[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45640-45642]
[FR Doc No: 2020-16394]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1339]

Multiple Function Device Products: Policy and Considerations;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Multiple Function
Device Products: Policy and Considerations; Guidance for Industry and
Food and Drug Administration Staff.'' This final guidance provides
FDA's regulatory approach for device products with multiple functions
including at least one device function and includes such device
products that are part of combination products, in accordance with the
21st Century Cures Act (Cures Act).

DATES: The announcement of the guidance is published in the Federal
Register on July 29, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1339 for ``Multiple Function Device Products: Policy and
Considerations; Guidance for Industry and Food and Drug Administration
Staff.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Multiple Function Device Products: Policy and Considerations;
Guidance for Industry and Food and Drug Administration Staff'' to the
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002;
or the Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Building, 4th
Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>; or Kristina Lauritsen, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 6162, Silver Spring, MD 20993-0002,
301-796-8936.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 13, 2016, the Cures Act (Pub. L. 114-255) was signed
into law. Section 3060(a) of this legislation entitled ``Clarifying
Medical Software Regulation'' amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to add section 520(o) (21 U.S.C. 360j(o)),
which excludes certain software functions from the definition of device
in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). In addition,
section 520(o)(2) of the FD&C Act describes the regulation and
assessment of a product with multiple functions including at least one
device function and at least one software function that is not a
device. Although section 520(o)(2) of the FD&C Act applies to the
regulation of software products containing at least one device function
and at least one non-device software function, FDA believes that a
similar approach should be used for the assessment of all multiple
function device products that contain at least one device function and
one ``other function'', which may be a non-device software function; a
function that meets the definition of a device, but is not subject to
premarket review; or a function that meets the definition of device,
but for which FDA has expressed its intention not to enforce compliance
with applicable regulatory controls. This approach also applies to
multiple function device products that are device constituent parts of
combination products. FDA considered comments received on the draft
guidance that appeared in the Federal Register of April 27, 2018 (83 FR
18570). FDA revised the guidance as appropriate in response to the
comments.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Multiple Function Device Products: Policy
and Considerations; Guidance for Industry and Food and Drug
Administration Staff.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov. Persons unable to
download an electronic copy of ``Multiple Function Device Products:
Policy and Considerations; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 17038 to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information have
been approved by OMB as follows:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
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803............................  Medical device                0910-0437
                                  reporting.
807, subparts A through D......  Registration and              0910-0625
                                  listing.
807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational device        0910-0078
                                  exemption.
814, subparts A through E......  Premarket approval            0910-0231
                                  applications.
814, subpart H.................  Humanitarian use              0910-0332
                                  devices.
820............................  Current good                  0910-0073
                                  manufacturing practice
                                  and the quality system
                                  regulation.
312............................  Investigational New           0910-0014
                                  Drug Regulations.
314............................  Applications for FDA          0910-0001
                                  Approval to Market a
                                  New Drug.
314............................  Abbreviated New Drug          0910-0786
                                  Applications and
                                  505(b)(2) Applications.
601; Form FDA 356h.............  Biologics License;            0910-0338
                                  Application to Market
                                  a New Drug or
                                  Abbreviated New Drug
                                  or Biologic for Human
                                  Use--Form FDA 356h.
``User Fees for 513(g) Requests  513(g) requests........       0910-0705
 for Information'' and ``FDA
 and Industry Procedures for
 Section 513(g) Requests for
 Information under the Federal
 Food, Drug, and Cosmetic Act``.
``De Novo Classification         De Novo requests.......       0910-0844
 Process (Evaluation of
 Automatic Class III
 Designation)``.
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    Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16394 Filed 7-28-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Notices]
[Page 42145-42149]
[DOCID:fr25jy06-118]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54167; File No. SR-NASDAQ-2006-002]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change and Amendment No. 1 Thereto To Add Generic Listing
Standards for Index-Linked Securities

July 18, 2006.
    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 March 29, 2006, The NASDAQ Stock Market, LLC (``Nasdaq''), 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 Nasdaq. On May 5, 2006, the Exchange filed
Amendment No. 1 to the proposed rule change.\3\ The Commission is
publishing this notice to solicit comments on the proposed rule change,
as amended, from interested persons and to approve the proposal on an
accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1 Nasdaq made minor revisions to the
proposed rule text.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to reflect in the Nasdaq rules the generic listing
standards for index-linked notes (``ILNs'') previously approved for
NASD pursuant to Rule 19b-4(e) under the Act.\4\ These ``generic''
listing standards were recently approved by the Commission for The
Nasdaq Stock Market, Inc. (``Nasdaq Market'') as part of the NASD, Inc.
rule book,\5\ but because their approval came several days after the
approval of Nasdaq's registration as a national securities exchange,\6\
they were not a part of the Nasdaq rule set included in the Exchange
Approval Order.
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    \4\ 17 CFR 240.19b-4(e).
    \5\ See Securities Exchange Act Release No. 53142 (Jan. 19,
2006), 71 FR 4180 (Jan. 25, 2006).
    \6\ See Securities Act Release No. 53128 (Jan. 13, 2006), 71 FR
3550 (Jan. 23, 2006 ``Exchange Approval Order'').
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    The text of the proposed rule change is available on Nasdaq's Web
site (http://www.nasdaq.com), at Nasdaq's principal office, and at the

Commission's Public Reference Room. The text of the proposed rule
change is also set forth below. Proposed new language is italicized;
proposed deletions are in [brackets].
* * * * *

4420. Quantitative Designation Criteria

    In order to be listed on the Nasdaq National Market, an issuer
shall be required to substantially meet the criteria set forth in
paragraphs (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), (l),
[or] (m) or (n) below.
    (a)-(l) No change.

(m) Index-Linked Securities

    Index-linked securities are securities that provide for the payment
at maturity of a cash amount based on the performance of an underlying
index or indexes. Such securities may or may not provide for the
repayment of the original principal investment amount. Nasdaq may
submit a rule filing pursuant to Section 19(b)(2) of the Securities
Exchange Act of 1934 to permit the listing and trading of index-linked
securities that do not otherwise meet the standards set forth below in
paragraphs (1) through (9). Nasdaq will consider for listing and
trading pursuant to Rule 19b-4(e) under the Securities Exchange Act of
1934 index-linked securities, provided:
    (1) Both the issue and the issuer of such security meet the
criteria for other securities set forth in paragraph (f) of this rule,
except that the minimum public distribution of the security shall be
1,000,000 units with a minimum of 400 public holders, unless the
security is traded in $1,000 denominations, in which case there is no
minimum number of holders.
    (2) The issue has a term of not less than one (1) year and not
greater than ten (10) years.
    (3) The issue must be the non-convertible debt of the issuer.
    (4) The payment at maturity may or may not provide for a multiple
of the positive performance of an underlying index or indexes; however,
in no event will payment at maturity be based on a multiple of the
negative performance of an underlying index or indexes.
    (5) The issuer will be expected to have a minimum tangible net
worth in excess of $250,000,000 and to exceed by at least 20% the
earnings requirements set forth in paragraph (a)(1) of this Rule. In
the alternative, the issuer will be expected: (i) to have a minimum
tangible net worth of $150,000,000 and to exceed by at least 20% the
earnings requirement set forth in paragraph (a)(1) of this Rule, and
(ii) not to have issued securities where the original issue price of
all the issuer's other index-linked note offerings (combined with
index-linked note offerings of the issuer's affiliates) listed on a
national securities exchange or traded through the facilities of Nasdaq
exceeds 25% of the issuer's net worth.
    (6) The issuer is in compliance with Rule 10A-3 under the
Securities Exchange Act of 1934.
    (7) Initial Listing Criteria-Each underlying index is required to
have at least ten (10) component securities. In addition, the index or
indexes to which the security is linked shall either (A) have been
reviewed and approved for the trading of options or other derivatives
by the Commission under Section 19(b)(2) of the 1934 Act and rules
thereunder and the conditions set forth in the Commission's approval
order, including comprehensive surveillance sharing agreements for non-
U.S. stocks, continue to be satisfied, or (B) the index or indexes meet
the following criteria:
    (i) Each component security has a minimum market value of at least
$75 million, except that for each of the lowest weighted component
securities in the index that in the aggregate account for no more than
10% of the weight of the index, the market value can be at least $50
million;

    (ii) Each component security shall have trading volume in each of
the last six months of not less than 1,000,000 shares, except that for
each of the lowest weighted component securities in the index that in
the aggregate account for no more than 10% of the weight of the index,
the trading volume shall be at least 500,000 shares in each of the last
six months;
    (iii) Each index will be calculated based on a capitalization,
modified capitalization, price, equal-dollar or modified equal-dollar
weighting methodology;
    (iv) Indexes based upon the equal-dollar or modified equal-dollar
weighting method will be rebalanced at least quarterly;
    (v) In the case of a capitalization-weighted or modified
capitalization-weighted index, the lesser of the five highest weighted
component securities in the index or the highest weighted component
securities in the index that in the aggregate represent at least 30% of
the total number of component securities in the index, each have an
average monthly trading volume of at least 2,000,000 shares over the
previous six months;
    (vi) No underlying component security will represent more than 25%
of the weight of the index, and the five highest weighted component
securities in the index do not in the aggregate account for more than
50% of the weight of the index (60% for an index consisting of fewer
than 25 component securities);
    (vii) 90% of the index's numerical value and at least 80% of the
total number of component securities will meet the then current
criteria for standardized option trading on a national securities
exchange or a national securities association;
    (viii) Each component security shall be issued by a 1934 Act
reporting company, shall be listed on Nasdaq or another national
securities exchange, and shall be an ``NMS stock'' as defined in Rule
600 of SEC Regulation NMS; and
    (ix) Foreign country securities or American Depository Receipts
(``ADRs'') that are not subject to comprehensive surveillance
agreements do not in the aggregate represent more than 20% of the
weight of the index.
    (8) Index Maintenance and Dissemination--(i) If the index is
maintained by a broker-dealer, the broker-dealer shall erect a
``firewall'' around the personnel who have access to information
concerning changes and adjustments to the index and the index shall be
calculated by a third party who is not a broker-dealer. (ii) The
current value of an index will be widely disseminated at least every 15
seconds, except as provided in the next clause (iii). (iii) The values
of the following indexes need not be calculated and widely disseminated
at least every 15 seconds if, after the close of trading, the
indicative value of the index-linked security based on one or more of
such indexes is calculated and disseminated to provide an updated
value: CBOE S&P 500 BuyWrite Index(sm), CBOE DJIA BuyWrite Index(sm),
CBOE Nasdaq-100 BuyWrite Index(sm). (iv) If the value of an index-
linked security is based on more than one index, then the composite
value of such indexes must be widely disseminated at least every 15
seconds.
    (9) Surveillance Procedures. NASD will implement on behalf of
Nasdaq written surveillance procedures for index-linked securities.
Nasdaq will enter into adequate comprehensive surveillance sharing
agreements for non-U.S. securities, as applicable.
    (10) Index-linked securities will be treated as equity instruments.
Furthermore, for the purpose of fee determination, index-linked
securities shall be deemed and treated as Other Securities.
    [(m)] (n) NASD Regulation
    No change.
* * * * *

4450. Quantitative Maintenance Criteria

    (a) and (b) No change.
(c) Other Securities Designated Pursuant to Rule 4420(f) and Index-
Linked Securities
    (1) The aggregate market value or principal amount of publicly held
units (except index-linked securities that were listed pursuant to Rule
4420(m)) must be at least $1 million.
    (2) Delisting or removal proceedings will be commenced (unless the
Commission has approved the continued trading) with respect to any
index-linked security that was listed pursuant to paragraph (7)(B) of
Rule 4420(m) if any of the standards set forth in paragraph (7)(B) of
such rule are not continuously maintained, except that:
    (i) the criteria that no single component represent more than 25%
of the weight of the index and the five highest weighted components in
the index may not represent more than 50% (or 60% for indexes with less
than 25 components) of the weight of the Index, need only be satisfied
for capitalization weighted and price weighted indexes as of the first
day of January and July in each year;
    (ii) the total number of components in the index may not increase
or decrease by more than 33\1/3\% from the number of components in the
index at the time of its initial listing, and in no event may be less
than ten (10) components;
    (iii) the trading volume of each component security in the index
must be at least 500,000 shares for each of the last six months, except
that for each of the lowest weighted components in the index that in
the aggregate account for no more than 10% of the weight of the index,
trading volume must be at least 400,000 shares for each of the last six
months; and
    (iv) in a capitalization-weighted or modified capitalization-
weighted index, the lesser of the five highest weighted component
securities in the index or the highest weighted component securities in
the index that in the aggregate represent at least 30% of the total
number of stocks in the index have had an average monthly trading
volume of at least 1,000,000 shares over the previous six months.
    (3) With respect to an index-linked security that was listed
pursuant to paragraph (7)(A) of Rule 4420(m), delisting or removal
proceedings will be commenced (unless the Commission has approved the
continued trading of the subject index-linked security) if an
underlying index or indexes fails to satisfy the maintenance standards
or conditions for such index or indexes as set forth by the Commission
in its order under Section 19(b)(2) of the 1934 Act approving the index
or indexes for the trading of options or other derivatives.
    (4) Delisting or removal proceedings will also be commenced with
respect to any index-linked security listed pursuant to Rule 4420(m)
(unless the Commission has approved the continued trading of the
subject index-linked security), under any of the following
circumstances:
    (i) if the aggregate market value or the principal amount of the
securities publicly held is less than $400,000;
    (ii) if the value of the index or composite value of the indexes is
no longer calculated or widely disseminated on at least a 15-second
basis, provided, however, that the values of the following indexes need
not be calculated and disseminated at least every 15 seconds if, after
the close of trading, the indicative value of any index-linked security
linked to one or more of such indexes is calculated and disseminated to
provide an updated value: CBOE S&P 500 BuyWrite Index(sm), CBOE DJIA
BuyWrite Index(sm), CBOE Nasdaq-100 BuyWrite Index(sm); or

    (iii) if such other event shall occur or condition exists which in
the opinion of Nasdaq makes further dealings on Nasdaq inadvisable.
    (d) through (i) No change.
* * * * *

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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 proposed rule change will add generic listing standards to
permit the listing and trading of ILNs pursuant to Rule 19b-4(e) under
the Act.\7\ Rule 19b-4(e) provides that the listing and trading of a
new derivative securities product by a self-regulatory organization
shall not be deemed a proposed rule change, pursuant to paragraph
(c)(1) of Rule 19b-4,\8\ if the Commission has approved, pursuant to
Section 19(b) of the Act,\9\ the self-regulatory organization's trading
rules, procedures and listing standards for the product class that
would include the new derivatives securities product, and the self-
regulatory organization has a surveillance program for the product
class.\10\
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    \7\ 17 CFR 240.19b-4(e).
    \8\ 17 CFR 240.19b-4(c)(1).
    \9\ 15 U.S.C. 78s(b).
    \10\ See Securities Exchange Act Release No. 40761 (Dec. 8,
1998), 63 FR 70952 (Dec. 22, 1998) (the ``19b-4(e) Order'').
---------------------------------------------------------------------------

    Nasdaq believes adopting generic listing standards for these
securities and applying Rule 19b-4(e) should fulfill the intended
objective of that Rule by allowing those ILNs that satisfy the proposed
generic listing standards to commence trading, without the need for the
public comment period and Commission approval. This has the potential
to reduce the time frame for bringing ILNs to market and thereby reduce
the burdens on issuers and other market participants. The failure of a
particular index to comply with the proposed generic listing standards
under Rule 19b-4(e), however, would not preclude a separate filing
pursuant to Section 19(b)(2), requesting Commission approval to list
and trade a particular ILN.
    On January 19, 2006, the Commission approved the proposed ILN
standards for the Nasdaq Market.\11\ However, on January 13, 2006, the
Commission also approved Nasdaq's registration as a national securities
exchange, and because of the timing of the two approvals, the ILN
standards were not included in the rule set that the Commission
approved for Nasdaq. The purpose of this filing is to update the Nasdaq
rules accordingly.
---------------------------------------------------------------------------

    \11\ See NASD Rule 4420(m).
---------------------------------------------------------------------------

    The proposed Nasdaq Rule 4420(m) is the same \12\ as the
corresponding NASD Rule 4420(m) for the Nasdaq Market and will be
administered in the same manner as the Nasdaq Market rule is being
administered currently. The proposed rule will become operative as soon
as Nasdaq begins its operations as an exchange.
---------------------------------------------------------------------------

    \12\ This proposal includes two clarifications. First, it
removes a potential conflict between the provisions of Rules
4450(c)(1) and 4450(c)(4)(i) by clarifying that Rule 4450(c)(1) does
not apply to ILNs (and, therefore, the minimum aggregate market
value or the principal amount of the publicly held securities is
$400,000, as stated in Rule 4450(c)(4)(i)). Second, it clarifies in
the wording of Rule 4420(m)(9) that despite NASD's obligations
pursuant to a regulatory services agreement to surveil Nasdaq
trading, Nasdaq itself must enter into appropriate written
surveillance sharing agreements. See Nasdaq Rule 4420(n). The
Commission made minor clarifying changes to this footnote to conform
it with Amendment No. 1. Telephone conversation between Alex Kogan,
Associate General Counsel, Nasdaq, Florence E. Harmon, Senior
Special Counsel, Division of Market Regulation, Commission, and
Rahman Harrison, Special Counsel, Division of Market Regulation,
Commission on July 17, 2006.
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    In transitioning to Nasdaq the ILNs that are listed on the Nasdaq
Market, Nasdaq will deem all such ILNs, without exception, as subject
to the continued listing standards in proposed Nasdaq Rules 4450(c)(3)
and (c)(4).\13\
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    \13\ The Commission deleted text from this paragraph pursuant to
authorization by Nasdaq staff. Telephone conversation between Alex
Kogan, Associate General Counsel, Nasdaq, Florence E. Harmon, Senior
Special Counsel, Division of Market Regulation, Commission, and
Rahman Harrison, Special Counsel, Division of Market Regulation,
Commission on July 17, 2006.
---------------------------------------------------------------------------

    Index Securities will be treated as equity instruments and will be
subject to all Nasdaq rules governing the trading of equity securities,
including trading halt rules. Index Securities will be subject to the
same fee schedule as Other Securities listed under Nasdaq Rule 4420(f).
The applicable fee schedule is currently codified as Nasdaq Rule 4530.
2. Statutory Basis
    Nasdaq believes that the proposed rule change, as amended, is
consistent with the provisions of Section 6 of the Act,\14\ in general,
and with Section 6(b)(5) of the Act,\15\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, remove impediments to a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
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    \14\ 15 U.S.C. 78f.
    \15\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    Nasdaq does not believe that the proposed rule change, as amended,
will result in 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

    Written comments on the proposed rule change, as amended, were
neither solicited nor received.

III. 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-NASDAQ-2006-002 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NASDAQ-2006-002.
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 Section. Copies of the filing also will
be available for inspection and copying at the principal office of the
Nasdaq. 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-
NASDAQ-2006-002 and should be submitted on or before August 15, 2006.

IV. Commission's Findings

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\16\ In particular, the Commission believes that
the proposed rule change is consistent with Section 6(b)(5) of the Act
\17\ in that it is designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
facilitating transactions in securities, and 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.
---------------------------------------------------------------------------

    \16\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission has previously approved the listing and trading of
several Index Securities based on a variety of debt structures and
market indexes.\18\ The Commission has also recently approved, pursuant
to Rule 19b-4(e) under the Act,\19\ generic listing standards for these
securities for the Nasdaq Market,\20\ that, in all material respects,
are identical to those listing standards proposed by Nasdaq.
---------------------------------------------------------------------------

    \18\ See Securities Exchange Act Release Nos. 41091 (Feb. 23,
1999), 64 FR 10515 (Mar. 4, 1999) (Narrow-Based Index Options);
42787 (May 15, 2000), 65 FR 33598 (May 24, 2000) (ETFs); and 43396
(Sept. 29, 2000), 65 FR 60230 (Oct. 10, 2000) (TIRs).
    \19\ 17 CFR 240.19b-4(e).
    \20\ See Securities Exchange Act Release No. 53142 (Jan. 19,
2006), 71 FR 4180 (Jan. 25, 2006).
---------------------------------------------------------------------------

    Consistent with its previous orders, the Commission believes that
generic listing standards proposed by Nasdaq for Index Securities
should fulfill the intended objective of Rule 19b-4(e) under the Act by
allowing those Index Securities that satisfy the generic listing
standards to commence trading without public comment and Commission
approval.\21\ This has the potential to reduce the time frame for
bringing Index Securities to market and thereby reduce the burdens on
issuers and other market participants and thus enhances investors'
opportunities.
---------------------------------------------------------------------------

    \21\ The Commission notes that the failure of a particular index
to comply with the proposed generic listing standards under Rule
19b-4(e) under the Act, however, would not preclude Nasdaq from
submitting a separate filing pursuant to Section 19(b)(2) of the
Act, requesting Commission approval to list and trade a particular
index-linked product.
---------------------------------------------------------------------------

A. Trading of Index Securities

    Taken together, the Commission finds that Nasdaq's proposal
contains adequate rules and procedures to govern the trading of Index
Securities listed pursuant to Rule 19b-4(e) on Nasdaq. All Index
Security products listed under the standards will be subject to the
full panoply of Nasdaq rules and procedures that now govern the trading
of Index Securities and the trading of equity securities on Nasdaq.
    Nasdaq has proposed asset/equity requirements and tangible net
worth for each Index Security issuer, as well as minimum distribution,
principal/market value, and term thresholds for each issuance of Index
Securities. As set forth more fully above, Nasdaq's proposed listing
criteria include minimum market capitalization, monthly trading volume,
and relative weighting requirements for the Index Securities. These
requirements are designed to ensure that the trading markets for index
components underlying Index Securities are adequately capitalized and
sufficiently liquid, and that no one stock dominates the index. The
Commission believes that these requirements should minimize the
potential for of manipulation. The Commission also finds that the
requirement that each component security underlying an Index Security
be listed on a national securities exchange or traded through the
facilities of a national securities system and subject to last sale
reporting will contribute to the transparency of the market for Index
Securities. Alternatively, if the index component securities are
foreign securities that are not reporting companies, the generic
listing standards permit listing of an Index Security if the Commission
previously approved the underlying index for trading in connection with
another derivative product and if certain surveillance sharing
arrangements exist with foreign markets. The Commission believes that
if it has previously determined that such index and its components were
sufficiently transparent, then Nasdaq may rely on this finding,
provided it has comparable surveillance sharing arrangements with the
foreign market that the Commission relied on in approving the previous
product.
    The Commission believes that by requiring pricing information for
both the relevant underlying index or indexes and the Index Security to
be readily available and disseminated, the proposed listing standards
should help ensure a fair and orderly market for Index Securities
approved pursuant to such proposed listing standards.
    The Commission also believes that the requirement that at least 90
percent of the component securities, by weight, and 80 percent of the
total number of Underlying Securities, be eligible individually for
options trading will prevent an Index Security from being a vehicle for
trading options on a security not otherwise options eligible.
    Nasdaq has also developed delisting criteria that will permit
Nasdaq to suspend trading of an Index Security in case of circumstances
that make further dealings in the product inadvisable. The Commission
believes that the delisting criteria will help ensure a minimum level
of liquidity exists for each Index Security to allow for the
maintenance of fair and orderly markets. Also, Nasdaq will commence
delisting proceedings in the event that the value of the underlying
index or index is no longer calculated and widely disseminated on at
least a 15-second basis.\22\
---------------------------------------------------------------------------

    \22\ In the case of the BuyWrite Index Securities, CBOE
disseminates a daily index value. Additionally, a daily indicative
value for the product is also disseminated.
---------------------------------------------------------------------------

B. Surveillance

    Nasdaq must have surveillance procedures to monitor trading in any
products listed under the generic listing standards. An Index Security,
just like an ETF, derives its value by reference to the underlying
index. For this reason, the Commission has required that markets that
list index based securities monitor the qualifications of not just the
actual security (e.g., the ETF, index option, or Index Securities), but
also of the underlying indexes (and of the index providers). In this
regard, the Commission believes that a surveillance

sharing agreement between a self-regulatory organization proposing to
list a stock index derivative product and the self-regulatory
organization trading the stocks underlying the derivative product is an
important measure for surveillance of the derivative and underlying
securities markets. When a new derivative securities product based upon
domestic securities is listed and traded on an exchange or national
securities association pursuant to Rule 19b-4(e) under the Act, the
self-regulatory organization should determine that the markets upon
which all of the U.S. component securities trade are members of the
Intermarket Surveillance Group (``ISG''), which provides information
relevant to the surveillance of the trading of securities on other
market centers.\23\ For derivative securities products based on
previously approved indexes that contain securities from one or more
foreign markets, the self-regulatory organization should have a
comprehensive Intermarket Surveillance Agreement, as prescribed in the
prior Commission order, which covers the securities underlying the new
securities product.\24\ With respect to indexes not previously approved
by the Commission, the Commission finds that Nasdaq's commitment to
implement comprehensive surveillance sharing agreements,\25\ as
necessary, and the definitive requirements that: (i) Each component
security shall be a registered reporting company under the Act; and
(ii) no more than 20 percent of the weight of the Underlying Index or
Underlying Indexes may be comprised of foreign country securities or
ADRs not subject to a comprehensive surveillance sharing agreement,\26\
will make possible adequate surveillance of trading of Index Securities
listed pursuant to the proposed generic listing standards.
---------------------------------------------------------------------------

    \23\ See Securities Exchange Act Release No. 40761 (Dec. 8,
1998), 63 FR 70952 (Dec. 22, 1998) (File No. S7-13-98). ISG was
formed on July 14, 1983, to, among other things, coordinate more
effectively surveillance and investigative information sharing
arrangements in the stock and options markets. The Commission notes
that all of the registered national securities exchanges, as well as
the NASD, are members of the ISG.
    \24\ Id.
    \25\ Proposed Nasdaq Rule 4420(m)(9).
    \26\ Proposed Nasdaq Rules 4420(m)(7)(viii)-(ix).
---------------------------------------------------------------------------

    With regard to actual oversight, Nasdaq represents that its
surveillance procedures are sufficient to detect fraudulent trading
among members in the trading of Index Securities pursuant to the
proposed generic listing standards.

C. Acceleration

    The Commission finds good cause for approving proposed rule change,
as amended, prior to the 30th day after the date of publication of
notice of filing thereof in the Federal Register. The proposal
implements generic listing standards substantially identical to those
already approved for the Nasdaq Market. The Commission does not believe
that Nasdaq's proposal raises any novel regulatory issues. The proposed
generic listing criteria should enable more expeditious review and
listing of Index Securities by Nasdaq, thereby reducing administrative
burdens and benefiting the investing public. Thus, the Commission finds
good cause to accelerate approval of the proposed rule change, as
amended.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\27\ that the proposed rule change (SR-NASDAQ-2006-002), as
amended, is hereby approved on an accelerated basis.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(2).
    \28\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\28\
Nancy M. Morris,
Secretary.
[FR Doc. E6-11788 Filed 7-24-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Page 6104]
[FR Doc No: 2016-02106]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Application of Elite Airways, LLC for Certificate Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause (Order 2016-1-12); Docket DOT-
OST-2015-0095.

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

SUMMARY: The Department of Transportation is directing all interested
parties to show cause why it should not issue an order finding Elite
Airways, LLC fit, willing, and able, and awarding it a certificate of
public convenience and necessity to conduct interstate scheduled air
transportation of persons, property and mail.

DATES: Persons wishing to file objections should do so no later than
February 11, 2016.

ADDRESSES: Objections and answers to objections should be filed in
Docket DOT-OST-2015-0095 and addressed to the U.S. Department of
Transportation, Docket Operations, (M-30, Room W12-140), 1200 New
Jersey Avenue SE., Washington, DC 20590, and should be served upon the
parties listed in Attachment A to the order.

FOR FURTHER INFORMATION CONTACT: Barbara Snoden, Air Carrier Fitness
Division (X-56, Room W86-471), U.S. Department of Transportation, 1200
New Jersey Avenue SE., Washington, DC 20590,<PHONE_NUMBER>.

    Dated: January 28, 2016.
Susan L. Kurland,
Assistant Secretary for Aviation and International Affairs.
[FR Doc. 2016-02106 Filed 2-3-16; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Page 59523]
[FR Doc No: 2020-20915]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2881-000]

Harts Mill Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Harts Mill Solar, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 6, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: September 16, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-20915 Filed 9-21-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 210 (Wednesday, November 1, 2017)]
[Rules and Regulations]
[Page 50580]
[FR Doc No: C1-2017-21947]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 97

[EPA-R06-OAR-2016-0611; FRL-9969-07-Region 6]

Promulgation of Air Quality Implementation Plans; State of Texas;
Regional Haze and Interstate Visibility Transport Federal
Implementation Plan

Correction

    In rule document 2017-21947, appearing on pages 48324-48380 in the
issue of Tuesday, October 17, 2017, make the following correction:
    On page 48370, in the first column, in the sixteenth line from the
top, ``97.404(b)(1)'', should read ``97.904(b)(1)''.

[FR Doc. C1-2017-21947 Filed 10-31-17; 8:45 am]
 BILLING CODE 1300-00-D


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37650-37652]
[FR Doc No: 2014-15488]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-8339]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency

 Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-
2953.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
Part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.
    Accordingly, 44 CFR Part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of   Current effective  map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
            Region V

Michigan:
    Benona, Township of, Oceana        260481  August 26, 1981,   August 4, 2014........  August 4, 2014
     County.                                    Emerg; August 1,
                                                1986, Reg;
                                                August 4, 2014,
                                                Susp.
    Claybanks, Township of,            260482  July 21, 1986,     ......do..............   Do.
     Oceana County.                             Emerg; March 18,
                                                1987, Reg;
                                                August 4, 2014,
                                                Susp.
    Golden, Township of, Oceana        260301  July 17, 1974,     ......do..............   Do.
     County.                                    Emerg; September
                                                1, 1986, Reg;
                                                August 4, 2014,
                                                Susp.
    Greenwood, Township of,            260483  August 10, 1976,   ......do..............   Do.
     Oceana County.                             Emerg; August 1,
                                                1986, Reg;
                                                August 4, 2014,
                                                Susp.
    Hart, City of, Oceana              260484  April 8, 1976,     ......do..............   Do.
     County.                                    Emerg; September
                                                1, 1986, Reg;
                                                August 4, 2014,
                                                Susp.
    Hart, Township of, Oceana          260777  September 26,      ......do..............   Do.
     County.                                    1986, Emerg;
                                                January 16,
                                                1987, Reg;
                                                August 4, 2014,
                                                Susp.
    Hesperia, Village of,              260485  March 10, 1982,    ......do..............   Do.
     Newaygo and Oceana                         Emerg; August 1,
     Counties.                                  1986, Reg;
                                                August 4, 2014,
                                                Susp.

    Newfield, Township of,             260697  September 20,      ......do..............   Do.
     Oceana County.                             1976, Emerg;
                                                September 1,
                                                1986, Reg;
                                                August 4, 2014,
                                                Susp.
    Pentwater, Township of,            260183  July 23, 1973,     ......do..............   Do.
     Oceana County.                             Emerg; March 1,
                                                1978, Reg;
                                                August 4, 2014,
                                                Susp.
    Pentwater, Village of,             260277  September 25,      ......do..............   Do.
     Oceana County.                             1973, Emerg; May
                                                15, 1978, Reg;
                                                August 4, 2014,
                                                Susp.

           Region VII

Kansas:
    Halstead, City of, Harvey          200131  April 3, 1975,     ......do..............   Do.
     County.                                    Emerg; September
                                                1, 1978, Reg;
                                                August 4, 2014,
                                                Susp.
    Harvey County,                     200585  October 19, 1978,  ......do..............   Do.
     Unincorporated Areas.                      Emerg; August
                                                15, 1983, Reg;
                                                August 4, 2014,
                                                Susp.
    Newton, City of, Harvey            200133  September 13,      ......do..............   Do.
     County.                                    1974, Emerg;
                                                October 2, 1979,
                                                Reg; August 4,
                                                2014, Susp.

          Region VIII

North Dakota:
    Bismarck, City of, Burleigh        380149  February 14,       ......do..............   Do.
     County.                                    1975, Emerg;
                                                September 18,
                                                1985, Reg;
                                                August 4, 2014,
                                                Susp.
    Burleigh County,                   380017  March 5, 1975,     ......do..............   Do.
     Unincorporated Areas.                      Emerg; September
                                                18, 1985, Reg;
                                                August 4, 2014,
                                                Susp.
    Lincoln, City of, Burleigh         385396  N/A, Emerg; May    ......do..............   Do.
     County.                                    12, 2008, Reg;
                                                August 4, 2014,
                                                Susp.
    Wing, City of, Burleigh            380213  July 1, 1977,      ......do..............   Do.
     County.                                    Emerg; August
                                                19, 1980, Reg;
                                                August 4, 2014,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*-do- = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp--Suspension.

    Dated: June 17, 2014.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2014-15488 Filed 7-1-14; 8:45 am]
BILLING CODE 9110-12-P


MEMORANDUM

DATE:		August 20, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Region 7, EPA

SUBJECT:	July 16, 2014, Conference Call Regarding Proposed Carbon Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      A conference call was held between EPA and the attendees listed below on July 16, 2014 to discuss the proposed Carbon Power Plan for Existing Power Plants. The majority of the discussion centered on how goals were established for the states in Region 7: Iowa, Kansas, Missouri, and Nebraska. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES

EPA Region 7: Joshua Tapp Mark A. Smith Ward Burns Toni Gargas Becky Weber Amy Bhesania John Smith

Iowa Department of Natural Resources: Catherine Fitzsimmons Martie Stein Jason Marcel

Kansas Department of Health and Environment Tom Gross Melissa Weide Miles Stotts Lynn Deahl

Missouri Department of Natural Resources  Mark Leath Paul Myers Emily Wilbur

Nebraska Department of Environmental Quality Shelly Schneider Adam Yarina Katie Gutierrez Brian Kozisek


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on June 6, 2005

NOTICE OF ACTION TAKEN -- DOCKETS OST-2005-21162

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of UNITED AIR LINES, INC. (UNITED) filed 5/3/2005 for:

XX  Exemption for two years under 49 U.S.C. 40109 to provide the
following service::

Scheduled foreign air transportation of persons, property, and mail
between the terminal point Denver, Colorado, and the terminal point
Cozumel, Mexico.  United proposes initially to operate this route on a
year-round basis except for September-October, beginning on or about
October 31, 2005.

Applicant rep:   Jeffrey A. Manley<PHONE_NUMBER>    DOT Analyst:  Thuy
H. Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: June 6, 2005 through June 6,
2007.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX   The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:     		XX  Holder’s
certificates of public convenience and necessity

		XX  Standard Exemption Conditions (attached)

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

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Consistent with our policy, the dormancy notice
period will begin on October 31, 2005, United’s proposed start-up date
for the above-mentioned service.

Responsive Pleadings and Remarks: Frontier filed an answer to United’s
application stating that it had no objections to United’s application
so long as its own Denver-Cozumel exemption application is granted as
soon as possible (see Frontier’s application in Docket
OST-2005-21033).  We have, today, granted each of the referenced
applications.

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

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Dockets.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action
set forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004


[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23284-23287]
[FR Doc No: 2016-09256]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting Notice

    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.
552b:

TIME AND DATE: April 21, 2016, 10 a.m.

PLACE: Room 2C, 888 First Street NE., Washington, DC 20426.

STATUS: Open.

MATTERS TO BE CONSIDERED: Agenda.
    * NOTE--Items listed on the agenda may be deleted without further
notice.

CONTACT PERSON FOR MORE INFORMATION: Kimberly D. Bose, Secretary,
Telephone<PHONE_NUMBER>.
    For a recorded message listing items struck from or added to the
meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's Web site at http://www.ferc.gov using the eLibrary link,
or may be examined in the Commission's Public Reference Room.

                             1026th--Meeting
              [Regular Meeting; April 21, 2016; 10:00 a.m.]
------------------------------------------------------------------------
  Item No.       Docket No.                      Company
------------------------------------------------------------------------
                             ADMINISTRATIVE
------------------------------------------------------------------------
A-1.........  AD16-1-000        Agency Administrative Matters.
A-2.........  AD16-7-000        Customer Matters, Reliability, Security
                                 and Market Operations.
A-3.........  AD16-19-000       National Labs Panel on Grid
                                 Modernization.
A-4.........  AD16-20-000       Electric Storage Participation in
                                 Regions with Organized Wholesale
                                 Electric Markets.
------------------------------------------------------------------------
                                ELECTRIC
------------------------------------------------------------------------
E-1.........  EL12-80-001       Exelon Wind 1, LLC.
              QF05-114-004      ........................................
              QF05-116-004      Exelon Wind 2, LLC.
              QF05-115-004      Exelon Wind 3, LLC.
              QF03-13-005       Exelon Wind 4, LLC.
              QF06-289-004      Exelon Wind 5 LLC.
              QF06-290-004      Exelon Wind 6, LLC.
              QF07-46-004       Exelon Wind 7, LLC.
              QF07-53-004       Exelon Wind 8, LLC.
              QF07-54-004       Exelon Wind 9, LLC
              QF07-55-004       Exelon Wind 10, LLC.
              QF07-56-004       Exelon Wind 11, LLC.
              QF07-257-003      High Plains Wind Power, LLC.
E-2.........  EL14-28-000       Occidental Chemical Corporation.
              QF00-64-002       ........................................
E-3.........  EL13-41-000       Occidental Chemical Corporation v.
                                 Midwest Independent Transmission System
                                 Operator, Inc.

E-4.........  EL13-88-000       Northern Indiana Public Service Company
                                 v. Midcontinent Independent System
                                 Operator, Inc. and PJM Interconnection,
                                 LLC.
E-5.........  EL14-20-000       Independent Market Monitor for PJM v.
                                 PJM Interconnection, LLC.
E-6.........  EL12-54-000       Viridity Energy, Inc. v. PJM
                                 Interconnection, LLC.
E-7.........  EF15-10-000       Western Area Power Administration.
E-8.........  QM14-3-001        Entergy Services, Inc.
              ................  Entergy Arkansas, Inc.
              ................  Entergy Gulf States Louisiana, LLC.
              ................  Entergy Louisiana, LLC.
              ................  Entergy Mississippi, Inc.
              ................  Entergy New Orleans, Inc.
              ................  Entergy Texas, Inc.
E-9.........  ER14-2850-004     Southwest Power Pool, Inc.
              ER14-2851-004     ........................................
E-10........  OMITTED           ........................................
E-11........  OMITTED           ........................................
E-12........  ER11-2275-003     Midwest Independent Transmission System
                                 Operator, Inc.
E-13........  ER15-952-001      New Jersey Energy Associates, a Limited
                                 Partnership.
E-14........  ER16-763-000      NorthWestern Corporation.
E-15........  ER15-1861-001     Tucson Electric Power Company.
              ER15-1862-001     ........................................
E-16........  ER15-553-001      San Diego Gas & Electric Company.
E-17........  ER16-866-000      MDU Resources Group, Inc.
E-18........  EL09-61-003       Louisiana Public Service Commission v.
                                 Entergy Corporation, Entergy Services,
                                 Inc., Entergy Louisiana, LLC, Entergy
                                 Arkansas, Inc., Entergy Mississippi,
                                 Inc., Entergy New Orleans, Inc.,
                                 Entergy Gulf States Louisiana, LLC and
                                 Entergy Texas, Inc.
E-19........  EL09-61-002       Louisiana Public Service Commission v.
                                 Entergy Corporation, Entergy Services,
                                 Inc., Entergy Louisiana, LLC, Entergy
                                 Arkansas, Inc., Entergy Mississippi,
                                 Inc., Entergy New Orleans, Inc.,
                                 Entergy Gulf States Louisiana, LLC and
                                 Entergy Texas, Inc.
E-20........  OMITTED           ........................................
E-21........  ER14-822-002      PJM Interconnection, LLC.
              ER14-822-003      ........................................
E-22........  ER14-504-001      PJM Interconnection, LLC.
E-23........  ER13-2108-001     PJM Interconnection, LLC.
E-24........  OMITTED           ........................................
E-25........  ER09-411-005      Midwest Independent Transmission System
                                 Operator, Inc.
E-26........  ER11-2275-002     Midwest Independent Transmission System
                                 Operator, Inc.
E-27........  OMITTED           ........................................
E-28........  EL07-86-012       Ameren Services Company and Northern
                                 Indiana Public Service Company v.
                                 Midwest Independent Transmission System
                                 Operator, Inc.
              EL07-88-012       Great Lakes Utilities.
              ................  Indiana Municipal Power Agency.
              ................  Missouri Joint Municipal Electric
                                 Utility Commission.
              ................  Missouri River Energy Services.
              ................  Prairie Power, Inc.
              ................  Southern Minnesota Municipal Power
                                 Agency.
              ................  Wisconsin Public Power Inc. v. Midwest
                                 Independent Transmission System
                                 Operator, Inc.
              EL07-92-012       Wabash Valley Power Association, Inc. v.
                                 Midwest Independent Transmission System
                                 Operator, Inc.
E-29........  OMITTED           ........................................
E-30........  EL16-41-000       Morongo Transmission LLC.
E-31........  EL14-66-003       E.ON Climate & Renewables North America
                                 LLC.
              ................  Pioneer Trail Wind Farm, LLC.
              ................  Settlers Trail Wind Farm, LLC v.
                                 Northern Indiana Public Service
                                 Company.
E-32........  EL16-29-000       North Carolina Electric Membership
                                 Corporation.
              ................  North Carolina Municipal Power Agency
                                 Number 1.
              ................  Piedmont Municipal Power Agency.
              ................  City of Concord, NC.
              ................  City of Kings Mountain, NC v. Duke
                                 Energy Carolinas, LLC.
              EL16-30-000       North Carolina Electric Membership
                                 Corporation.
              ................  North Carolina Eastern Municipal Power
                                 Agency.
              ................  Fayetteville Public Works Commission v.
                                 Duke Energy Progress, LLC.
E-33........  EL12-60-001       Southwest Power Pool, Inc.
              ................  Western Area Power Administration.
              ................  Basin Electric Power Cooperative.
              ................  Heartland Consumers Power District.
              ER12-1586-002     Southwest Power Pool, Inc.
              ER12-1586-003
E-34........  ER16-120-000      New York Independent System Operator,
                                 Inc.
              EL15-37-001
------------------------------------------------------------------------

                                   GAS
------------------------------------------------------------------------
G-1.........  RP13-743-004      ANR Pipeline Company and Great Lakes Gas
                                 Transmission Limited Partnership.
              RP15-138-002
              RP15-139-002
               (Consolidated)
              RP14-650-000
              RP14-650-001
              RP15-785-000
               (Not
               Consolidated)
G-2.........  OR14-17-001       Colonial Pipeline Company.
G-3.........  OR13-3-000        Buckeye Pipe Line Company, LP.
G-4.........  IS09-348-011      BP Pipelines (Alaska) Inc.
              IS09-395-011
              IS10-204-010
              IS10-491-000
              IS10-491-006
              IS09-384-010      ConocoPhillips Transportation Alaska,
                                 Inc.
              IS10-205-009
              IS10-476-000
              IS10-476-006
              IS09-391-010      ExxonMobil Pipeline Company.
              IS09-177-012
              IS10-200-009
              IS10-547-000
              IS10-547-005
              IS10-54-008       Koch Alaska Pipeline Company, LLC.
              IS10-496-000
              IS10-496-006
              IS09-176-011      Unocal Pipeline Company.
              IS07-41-009
              IS08-53-009
              IS10-52-008
              OR10-3-009
              IS10-490-000
              IS10-490-005
              IS11-3-000
              IS11-3-004
G-5.........  IS11-335-000      BP Pipelines (Alaska) Inc.
              IS12-458-000
              IS13-62-000
              IS13-108-000
              IS13-506-000
              IS15-88-000
              IS16-76-000
              IS11-306-000      ConocoPhillips Transportation Alaska,
                                 Inc.
              IS12-498-000
              IS13-480-000
              IS13-125-000
              IS14-596-000
              IS15-522-000
              IS11-336-000      ExxonMobil Pipeline Company.
              IS12-397-000
              IS13-55-000
              IS13-496-000
              IS14-575-000
              IS15-580-000
              IS11-546-000      Unocal Pipeline Company.
              IS11-328-000      Koch Alaska Pipeline Company, LLC.
G-6.........  IS15-522-001      ConocoPhillips Transportation Alaska,
                                 Inc.
              IS11-306-003, et  ConocoPhillips Transportation Alaska,
               al.               Inc.
               (Consolidated)
G-7.........  IS15-580-001      ExxonMobil Pipeline Company.
              IS11-306-004, et  ConocoPhillips Transportation Alaska,
               al.               Inc.
               (Consolidated)
------------------------------------------------------------------------
                                  HYDRO
------------------------------------------------------------------------
H-1.........  P-13287-004       City of New York, New York.
H-2.........  P-14316-002       Columbia Basin Hydropower.
              P-14318-002

              P-14349-002
              P-14351-002
H-3.........  P-13333-005       Public Utility District No. 1 of
                                 Klickitat County, Washington.
              P-14729-001       Clean Power Development, LLC.
H-4.........  P-7856-027        Willow Creek Hydro, LLC.
H-5.........  P-2146-141        Alabama Power Company.
------------------------------------------------------------------------
                              CERTIFICATES
------------------------------------------------------------------------
C-1.........  CP16-1-000        Dominion Transmission, Inc.
------------------------------------------------------------------------

    Issued: April 14, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

    A free webcast of this event is available through www.ferc.gov.
Anyone with Internet access who desires to view this event can do so by
navigating to www.ferc.gov's Calendar of Events and locating this event
in the Calendar. The event will contain a link to its webcast. The
Capitol Connection provides technical support for the free webcasts. It
also offers access to this event via television in the DC area and via
phone bridge for a fee. If you have any questions, visit
www.CapitolConnection.org or contact Danelle Springer or David
Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. 2016-09256 Filed 4-18-16; 4:15 pm]
 BILLING CODE 6717-01-P