[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45455-45456]
[DOCID:fr05au08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0417]

Draft Guidance for the Public and the Food and Drug
Administration Staff on Convening Advisory Committee Meetings;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Guidance for the
Public and FDA Staff on Convening Advisory Committee Meetings.'' This
draft guidance is intended to provide guidance on when FDA should
consider referring a matter to an advisory committee. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of
four guidances intended to improve FDA's advisory committee procedures.

DATES:  Although you can comment on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))), to ensure that the agency
considers your comment on this draft guidance before it begins work on
the final version of the guidance, submit written or electronic
comments on the draft guidance by October 6, 2008.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Office of Policy (HF-11), Office of the Commissioner, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit phone requests to<PHONE_NUMBER> or<PHONE_NUMBER>. Submit
written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of Policy
and Planning (HF-11), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for the Public and FDA Staff on Convening Advisory Committee
Meetings,'' dated July 2008. Advisory committees provide FDA with
independent, expert advice on a range of complex scientific and
technical issues related to the products it regulates. These issues
typically focus on a specific food or medical product, a class of foods
or medical products, the development and implementation of a specific
regulatory program, or the development and implementation of a
regulatory policy. Advisory committee meetings also facilitate public
discussion of important topics and provide a means for the public to
provide comments to the agency.
    To enhance the transparency of FDA's advisory committee program,
the agency is publishing this draft guidance to provide its current
thinking on when to bring a matter to an advisory committee. In some
instances, FDA refers a matter to an advisory committee because it is
required to do so by law. In others, FDA convenes an advisory committee
meeting at its own discretion. Regardless, FDA recognizes that advisory
committee meetings demand significant resource commitments by advisory
committee members, sponsors, and other public participants, as well as
for FDA itself, and should be used for important matters. The draft
guidance is intended to clarify how the agency identifies which matters
should be referred.
    In developing this draft guidance, FDA has been mindful of the
legal requirements of the Federal Advisory Committee Act (FACA), other
relevant statutes, regulations, guidance, and policies, and the goals
of FDA's of advisory committee program.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The draft guidance
represents the agency's current thinking on when FDA convenes an
advisory committee meeting. 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. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.

Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/ohrms/dockets/default.htm or http://
www.regulations.gov.

    Dated: August 1, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-18002 Filed 8-4-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Proposed Rules]
[Pages 45478-45479]
[FR Doc No: 2013-18147]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0531; Airspace Docket No. 13-ANM-20]

Proposed Establishment of Class E Airspace; Salmon, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at the
Salmon VHF Omni-Directional Radio Range/Distance Measuring Equipment
(VOR/DME) navigation aid, Salmon, ID, to facilitate vectoring of
Instrument Flight Rules (IFR) aircraft under control of Salt Lake City
and Seattle Air Route Traffic Control Centers (ARTCCs). The FAA is
proposing this action to enhance the safety and management of aircraft
operations within the National Airspace System.

DATES: Comments must be received on or before September 12, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2013-
0531; Airspace Docket No. 13-ANM-20, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2013-0531 and Airspace Docket No. 13-ANM-20) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2013-0531 and Airspace Docket No. 13-ANM-20.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and

5:00 p.m., Monday through Friday, except federal holidays. An informal
docket may also be examined during normal business hours at the
Northwest Mountain Regional Office of the Federal Aviation
Administration, Air Traffic Organization, Western Service Center,
Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by establishing Class E en route domestic
airspace extending upward from 1,200 feet above the surface at the
Salmon VOR/DME navigation aid, Salmon, ID. This action would contain
aircraft while in IFR conditions under control of Salt Lake City and
Seattle ARTCCs by vectoring aircraft from en route airspace to terminal
areas.
    Class E airspace designations are published in paragraph 6006, of
FAA Order 7400.9W, dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle I, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This proposed regulation is within the scope of that
authority as it would establish controlled airspace at the Salmon VOR/
DME, Salmon, ID.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 6006 En route domestic airspace areas.

* * * * *

ANM ID E6 Salmon, ID [New]

Salmon VOR/DME, ID
    (Lat. 45[deg]01'17'' N., long. 114[deg]05'03'' W.)

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 45[deg]50'06'' N., long.
117[deg]05'33'' W.; to lat. 45[deg]50'00'' N., long. 115[deg]45'00''
W.; to lat. 46[deg]40'00'' N., long. 115[deg]45'00'' W.; to lat.
46[deg]40'00'' N., long. 115[deg]00'00'' W.; to lat. 46[deg]02'00''
N., long. 115[deg]00'00'' W.; to lat. 46[deg]02'00'' N., long.
113[deg]20'00'' W.; to lat. 45[deg]51'00'' N., long. 113[deg]07'00''
W.; to lat. 45[deg]35'00'' N., long. 113[deg]25'00'' W.; to lat.
45[deg]01'02'' N., long. 113[deg]30'00'' W.; to lat. 44[deg]44'30''
N., long. 113[deg]13'20'' W.; to lat. 44[deg]38'18'' N., long.
112[deg]58'48'' W.; to lat. 44[deg]34'31'' N., long. 112[deg]25'54''
W.; to lat. 44[deg]41'00'' N., long. 111[deg]59'20'' W.; to lat.
44[deg]39'25'' N., long. 111[deg]52'32'' W.; to lat. 44[deg]19'00''
N., long. 112[deg]04'36'' W.; to lat. 43[deg]34'55'' N., long.
112[deg]29'22'' W.; to lat. 42[deg]57'33'' N., long. 113[deg]32'27''
W.; to lat. 43[deg]00'00'' N., long. 113[deg]52'20'' W.; to lat.
43[deg]57'38'' N., long. 113[deg]56'09'' W.; to lat. 43[deg]57'53''
N., long. 114[deg]51'05'' W.; to lat. 43[deg]05'36'' N., long.
114[deg]51'26'' W.; to lat. 43[deg]03'38'' N., long. 115[deg]19'32''
W.; to lat. 43[deg]17'24'' N., long. 115[deg]41'05'' W.; to lat.
43[deg]30'14'' N., long. 115[deg]36'38'' W.; to lat. 43[deg]47'52''
N., long. 115[deg]41'21'' W.; to lat. 43[deg]58'04'' N., long.
115[deg]51'09'' W.; to lat. 44[deg]03'41'' N., long. 116[deg]12'15''
W.; to lat. 44[deg]15'42'' N., long. 116[deg]19'34'' W.; to lat.
45[deg]07'42'' N., long. 116[deg]18'03'' W.; to lat. 45[deg]13'00''
N., long. 117[deg]05'42'' W., thence to the point of beginning.

    Issued in Seattle, Washington, on July 22, 2013.
Christopher Ramirez,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-18147 Filed 7-26-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Rules and Regulations]
[Pages 64403-64404]
[FR Doc No: 2013-25592]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 312

[EPA-HQ-SFUND-2013-0513; FRL-9902-22-OSWER]

Amendment to Standards and Practices for All Appropriate
Inquiries

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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SUMMARY: Because EPA received adverse comment, we are withdrawing the
direct final rule for the Amendment to Standards and Practices for All
Appropriate Inquiries published on August 15, 2013.

DATES: Effective October 29, 2013, EPA withdraws the direct final rule
published at 78 FR 49690, on August 15 2013.

FOR FURTHER INFORMATION CONTACT: Rachel Lentz, Office of Brownfields
and Land Revitalization (5105-T), U.S. Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0002; telephone
number:<PHONE_NUMBER>; fax number: 202-566-

1476; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Because EPA received adverse comment, we are
withdrawing the direct final rule for the Amendment to Standards and
Practices for All Appropriate Inquiries published on August 15, 2013
(78 FR 49690). We stated in that direct final rule that if we received
adverse comment by September 16, 2013, the direct final rule would not
take effect and we would publish a timely withdrawal in the Federal
Register. We subsequently received adverse comment on that direct final
rule. We will address the comments received in any subsequent final
action. As stated in the direct final rule and the parallel proposed
rule, we will not institute a second comment period on the parallel
proposed rule published on August 15, 2013 (78 FR 49714).

List of Subjects in 40 CFR Part 312

    Administrative practice and procedure, Hazardous substances.

    Dated: October 22, 2013.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.

    Accordingly, EPA withdraws the amendments to 40 CFR 312.11(c),
published in the Federal Register on August 15, 2013 (78 FR 49690), as
of October 29, 2013.

[FR Doc. 2013-25592 Filed 10-28-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Page 9912]
[FR Doc No: 2020-03316]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88189; SR-CboeBZX-2019-068]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change, as Modified by Amendment No. 1,
To List and Trade Shares of the iShares California Short Maturity Muni
Bond ETF Under Rule 14.11(i)

 February 13, 2020.
    On July 19, 2019, Cboe BZX Exchange, Inc. (``BZX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
allow the listing and trading of shares of the iShares California Short
Maturity Muni Bond ETF under BZX Rule 14.11(i). The proposed rule
change was published for comment in the Federal Register on August 7,
2019.\3\ On September 19, 2019, pursuant to Section 19(b)(2) of the
Act,\4\ the Commission extended the time period within which to approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether to approve or disapprove the
proposed rule change.\5\ On October 1, 2019, the Exchange filed
Amendment No. 1 to the proposed rule change, which replaced in its
entirety the proposed rule change as originally submitted.\6\ On
October 30, 2019, the Commission instituted proceedings pursuant to
Section 19(b)(2)(B) of the Act \7\ to determine whether to approve or
disapprove the proposed rule change as modified by Amendment No. 1.\8\
On January 30, 2020, pursuant to Section 19(b)(2) of the Act, the
Commission extended the time period within which to approve or
disapprove the proposed rule change as modified by Amendment No. 1.\9\
The Commission has received no comment letters on the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86546 (August 1,
2019), 84 FR 38689.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 87018, 84 FR 50501
(September 25, 2019).
    \6\ Amendment No. 1 is available at: https://www.sec.gov/comments/sr-cboebzx-2019-068/srcboebzx2019068-6362715-196411.pdf.
    \7\ 15 U.S.C. 78s(b)(2)(B).
    \8\ See Securities Exchange Act Release No. 87421, 84 FR 59669
(November 5, 2019).
    \9\ See Securities Exchange Act Release No. 88089, 85 FR 6587
(February 5, 2019). The Commission designated April 3, 2020 as the
date by which it would either approve or disapprove the proposed
rule change.
---------------------------------------------------------------------------

    On February 12, 2020, the Exchange withdrew the proposed rule
change (SR-CboeBZX-2019-068), as modified by Amendment No. 1.

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

    \10\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2020-03316 Filed 2-19-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1516-1517]
[FR Doc No: 2021-00118]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2300]

Determination That ARALEN (Chloroquine Phosphate) Oral Tablets,
500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table are
no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
          Application No.                   Drug name         Active ingredient(s)        Strength(s)         Dosage form/route          Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 006002.........................  ARALEN................  Chloroquine Phosphate.  500 milligrams (mg)..  Tablet; Oral.........  Sanofi-Aventis U.S.
                                                                                LLC.
NDA 006134.........................  DOLOPHINE               Methadone               5 mg; 10 mg..........  Tablet; Oral.........  Hikma Pharmaceuticals
                                      HYDROCHLORIDE.          Hydrochloride.                                                        PLC.
NDA 007409.........................  BENTYL................  Dicyclomine             10 mg................  Capsule; Oral........  Allergan
                                                              Hydrochloride.                                                        Pharmaceuticals.
                                                             Dicyclomine             20 mg................  Tablet; Oral.........
                                                              Hydrochloride.
NDA 008085.........................  Methotrexate Sodium...  Methotrexate Sodium...  Equivalent to (EQ)     Tablet; Oral.........  DAVA Pharmaceuticals,
                                                                                2.5 mg Base.                                  Inc.
NDA 008678.........................  Isoniazid.............  Isoniazid.............  100 mg; 300 mg.......  Tablet; Oral.........  Sandoz.
NDA 012945.........................  DIAMOX................  Acetazolamide.........  500 mg...............  Extended-Release       Teva Branded
                                                                                Capsule; Oral.         Pharmaceutical
                                                                                Products.
NDA 014103.........................  ONCOVIN...............  Vincristine Sulfate...  1 mg/milliliter (mL);  Injectable; Injection  Eli Lilly and Co.
                                                                                1 mg/Vial; 5 mg/Vial.
NDA 016792.........................  SURMONTIL.............  Trimipramine Maleate..  EQ 25 mg/Base; EQ 50   Capsule; Oral........  Teva Women's Health,
                                                                                mg/Base; EQ 100 mg/                           Inc.
                                                                                Base.

NDA 016801.........................  XYLOCAINE PRESERVATIVE  Lidocaine               1%; 2%; 4%; 10%; 20%.  Injectable; Injection  Fresenius Kabi USA,
                                      FREE.                   Hydrochloride.                                                        LLC.
NDA 018238.........................  MICRO-K...............  Potassium Chloride....  8 milliequivalents     Extended-Release       Nesher
                                                                                (mEq); 10 mEq.         Capsule; Oral.         Pharmaceuticals LLC.
NDA 019568.........................  DERMATOP..............  Prednicarbate.........  0.10%................  Ointment; Topical....  Valeant
                                                                                Pharmaceuticals.
NDA 020192.........................  LAMISIL...............  Terbinafine             1%...................  Cream; Topical.......  Novartis.
                                                              Hydrochloride.
NDA 020482.........................  PRECOSE...............  Acarbose..............  25 mg; 50 mg; 100 mg.  Tablet; Oral.........  Bayer Healthcare.
NDA 020591.........................  TARKA.................  Trandolapril;           1 mg; 240 mg.........  Extended-Release       AbbVie Inc.
                                                              Verapamil                                      Tablet; Oral.
                                                              Hydrochloride.
NDA 020635.........................  LEVAQUIN..............  Levofloxacin..........  EQ 500 mg/20 mL; EQ    Injectable; Injection  Janssen
                                                                                750 mg/30 mL.                                 Pharmaceuticals,
                                                                                Inc.
NDA 020823.........................  EXELON................  Rivastigmine Tartrate.  EQ 1.5 mg Base; EQ 3   Capsule; Oral........  Novartis.
                                                                                mg Base; EQ 4.5 mg
                                                                                Base; EQ 6 mg Base.
NDA 020920.........................  NATRECOR..............  Nesiritide............  1.5 mg/Vial..........  For Solution;          Scios Inc.
                                                                                Intravenous.
NDA 021549.........................  EMEND.................  Aprepitant............  40 mg................  Capsule; Oral........  Merck.
NDA 021590.........................  FAZACLO ODT...........  Clozapine.............  12.5 mg; 25 mg; 100    Orally Disintegrating  Jazz Pharmaceuticals
                                                                                mg; 150 mg; and 200    Tablet; Oral.          PLC.
                                                                                mg.
NDA 202535.........................  PREPOPIK..............  Citric Acid, Magnesium  12 grams (g)/Packet;   For Solution; Oral...  Ferring
                                                              Oxide, and Sodium       3.5 g/Packet; 10 mg/                          Pharmaceuticals Inc.
                                                              Picosulfate.            Packet.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed are
unaffected by the discontinued marketing of the products subject to
those NDAs and ANDAs. Additional ANDAs that refer to these products may
also be approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00118 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 30, 2008 (Volume 73, Number 211)]
[Notices]
[Page 64645-64647]
[DOCID:fr30oc08-81]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58839; File No. SR-NYSEALTR-2008-03]

Self-Regulatory Organizations; NYSE Alternext US LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Regarding
Relocation of the Trading of Certain Debt Securities Conducted on or
Through the Exchange's Legacy Trading Systems and Facilities to an
Automated Bond Trading Platform Based on NYSE Bonds\SM\

October 23, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 22, 2008, NYSE Alternext US LLC (``NYSE Alternext'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 USC. 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 adopt NYSE Alternext Equities Rule 86 in
order to implement the relocation (``Bonds Relocation'') of the trading
of certain debt securities conducted on or through the Exchange's
legacy trading systems and facilities to an automated bond trading
platform based on NYSE Bonds\SM\ that will be operated by the New York
Stock Exchange LLC (``NYSE'') on behalf of NYSE Alternext (``NYSE
Alternext Bonds''). The Bonds Relocation is being implemented in
connection with the recent acquisition of The Amex Membership
Corporation (``AMC'') by NYSE Euronext. This proposal also includes
non-substantive and technical changes to other NYSE Alternext Equities
Rules that relate to bond trading at the Exchange. The text of the
proposed rule change is available on the Exchange's Web site at http://
www.nyse.com/equities/nysealternextequities, at the Exchange's
principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the NYSE
Alternext Equities Rules as needed and to adopt, subject to such
changes as are necessary to apply the rule to the Exchange, NYSE Rule
86, which governs trading on the NYSE Bonds platform that NYSE
Alternext Bonds is based on.
Background
    As described more fully in a related rule filing, NYSE Euronext
acquired AMC pursuant to an Agreement and Plan of Merger, dated January
17, 2008 (the ``Merger''). In connection with the Merger, the
Exchange's predecessor, the American Stock Exchange LLC (``Amex''), a
subsidiary of AMC, became a subsidiary of NYSE Euronext called NYSE
Alternext US LLC \3\, and will continue to operate as a national
securities exchange registered under Section 6 of the Securities
Exchange Act of 1934, as amended (the ``Act'').\4\ The effective date
of the Merger was October 1, 2008.
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    \3\ See Securities Exchange Act Release No. 58673 (September 29,
2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60 and SR-Amex
2008-62) (approving the Merger). As noted, Amex was renamed NYSE
Alternext US LLC and will be referred to as NYSE Alternext or the
Exchange for all purposes throughout this rule filing. For the
avoidance of doubt, NYSE Alternext US LLC will be a self regulatory
organization distinct from NYSE Euronext's European-market
subsidiary, NYSE Alternext.
    \4\ 15 USC. 78f.
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    In connection with the Merger, the Exchange will relocate all
equities trading conducted on the Exchange legacy trading systems and
facilities located at 86 Trinity Place, New York, New York (the ``86
Trinity Trading Systems''), to trading systems and facilities located
at 11 Wall Street, New York, New York (the ``Equities Relocation'').
The Exchange's equity trading systems and facilities at 11 Wall Street
(the ``NYSE Alternext Trading Systems'') will be operated by the NYSE
on behalf of the Exchange. Similarly, the Exchange will relocate all
options trading currently conducted on the 86 Trinity Trading Systems
to new facilities of the Exchange to be located at 11 Wall Street,
which will use a trading system based on the options trading system
used by NYSE Arca, Inc. (``NYSE Arca'') (the ``Options
Relocation'').\5\ After the Equities Relocation, the Exchange will
trade all equities securities currently listed on the Exchange on the
NYSE Alternext Trading Systems.
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    \5\ See Securities Exchange Act Release No. 58705 (October 1,
2008), 73 FR 58995 (October 8, 2008) (SR-Amex 2008-63) (approving
the Equities Relocation). The Exchange will submit a separate rule
filing to adopt a new rule set to govern NYSE Alternext options
trading following the Options Relocation.
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    Post-Merger, all Exchange members and member organizations that
were authorized to trade on the Exchange before the Merger will receive
trading permits (referred to as ``86 Trinity Permits'') that authorize
continued trading on the 86 Trinity Trading Systems. Holders of the 86
Trinity Permits are eligible to apply for an NYSE Alternext equities
trading license or options trading permit upon the Equities or Options
Relocation, as applicable.\6\ In addition, pursuant to the Merger, all
NYSE Alternext members and member organizations that apply for an NYSE
Alternext equities trading license are automatically waived in as NYSE
members and member organizations.\7\ Similarly, all NYSE members and
member organizations are automatically waived in as NYSE

Alternext members and member organizations.\8\
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    \6\ See Securities Exchange Act Release No. 58706 (October 1,
2008), 73 FR 59019 (October 8, 2008) (SR-NYSE-2008-70) (describing
and approving membership rule changes related to the Merger);
Securities Exchange Act Release No. 58705 (October 1, 2008), 73 FR
58995 (October 8, 2008) (SR-Amex 2008-63) (approving the Equities
Relocation).
    \7\ See NYSE Rules 2.10 and 2.20. NYSE Alternext members and
member organizations will have a six-month grace period within which
to meet NYSE and NYSE Alternext Equities membership requirements. If
a member organization fails to meet those requirements by the close
of the grace period, both the NYSE and NYSE Alternext will revoke
trading approvals on their respective exchanges. See NYSE Rule
300.10T and NYSE Alternext Equities Rule 300.10T. See also
Securities Exchange Act Release No. 58706 (October 1, 2008), 73 FR
59019 (October 8, 2008) (SR-NYSE-2008-70) (describing and approving
membership issues related to the Merger); Securities Exchange Act
Release No. 58705 (October 1, 2008), 73 FR 58995 (October 8, 2008)
(SR-Amex 2008-63) (including discussion of membership issues).
    \8\ See NYSE Alternext Equities Rules 2.10 and .20. See also
Securities Exchange Act Release No. 58706 (October 1, 2008), 73 FR
59019 (October 8, 2008) (SR-NYSE-2008-70); Securities Exchange Act
Release No. 58705 (October 1, 2008), 73 FR 58995 (October 8, 2008)
(SR-Amex 2008-63).
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The Bonds Relocation
    As with the Equities and Options Relocations, the Exchange now
proposes to relocate the trading of certain debt securities currently
conducted on the 86 Trinity Trading Systems \9\ to NYSE Alternext
Bonds.\10\ The Exchange believes that the NYSE Alternext Bonds platform
is technologically superior to the 86 Trinity Trading Systems and the
Exchange believes that the use and implementation of NYSE Alternext
Bonds will promote increased market activity in debt securities trading
at the Exchange.
---------------------------------------------------------------------------

    \9\ See Exhibit 3A for a list of the securities involved in the
Bonds Relocation.
    \10\ In the filing governing the Equities Relocation, the
Exchange noted that it expected to delist certain debt securities
and that those securities would subsequently be listed and traded on
NYSE Bonds. See Securities Exchange Act Release No. 58705 (October
1, 2008), 73 FR 58995 (October 8, 2008) (SR-Amex 2008-63). In the
interim period since that filing was submitted to the Commission,
the Exchange has determined that it will retain the listing of these
debt securities while adopting and using the advanced technology of
NYSE Alternext Bonds to trade them.
---------------------------------------------------------------------------

    Although they will be traded on a new technological platform, the
Exchange will maintain the listings of the securities involved in the
Bond Relocation in accordance with its listing standards. The Exchange
will not cross-list any NYSE-listed securities on the Exchange and will
not cross-list any Exchange-listed securities on the NYSE. The Exchange
understands that NYSE does not currently trade any debt securities on a
UTP basis, and the Exchange does not intend to trade any securities on
NYSE Alternext Bonds on a UTP basis. Moreover, neither the Exchange nor
NYSE will trade debt securities listed on their respective exchanges on
a UTP basis.
    The Exchange anticipates that the Bonds Relocation will occur as
soon as reasonably practicable following the date of the Merger,
concurrent with the Equities Relocation.
Proposed NYSE Alternext Bond Trading Rules
    The Exchange proposes to adopt NYSE Rule 86 as NYSE Alternext
Equities Rule 86, and to make conforming amendments to other NYSE
Alternext Equities Rules.\11\ The adoption of these rules is necessary
in order to trade debt securities on NYSE Alternext Bonds. Following
the Bonds Relocation, NYSE Alternext Equities Rule 86 and the related
rules will govern all debt securities transactions conducted on NYSE
Alternext Bonds.\12\
---------------------------------------------------------------------------

    \11\ The Commission approved NYSE Rule 86 in March 2007 after
full notice and comment. See Securities Exchange Act Release No.
55496 (March 20, 2007), 72 FR 14631 (March 28, 2007) (SR-NYSE-2006-
37) (approving NYSE Bonds).
    \12\ See Amex Rule 0 and NYSE Alternext Equities Rule 0.
Together these rules prescribe that all trading conducted on the
systems and facilities operated by NYSE on behalf of the Exchange,
including the NYSE Alternext Bonds trading platform, shall be
governed solely by the NYSE Alternext Equities Rules unless
otherwise specifically designated.
---------------------------------------------------------------------------

    Because NYSE Alternext Bonds will be operated by the NYSE on behalf
of the Exchange, NYSE Alternext Equities Rule 86 and the related rules
will be substantially identical to the existing NYSE Rules, subject to
certain minor changes necessary to apply these rules to the Exchange.
The Exchange's bond market structure will be identical to the NYSE's
and they will have the same rules governing, among other things, (i)
the processing and trading of debt securities, including receipt,
execution and reporting of transactions, (ii) the types of market
participants, (iii) clearly erroneous executions, and (iv) trading
halts.
Rule Modifications Relating to NYSE Alternext
    As noted above, the Exchange proposes to adopt NYSE Rule 86 as NYSE
Alternext Equities Rule 86, subject to a few minor modifications. This
filing conforms with amendments to NYSE Rule 86 that were recently
filed by the NYSE.\13\
---------------------------------------------------------------------------

    \13\ See SR-NYSE-2008-106.
---------------------------------------------------------------------------

    In order to facilitate trading on NYSE Alternext Bonds, the
Exchange proposes that NYSE Alternext Equities Rule 86 provide that all
NYSE Alternext members and member organizations will be automatically
eligible to access NYSE Alternext Bonds.\14\ By providing that all NYSE
Alternext members and member organizations, which, as described above,
includes by cross-designation all NYSE members and member
organizations, are automatically eligible to access NYSE Alternext
Bonds without any further requirements, both NYSE and NYSE Alternext
members and member organizations will be able to trade on NYSE
Alternext Bonds. The Exchange believes that these modifications will
maximize participation, increase liquidity and improve pricing, which
benefits all market participants.
---------------------------------------------------------------------------

    \14\ See proposed NYSE Alternext Equities Rule 86(o).
---------------------------------------------------------------------------

    Similar to the manner in which NYSE designates the securities it
trades on NYSE Bonds, the Exchange will indicate on the NYSE Alternext
Bonds website which securities are listed with the NYSE and which are
listed with NYSE Alternext. Executions of NYSE Alternext-listed
securities will be designated with an ``A'' indicator and executions of
NYSE-listed securities will be designated with an ``N'' indicator.\15\
---------------------------------------------------------------------------

    \15\ Pursuant to an SEC Exemptive Order for NYSE Bonds, NYSE is
permitted to trade certain unregistered and unlisted securities on
NYSE Bonds. See Securities Exchange Act Release No. 54766 (November
16, 2006), 71 FR 67657 (November 22, 2006) (S7-06-05). See also NYSE
Rules 1400-1401. Executions of these securities on NYSE Bonds are
designated with a ``U'' indicator. The securities included in the
Bonds Relocation (listed in Exhibit 3A) are not subject to the SEC's
Exemptive Order and thus the Exchange will not need the ``U''
indicator for any securities traded on NYSE Alternext Bonds.
---------------------------------------------------------------------------

Regulation of Trading on NYSE Alternext Bonds
    Trading on NYSE Alternext Bonds and maintenance of the applicable
listing standards will be regulated by NYSE Regulation Inc. (``NYSER'')
in accordance with the terms and conditions of the Regulatory Services
Agreement the Exchange entered into with NYSER pursuant to the Merger,
effective October 1, 2008.
Proposed Amendments to Related NYSE Alternext Equities Rules
    The Exchange proposes conforming amendments to NYSE Alternext
Equities Rules 13, 51, 55, 61, 72, 76, 79A, 123D and 342 to accommodate
the trading of debt securities on NYSE Alternext Bonds. The Exchange
also proposes to adopt NYSE Rule 119 as NYSE Alternext Equities Rule
119, which prescribes the procedures for canceling an order in NYSE
Alternext Bonds when there is a change in the basis of bonds trading
from ``and interest'' to ``flat'' as determined by the Exchange.
Operative Date
    The Exchange proposes that the operative date of the proposed rule
changes be the date of the Equities and Bonds Relocations.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\17\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, 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 proposed rule change also supports the principles
of Section 11A(a)(1) \18\ of the Act in that it seeks to ensure
economically efficient execution of securities transactions and fair
competition among brokers and dealers and among exchange markets.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
    \18\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

    The Exchange believes that the proposed adoption of NYSE Alternext
Rule 86 and other rule amendments will enhance the efficient execution
of transactions and fair competition among broker-dealers and markets
and provide increased bond market activity for the benefit of all
market participants

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

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

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

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

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

    The Exchange believes that this proposal qualifies for immediate
effectiveness upon filing as a non-controversial rule change pursuant
to Section 19(b)(3)(A) of the Act \19\ and Rule 19b-4(f)(6) \20\
thereunder. The Exchange asserts that the proposed rule change (i) will
not significantly affect the protection of investors or the public
interest, (ii) will not impose any significant burden on competition,
and (iii) by its terms, will not become operative for 30 days after the
date of this filing.\21\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give 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.
NYSE Alternext complied with this requirement.
---------------------------------------------------------------------------

    The Exchange believes that this filing is non-controversial because
it raises no novel issues and is consistent with the Commission's prior
approvals of the NYSE Bonds platform, the relocation of equities
trading on NYSE Alternext, and recent amendments to NYSE Rule 86, upon
which this filing is modeled.\22\ As described above, this proposal
seeks only to implement NYSE Alternext Bonds, which is based on the
existing NYSE Bonds platform, and to adopt the related rules (subject
to minor modifications to apply them to the Exchange), to govern the
trading of debt securities on NYSE Alternext.
---------------------------------------------------------------------------

    \22\ See Securities Exchange Act Release No. 55496 (March 20,
2007), 72 FR 14631 (March 28, 2007) (SR-NYSE-2006-37); Securities
Exchange Act Release No. 58705 (October 1, 2008), 73 FR 58995
(October 8, 2008) (SR-Amex 2008-63); SR-NYSE-2008-106.
---------------------------------------------------------------------------

    The operative date of the proposed rule changes is the date of the
Equities and Bonds Relocations.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEALTR-2008-03 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-NYSEALTR-2008-03. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of the
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-NYSEALTR-2008-03 and should be submitted on or before
November 20, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-25914 Filed 10-29-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Pages 44347-44348]
[FR Doc No: 2020-15798]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-664, OMB Control No. 3235-0740]

Submission for OMB Review: Comment Request

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

Extension:
    Joint Standards for Assessing Diversity Policies and Practices

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    In accordance with the requirements of Section 342 of the Dodd-
Frank Wall Street Reform and Consumer Protection Act of 2010 (12 U.S.C.
5452), the Commission joined with the Office of the Comptroller of the
Currency, Board of Governors of the Federal Reserve System, Federal
Deposit Insurance Corporation, Bureau of Consumer Financial Protection,
and the National Credit Union Administration (Agencies) to develop
Joint Standards for Assessing the Diversity Policies and Practices of
Entities Regulated by the Agencies (Joint Standards), which were issued
through an interagency policy statement published in the Federal
Register on June 15, 2015 (80 FR 33016). To facilitate the collection
of information envisioned by the Joint Standards, the Commission
developed a form entitled the ``Diversity Assessment Report for
Entities Regulated by the SEC'' (Diversity Assessment Report).
    The Diversity Assessment Report (1) asks for general information
about the respondent; (2) includes a checklist and questions relating
to the policies and practices set forth in the Joint Standards; (3)
requests data related to workforce diversity and supplier diversity;
and (4) provides respondents with the opportunity to describe their
successful policies and practices for promoting diversity and
inclusion.
    The information collection is voluntary. The Commission may use
information submitted to monitor progress and trends in the financial
services industry regarding diversity and inclusion and to identify and
highlight diversity and inclusion policies and practices that have been

successful. In addition, the Commission may publish information
submitted, such as leading practices, in a form that does not identify
a particular entity or disclose confidential business information.
Further, the Commission may share information with other Agencies, when
appropriate, to support coordination of efforts and to avoid
duplication.
    Title of Collection: Joint Standards for Assessing Diversity
Policies and Practices.\1\
---------------------------------------------------------------------------

    \1\ The title of the currently approved collection--Joint
Standards for Assessing the Diversity Policies and Practices of
Entities Regulated by the Agencies-- has been shortened.
---------------------------------------------------------------------------

    Type of Review: Extension of currently approved collection.
    Frequency of Response: Biennially.
    Estimated Number of Respondents: 260.
    Estimated Burden Hours per Respondent: 10 hours; 5 hours
annualized.
    Estimated Total Annual Burden Hours: 2,600; 1,300 annualized.
    Since the last approval of this information collection, we have
adjusted the estimated number of respondents, from 1,500 to 260
respondents, based on the actual response rate to the requests for
Diversity Assessment Reports made two years ago and the anticipated
increase in that response rate as a result of ongoing outreach to
regulated entities to encourage them to submit Diversity Assessment
Reports. This reduction in the number of respondents has resulted in a
6,200-hour reduction in the estimated total burden hours (annualized).
    On March 30, 2020, the Commission published a notice in the Federal
Register (85 FR 17608) of its intention to request an extension of this
currently approved collection of information, and allowed the public 60
days to submit comments. The Commission received no comments.
    Written comments continue to be invited on: (a) Whether this
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the 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.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: July 16, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-15798 Filed 7-21-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19629-19634]
[FR Doc No: 2021-07576]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2021-0012]

Assistance to Firefighters Grant Program

AGENCY: Federal Emergency Management Agency (FEMA), Department of
Homeland Security (DHS).

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Fire Prevention and Control Act of
1974, as amended, the Administrator of FEMA is publishing this notice
describing the fiscal year (FY) 2020 Assistance to Firefighters Grant
(AFG) Program application process, deadlines, and award selection
criteria. This notice explains the differences, if any, between these
guidelines and those recommended by representatives of the national
fire service leadership during the annual meeting of the Criteria
Development Panel, which was held December 11, 2019. The application
period for the FY 2020 AFG Program was January 4, 2021 through February
12, 2021, and was announced on the AFG website at: https://
www.fema.gov/

grants/preparedness/firefighters, as well as at www.grants.gov.

DATES: Grant applications for the FY 2020 AFG Program were accepted
electronically at https://go.fema.gov, from January 4, 2021, through
February 12, 2021, at 5:00 p.m. Eastern Standard Time.

ADDRESSES: Assistance to Firefighters Grant Branch, DHS/FEMA, 400 C
Street SW, 3N, Washington, DC 20472-3635.

FOR FURTHER INFORMATION CONTACT: Catherine Patterson, Branch Chief,
Assistance to Firefighters Grant Branch, 1-866-274-0960.

SUPPLEMENTARY INFORMATION: The AFG Program awards grants directly to
fire departments, non-affiliated emergency medical services (EMS)
organizations, and State Fire Training Academies (SFTAs) for the
purpose of enhancing the health and safety of first responders and
improving their abilities to protect the public from fire and fire-
related hazards.
    Applications for the FY 2020 AFG Program were submitted and
processed online at https://go.fema.gov. Before the application period
started, the FY 2020 AFG Program Notice of Funding Opportunity (NOFO)
was published on FEMA's AFG Program website. The AFG Program website
provides additional information and materials useful for FY 2020 AFG
Program applicants including Frequently Asked Questions, Application
Checklist, Get Ready Guide Narrative, Self-Evaluation Sheets for
Vehicle Acquisition and Operations Safety, and a Cost Share Calculator.
Based on past AFG Program application periods, FEMA anticipates
receiving 10,000 to 15,000 applications for the FY 2020 AFG Program,
and the ability to award approximately 2,000 grants.

Congressional Appropriations

    For the FY 2020 AFG Program, Congress appropriated $355 million
(Consolidated Appropriations Act, 2020, Pub. L. 116-93). From this
amount, $319.5 million will be made available for FY 2020 AFG Program
awards. In addition, Section 33 of the Federal Fire Prevention and
Control Act of 1974, as amended (15 U.S.C. 2229), requires that a
minimum of 10 percent of available funds be expended for Fire
Prevention and Safety (FP&S) Program grants. FP&S Program awards will
be made directly to local fire departments and to local, regional,
State, or national entities recognized for their expertise in the
fields of fire prevention and firefighter safety research and
development. Funds appropriated for FY 2020 will be available for
obligation and award until September 30, 2021.
    The Federal Fire Prevention and Control Act of 1974 further directs
FEMA to administer these appropriations according to the following
requirements:
     Career fire departments: Not less than 25 percent of
available grant funds.
     Volunteer fire departments: Not less than 25 percent of
available grant funds.
     Combination fire departments and departments using paid-
on-call firefighting personnel: Not less than 25 percent of available
grant funds.
     Open competition (career, volunteer, and/or combination
fire departments and departments using paid-on-call firefighting
personnel): Not less than 10 percent of available grant funds awarded.
     EMS providers including fire departments and nonaffiliated
EMS organizations: Not less than 3.5 percent of available grant funds
awarded, with nonaffiliated EMS providers receiving no more than 2
percent of the total available grant funds.
     SFTAs: Not more than 3 percent of available grant funds
shall be collectively awarded to SFTA applicants, with a maximum of $1
million per applicant.
     Vehicles: Not more than 25 percent of available grant
funds may be used for the purchase of vehicles; 10 percent of those
vehicle funds will be dedicated to the funding of ambulances. Vehicle
funds will be distributed as equally as possible among urban, suburban,
and rural community applicants.
     Micro grants: This is a voluntary funding limitation
choice made by the applicant for requests submitted within the
operations and safety activity; it is not an additional funding
opportunity. Micro grants are awards that have a Federal participation
(share) that does not exceed $50,000. Only fire departments and
nonaffiliated EMS organizations are eligible to choose micro grants,
and the only eligible micro grants requests are for training,
equipment, personal protective equipment (PPE), and wellness and
fitness activities. Applicants that select micro grants as a funding
opportunity may receive additional consideration for award. If an
applicant selects micro grants in their application, they will be
limited in the total amount of funding their organization can be
awarded; if they are requesting funding in excess of $50,000 Federal
participation, they should not select micro grants.

Background of the AFG Program

    Since 2001, the AFG Program has helped firefighters and other first
responders obtain critically needed equipment, protective gear,
emergency vehicles, training, and other resources needed to protect
emergency personnel and the public from fire and related hazards. FEMA
awards grants on a competitive basis to the applicants that best
address the AFG Program's priorities and provide the most compelling
justification. Applications that best address AFG Program priorities,
as identified in the Application Evaluation Criteria, will be reviewed
by a peer review panel composed of fire service personnel.
    The AFG Program has three program activities:

 Operations and Safety
 Vehicle Acquisition
 Regional Projects

    The priorities for each activity are fully outlined in the NOFO.

Application Evaluation Criteria

    Prior to making a grant award, FEMA is required by 31 U.S.C. 3354,
as amended by the Payment Integrity Information Act of 2019, Public Law
116-117 (2020), 41 U.S.C. 2313, and 2 CFR 200.206 to review information
available through any Office of Management and Budget (OMB) designated
repositories of government-wide eligibility qualification or financial
integrity information. Therefore, application evaluation criteria may
include the following risk-based considerations of the applicant: (1)
Financial stability; (2) quality of management systems and ability to
meet management standards; (3) history of performance in managing
Federal awards; (4) reports and findings from audits; and (5) ability
to effectively implement statutory, regulatory, or other requirements.
    FEMA will rank all complete and submitted applications based on how
well they match program priorities for the type of jurisdiction(s)
served. Answers to activity specific questions provide information used
to determine each application's ranking relative to the stated program
priorities.
    Funding priorities and criteria for evaluating AFG Program
applications are established by FEMA based on the recommendations from
the Criteria Development Panel (CDP). CDP is comprised of fire service
professionals who make recommendations to FEMA regarding the creation
of new, or the modification of previously established, funding
priorities, as well as developing criteria for awarding grants. The
content of the NOFO reflects implementation of CDP's recommendations
with respect to the priorities and evaluation criteria for awards.

    The nine major fire service organizations represented on the CDP
are:

 International Association of Fire Chiefs
 International Association of Fire Fighters
 National Volunteer Fire Council
 National Fire Protection Association
 National Association of State Fire Marshals
 International Association of Arson Investigators
 International Society of Fire Service Instructors
 North American Fire Training Directors
 Congressional Fire Service Institute

Review and Selection Process

    AFG Program applications are reviewed through a multi-phase
process. All applications are electronically pre-scored and ranked
based on how well they align with the funding priorities outlined in
this notice. Applications with the highest pre-score rankings are then
scored competitively by (no less than three) members of a Peer Review
Panel. Applications will also be evaluated through a series of internal
FEMA review processes for completeness, adherence to programmatic
guidelines, technical feasibility, and anticipated effectiveness of the
proposed project(s). Below is the process by which applications will be
reviewed:

i. Pre-Scoring Process

    The application undergoes an electronic pre-scoring process based
on established program priorities listed within the NOFO and answers to
activity specific questions within the online application. Application
narratives are not reviewed during pre-scoring. Request details and
budget information should comply with program guidance and statutory
funding limitations. The pre-score is 50 percent of the total
application score.

ii. Peer Review Panel Process

    Applications with the highest pre-score will undergo peer review.
The peer review is comprised of fire service representatives
recommended by the organizations represented on the CDP. The panelists
assess the merits of each application based on the narrative section of
the application, including the evaluation elements listed in the
Narrative Evaluation Criteria below. Panelists independently score each
project within the application, discuss the merits and/or shortcomings
of the application with their peers, and document the findings. A
consensus is not required. The panel score is 50 percent of the total
application score.

iii. Technical Evaluation Process

    The highest ranked applications are considered within the fundable
range. Applications that are in the fundable range undergo both a
technical review by a subject matter expert, as well as a FEMA AFG
Branch review prior to being recommended for an award. The FEMA AFG
Branch will assess the request with respect to costs, quantities,
feasibility, eligibility, and recipient responsibility prior to
recommending an application for award. Once the technical evaluation
process is complete, the cumulative score for each application will be
determined and FEMA will generate a final ranking of applications. FEMA
will award grants based on this final ranking and the statutorily
required funding limitations listed in this notice and the NOFO.

Narrative Evaluation Criteria

1. Financial Need (25 Percent)

    Applicants should describe their financial need and how consistent
it is with the intent of the AFG Program. This statement should include
details describing the applicant's financial distress, summarized
budget constraints, unsuccessful attempts to secure other funding, and
proof that their financial distress is out of their control.

2. Project Description and Budget (25 Percent)

    This statement should clearly explain the applicant's project
objectives and the relationship between those objectives and the
applicant's budget and risk analysis. The applicant should describe the
activities, including program priorities or facility modifications,
ensuring consistency with project objectives, the applicant's mission,
and any national, State, and/or local requirements. Applicants should
link the proposed expenses to operations and safety, as well as the
completion of the project goals.

3. Cost Benefit (25 Percent)

    Applicants should describe how they plan to address the operations
and personal safety needs of their organization, including cost
effectiveness and sharing assets. This statement should also include
details about gaining the maximum benefits from grant funding by citing
reasonable or required costs, such as specific overhead and
administrative costs. The applicant's request should also be consistent
with their mission and identify how funding will benefit their
organization and personnel.

4. Statement of Effect on Daily Operations (25 Percent)

    This statement should explain how these funds will enhance the
applicant's overall effectiveness. It should address how an award will
improve daily operations and reduce the applicant's risks. Applicants
should include how frequently the requested items will be used, and in
what capacity. Applicants should also indicate how the requested items
will help the community and increase the organization's ability to save
additional lives or property. Jurisdictions that demonstrate their
commitment and proactive posture to reducing fire risk, by explaining
their code enforcement (to include Wildland Urban Interface code
enforcement) and mitigation strategies (including whether or not the
jurisdiction has a FEMA-approved mitigation strategy) may receive
stronger consideration under this criterion.

Eligible Applicants

    Fire Departments: Fire departments operating in any of the 50
States, as well as fire departments in the District of Columbia, the
Commonwealth of the Northern Mariana Islands, the U.S. Virgin Islands,
Guam, American Samoa, the Commonwealth of Puerto Rico, or any
federally-recognized Indian Tribe or Tribal organization.
    A fire department is an agency or organization having a formally
recognized arrangement with a State, territory, local, or Tribal
authority (city, county, parish, fire district, township, town, or
other governing body) to provide fire suppression to a population
within a geographically fixed primary first due response area.
    Nonaffiliated EMS organizations: Nonaffiliated EMS organizations
operating in any of the 50 States, as well as the District of Columbia,
the Commonwealth of the Northern Mariana Islands, the U.S. Virgin
Islands, Guam, American Samoa, the Commonwealth of Puerto Rico, or any
federally-recognized Indian Tribe or Tribal organization.
    A nonaffiliated EMS organization is an agency or organization that
is a public or private nonprofit emergency medical services entity
providing medical transport that is not affiliated with a hospital and
does not serve a geographic area in which emergency medical services
are adequately provided by a fire department.
    FEMA considers the following as hospitals under the AFG Program:

 Clinics
 Medical centers

 Medical colleges or universities
 Infirmaries
 Surgery centers
 Any other institutions, associations, or foundations providing
medical, surgical, or psychiatric care and/or treatment for the sick or
injured.

    State Fire Training Academies: SFTAs operating in any of the 50
States, as well as the District of Columbia, the Commonwealth of the
Northern Mariana Islands, the U.S. Virgin Islands, Guam, American
Samoa, or the Commonwealth of Puerto Rico. Applicants must be
designated either by legislation or by a Governor's declaration as the
sole fire service training agency within a State, territory, or the
District of Columbia. The designated SFTA shall be the only agency/
bureau/division, or entity within that State, territory, or the
District of Columbia.

Ineligibility

     To avoid a duplication of benefits, FEMA reserves the
right to review all program activities or grant applications where two
or more organizations share a single facility. To be eligible as a
separate organization, two or more fire departments or nonaffiliated
EMS organizations will have different funding streams, personnel
rosters, or Employer Identification Numbers (EINs). If two or more
organizations share facilities and each submits an application in the
same program area (e.g., Equipment, Modify Facilities, PPE, Training,
and/or Wellness and Fitness Programs) FEMA will carefully review each
program for eligibility.
     Fire-based EMS organizations are not eligible to apply as
nonaffiliated EMS organizations. Fire-based EMS training and equipment
must be requested by a fire department under the AFG Program component
program of Operations and Safety.
     Eligible applicants may submit only one application for
each activity (e.g., Operations and Safety, Regional, etc.), but may
submit for multiple projects within each activity. Under the Vehicle
Activity, applicants may submit one application for vehicles for their
department and one separate application to host a Regional vehicle.
Duplicate applications (more than one application in the same activity)
may be disqualified.
     An Operations and Safety applicant may submit one
application for an eligible project (ie.g., turn out gear); it may not
submit a Regional application for the same project.

Statutory Limits to Funding

     Congress has enacted statutory limits to the amount of
funding that a grant recipient may receive from the AFG Program in any
single fiscal year based on the population served (15 U.S.C.
2229(c)(2)). Awards will be limited based on the size of the population
protected by the applicant, as indicated below. Notwithstanding the
annual limits stated below, the Administrator of FEMA may not award a
grant in an amount that exceeds one percent of the available grant
funds in such fiscal year, except where it is determined that such
recipient has an extraordinary need for a grant in an amount that
exceeds the one percent aggregate limit.
     In the case of a recipient that serves a jurisdiction with
100,000 people or fewer, the amount of available grant funds awarded to
such recipient shall not exceed $1 million in any fiscal year.
     In the case of a recipient that serves a jurisdiction with
more than 100,000 people, but not more than 500,000 people, the amount
of available grant funds awarded to such recipient shall not exceed $2
million in any fiscal year.
     In the case of a recipient that serves a jurisdiction with
more than 500,000, but not more than 1 million people, the amount of
available grant funds awarded to such recipient shall not exceed $3
million in any fiscal year.
     In the case of a recipient that serves a jurisdiction with
more than 1 million people but not more than 2.5 million people, the
amount of available grant funds awarded to such recipient is subject to
the one percent aggregate cap of $3.55 million for FY 2020, but FEMA
may waive this aggregate cap in individual cases where FEMA determines
that a recipient has an extraordinary need for a grant that exceeds the
aggregate cap; if FEMA waives the aggregate cap, the amount of grant
funds awarded to such recipient shall not exceed $6 million for any
fiscal year.
     In the case of a recipient that serves a jurisdiction with
more than 2.5 million people, the amount of available grant funds
awarded to such recipient is subject to the one percent aggregate cap
of $3.55 million for FY 2020, but FEMA may waive this aggregate cap in
individual cases where FEMA determines that a recipient has an
extraordinary need for a grant that exceeds the aggregate cap; if FEMA
waives the aggregate cap, the amount of grant funds awarded to such
recipient shall not exceed $9 million for any fiscal year.
     FEMA may not waive the population-based limits on the
amount of grant funds awarded as set by 15 U.S.C. 2229(c)(2)(A).
    The cumulative total of the Federal share of awards in Operations
and Safety, Regional, and Vehicle Acquisition activities will be
considered when assessing award amounts and any limitations thereto.
Applicants may request funding up to the statutory limit on each of
their applications.
    For example, an applicant that serves a jurisdiction with more than
100,000 people, but not more than 500,000 people, may request up to $2
million on their Operations and Safety Application, and up to $2
million on their Vehicle Acquisition request. However, should both
grants be awarded, the applicant would have to choose which award to
accept if the cumulative value of both applications exceeds the
statutory limits.

Cost Sharing and Maintenance of Effort

    Grant recipients must share in the costs of the projects funded
under this grant program as required by 15 U.S.C. 2229(k)(1) and in
accordance with applicable Federal regulations at 2 CFR part 200, but
they are not required to have the cost-share at the time of application
nor at the time of award. However, before a grant is awarded, FEMA
validates that the grant recipient has provided sufficient evidence
that the cost-share requirement will be fulfilled during the period of
the grant award.
    In general, an eligible applicant seeking a grant shall agree to
make available non-Federal funds equal to not less than 15 percent of
the grant awarded. However, the cost share will vary as follows based
on the size of the population served by the organization, with
exceptions to this general requirement for entities serving smaller
communities:
     Applicants that serve populations of 20,000 or less shall
agree to make available non-Federal funds in an amount equal to not
less than 5 percent of the grant awarded.
     Applicants serving areas with populations above 20,000,
but not more than 1 million, shall agree to make available non-Federal
funds in an amount equal to not less than 10 percent of the grant
awarded.
     Applicants serving areas with populations above 1 million
shall agree to make available non-Federal funds in an amount equal to
not less than 15 percent of the grant awarded.
    The cost share for SFTAs will apply the requirements above based on
the total population of the State.
    The cost share for a regional application will apply the
requirements above based on the aggregate population of the primary
first due response areas

of the host and participating partner organizations that execute a
Memorandum of Understanding as described in Appendix B, Section J,
Regional projects, of the FY 2020 AFG Program NOFO.
    On a case-by-case basis, FEMA may allow a grant recipient that may
already own assets (equipment or vehicles), acquired with non-Federal
cash, to use the trade-in allowance/credit value of those assets as
``cash'' for the purpose of meeting the cost-share obligation of their
AFG Program award. In-kind, cost-share matches are not allowed.
    Grant recipients under this grant program must also agree to a
maintenance of effort requirement as required by 15 U.S.C. 2229(k)(3)
(referred to as a ``maintenance of expenditure'' requirement in that
statute). A grant recipient shall agree to maintain during the term of
the grant the applicant's aggregate expenditures relating to the
activities allowable under the NOFO at not less than 80 percent of the
average amount of such expenditures in the two fiscal years preceding
the fiscal year in which the grant amounts are received.
    In cases of demonstrated economic hardship, and at the request of
the grant recipient, the Administrator of FEMA may waive or reduce a
grant recipient's cost share requirement or maintenance of expenditure
requirement. AFG Program applicants for FY 2020 must indicate at the
time of application whether they are requesting a waiver and whether
the waiver is for the cost share requirement, for the maintenance of
effort requirement, or both. As required by statute, the Administrator
of FEMA is required to establish guidelines for determining what
constitutes economic hardship. FEMA has published these guidelines at
FEMA's website: https://www.fema.gov/sites/default/files/2020-04/Eco_Hardship_Waiver_FPS_SAFER_AFG_IB_FINAL.pdf.
    Prior to the start of the FY 2020 AFG Program application period,
FEMA conducted applicant internet webinars to inform potential
applicants about the AFG Program. In addition, FEMA provided applicants
with information at the AFG Program website: https://www.fema.gov/grants/preparedness/firefighters to help them prepare quality grant
applications. The AFG Program Help Desk is staffed throughout the
application period to assist applicants with the automated application
process as well as assistance with any questions.
    Applicants can reach the AFG Program Help Desk through a toll-free
telephone number during normal business hours (1-866-274-0960) or
electronic mail<EMAIL_ADDRESS>
Application Process

    Organizations may submit one application per application period in
each of the three AFG Program activities (e.g., one application for
Operations and Safety, one for Vehicle Acquisition, and/or a separate
application to be a Joint/Regional Project host). If an organization
submits more than one application for any single AFG Program activity
(e.g., two applications for Operations and Safety, two for Vehicles,
etc.), either intentionally or unintentionally, both applications may
be disqualified.
    Applicants accessed the grant application electronically at https://go.fema.gov. The application is also accessible from the U.S. Fire
Administration's website http://www.usfa.fema.gov and http://www.grants.gov. New applicants must register and establish a user name
and password for secure access to the grant application. Previous AFG
Program applicants must use their previously established user name and
passwords.
    Applicants are expected to answer questions about their grant
request that reflect the AFG Program funding priorities, described
below. In addition, each applicant must complete four separate
narratives for each project or grant activity requested. Grant
applicants will also provide relevant information about their
organization's characteristics, call volume, and existing
organizational capabilities.

System for Award Management (SAM)

    Per 2 CFR 25.200, all Federal grant applicants and recipients must
register at https://SAM.gov. SAM is the Federal Government's System for
Awards Management, and registration is free of charge. Applicants must
maintain current information in SAM that is consistent with the data
provided in their AFG Program grant application and in the Dun &
Bradstreet (DUNS) database. FEMA may not accept any application,
process any awards, or consider any payment or amendment requests,
unless the applicant or grant recipient has complied with the
requirements to provide a valid DUNS number and an active SAM
registration. The grant applicant's banking information, EIN,
organization/entity name, address, and DUNS number must match the same
information provided in SAM.

Criteria Development Panel Recommendations

    If there are any differences between the published AFG Program
guidelines and the recommendations made by the CDP, FEMA must explain
them and publish the information in the Federal Register prior to
awarding any grant under the AFG Program. For FY 2020, FEMA accepted,
and will implement, all but two of the CDP's recommendations for the
prioritization of eligible activities.

Adopted Recommendations for FY 2020

    The FY 2020 AFG Program NOFO contains some changes to definitions,
descriptions, and priority categories. Changes to the FY 2020 AFG
Program NOFO include:
     Under Sections D--Application and Submission Information,
E--Application Review Information, F--Federal Award Administration
Information, G--DHS Awarding Agency Contact and Resource. Information,
and H--Additional Information:
    [cir] Various grants management changes due to the recent OMB
revision to 2 CFR In particular, changes regarding SAM registration,
performance measures, procurement, closeout, and termination are
included.
     Under Federal Award Information:
    [cir] Period of performance for AFG Program awards is 24 months.
     Under Supporting Definitions:
    [cir] Paid on-call/Stipend departments are added to the definition
for Combination Fire Department.
     Under Application Tips:
    [cir] Explanation of AFG Program-approved seated riding positions
was added.
     Under Training Activity:
    [cir] Rental of Audio/Visual equipment was added as eligible
activity.
     Under Operations and Safety Activity:
    [cir] Radio over internet Protocol (RoIP) communication equipment
was added as a Medium Priority.
    [cir] Integrated thermal imaging cameras were added to the
ineligible list under the PPE category.
     Under Modifications to Facility Activity:
    [cir] Intruder alerting systems and deployment notification systems
were added as ineligible.
     Under Regional Applications:
    [cir] Guidance requiring purchases from same vendor added.
     Under Environmental Planning and Historic Preservation
(EHP):
    [cir] Updated process for EHP added.
     Under Award Administration Information (Appendix C):

    [cir] Updated process for Economic Hardship Waiver added.
    [cir] Excess Funds Restrictions specifies High Priority items as
eligible under this option.
    [cir] Updated instruction on supporting documentation is added for
advance and reimbursement payment request.

Recommendations Not Adopted for FY 2020

     The CDP recommended that fire departments implement a
requirement where National Fire Protection Association (NFPA) standards
listed as 1582 physicals become a requirement for all awards. FEMA
recommends evaluating the impact of this requirement prior to
implementation. Data on fire departments' abilities to meet this
standard was collected in the FY 2020 application. It will not be
considered during the application review.
     The CDP recommended that FEMA adopt new definitions for
career and combination departments to align with NFPA changes in the
1710 and 1720 standards. FEMA is unable to adopt this recommendation as
it conflicts with statutory definitions.

    Authority: 15 U.S.C. 2229.

Robert Fenton,
Senior Official Performing the Duties of the FEMA Administrator,
Federal Emergency Management Agency.
[FR Doc. 2021-07576 Filed 4-13-21; 8:45 am]
BILLING CODE 9111-64-P


[Federal Register: February 23, 2007 (Volume 72, Number 36)]
[Notices]
[Page 8218-8219]
[DOCID:fr23fe07-100]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55289; File No. SR-ISE-2007-04]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Network Fee Changes

February 13, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 17, 2007, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the ISE. The ISE has designated this proposal as one
establishing or changing a due, fee, or other charge applicable only to
a member under section 19(b)(3)(A)(ii) of the Act,\3\ and rule 19b-
4(f)(2) thereunder,\4\ which renders the proposal effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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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)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to adopt a
tiered structure for one of the Exchange's network fees. The text of
the proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and at http://www.iseoptions.com.

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

    In its filing with the Commission, the ISE 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 ISE has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of this proposed rule change is to amend the Exchange's
Schedule of Fees to adopt a tiered structure for the Ethernet/Managed
Service Provider fee charged to members.
    The Ethernet/Managed Service Provider fee is a fee charged to ISE
members to access the ISE's trading system via an Ethernet connection
or a third-party managed service provider. The Ethernet/Managed Service
Provider connection carries the same information (such as quotation and
trade information) as other forms of connection (such as T-1 and T-3
point-to-point connections) and does not require any changes to the
Exchange's surveillance or communications rules. There is no change to,
or impact on, the Exchange's trading systems as a result of this method
of connection.
    An Ethernet/Managed Service Provider connection enables users to
acquire bandwidth in megabit increments. The ISE currently charges
members $25.00 per Megabit (MB), and members may purchase up to 15MBs.
The Exchange recently launched a new service whereby members will now
be able to purchase up to 1000MBs. To bring this network fee in line
with the new service, the ISE proposes to establish a new pricing
structure for connection speeds. Specifically, the ISE proposes to
charge members $100.00 per month for a member's purchase of up to 10MBs
of connection speed, $250.00 per month for the purchase of 11 to 100MBs
of connection speed, and $500.00 per month for the purchase of 101MBs
to 1GB (1000MBs) of connection speed. These fees will be charged on a
per connection basis. As noted above, the Exchange previously limited
any connection to a maximum of 15MBs. The Exchange notes that the fees
proposed herein are intended to cover and reasonably relate to its
costs in rolling out and supporting the new service.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under section 6(b)(4) \5\ that an exchange have an
equitable allocation of reasonable dues, fees and other charges among
its members and other persons using its facilities. In particular,
these fees will enable the Exchange to cover

its costs in providing a faster form of connectivity by members to the
Exchange.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \6\ and paragraph (f) of Rule 19b-4 \7\
thereunder. At any time within 60 days of the filing of such proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2007-04 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2007-04. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. 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-ISE-2007-04 and should be submitted on or before March
16, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-3069 Filed 2-22-07; 8:45 am]

BILLING CODE 8010-01-P