[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51717-51718]
[FR Doc No: 2013-20348]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12613-004]

Tygart, LLC; Notice of Application Accepted for Filing,
Soliciting Motions to Intervene and Protests, Ready for Environmental
Analysis, and Soliciting Comments, Recommendations, Preliminary Terms
and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: 12613-004.
    c. Date Filed: April 30, 2013.
    d. Applicant: Tygart, LLC.
    e. Name of Project: Tygart Hydroelectric Project.
    f. Location: The proposed project would be located at the U.S. Army
Corps of Engineers' (Corps) Tygart Dam on the Tygart River in Taylor
County, West Virginia. The project would occupy 1 acre of federal land
managed by the Corps.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: David Sinclair, President, Advanced Hydro
Solutions, 3000 Auburn Drive, Suite 430, Beachwood, OH 44122-4340 or by
email at<EMAIL_ADDRESS>    i. FERC Contact: Allyson Conner,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, recommendations, preliminary
terms and conditions, and preliminary fishway prescriptions using the
Commission's eFiling system at 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>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-12613-004.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The proposed project would utilize the Corps' existing Tygart
Dam, and would consist of the following new facilities: (1) A 15-foot-
wide by 21-foot-high steel intake structure; (2) a 270-foot-long
penstock which would bifurcate into a 110-foot-long and a 150-foot-long
penstock; (3) a 121-foot-long by 99-foot-wide concrete powerhouse; (4)
two unequal-sized turbines with a combined capacity of 30 megawatts;
(5) an excavated 60-foot-wide by 160-foot-long tailrace; (6) a 1.54-
mile-long transmission line; and (7) a switchyard with appurtenant
facilities. The average annual generation is estimated to be 108,600
megawatt-hours.
    The proposed project would operate in a run-of-release mode using
flows made available by the Corps.
    The proposed project boundary would enclose all of the generating
facilities located on 1 acre of Corps' land as well as the transmission
line located on 7 acres of privately owned land.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, preliminary      October 13, 2013.
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues EA......................  February 10, 2014.
Comments on EA............................  March 12, 2014.

Modified terms and conditions.............  May 11, 2014.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) the evidence of waiver of water quality certification.
    r. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.

    Dated: August 14, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-20348 Filed 8-20-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 28, 2010 (Volume 75, Number 123)]
[Proposed Rules]
[Page 36608-36609]
[DOCID:fr28jn10-25]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0051]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway,
(AIWW) Scotts Hill, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking; withdrawal.

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SUMMARY: The Coast Guard is withdrawing its notice of proposed
rulemaking concerning the proposed change to the regulations that
governed the operation of the Figure Eight Swing Bridge, at AIWW mile
278.1, at Scotts Hill, NC. The requested change would have allowed the
drawbridge to open on signal every hour on the half hour for the
passage of pleasure vessels.

DATES: The notice of proposed rulemaking is withdrawn on June 28, 2010.

ADDRESSES: The docket for this withdrawn rulemaking is available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. You may also find
this docket on the Internet by going to http://www.regulations.gov,
inserting USCG[dash]2009[dash]0051 in the ``Keyword'' box and then
clicking ``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or e-mail Waverly W. Gregory, Jr., Fifth Coast Guard
District; telephone<PHONE_NUMBER>, e-mail

<EMAIL_ADDRESS>If you have questions on viewing material
in the docket call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On February 20, 2009, we published a notice of proposed rulemaking
(NPRM) entitled ``Drawbridge Operation Regulations; Atlantic
Intracoastal Waterway, (AIWW) Scotts Hill, NC'' in the Federal Register
(74 FR 7844-7847). The rulemaking would have allowed the drawbridge to
open on signal every hour on the half hour for the passage of pleasure
vessels. Our investigation along with comments received revealed that
the proposed change would significantly increase delays to recreational
boaters and would provide an unsafe environment for slow moving vessel
traffic.

Withdrawal

    The Figure Eight Homeowner Association Inc. (FEHAI), who owns and
operates the Figure Eight Swing Bridge, had requested a change to the
existing regulations in an effort to improve the schedule for both
roadway and waterway users. The swing bridge provides the only route on
and off Figure Eight Island. The proposal would not have changed the
requirement for the bridge to open on signal at any time for commercial
and government vessels. FEHAI believed that the proposal would
facilitate pleasure craft in navigating the AIWW, and also help ease
vehicular traffic congestion.
    The Coast Guard received several comments opposing changes to the
proposed rulemaking. We conducted a lengthy and thorough investigation
that included a site visit.
    Our investigation along with the majority of the comments revealed
that the request to change the regulations for pleasure craft from
half-hour openings to hourly openings would not affect power boats
along the AIWW, but would significantly affect sailboats. Increasing
travel time between drawbridge openings will increase the number of
vessels waiting for an opening in a narrow and restricted channel,
making safe navigation more difficult. In addition, no data was
submitted to the docket to support concerns that vehicle traffic across
the bridge had increased or was unreasonably impeded by the current
operating schedule of the bridge. The proposed amendment to the
operating schedule is withdrawn because this change would not improve
drawbridge operations.

Authority

    This action is taken under the authority of 33 U.S.C. 499; 33 CFR
1.05-1; Department of Homeland Security Delegation No. 0170.1.

    Dated: June 9, 2010.
Wayne E. Justice,
Rear Admiral, U.S. Coast Guard Commander, Fifth Coast Guard District.
[FR Doc. 2010-15560 Filed 6-25-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Page 62832]
[FR Doc No: 2023-19789]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-096, OMB Control No. 3235-0151]

Proposed Collection; Comment Request; Extension: Rule 17Ac3-1(a)
and Form TA-W

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule
17Ac3-1(a) (17 CFR 240.17Ac3-1(a)) and Form TA-W (17 CFR 249b.101),
under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
    Section 17A(c)(4)(B) of the Securities Exchange Act of 1934 (15
U.S.C. 78c(a)(34)(B) authorizes transfer agents registered with an
appropriate regulatory agency (``ARA'') to withdraw from registration
by filing with the ARA a written notice of withdrawal and by agreeing
to such terms and conditions as the ARA deems necessary or appropriate
in the public interest, for the protection of investors, or in the
furtherance of the purposes of Section 17A.
    In order to implement Section 17A(c)(4)(B) of the Exchange Act, the
Commission promulgated Rule 17Ac3-1(a) and accompanying Form TA-W on
September 1, 1977. Rule 17Ac3-1(a) provides that notice of withdrawal
of registration as a transfer agent with the Commission shall be filed
on Form TA-W. Form TA-W requires the withdrawing transfer agent to
provide the Commission with certain information, including: (1) the
locations where transfer agent activities are or were performed; (2)
the reasons for ceasing the performance of such activities; (3)
disclosure of unsatisfied judgments or liens; and (4) information
regarding successor transfer agents.
    The Commission uses the information disclosed on Form TA-W to
determine whether the registered transfer agent applying for withdrawal
from registration as a transfer agent should be allowed to deregister
and, if so, whether the Commission should attach to the granting of the
application any terms or conditions necessary or appropriate in the
public interest, for the protection of investors, or in furtherance of
the purposes of Section 17A of the Exchange Act. Without Rule 17Ac3-
1(a) and Form TA-W, transfer agents registered with the Commission
would not have a means to voluntarily deregister it is necessary or
appropriate to do so.
    On average, respondents have filed approximately 50 TA-Ws with the
Commission annually from 2020 to 2023. A Form TA-W filing occurs only
once, when a transfer agent is seeking deregistration. In view of the
readily available information requested by Form TA-W, its short and
simple presentation, and the Commission's experience with the filers,
we estimate that approximately 30 minutes is required to complete and
file Form TA-W. Thus, the total annual time burden to the transfer
agent industry is approximately 25 hours (50 filings x 0.5 hours). We
estimate that the internal labor cost of compliance per filing is $39
(0.5 hours x $78 average hourly rate for clerical staff time).\1\ Thus,
the total internal compliance cost per year is thus approximately $975
(25 hours x $39 = $975).
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    \1\ The $78 per hour figure for clerical staff time is from
SIFMA's Office Salaries in the Securities Industry 2013, modified by
Commission staff to account for an 1800-hour work-year and
inflation, and multiplied by 2.93 to account for bonuses, firm size,
employee benefits and overhead.
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    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted by
November 13, 2023.
    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.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
[email protected].

    Dated: September 8, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19789 Filed 9-12-23; 8:45 am]
BILLING CODE 8011-01-P


        Reid Vapor Pressure (RVP) of Gasoline Spreadsheet Example Key

                              Compliance Division                    Office of Transportation and Air Quality                      U.S. Environmental Protection Agency                                    May 2023

    This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. OMB Control No 2060-0731. Responses to this collection of information are voluntary 1090 CFR 1360 through 1090 1365. 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. The public reporting and recordkeeping burden for this collection of information is estimated to average 180 hours per response.  Send comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

PBMS0002                                                                                Disclaimer

The discussion in this document is intended solely as guidance.  The statutory provisions and EPA regulations described in this document contain legally binding requirements.  This document is not a regulation itself, nor does it change or substitute for those provisions and regulations.  Thus, it does not impose legally binding requirements on EPA, States, or the regulated community.  This spreadsheet example key does not confer legal rights or impose legal obligations upon any member of the public.

While EPA has made every effort to ensure the accuracy of the discussion in this spreadsheet example key for use with its associated spreadsheet example, the obligations of the regulated community are determined by statutes, regulations, or other legally binding requirements.  In the event of a conflict between the discussion in this document and any statute or regulation, this document would not be controlling.

The general description of the self-qualification process provided here may not apply to a particular situation.  Interested parties are free to raise questions about the substance of this spreadsheet example key, its associated spreadsheet example, and its applicability to a particular situation.  EPA may adopt approaches on a case-by-case basis that differ from those described in this spreadsheet example key.

Mention of trade names or commercial products does not constitute endorsement or recommendation for their use.

This is a living document and may be revised periodically without public notice.  EPA welcomes public input on this document at any time.

Introduction: On December 4, 2020, EPA promulgated regulatory streamlining requirements (see 85 FR 78412).

Beginning January 1, 2021, for RVP of gasoline, a test facility must self-qualify a voluntary consensus-based standard body (VCSB) test method to show that it has met the precision requirements codified in the regulations at §1090.1365(b).  A test facility must also self-qualify that it has met the qualification criteria for accuracy by conducting an ASTM D6708 assessment as codified in the regulations at §1090.1365(d).  The regulations also specify criteria for the designated EPA referee test method reference installation used to qualify accuracy of method defined alternative test methods used to measure RVP at §1090.1370.

If your test facility was utilizing the designated EPA referee test method, ASTM D5191-20 (IBR §1090.95(c)(21)), the regulations provide for an exemption in meeting these precision and accuracy self-qualification requirements.  It is important to note, the on-going statistical quality control requirements at §1090.1375 apply to all methods, including the EPA referee test method.

The following spreadsheet example key applies to any party self-qualifying in meeting the PBMS requirements at §1090.1365(b) and §1090.1365(d).  This guidance deals only with the self-qualification of analytical test methods at a testing facility for measuring RVP of gasoline.

The discussions of the applicable regulations in this document are not verbatim.  The reader is encouraged to read and become familiar with the applicable regulations of §10901360, §1090.1365, §1090.1370 and §1090.1375.  These instructions are intended to help a test facility self-qualify a VCSB analytical test method for the measurement of RVP of gasoline.

Applicable Dates: These requirements for method qualification under §1090.1365 became effective on January 1, 2021.

Note: Please see below for instructions on use of this spreadsheet example key along with its associated spreadsheet example for RVP of gasoline which is provided by the Agency for determining compliance with the precision criteria of §1090.1365(b) in Part I.  Please see Part II for the ASTM D6708-19a accuracy assessment requirements of §1090.1365(d), and reference installation requirement of §1090.1370 along with other PBMS information in Part III.  We encourage parties to use this spreadsheet example key and its associated spreadsheet example for RVP of gasoline as an affirmative defense in meeting the PBMS requirements at §1090.1360, §1090.1365, §1090.1370 and §1090.1375.

Part I - 	Precision demonstration for Reid Vapor Pressure (RVP) of gasoline.

Precision Criteria (§1090.1365(b)) - the maximum allowable standard deviation computed from results of a minimum of 20 tests made over 20 days on samples using good laboratory practices taken from a single homogenous commercially available gasoline must be less than or equal to 0.3 times the Reproducibility (R), where "R" equals the ASTM reproducibility (R) of ASTM D5191-20, except as specified in §1090.1355(a). You may make up to 4 separate measurements in a 24-hour period, as long as the interval between measurements is at least 4 hours. Example: A gasoline sample having an RVP of 6.8 pounds per square inch (psi): Maximum allowable standard deviation of 20 tests <=0.3*(0.40 psi) = 0.12 psi.1

A.	In the workbook entitled "draft-vcsb-rvp-content-gas-test-method-sprdsht-example", locate the worksheet entitled, "RVP Precision Demonstration". Enter precision demonstration data in the light shaded green areas of the worksheet.      Test results must: be entered to the nearest thousandth of a pound per square inch (0.001 pounds per square inch (psi)).  The date and time of each test measurement must be reported.  Please include the laboratory sample test identification number for each test result.

B.	After entering the data into the light shaded green area of the "RVP Precision Demonstration" worksheet, go to the "File" menu at the top of the screen and select "Save" to save your data.  Once all the data are entered into the "RVP Precision Demonstration" worksheet, the standard deviation of the data set (located in cell B16), and an indication as to whether the RVP precision criterion are met will be determined by the worksheet.  The indication of "PASSED" or "FAILED" is in the worksheet in cell B15, after the question, "Is RVP Precision Criterion Met?".  If the worksheet is missing required data, an indication of "REQUIRED DATA MISSING" will appear after this question.  There is a QC data entry check for each test result in column E (i.e., if data is entered in a test result cell, an indication of "OK" will appear next to that cell, but if no data is entered in a test result cell, an indication of "DATA REQUIRED IN CELL #" will appear next to that cell).  Note: If the applicant wishes to include more than the 20 minimum tests, please report the additional data by adding rows to the spreadsheet.2

Part II - ASTM D6708-19a Accuracy demonstration for RVP of gasoline (§1090.1365(d)).

 In the workbook entitled "Spreadsheet Example VCSB RVP content gasoline test method", locate the worksheet entitled, "D6708 Assessment Accuracy".  Enter applicable information as discussed below in the D6708 Assessment Accuracy worksheet.        Include information reported in the test method documentation to the user of the Voluntary Consensus Standards Body (VCSB) organization test method, including a description of the technology and/or instrumentation that makes the method functional.

 Include information reported in the test method that demonstrates the test facility is using a VCSB test method ASTM D6708 assessment (§1090.1365(d), IBR 1090.95(c)(33)).  Indicate by typing "Yes" in cell "B15",

 Include the correlation equation via an ASTM D6708-19a accuracy assessment to utilize for reporting purposes for the fuel parameter in cell "B16".  If the ASTM D6708 assessment between the candidate VCSB alternative test method and the VCSB EPA referee test method results in a "null" comparison, then type the word "null" in cell "B16" indicating the ASTM D6708 assessment has determined the alternative test method provides equivalent results to its respective EPA referee test method, ASTM D5191-20, (IBR 1090.95(c)(21)).

Part III  -  Additional PBMS Information.

 1090.1365. For test methods that are approved by a voluntary consensus-based standards body (VCSB) organization, such as the American Society for Testing and Materials (ASTM) or International Standards Organization (ISO), each individual test facility must demonstrate through self-qualification that the applicable for accuracy and precision criteria specified under §1090.1365 are met (Please see Part I and Part II of this spreadsheet example key).  The self-qualification of the test method is limited to the single test facility that performed the testing for accuracy and precision.

 §1090.1360(5)(i). Testing you performed to qualify alternative procedures under 40 CFR part 80.47 continues to be valid for making the demonstrations required in part 1090.

 §1090.1370. Reference installation requirements at §1090.1370 are used for grounding the EPA referee test method, ASTM D5191-20, (IBR §1090.95(c)(21)) for use in the ASTM D6708-19a, (IBR 1090.95(c)(33)), accuracy assessment with the candidate alternative test method.

 §1090.1375. Quality Assurance procedures for benzene content in gasoline measurement instrumentation.  A test method shall not be considered a test using an approved test method unless the quality control procedures specified at 1090.1375 for both precision and accuracy are met separately for each instrument at the test facility.

 §1090.1345. See this section of the regulations for sample retention requirements that apply to your specific test facility.

F.	§1090.1200. Record retention requirements for approved test methods. Each individual test facility must retain records related to the establishment of accuracy and precision values, all test method documentation, and any quality control test and analysis under §1090.1365, §1090.1370 and §1090.1375 for five years.

 EPA Contact: <EMAIL_ADDRESS>


[Federal Register Volume 85, Number 43 (Wednesday, March 4, 2020)]
[Notices]
[Page 12816]
[FR Doc No: 2020-04413]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on a Land Release Request for Change in
Use From Aeronautical to Non-Aeronautical at Bay Bridge Airport,
Stevensville, MD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request for a change in use of on-airport property.

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SUMMARY: The FAA proposes to rule and invites public comment on Queen
Anne's County's request to change 7.663 acres of federally obligated
airport property at Bay Bridge Airport, Stevensville, MD from
aeronautical to non-aeronautical use. This acreage was originally
purchased with federal financial assistance through the Airport
Improvement Program. The proposed use of land after the sale will be
compatible with the airport and will not interfere with the airport or
its operation.

DATES: Comments must be received on or before April 3, 2020.

FOR FURTHER INFORMATION CONTACT: Comments on this application may be
mailed or delivered to the following address:

Linda Steiner, Airport Manager, Bay Bridge Airport, 202 Airport Road,
Stevensville, MD 21666,<PHONE_NUMBER>

and at the FAA Washington Airports District Office:

Matthew Thys, Manager, Washington Airports District Office, 13873 Park
Center Road, Suite 490S, Herndon, VA 20171,<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION: In accordance with the Wendell H. Ford
Aviation Investment and Reform Act for the 21st Century (AIR 21),
Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be
published in the Federal Register 30 days before the Secretary may
waive any condition imposed on a federally obligated airport by grant
agreements. The following is a brief overview of the request.
    Queen Anne's County has submitted a land release request seeking
FAA approval for the change in use of approximately 7.663 acres of
federally obligated airport property from aeronautical to non-
aeronautical use. The property is situated on the north side of Pier
One Road. Due to this location, the subject area is unable to be
utilized for aviation purposes because the airport operations area is
located to the south of Pier One Road. Thus, the subject area is
inaccessible to aircraft.
    The 7.663 acres of land to be released was originally purchased as
part of a 24.835-acre parcel with federal financial assistance through
the AIP program under Grant Agreement 3-24-0036-17-2005. As foreseen at
the time of the execution of this Grant Agreement, the only portion of
the 24.835-acre parcel that was required for aeronautical use is the
portion of the parcel to the south of Pier One Road. Subsequent to the
implementation of the proposed change in use, rents received by the
airport from this property is considered airport revenue, and will be
used in accordance with 49 U.S.C. 47107(b) and the FAA's Policy and
Procedures Concerning the Use of Airport Revenue published in the
Federal Register on February 16, 1999. The proposed use of the property
will not interfere with the airport or its operation.

    Issued in Herndon, Virginia.
Matthew Thys,
Manager, Washington Airports District Office.
[FR Doc. 2020-04413 Filed 3-3-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14380-14386]
[FR Doc No: 2013-05004]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69003; File No. SR-EDGX-2013-08]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
EDGX Rules 1.5, 11.5, 11.8, 11.9 and 11.14 in Connection With the
Implementation of the National Market System Plan To Address
Extraordinary Market Volatility

February 27, 2013.
    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 February 13, 2013, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rules 1.5, 11.5, 11.8, 11.9 and
11.14 regarding the implementation of the National Market System Plan
to Address Extraordinary Market Volatility (as amended, the ``Plan'')
as approved by the Securities and Exchange Commission.\3\ All of the
changes described herein are applicable to EDGX Members. The text of
the proposed rule change is available on the Exchange's Internet Web
site at www.directedge.com, at the Exchange's principal office, on the
Commission's Internet Web site at www.sec.gov, and at the Commission's
Public Reference Room.
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    \3\ See Securities Exchange Release No. 67091 (May 31, 2012), 77
FR 33498 (June 6, 2012) (approving the Plan on a pilot basis).
---------------------------------------------------------------------------

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 these statements may be examined at

the places specified in Item IV below. The self-regulatory organization
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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    EDGX proposes to amend Rules 1.5, 11.5, 11.8, 11.9 and 11.14 in
connection with the implementation of the Plan.
Background
    On April 5, 2011, NYSE Euronext, on behalf of the New York Stock
Exchange LLC (``NYSE''), NYSE Amex LLC, and NYSE Arca, Inc. (``Arca''),
and the following parties to the Plan: BATS Exchange, Inc., BATS Y-
Exchange, Inc. (together, ``BATS''), Chicago Board Options Exchange,
Incorporated, Chicago Stock Exchange, Inc., EDGX, EDGA Exchange, Inc.,
Financial Industry Regulatory Authority, Inc., NASDAQ OMX BX, Inc.,
NASDAQ OMX PHLX LLC, the Nasdaq Stock Market LLC, and National Stock
Exchange, Inc. (collectively with NYSE, NYSE MKT, and Arca, the
``Participants''), filed with the Commission pursuant to Section 11A of
the Securities Exchange Act of 1934 (``Act''),\4\ and Rule 608
thereunder,\5\ the Plan to create a market-wide limit up-limit down
(``LULD'') mechanism that is intended to address extraordinary market
volatility in NMS Stocks.\6\ The Plan sets forth procedures that
provide for market-wide LULD requirements that would be designed to
prevent trades in individual NMS Stocks from occurring outside of
specified price bands. These LULD requirements would be coupled with
trading pauses\7\ to accommodate more fundamental price moves (as
opposed to erroneous trades or momentary gaps in liquidity).
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    \4\ 15 U.S.C. 78k-1.
    \5\ 17 CFR 242.608.
    \6\ See Letter from Janet M. McGinness, Senior Vice President,
Legal and Corporate Secretary, NYSE Euronext, to Elizabeth M.
Murphy, Secretary, Commission, dated April 5, 2011 (``Transmittal
Letter''). The term ``NMS Stock'' shall have the meaning provided in
Rule 600(b)(47) of Regulation NMS under the Act.
    \7\ As defined in Section I(X) of the Plan.
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    The price bands would consist of a Lower Price Band (the ``Lower
Price Band'') and an Upper Price Band (the ``Upper Price Band''--each a
``Price Band'' and, together with the Lower Price Band, the ``Price
Bands'') for each NMS Stock. The Price Bands would be calculated by the
Securities Information Processors (the ``SIP'' or ``Processors'')
responsible for consolidation of information for an NMS Stock pursuant
to Rule 603(b) of Regulation NMS under the Act.\8\ The Price Bands
would be based on a Reference Price \9\ that equals the arithmetic mean
price of Eligible Reported Transactions \10\ for the NMS Stock over the
immediately preceding five-minute period. The Price Bands for an NMS
Stock would be calculated by applying the Percentage Parameter \11\ for
such NMS Stock to the Reference Price, with the Lower Price Band being
a Percentage Parameter below the Reference Price, and the Upper Price
Band being a Percentage Parameter above the Reference Price. Between
9:30 a.m. and 9:45 a.m. ET and 3:35 p.m. and 4:00 p.m. ET, the Price
Bands would be calculated by applying double the Percentage Parameters.
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    \8\ 17 CFR 242.603(b).
    \9\ As defined in Section I(T) of the Plan.
    \10\ As defined in the proposed Plan, Eligible Reported
Transactions would have the meaning prescribed by the Operating
Committee for the proposed Plan, and generally mean transactions
that are eligible to update the sale price of an NMS Stock.
    \11\ As initially proposed by the Participants, the Percentage
Parameters for Tier 1 NMS Stocks (i.e., stocks in the S&P 500 Index
or Russell 1000 Index and certain ETPs) with a Reference Price of
$1.00 or more would be five percent and less than $1.00 would be the
lesser of (a) $0.15 or (b) 75 percent. The Percentage Parameters for
Tier 2 NMS Stocks (i.e., all NMS Stocks other than those in Tier 1)
with a Reference Price of $1.00 or more would be 10 percent and less
than $1.00 would be the lesser of (a) $0.15 or (b) 75 percent. The
Percentage Parameters for a Tier 2 NMS Stock that is a leveraged ETP
would be the applicable Percentage Parameter set forth above
multiplied by the leverage ratio of such product. On May 24, 2012,
the Participants amended the Plan to create a 20% price band for
Tier 1 and Tier 2 stocks with a Reference Price of $0.75 or more and
up to and including $3.00. The Percentage Parameter for stocks with
a Reference Price below $0.75 would be the lesser of (a) $0.15 or
(b) 75 percent. See Securities Exchange Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012).
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    Under the Plan, the Exchange is required to establish, maintain,
and enforce written policies and procedures reasonably designed to
prevent the display of offers below the Lower Price Band and bids above
the Upper Price Band for an NMS Stock. The Processors would disseminate
an offer below the Lower Price Band or bid above the Upper Price Band
that nevertheless inadvertently may be submitted despite such
reasonable policies and procedures, but with an appropriate flag
identifying it as non-executable; such bid or offer would not be
included in National Best Bid (``NBB'') or National Best Offer (``NBO''
and, together with the NBB, the ``NBBO'') calculations. In addition,
the Exchange is required to develop, maintain, and enforce policies and
procedures reasonably designed to prevent trades at prices outside the
Price Bands, with the exception of single-priced opening, reopening,
and closing transactions on the primary listing exchange.
    In connection with the upcoming implementation of the Plan on April
8, 2013, the Exchange proposes to amend the following rules:
Order Execution (Rule 11.9)
    The Exchange proposes to re-organize Rule 11.9 so that matters
relevant to order execution would be covered in Rule 11.9(a), while
matters relevant to order routing would be covered in Rule 11.9(b).
Rules 11.9(a) and (b) would be structured so that each would contain
subsections that would describe the manner by which execution and
routing would be affected by the Plan, among other regulations. The
Exchange proposes to add Rule 11.9(a)(3) that would provide particular
details with regard to how the Plan would modify order behavior on the
Exchange. Proposed Rule 11.9(a)(3) and its subparagraphs are described
below.
Compliance With the Plan
    The Exchange proposes to add Rule 11.9(a)(3), which would state
that, except as provided in Section VI of the Plan,\12\ for any
executions to occur during Regular Trading Hours, such executions must
occur at a price that is greater than or equal to the Lower Price Band
and less than or equal to the Upper Price Band, when such Price Bands
are disseminated.
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    \12\ Section VI(A)(1) of the Plan provides that ``single-priced
opening, reopening, and closing transactions on the Primary Listing
Exchange, however, shall be excluded from this limitation. In
addition, any transaction that both (i) does not update the last
sale price (except if solely because the transaction was reported
late), and (ii) is excepted or exempt from Rule 611 under Regulation
NMS shall be excluded from this limitation.''
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Default Behavior for Non-Routable Orders Not Crossing the Price Bands
    The Exchange proposes to add Rule 11.9(a)(3)(A), which would state
that, when a non-routable buy (sell) order is entered into the System
\13\ at a price less (greater) than or equal to the Upper (Lower) Price
Band, such order will be posted to the EDGX Book \14\ or executed,
unless (i) the order is an Immediate-or-Cancel (``IOC'') Order,\15\ in
which case it will be cancelled if not executed, or (ii) the User \16\
has entered instructions to cancel the order.
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    \13\ As defined in Rule 1.5(cc).
    \14\ As defined in Rule 1.5(d).
    \15\ As defined in Rule 11.5(b)(1).
    \16\ As defined in Rule 1.5(ee).

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Default Behavior when a Non-Routable Buy (Sell) Order Arrives at a
Price Higher (Lower) than the Upper (Lower) Price Band
    The Exchange proposes to add Rule 11.9(a)(3)(B), which would state
that, when a non-routable buy (sell) order arrives at a price greater
(less) than the Upper (Lower) Price Band, the Exchange will re-price
and display such buy (sell) order at the price of the Upper (Lower)
Price Band.
Default Behavior When the Upper (Lower) Price Band Moves to a Price
Higher (Lower) Than a Resting Buy (Sell) Order's Displayed Posting
Price
    If the price of the Upper (Lower) Price Band moves above (below) a
non-routable buy (sell) order's displayed posting price, such buy
(sell) order will not be adjusted further and will remain posted at the
original price at which it was posted to the EDGX Book.
Default Behavior When the Upper (Lower) Price Band Crosses a Resting
Buy (Sell) Order's Displayed Posting Price
    Proposed Rule 11.9(a)(3)(B) would also state that, when the Upper
(Lower) Price Band crosses a non-routable buy (sell) order resting on
the EDGX Book, such buy (sell) order will be re-priced to the price of
the Upper (Lower) Price Band.
Routable Market and Limit Orders
    The Exchange proposes to add Rule 11.9(a)(3)(C), which would cross
reference how routable market and limit orders would behave under the
Plan.\17\ The proposed order handling under the Plan would be set forth
in proposed Rule 11.9(b)(1)(B) and described in the section entitled
``Changes in Routing Behavior to Comply with the Plan,'' below.
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    \17\ The Exchange notes that the behavior of stop orders and
stop limit orders, as defined in Exchange Rule 1.5, are not
specifically addressed in this filing as they are converted to
market and limit orders when the stop price is elected and will then
behave like market or limit orders, respectively, as described
above.
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Short Sale Behavior
    The Exchange proposes to add Rule 11.9(a)(3)(D), which would
describe how short sale orders would be re-priced in accordance with
both Regulation SHO and the Plan. In particular, the proposed rule
would state that, where a short sale order is entered into the System
with a limit price below the Lower Price Band and a short sale price
test restriction under Rule 201 of Regulation SHO (``short sale price
test restriction'') is in effect for the covered security, the System
will re-price such order to the Lower Price Band as long as the Lower
Price Band is at a Permitted Price.\18\ When a short sale order is
entered into the System with a limit price above the Lower Price Band
and a short sale price test restriction is in effect for the covered
security, the System will re-price such order, if necessary, at a
Permitted Price pursuant to Rule 11.5(c)(4).
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    \18\ As defined in Rule 11.5(c)(4)(B).

    Example:  Sell Short Order is priced at the Lower Price Band
where the Lower Price Band is above the NBB
    Assume the NBBO is $10.00 by $10.10, the Price Bands \19\ are
$10.01 by $10.15, and the short sale price test restriction is in
effect. A sell short order arrives to sell 100 shares at $10.00 and
is displayed at $10.01. The sell short order will be allowed to be
priced at the Lower Price Band so long as the Lower Price Band is
above the NBB during the short sale price test restriction.
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    \19\ Note that Price Band prices used in all examples in this
filing are for illustrative purposes only and do not reflect the
method by which the actual Price Bands will be calculated in
accordance with the Plan.
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Policies and Procedures
    The Exchange proposes to add Rule 11.9(a)(3)(E) to specify that
pursuant to Section IV of the Plan, all Trading Centers \20\ in NMS
Stocks, including those operated by Members of the Exchange, shall
establish maintain, and enforce written policies and procedures that
are reasonably designed to comply with the requirements specified in
Section VI of the Plan, and to comply with the Trading Pauses specified
in Section VII of the Plan.
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    \20\ As defined in Rule 2.11(a).
---------------------------------------------------------------------------

Applicability of the Plan to Specific Order Types
    The following examples and descriptions demonstrate how Rules
11.9(a)(3)(A)-(C), as described above, will affect specific order
functionality under the Plan.
Immediate-or-Cancel (``IOC'') Orders
    As described in proposed Rule 11.9(a)(3)(A), IOC Orders will be
executed to the extent allowed within the Price Bands, and the portion
not so executed will be cancelled.
    In general, IOC and IOC Intermarket Sweep Orders \21\ (``IOC ISO'')
will be handled the same way when the Price Bands are inside of the
NBBO. Buy IOC/IOC ISOs will be executed up to the Upper Price Band and
the remainder will be canceled back to the User. Sell IOC/IOC ISOs will
be executed down to the Lower Price Band and the remainder will be
canceled back to the User. IOC ISOs will be prevented from executing at
prices that cross the Price Bands when the limit price of the ISO
crosses a Price Band that is outside of the NBBO.
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    \21\ ISO Orders are described in Exchange Rule 11.5(d) and
defined under Regulation NMS. See Securities Exchange Act Release
No. 51808 (June 9, 2005), 70 FR 37496 (June 29, 2005).

    Example 1:  Sell IOC Order Executes Down to the Lower Price Band
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$10.04 by $10.15. Three orders are placed: Order1 to buy 100 shares
at $10.02; Order2 to buy 100 shares at $10.04; and an IOC Order to
sell 200 shares at $10.02. The IOC Order will execute 100 shares at
$10.04 against Order2 and the remaining 100 shares will be cancelled
back to the User. The IOC Order cannot execute against Order1
because Order1 is priced below the Lower Price Band.
    Example 2:  Sell IOC ISO Executes through NBBO Down to the Lower
Price Band
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.99 by $10.15. Three orders are placed: Order1 to buy 100 shares
at $9.99; Order2 to buy 100 shares at $9.98; and an IOC ISO to sell
200 shares at $9.98. The IOC ISO will execute 100 shares at $9.99
against Order1 and the remaining 100 shares will be canceled back to
the User. The IOC ISO cannot execute against Order2 because Order2
is priced below the Lower Price Band.
EDGX Only/Post Only Orders \22\
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    \22\ As defined in Rules 11.5(c)(4) and (5).
---------------------------------------------------------------------------

    As described in proposed Rule 11.9(a)(3)(B), where a non-routable
order such as a EDGX Only/Post Only buy (sell) Order is entered into
the System at a price above (below) the Upper (Lower) Price Band, such
buy (sell) order will be re-priced and displayed at the price of the
Upper (Lower) Price Band. If the Upper (Lower) Price Band moves higher
(lower) than the EDGX Only/Post Only buy (sell) Order's posting price,
such buy (sell) order will not be adjusted further and will remain at
the original price at which it was posted to the EDGX Book.

    Example 1:  EDGX Only/Post Only Order is entered into the System
at a Price That Crosses the Price Bands
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.08. An EDGX Only/Post Only buy Order arrives at $10.09.
The buy order will be re-priced, displayed and posted to the EDGX
Book at $10.08, the price of the Upper Price Band.
    Example 2:  Price Band Moves Higher Than EDGX Only/Post Only Buy
Order on the EDGX Book
    Assume the same facts as in Example 1, but now the Price Bands
adjust to $9.95 by $10.10. The buy order will not be adjusted
further and will instead remain on the EDGX Book at $10.08, the
original price at which it was posted to the EDGX Book.

Changes in Routing Behavior to Comply With the Plan
    The Exchange proposes to add Rule 11.9(b)(1)(B), which would
describe how routing will function under the Plan and would be divided
into three major subsections, detailed under the subheadings listed
below.
Default Routing Behavior
    The first major subsection, proposed Rule 11.9(b)(1)(B)(i), would
describe how default routing behavior would function in accordance with
the Plan and would state that, in order to comply with the Plan, a
routable buy (sell) market or routable marketable limit order will be
routed by the Exchange only when the NBO (NBB) is or becomes executable
according to the Plan, which would be when the NBO is less than or
equal to the Upper Price Band (NBB is greater than or equal to the
Lower Price Band). According to the Plan, the NBO (NBB) is or becomes
non-executable when the NBO is greater than the Upper Price Band (the
NBB is less than the Lower Price Band) (``Non-Executable''). Proposed
Rule 11.9(b)(1)(B)(i) would also state that, excluding routing
strategies SWPA, SWPB and SWPC, for purposes of Rules
11.9(b)(1)(B)(i)(I) and (II), routing strategies that access all
Protected Quotations include the following routing strategies as
described in current Rule 11.9(b)(3) (proposed to be re-numbered Rule
11.9(b)(2)): ROUT, ROUX, ROUC, ROUE and ROOC. Routing strategies that
do not access all Protected Quotations include all other routing
strategies listed in current Rule 11.9(b)(3).
    Routing strategies that access all Protected Quotations (other than
SWPA, SWPB and SWPC) are designed to maximize liquidity with the
intention to fully execute a marketable order. Routing strategies that
do not access all Protected Quotations are designed with other
objectives in mind and are not as likely to fully execute a marketable
order because of the smaller number of liquidity sources accessed. For
example, routing strategy ROUZ, which does not access all Protected
Quotations, will only access dark pools after interacting with the EDGX
Book and then post any remainder to the EDGX Book unless otherwise
instructed by the User.
    If a marketable order utilizing a routing strategy that accesses
all Protected Quotations cannot be executed because the Upper (Lower)
Price Band crosses the NBO (NBB) (i.e., the NBO/NBB is non-executable),
the Exchange believes that, in order to fulfill the routing strategy's
objective of maximizing liquidity and fully executing a marketable
order, it is appropriate to re-price such order up to the order's limit
price and re-route such order once the Upper (Lower) Price Band no
longer crosses the NBO (NBB) (i.e., the NBO/NBB becomes executable).
    Below are examples illustrating how default routing behavior will
function in accordance with the Plan.\23\
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    \23\ All of the below examples in this section on changes to the
behavior of routable orders as a result of compliance with the Plan
assume that there is no liquidity on the EDGX Book.

    Example:  Buy Order Example where NBO is Above the Upper Price
Band
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.05. Order1 arrives to buy 100 shares at $10.15; Order2
arrives to buy 100 shares as a market order. Neither Order1 nor
Order2 will be routed because no buy orders will be routed when the
NBO is above the Upper Price Band.
Routable Market Orders
    Proposed Rule 11.9(b)(1)(B)(i) would contain two minor subsections,
the first of which, proposed Rule 11.9(b)(1)(B)(i)(I), would describe
routing behavior under the Plan applicable to routable market orders
and would state that, for routing strategies that access all Protected
Quotations, if the NBO (NBB) is Non-Executable and a buy (sell) market
order is placed, the System will default to re-price such buy (sell)
market order and display it at the price of the Upper (Lower) Price
Band and will continue to re-price it to the price of the Upper (Lower)
Price Band as the Upper (Lower) Price Band adjusts, so long as the buy
(sell) market order does not move above (below) its market collar
price, as defined in Rule 11.5(a)(2), or alternatively, such buy (sell)
market order may be cancelled pursuant to User instruction. For all
other routing strategies that do not access all Protected Quotations,
routable market orders will not be re-priced and displayed at the price
of the Upper (Lower) Price Band and will instead be cancelled if the
NBO (NBB) is Non-Executable.
    The rule further provides that if the Upper (Lower) Price Band
crosses a routable buy (sell) order resting on the EDGX Book, such buy
(sell) order will be re-priced to the price of the Upper (Lower) Price
Band.

    Example 1:  Buy Market Order where NBO is Above Upper Price Band
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.05. A routable buy market order arrives for 100 shares
utilizing a routing strategy that accesses all Protected Quotations
(e.g., ROUT). The buy order will not be routed as the NBO is Non-
Executable (greater than the Upper Price Band) and will be posted
and displayed at $10.05 or cancelled according to the User's
instructions.

    If the Price Bands move up after the initial re-price to $9.98 by
$10.08, the buy order will be re-priced and displayed at $10.08. If the
Price Bands moves down after the initial re-price to $9.92 by $10.02,
the buy order will be re-priced and displayed at $10.02.
    In the same example, if the buy market order arrives for 100 shares
utilizing a routing strategy that does not access all Protected
Quotations, such as ROCO, then the System will cancel the buy market
order when the NBO is Non-Executable and will not re-price and display
the order at the price of the Upper Price Band.

    Example 2:  Market Order is Re-Priced to Market Collar Price as
a Result of Movement of the Price Bands
    Assume the NBBO is $10.00 by $11.00, the Price Bands are $9.05
by $10.05 and the last sale was at $10.00. A market order arrives to
buy 100 shares and is displayed at $10.05 with a market collar of
$10.50. The Price Bands then change to $10.00 by $11.00. As a
result, the market order is posted and displayed at its collar price
of $10.50.
Routable Limit Orders
    The second minor subsection, proposed Rule 11.9(b)(1)(B)(i)(II),
would describe routing behavior under the Plan applicable to routable
limit orders and would state that, if the price of (i) a routable buy
(sell) limit order that is entered into the System or (ii) the unfilled
balance of such order returned from routing to away Trading Centers is
greater (less) than the Upper (Lower) Price Band and is ineligible for
routing as a result of the NBO (NBB) being or having become Non-
Executable, then the System will default to re-price such buy (sell)
order and display it at the price of the Upper (Lower) Price Band, or
alternatively, it may be cancelled pursuant to User instruction. For
routing strategies that access all Protected Quotations, if the Upper
(Lower) Price Band subsequently moves above (below) the routable buy
(sell) order's posting price, such routable order will continue to be
re-priced to the Upper (Lower) Price Band until the order reaches its
limit price. For all other routing strategies that do not access all
Protected Quotations, the routable order will not be re-priced to a
price above (below) the original price at which it was posted to the
EDGX Book.
    The rule further provides that if the Upper (Lower) Price Band
crosses a routable buy (sell) order resting on the EDGX Book, such buy
(sell) order will be re-priced to the price of the Upper (Lower) Price
Band.

    Example 1:  Sell Limit Order That Accesses All Protected
Quotations Where NBB Is Below Lower Price Band
    Assume the NBBO is $10.02 by $10.10 and the Price Bands are
$10.04 by $10.15. A routable sell order arrives for 100 shares at
$10.01 utilizing a routing strategy that accesses all Protected
Quotations (e.g., ROUT). The sell order will not be routed and will
be posted and displayed at $10.04 or cancelled according to the
User's instructions.
    If the Lower Price Band moves up after the initial re-price to
$10.06 by $10.16, the order will be re-priced to display at $10.06.
If the Lower Price Band moves down after the initial re-price to
$10.03 by $10.13, the order will be re-priced to display at $10.03.
Example 2: Sell Limit Order that does not access all Protected
Quotations
    Assume the NBBO is $10.02 by $10.10 and the Price Bands are
$10.04 by $10.15. A routable sell order arrives for 100 shares at
$10.01 utilizing a routing strategy that does not access all
Protected Quotations (e.g., ROUZ). The sell order will not be routed
and will instead be posted and displayed at $10.04 or cancelled
according to the User's instructions.
    If the Lower Price Band moves up to $10.06 by $10.16 after the
initial re-price, the order will be re-priced and displayed at
$10.06. If the Lower Price Band moves down to $10.03 by $10.13 after
the initial re-price, the order will be re-priced and displayed at
$10.04, the original price at which it was posted to the EDGX Book.
Re-Routing Behavior
    The second major subsection, proposed Rule 11.9(b)(1)(B)(ii), would
describe how re-routing will function under the Plan and would state
that, for routing strategies that access all Protected Quotations, when
the Upper (Lower) Price Band adjusts such that the NBO (NBB) becomes
executable, a routable buy (sell) market or marketable limit order will
be eligible to be re-routed by the Exchange.

    Example 1:  Routing Buy Order when NBO Becomes Executable
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.94 by $10.09. A routable buy market order arrives for 100 shares
utilizing a routing strategy that accesses all Protected Quotations
(e.g., ROUT).\24\ The buy order will not be routed and will instead
be posted and displayed at $10.09. The Price Bands change to $9.95
by $10.10. The order will be routed since the NBO is now executable.
---------------------------------------------------------------------------

    \24\ If, for example, a routing strategy that does not access
all Protected Quotations, such as ROUZ, is elected by the User, the
order is not re-routed and remains posted on the EDGX Book.
---------------------------------------------------------------------------

    Example 2:  Routing Sell Order when NBB Becomes Executable
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$10.05 by $10.15. A routable sell order arrives for 100 shares at
$9.99 utilizing a routing strategy that accesses all Protected
Quotations (e.g., ROUT). The sell order will be re-priced and
displayed at $10.05. The Price Bands then change to $9.98 by $10.10.
The sell order will be routed since the NBB is now executable.
Behavior of Orders Utilizing SWP Routing Strategies
    The third and final major subsection, Rule 11.9(b)(1)(B)(iii),
would describe how orders utilizing routing strategies SWPA, SWPB and
SWPC \25\ (together, ``SWP routing strategies'') will function under
the Plan and would state that the System will immediately cancel orders
utilizing a SWP routing strategy when an order to buy utilizing an SWP
routing strategy has a limit price that is greater than the Upper Price
Band or if a sell order utilizing an SWP routing strategy has a limit
price that is less than the Lower Price Band. The following examples
illustrate how an order utilizing a SWP routing strategy (an ``SWP
order'') would behave in accordance with the Plan:
---------------------------------------------------------------------------

    \25\ Rules 11.9(b)(3)(o), (p) and (q) define SWPA, SWPB and SWPC
routing strategies, respectively.

    Example 1:  Buy SWP Limit Price Crosses the Upper Price Band
(Price Band Inside the NBBO)
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$10.00 by $10.08. A SWP order is placed to buy 100 shares at $10.10.
The order is rejected immediately because its $10.10 limit price
crosses the Upper Price Band.
    Example 2:  Buy SWP Limit Price Crosses the Upper Price Band
(Price Band Outside the NBBO)
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.11. A SWP order is placed to buy 100 shares at $10.12.
The order is rejected immediately because its $10.12 limit price
crosses the Upper Price Band.
    Example 3:  Buy SWP Limit Price is the same as the price of the
Upper Price Band (Price Band Outside the NBBO)
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.11. A SWP order is placed to buy 100 shares at $10.11.
The order is executed and ISOs can be routed out since the limit of
$10.11 is equal to the Upper Price Band.
Miscellaneous Organizational Amendments to Rule 11.9
    The Exchange proposes to add Rule 11.9(a)(1) (Compliance with
Regulation SHO), which would contain unchanged text from current Rule
11.9(a) relevant to compliance with Regulation SHO. The Exchange
proposes to add Rule 11.9(a)(2) (Compliance with Regulation NMS), which
would contain unchanged text from current Rule 11.9(a) relevant to
compliance with Regulation NMS. The Exchange proposes to re-number
current Rule 11.9(a)(1) (Execution against EDGX Book) to new Rule
11.9(a)(4). The text of the rule would remain unchanged.
    The Exchange proposes to rename current Rule 11.9(b) (Execution and
Routing) to Rule 11.9(b) (Routing). The Exchange proposes to add Rule
11.9(b)(1), which would contain text in current Rule 11.9(b)(2) with
regard to routing to away trading centers. The text of the rule will
remain unchanged aside from updated cross references. The Exchange also
proposes to add Rule 11.9(b)(1)(A), which would contain unchanged text
in current Rule 11.9(b)(2) relevant to Regulation SHO. The Exchange
proposes to add new Rules 11.9(b)(1)(C) and (D), which would contain
the unchanged text of current Rules 11.9(b)(2)(A) and (B),
respectively. Lastly, the Exchange proposes to re-number current Rule
11.9(b)(3) to new Rule 11.9(b)(2). The text of the rule will remain
unchanged.
Orders and Modifiers (Rule 11.5)
    The Exchange proposes to amend cross references in Rules
11.5(a)(2), 11.5(c)(4)-(10), and 11.5(d)(1) in response to the re-
numbering of subsections within Rule 11.9, as discussed in detail
above.
Mid-Point Match Orders
    The Exchange proposes to amend Rule 11.5(c)(7) to describe the
behavior of Mid-Point Match (``MPM'') Orders \26\ under the Plan.
---------------------------------------------------------------------------

    \26\ As defined in Rule 11.5(c)(7).
---------------------------------------------------------------------------

    The Exchange believes that, when a Protected Quotation \27\ is
crossed by the Price Bands and all Trading Centers have not yet
replaced their quotes to re-align them with the Price Bands, the
integrity of the NBBO is compromised. In such circumstances, the
Exchange believes that it is fair and reasonable to shut down all
midpoint trading until the Protected Quotation(s) is(are) no longer
crossed by the Price Bands.
---------------------------------------------------------------------------

    \27\ As defined in Rule 11.5(v).
---------------------------------------------------------------------------

    In addition, pursuant to Rule 11.9(a)(3), MPM Orders will not trade
with any other orders when the midpoint of the NBBO is below the Lower
Price Band or above the Upper Price Band since MPM Orders only execute
at the midpoint of the NBBO. MPM Orders will continue to execute at the
midpoint of the NBBO as long as the execution price is between the
Lower and Upper Price Bands.

    Example 1:  MPM Order Does Not Trade when Upper Price Band
Crosses Protected Bids from other Exchanges
    Assume the NBBO is $10.00 by $10.01 and the Price Bands are
$9.02 by $10.02. The best bids are $10.00 at NYSE, $10.00 at BATS
and $9.95 at ARCA. Order1 is placed to Sell 100 shares at $9.95 as a
MPM Order. The Price Bands then change to $8.99 by $9.99 and the
NBBO changes to $9.95 by $10.01 (BATS and

NYSE's best bids are excluded from the NBBO by the SIP and neither
exchange has yet submitted new quotes to the SIP). Order2 is placed
to buy 100 shares at $9.99. Order2 does not trade with Order1 and
remains posted on the EDGX Book at $9.99.
    Example 2:  MPM Orders Cannot Trade when the Price Band is
Crossing the Midpoint of the NBBO
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$10.00 by $10.04. A MPM Order is placed to buy 100 shares at $11.00
and posted at $10.05. A MPM Order is placed to sell 100 shares at
$10.00. The MPM Orders cannot trade at $10.05 because the Upper
Price Band is crossing the midpoint of the NBBO. Both orders will
remain posted on the EDGX Book at $10.05. No execution will occur
between the orders until the Upper Price Band no longer crosses the
midpoint of the NBBO.
Priority of Orders (Rule 11.8)
    The Exchange proposes to add new Rule 11.8(a)(8), which would state
that when a Price Band crosses an order resting on the EDGX Book, such
order will be provided a new time stamp \28\ and prioritized based on
its existing time stamp at the time the new Price Bands are
established. Furthermore, if an order is resting on the Book at a price
equal to the Upper (Lower) Price Band, such order will not be re-
priced, but will be provided a new time stamp and prioritized based on
its existing time stamp at the time the new Price Bands are
established.
---------------------------------------------------------------------------

    \28\ A new time stamp enables the Exchange's System to record
every time an order is re-priced.
---------------------------------------------------------------------------

    The Exchange views this method of retaining priority based on time
as being the method that is most fair to its Members and subject to the
least amount of manipulation. The Exchange believes that time priority
is a superior approach to price priority because under a time priority
approach, it would be more difficult for certain Members to price their
orders on the EDGA Book in a way that gives them a potential priority
advantage when such orders are subsequently re-priced by a Price Band
crossing the price at which such orders reside on the Book.
    The following examples demonstrate how order priority will be
affected by the Plan.

    Example 1:  Price Band Crosses Orders Resting on the EDGX Book
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.15. Two orders are placed: Order1 arrives to buy 100
shares at $10.05 and then Order2 arrives to buy 100 shares at
$10.08. The Price Bands change to $9.95 by $10.05 and Order2 is re-
priced to $10.05 as a result of the adjustment of the Upper Price
Band. Order3 is then placed to sell 100 shares at $10.05. Order1
will trade with Order3. Initially, Order2 will have price priority
while the Price Bands are outside of the NBBO. However, after the
Price Bands adjust, Order1 will have priority based on its existing
time stamp at the time the new Price Bands were established.
    Example 2:  Price Band Crosses Orders Resting on the EDGX Book
    Assume the NBBO is $10.00 by $10.10 and the Price Bands are
$9.95 by $10.15. Two orders are placed: Order1 arrives to buy 100
shares at $10.08 and then Order2 arrives to buy 100 shares at
$10.05. The Price Bands change to $9.95 by $10.05 and Order1 is re-
priced to $10.05 as a result of the adjustment of the Upper Price
Band. Order3 is then placed to sell 100 shares at $10.05. Order1
will trade with Order3 because it retains its priority based on its
existing time stamp at the time the new Price Bands were
established. When the Price Bands adjusted, both Order1 and Order2
obtained new time stamps and retained priority based on the time
stamps that existed relative to one another at the time the new
Price Bands were established.
Definitions (Rule 1.5)
    The Exchange proposes to add new Rule 1.5(gg), which would define
the term the ``Plan'' to mean The National Market System Plan to
Address Extraordinary Market Volatility as well as state that a number
of terms used in the Rules and related to the Plan shall have the
definitions and meanings ascribed to them under the Plan.
Trading Halts Due to Extraordinary Market Volatility (Rule 11.14)
    The Exchange proposes to amend Rule 11.14(d) (individual stock
trading pauses) to explain how the rule will operate during the phased
implementation of the Plan. Currently, under Rule 11.14(d), if a
primary listing market issues an individual stock trading pause in any
NMS stock, the Exchange will pause trading in that security until
trading has resumed on the primary listing market. If, however, trading
has not resumed on the primary listing market and ten minutes have
passed since the individual stock trading pause message has been
received from the responsible single plan processor, the Exchange may
resume trading in such stock. During Phase 1 of the Plan, an individual
stock trading pause in Tier 1 NMS Stocks that are subject to the
requirements of the Plan shall be subject to the Plan. Tier 1 NMS
Stocks not yet subject to the requirements of the Plan and Tier 2 NMS
Stocks shall be subject to the requirements set forth in paragraph (d)
of Rule 11.14. Once the Plan has been fully implemented and all NMS
stocks are subject to the Plan, Rule 11.14(d) will no longer apply.
2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Act,\29\ which requires the rules of an exchange 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. The
Exchange believes that the proposed rule change meets these
requirements in that it seeks to promote the efficient execution of
investor transactions, and thus strengthen investor confidence, over
the long term by providing additional transparency regarding the order
handling procedures employed by the Exchange and certain obligations of
Members when sending orders to the Exchange consistent with the Plan.
The Exchange also believes that the proposed amendments to Rules 11.8
and 11.9 will assist Users in executing or displaying their orders
consistent with the Plan, especially under fast moving conditions where
the Price Bands and NBBO are quickly updating. In addition, Users can
choose to use an IOC Order or opt out of certain default re-pricing
processes, as described in proposed Rules 11.9(b)(3) and
11.9(b)(1)(B)(i)(I-II), that re-price a buy (sell) order to the price
of the Upper (Lower) Price Band. If Users choose to do so, the Exchange
will instead cancel their orders instead as per User instructions.
---------------------------------------------------------------------------

    \29\ 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. The Exchange believes that
its rules are comparable, in part, with re-pricing and cancellation
processes offered by other exchanges in response to the Plan. The
Exchange also believes that there is no impact on competition as
analogous rule changes are being filed by all Participants to the Plan
and the Plan itself was developed and jointly filed by all Participants
in the first instance.

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

    The Exchange has filed the proposed rule change pursuant to Section

19(b)(3)(A)(iii) of the Act \30\ and Rule 19b-4(f)(6) thereunder.\31\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \31\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this 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) of the Act \32\ to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \32\ 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 No. SR-EDGX-2013-08 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-EDGX-2013-08. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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-EDGX-2013-08 and should be
submitted on or before March 26, 2013.
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-05004 Filed 3-4-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63189-63191]
[DOCID:fr14oc10-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0503]

Draft Guidance for Industry on Investigational New Drug
Applications--Determining Whether Human Research Studies Can Be
Conducted Without an Investigational New Drug Application; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled
``Investigational New Drug Applications (INDs)--Determining Whether
Human Research Studies Can Be Conducted Without an IND.'' This draft
guidance is intended to assist clinical investigators, sponsors, and
sponsor-investigators in determining whether planned human research
studies must be conducted under an investigational new drug application
(IND). The guidance describes the basic criteria for when an IND is
required, describes specific situations in which an IND is not
required, and discusses a range of issues that, in FDA's experience,
have been the source of confusion or misperceptions about the
application of the IND requirements.

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 comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 12, 2011. Submit either electronic or written
comments concerning proposed collection of information by December 13,
2010.

ADDRESSES: 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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation Research (CBER), Food and Drug Administration,
1401

Rockville Pike, Suite 200N, Rockville, MD 20852-1448. The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or<PHONE_NUMBER>. Send one self-addressed adhesive label to assist the
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Sandy Benton, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Investigational New Drug Applications (INDs)--Determining
Whether Human Research Studies Can Be Conducted Without an IND.'' FDA
receives frequent inquiries from external constituents, in particular
the academic research community (e.g., clinical investigators,
Institutional Review Boards (IRBs)) and the pharmaceutical industry,
concerning whether various types of human research studies can be
conducted without an IND. Because of the volume and nature of the
inquiries, this guidance is intended to be a resource to assist
potential sponsors and clinical investigators in determining whether an
IND should be submitted for their planned research. Generally, clinical
investigations in which a drug is administered to study subjects must
be conducted under an IND as required by part 312 (21 CFR part 312).
This guidance explains the general requirements for when an IND is
needed, describes the types of clinical studies that are exempt by
regulation from the IND requirements, and addresses a range of issues
that commonly arise in inquiries to FDA concerning the application of
the IND requirements.
    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 agency's current thinking on determining
whether human research studies can be conducted without an IND. 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 requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comment on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
    Title: Draft Guidance for Industry on Investigational New Drug
Applications (INDs)--Determining Whether Human Research Studies Can Be
Conducted Without an IND.
    Description: The draft guidance would assist clinical
investigators, sponsors, and sponsor-investigators in determining
whether human research studies must be conducted under an IND as
described in part 312, Investigational New Drug Application. The draft
guidance describes the basic criteria for when an IND is required,
specific situations in which an IND is not required, and a range of
issues that have been the source of confusion or misperceptions about
the application of the IND regulations. Section VIII of the draft
guidance, ``Process for Addressing Inquiries Concerning the Application
of the IND Requirements,'' provides a process for seeking advice from
FDA concerning the application of the IND regulations to a planned
clinical investigation. Under Sec.  312.2(e), FDA, on request, will
advise on the applicability of part 312 to a planned clinical
investigation.
    Part 312 contains an information collection that has been approved
by OMB under OMB control number 0910-0014, and this approval would
extend to the recommendations in the draft guidance. However, requests
for FDA advice, under Sec.  312.2(e), on the application of the IND
regulations to a planned clinical investigation has not been part of
this approval by OMB. Therefore, we are requesting OMB approval of the
information collection in Section VIII of the draft guidance. As
indicated in table 1 of this document, based on FDA's experience with
the requests it has received for advice on the application of the IND
regulations to planned clinical investigations, we estimate that we
will receive annually approximately 45 formal inquiries as described in
Section VIII of the draft guidance from approximately 20 sponsors and/
or investigators, and approximately 110 informal inquiries as described
in Section VIII from approximately 40 sponsors and/or investigators. We
also estimate that it will take approximately 8 hours to prepare and
submit each formal inquiry and approximately 30 minutes to prepare and
submit each informal inquiry.
    FDA requests comments on this analysis of information collection
burdens:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
                                 Number of     responses per   Total annual        Hours per        Total hours
                                respondents     respondent       responses         response
----------------------------------------------------------------------------------------------------------------
Formal Inquiry..............              20            2.25              45  8 hours...........             360
Informal Inquiry............              40            2.75             110  30 minutes........              55
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................             415
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
draft guidance, including comments regarding proposed collection of
information. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of any mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen 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 document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: October 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25851 Filed 10-13-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Page 85238]
[FR Doc No: 2016-28356]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4283-DR; Docket ID FEMA-2016-0001]

Florida; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4283-DR), dated October 8, 2016, and
related determinations.

DATES: Effective Date: November 4, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Florida is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of October 8, 2016.

    Broward, Orange, and Osceola Counties for Public Assistance,
including direct federal assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-28356 Filed 11-23-16; 8:45 am]
BILLING CODE 9111-23-P