENTARY INFORMATION: FRA is preparing an EIS for a 235-mile
intercity passenger railroad system proposed by AAF that will connect
Orlando and Miami, Florida, with intermediate stops in Fort Lauderdale
and West Palm Beach, Florida (Project). The proposed Project is
composed of two connected corridors: (1) A north-south corridor of
approximately 195 miles from Miami to Cocoa within an existing rail
right-of-way, and (2) an east-west corridor of approximately 40 miles
from Cocoa to the Orlando International Airport (MCO). The EIS will
evaluate the potential environmental and related impacts of
constructing and operating the Project within these corridors in
Florida.

Environmental Review Process

    The EIS will be developed in accordance with the Council on
Environmental Quality (CEQ) regulations (40 CFR part 1500 et. seq.)
implementing the National Environmental Policy Act of 1969 (42 U.S.C.
4321 et seq.) (NEPA) and FRA's Procedures for Considering Environmental
Impacts (64 FR 28545, May 26, 1999). In addition to NEPA, the EIS will
address other applicable statutes, regulations and executive orders,
including the 1980 Clean Air Act Amendments, Section 404 of the Clean
Water Act, the National Historic Preservation Act, Section 4(f) of the
Department of Transportation Act, the Endangered Species Act and
Executive Order 12898 on Environmental Justice. The EIS will consider
alternatives that could include the use of, or access over, an
interstate right-of-way and thus may involve the Federal Highway
Administration. The Project's new corridor from Cocoa to MCO may
involve alteration and fill of waters of the United States and thus the
EIS process will involve the US Army Corps of Engineers, which is
expected to serve as a cooperating agency. The Project is proposed to
terminate at MCO, the Orlando International Airport, and thus may
require review pursuant to the applicable requirements of the Federal
Aviation Administration. The purpose of the EIS will be to provide the
FRA, reviewing and cooperating agencies, and the public with
information to assess alternatives that will meet the Project's purpose
and need; to evaluate the potential environmental impacts; and to
identify potential avoidance/mitigation measures, associated with the
proposed Project alternatives.

Project Background

    Florida has historically experienced major population, employment,
and tourism growth, which is expected to continue in the coming
decades. Florida's travelers are subject to chronic congestion and
delays due to inadequate roadway capacity. The limited capacity results
in higher road maintenance costs, increased fuel consumption, greater
emissions and increased traffic incidents stemming from the high
traffic volume. Significant roadway expansion along the I-95 corridor
would be expected to cause a large number of displacements and other
substantial environmental impacts while failing to provide an
alternative to automobile travel.
    As an alternative to additional highway development, this Project
would help meet the existing need and demand for safe, convenient, and
reliable transportation through the development of a privately-owned,
operated and maintained intercity passenger rail service between four
stations in Orlando, West Palm Beach, Fort Lauderdale, and Miami.
Development of passenger rail will also support economic development by
generating new revenue and creating

jobs and fulfill several public policy objectives concerning the
environment.
    AAF is a subsidiary of Florida East Coast Industries, Inc. (FECI),
which is a transportation, infrastructure and commercial real estate
company based in Coral Gables, Florida. Florida East Coast Railway,
L.L.C. (FECR), an affiliate of FECI, owns the right-of-way and existing
railroad infrastructure within the corridor between Miami and
Jacksonville, over which FECR operates a freight rail service (FEC
Corridor). AAF has an exclusive, perpetual easement granted by FECR
whereby AAF may develop and operate the proposed passenger service
within the FEC Corridor. AAF will operate the proposed passenger rail
service within the FEC Corridor in coordination with FECR's continued
freight service. AAF is working to secure access to use the right-of-
way of State Road 528 between Cocoa and MCO through a combination of
passenger rail leases and easements.
    FRA issued a finding of no significant impact on January 31, 2013
for passenger rail service and rail and station improvements proposed
by AAF between Miami, Fort Lauderdale and West Palm Beach. These
improvements would return this 66 mile portion of the FEC Corridor to
its historic dual-track system, providing fast, dependable and
efficient passenger rail service between West Palm Beach and Miami. The
proposed Miami to Orlando passenger rail project would expand this
initial service to MCO.
    The proposed Project would use stations developed for the Miami to
West Palm Beach project that will be located in the central business
districts of Miami, Fort Lauderdale, and West Palm Beach, supporting
development in these urban centers. The proposed station at MCO is
expected to be developed by the Greater Orlando Airport Authority as
part of a $1 billion South Terminal Expansion that will include a
3,500-space parking garage and the development of a multi-modal depot.
    As proposed, 195 miles of the Project would operate within an
active freight rail corridor that has existed for more than 100 years.
Proposed alternatives for the remaining 40 miles connecting Cocoa and
Orlando generally parallel the existing State Road 528 right-of-way.

Scoping and Public Involvement

    FRA encourages broad participation in the EIS process during
scoping and review of the resulting environmental documents. Comments
are invited from all interested agencies and the public to ensure the
full range of issues related to the Proposed Action are addressed,
reasonable alternatives are considered, and significant issues are
identified. In particular, FRA is interested in identifying areas of
environmental concern where there might be a potential for significant
impacts. Public agencies with jurisdiction are requested to advise FRA
and AAF of the applicable permit and environmental review requirements
of each agency, and the scope and content of the environmental
information that is germane to the agency's statutory responsibilities
in connection with the proposed Project. Public agencies are requested
to advise FRA if they anticipate taking a major action in connection
with the proposed Project and if they wish to cooperate in the
preparation of the EIS.
    Public scoping opportunities and meetings will be scheduled as
described above and are an important component of the scoping process
for Federal environmental review. FRA is seeking participation and
input of interested Federal, State, and local agencies, Native American
groups, and other concerned private organizations and individuals on
the scope of the EIS. The Project may affect historic properties and
may be subject to the requirements of Section 106 of the National
Historic Preservation Act of 1966 (NHPA) (16 U.S.C. 470(f)). In
accordance with regulations issued by the Advisory Council on Historic
Preservation (36 CFR part 800), FRA intends to coordinate compliance
with Section 106 of the NHPA with the preparation of the EIS, beginning
with the identification of consulting parties through the scoping
process, in a manner consistent with the standards set out in 36 CFR
800.8.

    Issued in Washington, DC, on April 5, 2013.
Corey Hill,
Director, Passenger and Freight Programs.
[FR Doc. 2013-08745 Filed 4-12-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44425-44426]
[FR Doc No: 2017-20263]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5525]

Statistical Approaches To Evaluate Analytical Similarity; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Statistical Approaches to Evaluate Analytical Similarity.'' This
draft guidance, when finalized, will provide advice on the evaluation
of analytical similarity to sponsors interested in developing
biosimilar products. Specifically, this draft guidance describes the
type of information a sponsor of a proposed biosimilar product should
obtain about the structural/physicochemical and functional attributes
of the reference product, how that information is used in the
development of an analytical similarity assessment plan for the
proposed biosimilar, and the statistical approaches recommended for
evaluating analytical similarity.

DATES: Submit either electronic or written comments on the draft
guidance by November 21, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2017-D-5525 for ``Statistical Approaches to Evaluate Analytical
Similarity; Draft Guidance for Industry; Availability.'' Received
comments 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 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002, or the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests. See the SUPPLEMENTARY

INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Scott N. Goldie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD
20993-0002,<PHONE_NUMBER> or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Statistical Approaches to Evaluate Analytical Similarity.''
This draft guidance, when finalized, will provide advice on the
evaluation of analytical similarity to sponsors interested in
developing biosimilar products for licensure under section 351(k) of
the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). This
evaluation is performed to support a demonstration that the proposed
biosimilar is highly similar to a reference product licensed under
section 351(a) of the PHS Act.
    Specifically, this draft guidance, when finalized, will describe
the type of information that the sponsor of a proposed biosimilar
product should obtain about the structural/physicochemical and
functional attributes of the reference product, how that information is
used in the development of an analytical similarity assessment plan for
the proposed biosimilar, and the statistical approaches recommended for
evaluating analytical similarity.
    The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) created an abbreviated licensure pathway under section 351(k) of
the PHS Act for biological products shown to be biosimilar to or
interchangeable with a U.S.-licensed biological reference product (see
sections 7001 through 7003 of Pub. L. 111-148). As described in section
351(k)(2)(A)(i)(I)(aa) of the PHS Act, an application for a proposed
biosimilar product must include information demonstrating biosimilarity
based on data derived from, among other things, ``analytical studies
that demonstrate that the biological product is highly similar to the
reference product notwithstanding minor differences in clinically
inactive components.''
    This draft guidance is one in a series of guidance documents
intended to implement the BPCI Act. It serves as a companion document
to the guidance for industry entitled ``Quality Considerations in
Demonstrating Biosimilarity of a Therapeutic Protein Product to a
Reference Product'' (April 30, 2015, 80 FR 24257). The Quality
Considerations guidance describes the Agency's recommendations to
sponsors on the scientific and technical information, including the
analytical studies to support a demonstration that a proposed
biosimilar is highly similar to the U.S.-licensed reference product,
for the chemistry, manufacturing, and controls section of a marketing
application for a proposed biosimilar product.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on statistical
approaches to evaluating analytical similarity. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft 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). This
includes information collections related to: (1) The submission of an
investigational new drug application, which is covered under 21 CFR
part 312 and approved under OMB control number 0910-0014; (2) the
submission of a new drug application, which is covered under 21 CFR
314.50 and approved under OMB control number 0910-0001; (3) the
submission of a biologics license application under section 351(k) of
the PHS Act, which is covered under 21 CFR part 601 and approved under
OMB control number 0910-0719; and (4) meetings between FDA and
applicants or sponsors of a biologics license application under section
351(k) of the PHS Act, which is approved under OMB control number 0910-
0802.

III. Electronic Access

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

    Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20263 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 December 14, 2001 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Dr. Bruce Alberts President National Academy of Sciences 2101 Constitution Avenue, NW Washington, D. C. 20418 Dear Dr. Alberts:

I am writing to request that the National Academy of Sciences ( NAS) provide recommendations to the Agency to help address the scientific and ethical questions related to whether to accept, consider, or rely on research involving deliberate exposure of human subjects to toxicants when used to identify or quantify toxic endpoints. The Agency asks that the Academy review these issues and provide recommendations that will help EPA develop appropriate factors and criteria to apply when it makes these difficult decisions. The advice of the Academy will be weighed heavily as we develop and implement a policy to govern these decisions in future.

The Agency's particular focus of concern is on studies which, since they are not conducted or supported by a federal agency, may not be performed subject to regulations that protect human subjects, such as EPA's Protection of Human Subjects Rule (" the Common Rule"), 40 CFR 26. We are particularly concerned about ` third party' studies submitted by regulated entities for the Agency's consideration. For these purposes, EPA is considering " third party studies" as studies that have not been conducted or funded by a federal agency pursuant to regulations that protect human subjects. These types of studies generally come to the Agency's attention only after the research has been completed and reported. At this point it is generally too late for the Common Rule requirements to apply since these requirements cover prior review and approval of proposed research, involving fully informed, voluntary consent of the participants to protect the subjects in the research.

One particular concern of the Agency is for determining the acceptability of third party research designed to identify or quantify toxic endpoints in human subjects, such as those done to define a No Observed Adverse Effect Level ( NOAEL) or No Observed Effect Level ( NOEL) for systemic toxicity in humans. Studies of this kind are submitted to the agency from time to time, and have been evaluated prior to regulatory decision in several Agency programs. In the recent past most such submissions have been of studies designed to define a NOAEL for pesticide toxicity in humans. 2 EPA asks the Academy to undertake a critical review of appropriate standards for the scientific and ethical assessment of research entailing deliberate dosing of human subjects with toxic agents. This review should incorporate and be informed by an early open, public, participatory process through which interested people can express their suggestions or concerns to the Academy reviewers.

The Agency subscribes fully to the principles of the Common Rule and the related rules of other federal agencies, as they protect the human subjects of research conducted or supported by the federal government. We are pleased with our record of compliance with the Common Rule in our own research, and of the favorable review by our human subjects protection program in a recent survey by the National Bioethics Advisory Commission.

The Agency will consider the Academy's advice resulting from this review as we develop a policy to guide its future decisions to accept, consider, or rely on such studies in regulatory decision making. As the Academy evaluates the scientific rationale and the ethical framework for these studies, it would be most helpful if the Academy would include in its general advice responses to the following questions:

$ What factors should the Agency consider in determining whether to accept, consider, or rely on human studies performed by third parties? Are there clear boundaries between acceptable and unacceptable human research? If so, what are they? If not, what range of factors should the agency consider, and how should these factors be applied in making decisions to accept, consider, or rely on specific research?

$ What range of information should the Agency consider in determining whether completed research with human subjects conducted by third parties was conducted in compliance with the appropriate ethical standards, such as the Declaration of Helsinki, which may be cited in the research report?

$ Do criteria such as those in the Common Rule provide an adequate framework for assessing the scientific and ethical acceptability of such studies? Should such a standard, designed to protect human participants in research, be applied after the fact to completed research conducted by third parties to determine whether it is acceptable as the basis for regulatory action?

$ Are there other standards, such as the Declaration of Helsinki or various standards of good clinical practice, relevant to assessing acceptability of research to define or quantify toxic endpoints in human research subjects? Should standards intended to govern human safety studies for diagnostic or therapeutic agents be applied to research involving deliberate exposures to environmental toxins?

I look forward to meeting with you soon to work out the details and timing of your review, and to a constructive collaboration on this project.

Sincerely, 3 Stephen L. Johnson Assistant Administrator cc: E. William Colglazier Ann Marie Mazza


Panel Members for the Meeting of the Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (FIFRA SAP)

to consider and review

Selected Issues Associated with the Risk Assessment Process for Pesticides with Persistent, Bioaccumulative and Toxic Characteristics

October 28-31, 2008

Docket number:  EPA-HQ-OPP-2008-0550			OPP Docket Tel:<PHONE_NUMBER>

FIFRA SAP Chair

Steven G. Heeringa, Ph.D.

Research Scientist & Director for Statistical Design

University of Michigan Institute for Social Research

Ann Arbor, Michigan

Designated Federal Official

Myrta Christian, M.S.

US Environmental Protection Agency

Office of Science Coordination & Policy

FIFRA Scientific Advisory Panel

EPA East Building, MC 7201M

1200 Pennsylvania Avenue, NW

Washington, DC  20460

Tel:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,   HYPERLINK <EMAIL_ADDRESS><EMAIL_ADDRESS>

FIFRA Scientific Advisory Panel Members

John R. Bucher, Ph.D., DABT

Associate Director

Environmental Toxicology Program

National Institute of Environmental Health Sciences

Research Triangle Park, North Carolina

Janice E. Chambers, Ph.D., DABT, ATS

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, Mississippi

Kirby C. Donnelly, Ph.D.

Professor and Head

Department of Environmental and Occupational Health

School of Rural Public Health

Texas A&M University System Health Science Center

College Station, Texas

Kenneth M. Portier, Ph.D.

Program Director, Statistics

American Cancer Society

National Home Office

Atlanta, Georgia

Carey N. Pope, Ph.D.

Professor, Head & Sitlington Chair of Toxicology

Department of Physiological Sciences

Oklahoma State University College of Veterinary Medicine

Stillwater, Oklahoma

Daniel Schlenk, Ph.D.

Professor of Aquatic Ecotoxicology & Environmental Toxicology

Department of Environmental Sciences

University of California, Riverside

Riverside, California

FQPA Science Review Board Members

Linda Abbott, Ph.D.

Regulatory Risk Analyst

Office of Risk Assessment and Cost-Benefit Analysis

United States Department of Agriculture

Washington, D.C.

Terry F. Bidleman, Ph.D.

Senior Research Scientist

Air Quality Research Division

Centre for Atmospheric Research Experiments

Environment Canada

Egbert, Ontario

CANADA

Peter DeLorme, Ph.D.

Senior Science Advisor

Environmental Assessment Directorate

PMRA, Health Canada

Ottawa, Ontario

CANADA

William J. Doucette, Ph.D.

Professor

Department of Civil & Environmental Engineering

Utah Water Research Laboratory

Center for Environmental Toxicology

Utah State University

Logan, Utah

Jay Gan, Ph.D.

Water Quality Specialist

Professor and Chair

Department of Environmental Sciences

University of California

Riverside, California

James W. Gillett, Ph.D.

Professor Emeritus of Natural Resources

Cornell University

Ithaca, New York

Brendan Hickie, Ph.D.

Assistant Professor

Environmental & Resource Studies Program

Trent University

Peterborough, Ontario

CANADA

Wilbert J. Lick, Ph.D.

Research Professor

Department of Mechanical Engineering

University of California

Santa Barbara, California

Randy L. Maddalena, Ph.D.

Research Scientist

Environmental Energy Technology Division

Indoor Environment Department

Lawrence Berkeley National Laboratory

Berkeley, California

James Meador, Ph.D.

Environmental Toxicologist

NOAA Fisheries, Northwest Fisheries Science Center

Ecotoxicology and Environmental Fish Health Program

Seattle, Washington

Ashish J. Mehta, Ph.D.

Professor, Department of Civil and Coastal Engineering

University of Florida

Gainesville, Florida

James T. Oris, Ph.D.

Associate Dean for Research and Scholarship

Professor

Department of Zoology

Miami University of Ohio

Oxford, Ohio

Staci L. Simonich, Ph.D.

Associate Professor

Department of Environmental and Molecular Toxicology

and Department of Chemistry

Oregon State University

Corvallis, Oregon

Tammo S. Steenhuis, Ph.D.

Professor of Watershed Management

Department of Biological and Environmental Engineering

Cornell University

Ithaca, New York

Louis J. Thibodeaux, Ph.D.

Jesse Coates Professor of Engineering

Gordon A. & Mary Cain Department of Chemical Engineering

Chair Geology and Geophysics

Emeritus Director of Hazardous Substance Research Center (S/SW)

Louisiana State University

Baton Rouge, Louisiana


From:
"Ulatowski, Rhiannon"<EMAIL_ADDRESS>Sent:
Wed, 07 Dec 2022 07:27:08
To:
"Jones; DonnaLee"<EMAIL_ADDRESS>"French; Chuck"<EMAIL_ADDRESS>GABRIELLE RAYMOND<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>"McGinn; Kevin"<EMAIL_ADDRESS>"Shappley; Ned"<EMAIL_ADDRESS>Cc:
Kistler, Katie E<EMAIL_ADDRESS>Zavoda, Rich<EMAIL_ADDRESS>Beranek, Rob<EMAIL_ADDRESS>Maicher, Thomas W<EMAIL_ADDRESS>Kurdila, Julianne<EMAIL_ADDRESS>Subject:
RE: Cleveland-Cliffs Steel  -  Burns Harbor, IN - Cooling tower tests
Good morning, Dr. Jones,

Cleveland-Cliffs Burns Harbor does not have a cooling tower in the Coke Plant By-Product Recovery Plant.  Therefore, this testing is not applicable.  Please call me if you have any questions.

Thank you,

Rhiannon ulatowski
Environmental Engineer-Air
p<PHONE_NUMBER>   m<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>CLEVELAND-CLIFFS INC.

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Tuesday, December 6, 2022 11:50 AM
To: Ulatowski, Rhiannon<EMAIL_ADDRESS>French, Chuck<EMAIL_ADDRESS>GABRIELLE RAYMOND<EMAIL_ADDRESS><EMAIL_ADDRESS>McGinn, Kevin<EMAIL_ADDRESS>Shappley, Ned<EMAIL_ADDRESS>Cc: Kistler, Katie E<EMAIL_ADDRESS>Zavoda, Rich<EMAIL_ADDRESS>Beranek, Rob<EMAIL_ADDRESS>Maicher, Thomas W<EMAIL_ADDRESS>Kurdila, Julianne<EMAIL_ADDRESS>Subject: [EXTERNAL] RE: Cleveland-Cliffs Steel  -  Burns Harbor, IN - Cooling tower tests

Hi. I don't see any submittal for your Burns Harbor cooling tower test report. I apologize if I've missed it. Can you please tell me the status if you are still working on it? Thanks

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 (D243-02)
Research Triangle Park, NC  27711
Tele:<PHONE_NUMBER>
--------------------------------------------------------------------------------
Fax<PHONE_NUMBER>
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Ulatowski, Rhiannon<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Sent: Wednesday, November 30, 2022 1:15 PM
To: Jones, DonnaLee<EMAIL_ADDRESS><EMAIL_ADDRESS>>; French, Chuck<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Cc: Kistler, Katie E<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Zavoda, Rich<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Beranek, Rob<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Maicher, Thomas W<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Kurdila, Julianne<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Subject: Cleveland-Cliffs Steel  -  Burns Harbor, IN Coke Ovens Section 114 Request - Enclosure 2 Submittals

Dear Mr. French and Dr. Jones:

Attached are Enclosure 2 responses to the Coke Clean Air Act Section 114 Information Collection Request (ICR) dated June 28, 2022, for Cleveland-Cliffs Burns Harbor LLC .  The EPA-provided Excel answer files, Method 22 sheets, and certifications are attached to this email.

Please let me know if you have any questions,

Rhiannon ulatowski
Environmental Engineer-Air
p<PHONE_NUMBER>   m<PHONE_NUMBER>
<EMAIL_ADDRESS>CLEVELAND-CLIFFS INC.


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Pages 69314-69316]
[FR Doc No: 2011-28829]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65666; File No. SR-Phlx-2011-118]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change Relating to Transfer of Positions Off
the Floor

November 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on October 20, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been

prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange, pursuant to Section 19(b)(1) of the Act \3\ and Rule
19b-4 thereunder,\4\ proposes a new Exchange Rule 1058 entitled
``Transfer of Positions'' to provide a process by which members and
member organizations may transfer option positions in limited
circumstances.
---------------------------------------------------------------------------

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

    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant 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 the proposed rule change is to provide members and
member organizations a mechanism in which to transfer option positions
in certain specified circumstances. The Exchange is proposing to amend
its Rules to adopt a new Exchange Rule 1058, entitled ``Transfer of
Positions.'' \5\ The purpose of this Rule is to address narrowly-
defined transfers of option positions between accounts, individuals, or
entities and codify a current policy at the Exchange for off the floor
transfers.
---------------------------------------------------------------------------

    \5\ Exchange Rule 1058 is currently reserved. The Exchange
proposes to delete the word ``Reserved'' and insert this new Rule in
its place.
---------------------------------------------------------------------------

    Currently, Exchange Rules do not specifically address transfers of
option positions between accounts, individuals or entities. The
Exchange, however, has made exceptions to allow off the floor transfers
in situations similar to those permitted on other exchanges. The
proposed rule would formalize the Exchange's policies with respect to
off the floor transfers of options positions in certain limited
circumstances.
    Specifically, the Exchange would permit off the floor transfers of
options listed on the books of member or member organization only if
such transfer involves one or more of the following events: (i) The
dissolution of a joint account in which the remaining member or member
organization assumes the positions of the joint account; (ii) the
dissolution of a corporation or partnership in which a former nominee
of that corporation or partnership assumes the positions; (iii)
positions transferred as part of a member or member organization's
capital contribution to a new joint account, partnership, or
corporation; (iv) the donation of positions to a not-for-profit
corporation; (v) the transfer of positions to a minor under the Uniform
Gifts to Minors Act; (vi) a merger or acquisition resulting in a
continuity of ownership or management; or (vii) consolidation of
accounts within a member or member organization. The members and member
organizations would be required to provide the Exchange with prior
written notice of the transfer, specifically the positions to be
transferred and the reason for the transfer.
    The proposed Exchange Rule 1058 provides that members and member
organizations must transfer positions pursuant to this Rule at the same
prices that appear on the books of the transferring member or member
organization,\6\ and the transfer must indicate the date when the
original trade was made. In the course of transferring positions, no
position shall net itself against another position.\7\ Each member or
member organization that is a party to a transfer of positions would be
required to make and retain records which include: (i) The nature of
the transaction; (ii) the name of the counter-party; and (iii) any
other information required by the Exchange.\8\
---------------------------------------------------------------------------

    \6\ The same cost basis would apply to the positions once they
have been transferred.
    \7\ Long positions and short positions will not be permitted to
``net'' against each other. For example, if a member desired to
transfer 100 long calls into another account that contained 100
short calls of the same options series along with other positions,
and the transfer met one of the above permitted exceptions, that
transfer of the offsetting options series could not occur pursuant
to this Rule because those positions would net against each other
resulting in a closing of the position. The member would be required
to trade out of that position as per the Exchange's Rules, either on
the floor or electronically.
    \8\ Records should be maintained in accordance with the member
or member organization's books and records policy and in conformity
with Rules 17a-3 and 17a-4 of the Act.
---------------------------------------------------------------------------

    The Exchange believes that permitting off the floor transfers in
very limited circumstances such as where there is no change is
beneficial ownership, to contribute to a non-profit corporation, to
transfer to a minor or a transfer by operation of law is reasonable to
allow a member or member organization to accomplish certain goals
efficiently. The Exchange is seeking to memorialize its current policy
regarding off the floor transfers in order to allow its members to
transfer positions in the same manner as on other exchanges.\9\
---------------------------------------------------------------------------

    \9\ The Chicago Board Options Exchange, Incorporated (``CBOE'')
and NYSE Arca, Inc. (``NYSE Arca'') permit members to effect off-
floor transfers in certain circumstances. See CBOE Rule 6.49A. See
also NYSE ARCA Rule 6.78.
---------------------------------------------------------------------------

    The above-referenced exceptions would allow the Exchange to permit
transfers in situations involving dissolutions of entities or accounts,
for purposes of donations, mergers or by operation of law. For example,
a member that is undergoing a structural change and a one-time movement
of positions may require a transfer of positions or a member is leaving
a firm that will no longer be in business may require a transfer of
positions to another firm. Also, a member may require a transfer of
positions to make a capital contribution. The above-referenced
circumstances are situations where the transferor continues to maintain
some ownership interest or manage the positions transferred.
    To date, the Exchange has permitted such off-the floor transfers in
limited circumstances and this Rule seeks to codify the specific
circumstances where off the floor transfers of positions would be
permitted.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \10\ in general, and furthers the objectives of Section
6(b)(5) of the Act \11\ in particular, in that it is designed to
promote just and equitable principles of trade, 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, by providing an accommodation for members and member
organizations who desire to transfer options positions. The Exchange
believes that establishing a new Rule which provides clear

guidelines on when such off the floor transfers would be permissible
would assist members and member organizations seeking to transfer
positions and provide notification to the Exchange.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The primary reason that members prefer to transfer positions as
opposed to trading out of them is that transferring positions affords a
reduction in administrative overhead and cost. In the typical
situation, a member is undergoing a structural change and a one-time
movement of positions offers efficiency in that process. The Exchange
believes that this new Exchange Rule 1058 would allow members and
member organizations the opportunity to efficiently and effectively
transfer their option positions in limited situations off the floor.
    The Exchange believes that the proposed rule creates an orderly
process for allowing such transfers. The Rule serves to protect
investors and the public interest because the proposed Rule permits
transfers off-floor only in limited instances.

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 not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2011-118 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-Phlx-2011-118. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
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 Number SR-Phlx-2011-118 and should be
submitted on or before November 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-28829 Filed 11-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 3, 2007 (Volume 72, Number 191)]
[Notices]
[Page 56425-56427]
[DOCID:fr03oc07-116]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56545; File No. SR-NYSEArca-2007-95]

Self-Regulatory Organizations; NYSEArca, Inc.; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend Rules
7.34 and 7.35

September 27, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 17, 2007, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange''), through its wholly owned subsidiary, NYSE Arca Equities,
Inc. (``NYSE Arca Equities'' or ``Corporation''), filed with the
Securities and Exchange Commission (``Commission'' or ``SEC'') the
proposed rule change as described in Items I, II and III below, which
Items have been substantially prepared by the Exchange. NYSE Arca has
designated this proposal pursuant to Section 19(b)(3)(A) of the Act \3\
and Rule 19b-4(f)(5) \4\ thereunder, which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(5).
---------------------------------------------------------------------------

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

    The Exchange proposes, among other minor changes, to amend NYSE
Arca Equities Rule 7.35 in order to reduce the Opening, Market Order,
and Closing auction lock-out period to one minute. The text of the
proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.nyse.com.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has substantially 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 Exchange proposes to amend NYSE Arca Equities Rule 7.35 in
order to reduce the Opening, Market Order, and Closing Auction lock-out
periods to one minute.\5\ The Exchange believes that compressing the
lock-out periods will offer its Users \6\ greater order entry or
cancellation flexibility and more informed market participation by
allowing its Users to benefit from the dissemination of auction related
information for an additional minute prior to the lock-out periods.
---------------------------------------------------------------------------

    \5\ NYSE Arca Equities Rule 7.34(a) provides for three equities
trading sessions on the Exchange: The Opening Session (4 a.m. to
9:30 a.m. Eastern Time (``E.T.'')), the Core Trading Session (9:30
a.m. to 4 p.m. E.T.), and the Late Trading Session (4 p.m. to 8 p.m.
E.T.).
    \6\ See NYSE Arca Rule 1.1(yy) for the definition of ``User.''
---------------------------------------------------------------------------

Opening Auction
    Pursuant to NYSE Arca Rule 7.35(a)(4), Users are currently
prevented from cancelling orders that are eligible

for the Opening Auction in the last two minutes prior to the Opening
Session until the conclusion of the Opening Auction. The Exchange
proposes to reduce this freeze or lock-out period to one minute.
Market Order Auction
    Pursuant to NYSE Arca Rule 7.35(c)(2), Users are also currently
prevented from entering certain orders for the final two minutes before
the Opening Auction and the Start of the Exchange's Core Trading
Session. Specifically, Market Orders and Auction-Only Limit Orders may
not be entered on the same side as the imbalance between 6:28 a.m.
(Pacific Time) and the conclusion of the Market Order Auction. Also,
Limited Price Orders not eligible for the Opening Session, Market
Orders, Auction-Only Limit Orders, and Cleanup Orders may not be
cancelled between 6:28 a.m. (Pacific Time) and the conclusion of the
Market Order Auction. The Exchange proposes herein to amend NYSE Arca
Rule 7.35(c)(2)(A)(1)(iii) and NYSE Arca Rules 7.35(c)(2)(A)(2) & (3)
to compress these freeze or lock-out periods to one minute. In
addition, the Exchange proposes to amend NYSE Arca Rules 7.35(d)(1) &
(2) in order to compress the lock-out periods governing the execution
eligibility of Limit Price Orders and Market Orders entered before the
Market Order Auction to one minute, from 6:28 a.m. (Pacific Time) to
6:29 a.m. (Pacific Time). Similarly, the Exchange proposes amending
Rule 7.34(d)(1)(H) to permit Limit Price Orders designated for the Core
Trading Session, entered for an additional minute up until 6:29 a.m.
(Pacific Time) (instead of 6:28 a.m. Pacific Time), to participate in
the Market Order Auction.
Closing Auction
    Further, according to NYSE Arca Rule 7.35(e)(2)(B), Market-on-Close
Orders and Limit-on-Close Orders may not be cancelled between 12:58
p.m. (Pacific Time) and the conclusion of the Closing Auction. In
addition, according to NYSE Arca Rule 7.35(e)(2)(C), Market-on-Close
Orders and Limit-on-Close Orders may not be entered on the same side as
the imbalance between 12:58 p.m. (Pacific Time) and the conclusion of
the Closing Auction. The Exchange proposes to compress the lock-out
periods for either entering or cancelling certain orders preceding the
Closing Auction, as described above, from two minutes to one minute.
Exchange Traded Funds
    The Closing Auction for Exchange Traded Funds (``ETFs'') commences
at 1:15 p.m. (Pacific Time). Pursuant to NYSE Arca Rule 7.35(e)(3)(E),
Closing Auctions for ETFs follow the same two-minute freeze or lock-out
limitations described above. Specifically, Market-on-Close Orders and
Limit-on-Close Orders may not be cancelled, and Market-on-Close Orders
and Limit-on-Close Orders may not be entered on the same side as the
imbalance between 1:13 p.m. (Pacific Time) and the conclusion of the
Closing Auction.\7\ Consistent with the above described rule change
pertaining to Closing Auctions, the Exchange proposes reducing this
lock-out period to one minute.
---------------------------------------------------------------------------

    \7\ Pursuant to telephone conversation between Hong-Anh Tran,
Special Counsel, Division of Market Regulation, and Andrew Stevens,
Assistant General Counsel, Exchange, dated September 19, 2007.
---------------------------------------------------------------------------

    By compressing the lock-out periods to one minute as described
above, Users will benefit from the dissemination of auction related
information for an additional minute resulting in greater order entry
or cancellation flexibility and more informed market participation. The
Exchange intends this system change to be effective on filing and
operative on September 17, 2007.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \8\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \9\ in particular, because 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, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    Because the foregoing proposed rule change effects a change in an
existing order-entry or trading system of a self-regulatory
organization that: (i) Does not significantly affect the protection of
investors or the public interest; (ii) does not impose any significant
burden on competition; and (iii) does not have the effect of limiting
the access to or availability of the system, it has become effective
pursuant to Section 19(b)(3)(A) \10\ of the Act and Rule 19b-4(f)(5)
\11\ thereunder. At any time within 60 days of the filing of such
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.
---------------------------------------------------------------------------

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

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-NYSEArca-2007-95 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-95. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the

Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for inspection and copying in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2007-95 and should be submitted on or before
October 24, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-19535 Filed 10-2-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62593-62595]
[FR Doc No: 2018-26282]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-3547]

Determination of Regulatory Review Period for Purposes of Patent
Extension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM

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 EXABLATE NEURO MODEL 4000
TYPE 1.0 SYSTEM (EXABLATE) 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 medical device.

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
February 4, 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 June 3, 2019.
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 February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 4, 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-2017-E-3547 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; EXABLATE.'' 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device EXABLATE.
EXABLATE is indicated for use in the unilateral thalamotomy treatment
of idiopathic essential tremor patients with medication-refractory
tremor. Patients must be at least age 22. The designated area in the
brain responsible for the movement disorder symptoms (ventralis
intermedius) must be identified and accessible for targeted thermal
ablation by the EXABLATE device. Subsequent to this approval, the USPTO
received a patent term restoration application for EXABLATE (U.S.
Patent No. 6,612,988) from Brigham and Women's Hospital, Inc. and
InSightec, Ltd., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated August 1, 2017, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of EXABLATE 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
EXABLATE is 2,050 days. Of this time, 1,785 days occurred during the
testing phase of the regulatory review period, while 265 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: December 2, 2010. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was December 2, 2010.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): October
21, 2015. The applicant claims October 20, 2015, as the date the
premarket approval application (PMA) for EXABLATE (PMA P150038) was
initially submitted. However, FDA records indicate that PMA P150038 was
submitted on October 21, 2015.
    3. The date the application was approved: July 11, 2016. FDA has
verified the applicant's claim that PMA P150038 was approved on July
11, 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 1,158 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: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26282 Filed 12-3-18; 8:45 am]
 BILLING CODE 4164-01-P