[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75456-75458]
[FR Doc No: 2016-26131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79148; File No. SR-BatsBYX-2016-27]

Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
BYX Rule 11.13, Order Execution and Routing

October 25, 2016.
    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 October 12, 2016, Bats BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange has designated this proposal as a ``non-controversial''
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(6)(iii) thereunder,\4\ which renders it effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend Exchange Rule 11.13(b)(1) to
describe when an order marked as ``short'' may be eligible for routing
when a short sale price test restriction is in effect.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Exchange Rule 11.13(b)(1) to
describe when an order to sell marked \5\ as ``short'' \6\ may be
eligible for routing when a short sale price test restriction is in
effect. Under Rule 201 of Regulation SHO,\7\ short sale orders in a
covered security \8\ generally cannot be executed or displayed by a
Trading Center,\9\ such as the Exchange, at a price that is at or below
the current national best bid (``NBB'') \10\ when a short sale circuit
breaker is in effect for the covered security (the ``short sale price
test restriction'').\11\
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    \5\ 17 CFR 242.200(g).
    \6\ The term ``short sale'' is defined as ``any sale of a
security which the seller does not own or any sale which is
consummated by the delivery of a security borrowed by, or for the
account of, the seller.'' 17 CFR 242.200(a).
    \7\ See 17 CFR 242.201; Securities Exchange Act Release No.
61595 (February 26, 2010), 75 FR 11232 (March 10, 2010).
    \8\ Rule 201(a)(1) of Regulation SHO defines the term ``covered
security'' to mean any ``NMS stock'' as defined under Rule
600(b)(47) of Regulation NMS. Rule 600(b)(47) of Regulation NMS
defines an ``NMS stock'' as ``any NMS security other than an
option.'' Rule 600(b)(46) of Regulation NMS defines an ``NMS
security'' as ``any security or class of securities for which
transaction reports are collected, processed, and made available
pursuant to an effective transaction reporting plan, or an effective
national market system plan for reporting transactions in listed
options.'' 17 CFR 242.201(a)(1); 17 CFR 242.600(b)(46); and 17 CFR
242.600(b)(47).
    \9\ Rule 201(a)(9) of Regulation SHO states that the term
``Trading Center'' shall have the same meaning as in Rule 600(b)(78)
of Regulation NMS. Rule 600(b)(78) of Regulation NMS defines a
``Trading Center'' as ``a national securities exchange or national
securities association that operates an SRO trading facility, an
alternative trading system, an exchange market maker, an OTC market
maker, or any other broker or dealer that executes orders internally
by trading as principal or crossing orders as agent.'' 17 CFR
242.200(a)(9); 17 CFR 242.600(b)(78).
    \10\ 17 CFR 242.201(a)(4); 17 CFR 242.600(b)(42).
    \11\ 17 CFR 242.201(b)(1).
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    Under Rule 11.13(b)(1), an order marked ``short'' when a short sale
price test restriction is in effect is not eligible for routing by the
Exchange. If an order is ineligible for routing due to a short sale
price test restriction and such order is an Immediate or Cancel
(``IOC'') Order \12\ or a BYX Market Order,\13\ then

the order will be cancelled. If an order is ineligible for routing due
to a short sale price test restriction and such order is a Limit
Order,\14\ the Exchange will post the unfilled balance of the order to
the BYX Book,\15\ subject to the price sliding process as defined in
paragraph (g) of Exchange Rule 11.9.\16\
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    \12\ See Exchange Rule 11.9(b)(1).
    \13\ See Exchange Rule 11.9(a)(2). The Exchange also proposes to
remove the reference to BYX Market Orders in Rule 11.13(b)(1) as BYX
Market Orders with a time-in-force of Day that are ineligible for
routing due to a short sale price test restriction pursuant to Rule
201 of Regulation SHO are not cancelled, but rather posted to the
BYX Book pursuant to Exchange Rule 11.9(a)(2). All other BYX Market
Orders are handled in accordance with Exchange Rule 11.13(a).
    \14\ See Exchange Rule 11.9(a)(1).
    \15\ See Exchange Rule 1.5(e).
    \16\ In sum, under Exchange Rule 11.9(g), a short sale order
that, at the time of entry, could not be executed or displayed in
compliance with Rule 201 of Regulation SHO will be re-priced by the
System at one minimum price variation above the current NBB
(``Permitted Price''). See Exchange Rule 11.9(g) for a full
description of the Exchange's Short Sale Price Sliding Process.
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    The Exchange proposes to specify in Rule 11.13 that orders marked
``short'' may be eligible for routing by the Exchange when a short sale
price test restriction is in effect where the User \17\ selects the
Post to Away \18\ routing option.\19\ In contrast to all other routing
strategies, which are routed to other Trading Centers for immediate
execution, the Post to Away routing option is an order that is sent to
other Trading Centers for posting and/or later execution as further
described below. Under the Post to Away routing option, the remainder
of a routed order is routed to and posted to the order book of a
destination on the System routing table,\20\ as specified by the User.
Orders routed pursuant to the Post to Away routing option that are
identified as ``short'' are subject to the receiving Trading Center's
processes for handling short sale orders in compliance with Rule 201 of
Regulation SHO.\21\
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    \17\ See Exchange Rule 1.5(cc).
    \18\ See 11.13(b)(3)(H).
    \19\ The Exchange also proposes to specify within Rule
11.13(b)(1) that the short sale price test restriction is declared
pursuant to Rule 201 of Regulation SHO.
    \20\ The term ``System routing table'' is defined as the ``the
proprietary process for determining the specific trading venues to
which the System routes orders and the order in which it routes
them.'' See Exchange Rule 11.13(b)(3).
    \21\ See, e.g., Nasdaq Stock Market LLC (``Nasdaq'') Rule 4763;
New York Stock Exchange, Inc. (``NYSE'') Rule 440B; and Nasdaq's
Regulation SHO Frequently Asked Questions (updated March 10, 2011),
available at https://nasdaqtrader.com/content/marketregulation/regsho/regshoFAQs.pdf.
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    Under Exchange Rule 11.13(b)(1), IOC Orders marked ``short'' that
are not eligible for routing during a short sale price test restriction
will continue to be cancelled.\22\ The unfilled portions of Limit
Orders marked ``short'' that are ineligible for routing due to a short
sale price test restriction Exchange will continue to be posted to the
BYX Book subject to the price sliding process as defined in paragraph
(g) of Exchange Rule 11.9.
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    \22\ See supra note 13.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \23\ and furthers the objectives of
Section 6(b)(5) of the Act \24\ because it is designed to promote just
and equitable principles of trade, remove impediments to and perfect
the mechanism of a free and open market and a national market system,
foster cooperation and coordination with persons engaged in
facilitating transactions in securities, and, in general, protect
investors and the public interest. Specifically, the proposed changes
are designed to ensure clarity in the Exchange's rulebook with respect
to the routing of orders in compliance with Rule 201 of Regulation SHO.
In addition, providing Users the ability to send short sale orders that
are routable pursuant to the Post to Away routing option provides them
additional flexibility with regard to the handling of their orders. The
Exchange notes that short sale orders routed pursuant to the Post to
Away routing option are identified as ``short'' and, therefore, subject
to the receiving Trading Center's processes for handling short sale
orders in compliance with Rule 201 of Regulation SHO.\25\ The Exchange
also notes that other national securities exchanges do not expressly
prohibit the routing of short sale orders. For example, Nasdaq and NYSE
Arca, Inc. (``NYSE Arca'') allow for the routing of short sale orders
generally, and do not limit a short sale order's ability to route to
certain routing options.\26\ Thus, the proposal is directly targeted at
removing impediments to and perfecting the mechanism of a free and open
market and national market system. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \27\ of the Act
in that it seeks to assure fair competition among brokers and dealers
and among exchange markets.
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    \23\ 15 U.S.C. 78f(b).
    \24\ 15 U.S.C. 78f(b)(5).
    \25\ See supra note 21.
    \26\ See e.g., Nasdaq Rules 4702(a) (stating generally that an
``[o]rder may . . . may be routed to other market centers for
potential execution if designated as `Routable' '') and 4763 (not
prohibiting the routing of a short sale order during a short sale
price test). See also e.g., NYSE Arca Rule 7.6P (not prohibiting the
routing of a short sale order during a short sale price test).
    \27\ 15 U.S.C. 78k-1(a)(1).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange is
simply proposing to reflect in its rules that orders marked ``short''
may be routed to an away market for execution under one specific
routing strategy offered by the Exchange.

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

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

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

    Because the foregoing proposed rule change does not: (A)
Significantly affect the protection of investors or the public
interest; (B) impose any significant burden on competition; and (C) by
its terms, become operative for 30 days from the date on which it was
filed or such shorter time as the Commission may designate it has
become effective pursuant to Section 19(b)(3)(A) of the Act \28\ and
paragraph (f)(6) of Rule 19b-4 thereunder,\29\ the Exchange has
designated this rule filing as non-controversial. The Exchange has
given the Commission written notice of its 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.
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    \28\ 15 U.S.C. 78s(b)(3)(A).
    \29\ 17 CFR 240.19b-4.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BatsBYX-2016-27 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BatsBYX-2016-27. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for 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 Number SR-BatsBYX-2016-27, and should
be submitted on or before November 21, 2016.
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    \30\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
Brent J. Fields,
Secretary.
[FR Doc. 2016-26131 Filed 10-28-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14063-14064]
[FR Doc No: 2014-05398]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2014-USCG-2014-0126]

International Code for Ships Using Gases or Other Low-Flashpoint
Fuels (IGF Code)

AGENCY: Coast Guard, DHS.

ACTION: Notice of public workshop.

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SUMMARY: The United States Coast Guard will hold a public workshop in
Washington, DC on topics related to the development of the
International Maritime Organization's International Code for Ships
Using Gases or Other Low-Flashpoint Fuels (IGF Code). Various safety
topics will be discussed including design, equipment, operational and
training requirements. This workshop is intended to be an interactive
exchange of information between policymakers, industry experts, and
interested members of the public.

DATES: The public workshop will be held on Tuesday, April 1, 2014,
beginning at 9 a.m., Eastern Time and ending at 4 p.m., Eastern Time.
This workshop is open to the public.

ADDRESSES: The public workshop will be held at the U.S. Department of
Transportation, West Building Conference Center, 1200 New Jersey Avenue
SE., Washington, DC 20590-0001, approximately 1 block from the Navy
Yard Metro Station. Due to building security requirements, each visitor
must present two forms of government-issued photo identification in
order to gain entrance to the building.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
workshop, please call or email Mr. Timothy Meyers, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    This workshop is intended to be an interactive exchange of
information between policymakers, industry experts, and interested
members of the public. It will include an overview of the IGF Code
development to date, and a discussion of the current draft text with
focus on specific areas of interest to vessel design and operational
safety. The primary topics that will be considered at the public
workshop include:
     General overview--U.S. involvement in development of the
IGF Code,
     Review of draft IGF Code layout/structure/table of
contents,
     Ship design areas of focus, including: risk analysis
requirements; machinery space concepts; fuel tank design & arrangement;
piping systems; bunkering arrangements; ventilation; hazardous areas;
gas detection and fire safety systems,
     Operational and training requirements,
     Fuels other than liquefied natural gas.
    If you are interested in formally presenting information on a topic
on the agenda please contact Mr. Timothy Meyers (see FOR FURTHER
INFORMATION CONTACT). All presentations received will be posted without
change to http://www.regulations.gov, where they will appear under
Docket No. USCG-2014-0126 and can be viewed by following that Web
site's instructions. Please note that any personal information you
include can be searchable online (see the Federal Register Privacy Act
notice regarding our public dockets, 73 FR 3316, Jan. 17, 2008).

    Please note that the workshop has a limited number of seats and may
close early if all business is finished.
    Members of the public may attend this workshop up to the seating
capacity of the room, and are encouraged to participate and join in
discussions, subject to the discretion of the moderator. To facilitate
the security process related to building access, or to request
reasonable accommodation for persons with disabilities or special
needs, those who plan to attend should contact the meeting coordinator,
Mr. Timothy Meyers (see FOR FURTHER INFORMATION CONTACT), or in writing
at Commandant (CG-ENG-3), U.S. Coast Guard, Stop 7509, 2703 Martin
Luther King Jr. Ave. SE., Washington, DC 20593-7509, not later than
Monday, March 24, 2014. We may not be able to accommodate requests made
after March 24, 2014. Please note that due to building security
requirements, each visitor must present two valid, government-issued
photo identifications.
    This notice is published under the authority of 5 U.S.C. 552(a).

    Dated: March 4, 2014.
J. G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2014-05398 Filed 3-11-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34783-34784]
[FR Doc No: 2015-14887]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2012-0033

Notice of Intent To Grant a Buy America Waiver to the City of
Sacramento, California, Department of Public Works, for the Purchase of
a Variable Refrigerant Flow Heating, Ventilation, and Air Conditioning
System

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

ACTION: Notice of intent to grant Buy America waiver.

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SUMMARY: FRA is issuing this notice to advise the public that it
intends to grant the City of Sacramento, California, Department of
Public Works (Sacramento), a waiver from FRA's Buy America requirement
under 49 U.S.C. 24405(a)(2)(B) for the purchase of a variable
refrigerant flow (VRF) heating, ventilation, and air conditioning
system for use in the Sacramento Valley Station Phase II intermodal
project. The $30 million project is partially funded with a $15 million
2012 Transportation Infrastructure Generating Economic Recovery grant.
The cost of the non-domestic material in the VRF system is
approximately $202,500. FRA believes a waiver is appropriate under 49
U.S.C. 24405(a)(2)(B) for the VRF system because VRF systems are not
currently produced in the U.S.

DATES: Written comments on FRA's determination to grant Sacramento's
Buy America waiver request should be provided to the FRA on or before
June 22, 2015.

ADDRESSES: Please submit your comments by one of the following means,
identifying your submissions by docket number FRA-2012-0033. All
electronic submissions must be made to the U.S. Government electronic
site at http://www.regulations.gov. Commenters should follow the
instructions below for mailed and hand-delivered comments.
    (1) Web site: http://www.regulations.gov. Follow the instructions
for submitting comments on the U.S. Government electronic docket site;
    (2) Fax:<PHONE_NUMBER>;

    (3) Mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590-0001;
or
    (4) Hand Delivery: Room W12-140 on the first floor of the West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must make reference to the ``Federal
Railroad Administration'' and include docket number FRA-2012-0033. Due
to security procedures in effect since October 2001, mail received
through the U.S. Postal Service may be subject to delays. Parties
making submissions responsive to this notice should consider using an
express mail firm to ensure the prompt filing of any submissions not
filed electronically or by hand. Note that all submissions received,
including any personal information therein, will be posted without
change or alteration to http://www.regulations.gov. For more
information, you may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477), or visit
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. John Johnson, Attorney-Advisor,
FRA Office of Chief Counsel, 1200 New Jersey Avenue SE., Mail Stop 25,
Washington, DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The letter granting Sacramento's request is quoted below:

Mr. Gregory Taylor
AIA, Supervising Architect/Project Manager
City of Sacramento, Department of Public Works
915 I Street
Room 2000
Sacramento, CA 95814-2604.

Re: Request for Waiver of Buy America Requirement

Dear Mr. Taylor:
    As you are aware, on November 24, 2014, the City of Sacramento,
California, Department of Public Works (Sacramento) requested a
waiver from the Federal Railroad Administration's (FRA) Buy America
requirement (49 U.S.C. 24405(a)) to purchase a variable refrigerant
flow (VRF) heating, ventilation, and air conditioning (HVAC) system
for use in the Sacramento Valley Station (SVS) Phase II intermodal
project.\1\
---------------------------------------------------------------------------

    \1\ Sacramento also requested a waiver for Marmoleum flooring.
However, FRA has chosen to bifurcate the waiver requests since the
VRF waiver is more advanced in terms of processing and in urgent
need by Sacramento. FRA is still deciding whether a waiver for the
flooring is warranted.
---------------------------------------------------------------------------

    The SVS Phase II intermodal project is the rehabilitation of the
historic 68,000 square foot train station in downtown Sacramento,
California. The $30 million project is partially funded with a $15
million 2012 Transportation Infrastructure Generating Economic
Recovery (TIGER) grant. The U.S. Department of Transportation (DOT)
selected each project for 2012 TIGER Grant funding based on whether
it would, among other things, promote a more environmentally
sustainable transportation system. 77 FR 4863, 4867 (January 31,
2012). After rehabilitation, the SVS will include Amtrak station
facilities, commercial retail and office space.
    FRA is granting Sacramento's waiver request. FRA concludes a
waiver is appropriate under 49 U.S.C. 24405(a)(2)(B) for the VRF
system because domestically-produced HVAC systems meeting the
specific needs of Sacramento for this application (i.e., energy
efficiency and historic preservation) are not currently ``produced
in sufficient and reasonably available amount or are not of a
satisfactory quality.'' 49 U.S.C. 24405(a)(2)(B).
    With respect to historic building preservation and energy
efficiency, FRA concludes that the VRF system is the only choice for
the rehabilitation of the SVS for the following reasons:

 The VRF system has small distribution pipes instead of
larger ductwork that would create problematic penetrations in the
existing older structures.
 The VRF system has smaller equipment in the conditioned
allowable space.
 The VRF system does not require heavy, large air handling
units that would overburden an historic building's capacity.
 The VRF system has zone-to-zone heat recovery and high
efficiency heating and cooling.

In addition to concluding that VRF is the only system meeting the
project's needs, FRA also conducted due diligence with regard to
determining the availability of domestic manufacturers of the VRF
system. FRA concludes that no company manufactures VRF systems
domestically. FRA bases this determination on the following facts:

 In 2010, the U.S. Department of Energy (DOE) issued a
blanket non-availability waiver for VRF HVAC systems procured with
American Reinvestment and Recovery Act funding. See 75 FR 35447,
June 22, 2010.
 In 2014, the Federal Transit Administration (FTA) granted
two non-availability waivers for VRF systems. See St. Louis'
MetroLink, 79 FR 34653, June 17, 2014, and San Bernardino Associated
Governments, 79 FR 61129, October 9, 2014. FTA is currently
reviewing another non-availability waiver for a VRF system.
 On December 9, 2014, FRA provided public notice of this
waiver request and a 15-day opportunity for comment on its Web site.
FRA also emailed notice to over 6,000 persons who have signed up for
Buy America notices through ``GovDelivery.'' See http://www.fra.dot.gov/Page/P0719. FRA received one comment. The commenter
supported granting the waiver and stated, ``The efficiency of the
VRF system cannot be matched by other types of conventional
systems.''
 In February 2015, FTA engaged National Institute of
Standards and Technology's Hollings Manufacturing Extension
Partnership (NIST-MEP) to scout for Buy America-compliant VRF
systems. NIST-MEP did not locate any domestic VRF systems. In fact,
Carrier Corporation responded to NIST-MEP's scouting efforts,
stating ``VRF system is a new technology . . . there are no current
domestic manufacturers of VRF systems.''

Pursuant to 49 U.S.C. 24405(a)(4), FRA will publish this letter
granting Sacramento's request in the Federal Register and provide
notice of such finding and an opportunity for public comment after
which this waiver will become effective.
    Question about this letter can be directed to, John Johnson,
Attorney-Advisor, at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

Sincerely,

Sarah Feinberg
Acting Administrator

Melissa L. Porter,
Chief Counsel.
[FR Doc. 2015-14887 Filed 6-16-15; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25494-25495]
[FR Doc No: 2022-09240]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0091]

Crohn's Disease: Developing Drugs for Treatment; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Crohn's
Disease: Developing Drugs for Treatment.'' This draft guidance
addresses FDA's current thinking about necessary attributes of clinical
trials for developing drugs for the treatment of Crohn's disease in
adults, including recommendations for trial population, trial design,
and efficacy and safety considerations.

DATES: Submit either electronic or written comments on the draft
guidance by June 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0091 for ``Crohn's Disease: Developing Drugs for
Treatment.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5353, Silver Spring, MD 20993-0002, 301-
796-9007, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Crohn's Disease: Developing Drugs for Treatment.'' This
guidance addresses FDA's current thinking about clinical trials for the
treatment of Crohn's disease in adults, including recommendations for
trial population, trial design, and efficacy and safety considerations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Crohn's
Disease: Developing Drugs for Treatment.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014. FDA receives information described in FDA's guidance
entitled ``Patient-Reported Outcome Measures: Use in Medical Product
Development to Support Labeling Claims'' to support the medical
product's effectiveness and to support claims in approved medical
product labeling; the collections of information in 21 CFR 314.50(d)(5)
and 21 CFR 601.2 have been approved under OMB control numbers 0910-0001
and 0910-0338, respectively, and the collections of information in 21
CFR 201.56 and 201.57 for medical product labeling have been approved
under OMB control number 0910-0572. The collections of information in
21 CFR parts 50 and 56 for protection of human subjects in clinical
trials and institutional review board considerations have been approved
under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09240 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P