[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Notices]
[Page 74062-74063]
[DOCID:fr30no10-96]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0588]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exceptions or Alternatives to Labeling Requirements
for Products Held by the Strategic National Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements for FDA regulations related to the exceptions or
alternatives to labeling requirements for products held by the
Strategic National Stockpile (SNS).

DATES: Submit either electronic or written comments on the collection
of information by January 31, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Exceptions or Alternatives to Labeling Requirements for Products Held
by the Strategic National Stockpile--(OMB Control Number 0910-0614)--
Extension

    Under the Public Health Service Act (the PHS Act), the Department
of Health and Human Services stockpiles medical products that are
essential to the health security of the Nation (see section 319F-2 of
the PHS Act (42 U.S.C. 247d-6b)). This collection of medical products
for use during national health emergencies, known as the SNS, is to
``provide for the emergency health security of the United States,
including the emergency health security of children and other
vulnerable populations, in the event of a bioterrorist attack or other
public health emergency.''
    It may be appropriate for certain medical products that are or will
be held in the SNS to be labeled in a manner that would not comply with
certain FDA labeling regulations given their anticipated circumstances
of use in an emergency. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
    In the Federal Register of December 28, 2007 (72 FR 73589), FDA
published an interim final rule entitled ``Exceptions or Alternatives
to Labeling Requirements for Products Held by the Strategic National
Stockpile.'' In the interim final rule, FDA issued regulations under
Sec. Sec.  201.26, 610.68, 801.128, and 809.11 (21 CFR 201.26, 610.68,
801.128, and 809.11), which allow the appropriate FDA Center Director
to grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included
in the SNS. An exception or alternative granted under the regulations
may include conditions or safeguards so that the labeling for such
products includes appropriate information necessary for the safe and
effective use of the product given the product's anticipated
circumstances of use. Any grant of an exception or alternative will
only apply to the specified lots, batches, or other units of medical
products in the request. The appropriate FDA Center Director may also
grant an exception or alternative to the labeling provisions specified
in the regulations on his or her own initiative.
    Under Sec.  201.26(b)(1)(i) (human drug products), Sec.
610.68(b)(1)(i) (biological products), Sec.  801.128(b)(1)(i) (medical
devices), and Sec.  809.11(b)(1)(i) (in vitro diagnostic products for
human use) an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate

FDA Center Director. Except when initiated by an FDA Center Director, a
request for an exception or alternative must be in writing and must:
     Identify the specified lots, batches, or other units of
the affected product;
     Identify the specific labeling provisions under this rule
that are the subject of the request;
     Explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
     Describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
     Provide copies of the proposed labeling of the specified
lots, batches, or other units of the affected product that will be
subject to the exception or alternative; and
     Provide any other information requested by the FDA Center
Director in support of the request.
    If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the New Drug Application, Biologics
License Application, Premarket Approval Application or Premarket
Notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
the interim final rule (72 FR 73589) may be used to satisfy certain
reporting obligations relating to changes to product applications under
Sec.  314.70 (21 CFR 314.70) (human drugs), Sec.  601.12 (21 CFR
601.12) (biological products), Sec.  814.39 (21 CFR 814.39) (medical
devices subject to premarket approval), or Sec.  807.81 (21 CFR 807.81)
(medical devices subject to 510(k) clearance requirements). The
information collection provisions in Sec. Sec.  314.70, 601.12, 807.81,
and 814.39 have been approved under OMB control numbers 0910-0001,
0910-0338, 0910-0120, and 0910-0231, respectively. On a case-by-case
basis, the appropriate FDA Center Director may also determine when an
exception or alternative is granted that certain safeguards and
conditions are appropriate, such as additional labeling on the SNS
products, so that the labeling of such products would include
information needed for safe and effective use under the anticipated
circumstances of use.
    Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute or store affected SNS products. Based on the number of
requests for an exception or alternative received by FDA since issuance
of the interim final rule, FDA estimates an average of two requests
annually. FDA is estimating that each respondent will spend an average
of 24 hours preparing each request. The hours per response for each
submission are based on the estimated time that it takes to prepare a
supplement to an application, which may be considered similar to a
request for an exception or alternative. To the extent that labeling
changes not already required by FDA regulations are made in connection
with an exception or alternative granted under the interim final rule,
FDA is estimating one occurrence annually in the event FDA would
require any additional labeling changes not already covered by FDA
regulations, and that it would take 8 hours to develop and revise the
labeling to make such changes.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR section              Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i),                               2               1               2              24              48
 610.68(b)(1)(i),
 801.128(b)(1)(i), and
 809.11(b)(1)(i)................
201.26(b)(1)(i),                               1               1               1               8               8
 610.68(b)(1)(i),...............
801.128(b)(1)(i), and
 809.11(b)(1)(i)................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              56
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30036 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Rules and Regulations]
[Pages 33790-33791]
[FR Doc No: 2017-15286]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9480; Airspace Docket No. 16-AEA-13]

Amendment of Class D and Class E Airspace; Morgantown, WV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace designated as an extension
to a Class D surface area by removing the Notice to Airmen (NOTAM)
part-time status at Morgantown Municipal Airport-Walter L. Bill Hart
Field, Morgantown, WV, and updating the airport's geographic
coordinates. Also, this action updates the geographic coordinates of
the airport listed in Class D airspace, Class E surface area airspace,
and Class E 700 foot airspace. This action enhances the safety and
management of instrument flight rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, October 12, 2017. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of 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
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class D and Class E airspace at Morgantown Municipal
Airport-Walter L. Bill Hart Field, Morgantown, WV, in support of IFR
operations at the airport.

History

    On April 7, 2017, the FAA published in the Federal Register (82 FR
16958) Docket No. FAA-2016-9480, a notice of proposed rulemaking (NPRM)
to amend Class E airspace designated as an extension to a Class D
surface area at Morgantown Municipal Airport-Walter L. Bill Hart Field,
Morgantown, WV, by removing the NOTAM part-time status of the Class E
airspace designated as an extension to a Class D surface area. Also,
the geographic coordinates of the airport would be adjusted in the
associated Class D and E airspace. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    This action also makes an editorial change to the associated Class
D and E airspace legal descriptions removing the words ``(previously
called Airport/Facility Directory). Except for this change, the rule is
the same as published in the NPRM.
    Class D and E airspace designations are published in paragraphs
5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A dated
August 3, 2016, and effective September 15, 2016, which is incorporated
by reference in 14 CFR part 71.1. The Class D and E airspace
designations listed in this document will be published subsequently in
the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E Airspace designated as an extension to a Class D
surface area at Morgantown Municipal Airport-Walter L. Bill Hart Field,
Morgantown, WV, by eliminating the NOTAM information from the
regulatory text that reads, ``This Class E airspace area is effective
during the specific dates and time established in advance by Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.'' This action also amends
Class D airspace, Class E surface area airspace, and Class E airspace
extending upward from 700 feet or more above the surface by updating
the geographic coordinates of the airport to be in concert with the
FAA's aeronautical database.
    Additionally, this action removes the words ``(previously called
Airport/Facility Directory)'' from the associated

Class D and E airspace legal descriptions.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the FAA amends 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 part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 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 FAA Order
7400.11A, Airspace Designations and Reporting Points, dated August 3,
2016, effective September 15, 2016, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AEA WV D Morgantown, WV [Amended]

Morgantown Municipal Airport-Walter L. Bill Hart Field, WV
    (Lat. 39[deg]38'37'' N., long. 79[deg]55'03'' W.)

    That airspace extending upward from the surface to and including
3,700 feet MSL within a 4-mile radius of Morgantown Municipal
Airport-Walter L. Bill Hart Field. This Class D airspace area is
effective during the specific dates and times established in advance
by a Notice to Airmen. The effective date and time will thereafter
be continuously published in the Chart Supplement.

Paragraph 6002 Class E Surface Area Airspace.

* * * * *

AEA WV E2 Morgantown, WV [Amended]

Morgantown Municipal Airport-Walter L. Bill Hart Field, WV
    (Lat. 39[deg]38'37'' N., long. 79[deg]55'03'' W.)

    Within a 4-mile radius of Morgantown Municipal Airport-Walter L.
Bill Hart Field. This Class E airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.

* * * * *

AEA WV E4 Morgantown, WV [Amended]

Morgantown Municipal Airport-Walter L. Bill Hart Field, WV
    (Lat. 39[deg]38'37'' N., long. 79[deg]55'03'' W.)

Morgantown VORTAC
    (Lat. 39[deg]33'24'' N., long. 79[deg]51'37'' W.)

    That airspace extending upward from the surface within 1 mile
either side of the Morgantown VORTAC 332[deg] radial extending from
the 4-mile radius of Morgantown Municipal Airport-Walter L. Bill
Hart Field to the Morgantown VORTAC.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA WV E5 Morgantown, WV [Amended]

Morgantown Municipal Airport-Walter L. Bill Hart Field, WV
    (Lat. 39[deg]38'37'' N., long. 79[deg]55'03'' W.)
Morgantown VORTAC
    (Lat. 39[deg]33'24'' N., long. 79[deg]51'37'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Morgantown Municipal Airport-Walter L.
Bill Hart Field, and within 3 miles each side of the Morgantown
VORTAC 152[deg] radial extending from the 6.5-mile radius to 8.8
miles southeast of the VORTAC, and within 3 miles west of the
Morgantown VORTAC 336[deg] radial clockwise to 3 miles east of
Morgantown Municipal Airport-Walter L. Bill Hart Field north
localizer course extending from the 6.5-mile radius to 15.1 miles
north of the airport.

    Issued in College Park, Georgia, on July 10, 2017.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2017-15286 Filed 7-20-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69887-69889]
[FR Doc No: 2016-24286]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32300; File No. 812-14583]

Legg Mason Global Asset Management Trust, et al.; Notice of
Application

October 3, 2016.
AGENCY:  Securities and Exchange Commission (``Commission'').

ACTION:  Notice of an application for an order pursuant to: (a) Section
6(c) of the Investment Company Act of 1940 (``Act'') granting an
exemption from sections 18(f) and 21(b) of the Act; (b) section
12(d)(1)(J) of the Act granting an exemption from section 12(d)(1) of
the Act; (c) sections 6(c) and 17(b) of the Act granting an exemption
from sections 17(a)(1), 17(a)(2) and 17(a)(3) of the Act; and (d)
section 17(d) of the Act and rule 17d-1 under the Act to permit certain
joint arrangements and transactions. Applicants request an order that
would permit certain registered open-end management investment
companies to participate in a joint lending and borrowing facility.

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Applicants:  Legg Mason Global Asset Management Trust, Legg Mason
Global Asset Management Variable Trust, Legg Mason Partners Income
Trust, Legg Mason Partners Institutional Trust, Legg Mason Partners
Money Market Trust, Legg Mason Partners Premium Money Market Trust,
Legg Mason Partners Variable Income Trust, Master Portfolio Trust, and
Western Asset Funds, Inc., registered under the Act as open-end
management investment companies with one or more series, and Legg Mason
Partners Fund Advisor, LLC (the ``Adviser''), registered as an
investment adviser under the Investment Advisers Act of 1940.

Filing Dates: The application was filed on November 27, 2015, and
amended on May 5, 2016.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request,

personally or by mail. Hearing requests should be received by the
Commission by 5:30 p.m. on October 28, 2016 and should be accompanied
by proof of service on the applicants, in the form of an affidavit, or,
for lawyers, a certificate of service. Pursuant to Rule 0-5 under the
Act, hearing requests should state the nature of the writer's interest,
any facts bearing upon the desirability of a hearing on the matter, the
reason for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES:  Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090; Applicants, c/o: Bryan
Chegwidden, Esq., Rope & Gray LLP, 1211 Avenue of the Americas, New
York, NY 10036, and Robert I. Frenkel, Legg Mason & Co., LLC, 100 First
Stamford Place, Stamford, CT 06902.

FOR FURTHER INFORMATION CONTACT:  Judy T. Lee, Senior Special Counsel,
at<PHONE_NUMBER> or Sara Crovitz, Assistant Chief Counsel, at (202)
551-6720 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:  The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would permit the applicants to
participate in an interfund lending facility where each Fund could lend
money directly to and borrow money directly from other Funds to cover
unanticipated cash shortfalls, such as unanticipated redemptions or
trade fails.\1\ The Funds will not borrow under the facility for
leverage purposes and the loans' duration will be no more than 7
days.\2\
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    \1\ Applicants request that the order apply to the applicants
and to any existing or future registered open-end management
investment company or series thereof for which the Adviser or any
successor thereto or an investment adviser controlling, controlled
by, or under common control with the Adviser or any successor
thereto serves as investment adviser (each a ``Fund'' and
collectively the ``Funds'' and each such investment adviser an
``Adviser''). For purposes of the requested order, ``successor'' is
limited to any entity that results from a reorganization into
another jurisdiction or a change in the type of a business
organization.
    \2\ Any Fund, however, will be able to call a loan on one
business day's notice.
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    2. Applicants anticipate that the proposed facility would provide a
borrowing Fund with a source of liquidity at a rate lower than the bank
borrowing rate at times when the cash position of the Fund is
insufficient to meet temporary cash requirements. In addition, Funds
making short-term cash loans directly to other Funds would earn
interest at a rate higher than they otherwise could obtain from
investing their cash in repurchase agreements or certain other short
term money market instruments. Thus, applicants assert that the
facility would benefit both borrowing and lending Funds.
    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the Application.
Among others, the Adviser, through a designated committee, would
administer the facility as a disinterested fiduciary as part of its
duties under the investment management and administrative agreements
with the Funds and would receive no additional fee as compensation for
its services in connection with the administration of the facility. The
facility would be subject to oversight and certain approvals by the
Funds' Board, including, among others, approval of the interest rate
formula and of the method for allocating loans across Funds, as well as
review of the process in place to evaluate the liquidity implications
for the Funds. A Fund's aggregate outstanding interfund loans will not
exceed 15% of its net assets, and the Fund's loan to any one Fund will
not exceed 5% of the lending Fund's net assets.\3\
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    \3\ Under certain circumstances, a borrowing Fund will be
required to pledge collateral to secure the loan.
---------------------------------------------------------------------------

    4. Applicants assert that the facility does not raise the concerns
underlying section 12(d)(1) of the Act given that the Funds are part of
the same group of investment companies and there will be no duplicative
costs or fees to the Funds.\4\ Applicants also assert that the proposed
transactions do not raise the concerns underlying sections 17(a)(1),
17(a)(3), 17(d) and 21(b) of the Act as the Funds would not engage in
lending transactions that unfairly benefit insiders or are detrimental
to the Funds. Applicants state that the facility will offer both
reduced borrowing costs and enhanced returns on loaned funds to all
participating Funds and each Fund would have an equal opportunity to
borrow and lend on equal terms based on an interest rate formula that
is objective and verifiable. With respect to the relief from section
17(a)(2) of the Act, applicants note that any collateral pledged to
secure an interfund loan would be subject to the same conditions
imposed by any other lender to a Fund that imposes conditions on the
quality of or access to collateral for a borrowing (if the lender is
another Fund) or the same or better conditions (in any other
circumstance).\5\
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    \4\ Applicants state that the obligation to repay an interfund
loan could be deemed to constitute a security for the purposes of
sections 17(a)(1) and 12(d)(1) of the Act.
    \5\ Applicants state that any pledge of securities to secure an
interfund loan could constitute a purchase of securities for
purposes of section 17(a)(2) of the Act.
---------------------------------------------------------------------------

    5. Applicants also believe that the limited relief from section
18(f)(1) of the Act that is necessary to implement the facility
(because the lending Funds are not banks) is appropriate in light of
the conditions and safeguards described in the application and because
the Funds would remain subject to the requirement of section 18(f)(1)
that all borrowings of a Fund, including combined interfund loans and
bank borrowings, have at least 300% asset coverage.
    6. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act. Rule
17d-1(b) under the Act provides that in passing upon an application
filed under the rule, the Commission will consider whether the
participation of the registered investment company in a joint
enterprise, joint arrangement or profit sharing plan on the basis
proposed is consistent with the provisions, policies and purposes of
the Act and the extent to which such

participation is on a basis different from or less advantageous than
that of the other participants.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-24286 Filed 10-6-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14269-14270]
[DOCID:fr27mr07-30]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL05-146-005]

Independent Energy Producers Association v. Independent System
Operator Corporation; Notice of Compliance Filing

March 21, 2007.
    Take notice that on March 15, 2007, The California Independent
System Operator Corporation filed a compliance filing pursuant to the
Commission Order issued on February 13, 2007, 118 FERC ] 61,096.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies

of the protest or intervention to the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 5, 2007.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-5517 Filed 3-26-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6568-6571]
[FR Doc No: 2017-01011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1307]

Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities--Questions and Answers;
Draft Guidance for Industry and Review Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry and review staff
entitled ``Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities--Questions and Answers.''
This draft guidance provides answers to common questions regarding the
communication of health care economic information (HCEI) about approved
prescription drugs by medical product manufacturers, packers,
distributers, and their representatives (firms) to payors, formulary
committees, or other similar entities with knowledge and expertise in
the area of health care economic analysis (collectively referred to as
payors). This draft guidance also provides answers to common questions
about firms' communications regarding investigational drugs and devices
(investigational products) to payors before FDA approval or clearance
of such products. The Agency is issuing this draft guidance to explain
FDA's current thinking on frequently asked questions regarding such
communications in order to provide clarity for firms and payors.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 19, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1307 for ``Drug and Device Manufacturer Communications With
Payors, Formulary Committees, and Similar Entities--Questions and
Answers.'' 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 Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; 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; the
Office of the Center Director, 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. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to this draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Hu Cunningham, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-

796-1200; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Paul Gadiock, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.
66, Rm. 5448, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Kristin
Davis, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32,
Rm. 4252, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and review staff entitled ``Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities--Questions and
Answers.'' This draft guidance provides answers to common questions
regarding firms' communications of HCEI about their approved
prescription drugs to payors. This draft guidance also addresses common
questions relating to firms' dissemination of information about
investigational products to payors before FDA approval or clearance of
such products. For purposes of this draft guidance, the term ``payors''
collectively refers to payors, formulary committees, or other similar
entities with knowledge and expertise in the area of health care
economic analysis that are responsible for making drug selection,
formulary management, and/or coverage and reimbursement decisions on a
population basis regarding drugs and/or devices for health care
organizations, which may include entities such as integrated health
care delivery networks, hospitals, and hospital systems.
    FDA is aware that payors seek a range of information on
effectiveness, safety, and cost-effectiveness of approved drugs,
including information from firms, to help support their drug selection,
formulary management, and/or coverage and reimbursement decisions on a
population basis. This information may differ from and may be in
addition to the information FDA reviews in order to make drug approval
decisions. Because coverage and reimbursement decisions by payors
impact a large number of patients, FDA believes it is essential that
HCEI provided by firms to payors about their approved drugs be truthful
and non-misleading.
    With respect to HCEI regarding approved drugs, section 502(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)), as amended
by section 114 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) and section 3037 of the 21st Century Cures Act
(Pub. L. 114-255), includes a provision regarding communication of HCEI
about such drugs to payors. Section 502(a) indicates that HCEI provided
to payors carrying out their responsibilities for the selection of
drugs for coverage or reimbursement shall not be considered to be false
or misleading if the HCEI relates to an FDA-approved indication for the
drug, is based on competent and reliable scientific evidence, and
includes, where applicable, a conspicuous and prominent statement
describing any material differences between the health care economic
information and the FDA-approved labeling for the drug. Section III.A
of this draft guidance provides FDA's current thinking on key concepts
in section 502(a) and recommendations for how firms can communicate
HCEI about approved drugs to payors in accordance with this section to
help ensure that payors have information needed to make informed drug
selection, formulary management, and/or coverage and reimbursement
decisions and to help ensure that the information is not false or
misleading. Section III.A also discusses how FDA's requirements for
submission of promotional materials apply to HCEI about approved drugs
disseminated by firms to payors. If a firm disseminates HCEI about an
approved drug in accordance with this draft guidance, when finalized,
FDA does not intend to consider such information false or misleading.
In addition, FDA does not intend to use HCEI about approved drugs
disseminated consistent with this draft guidance, when finalized, as
providing evidence of a new intended use.
    FDA also recognizes that due in part to their need, in some
situations, to plan for and make coverage and reimbursement decisions
far in advance of the effective date of such decisions, payors are also
interested in receiving information from drug and device firms about
medical products that are not yet approved or cleared by FDA for any
use (referred to in this draft guidance as investigational products).
Section III.B discusses FDA's thinking with respect to communication by
firms to payors of information about investigational products. As with
HCEI about approved prescription drugs, it is essential that
information provided by firms about their investigational products be
truthful and non-misleading. Therefore, section III.B also lays out a
series of recommendations to help achieve these goals.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a draft guidance for industry entitled ``Medical
Product Communications That Are Consistent With the Food and Drug
Administration-Required Labeling--Questions and Answers.'' The guidance
provides information for medical product firms about how FDA evaluates
their medical product communications, including their promotional
materials, that present information that is not contained in the FDA-
required labeling for the product but that may be consistent with the
FDA-required labeling for the product.
    In addition, FDA is announcing in this issue of the Federal
Register that it is reopening the comment period for the notice of
public hearing that appeared in the Federal Register of September 1,
2016, concerning manufacturer communications regarding unapproved uses
of approved or cleared medical products. The comment period will be
reopened for 90 days, until January 19, 2017. As announced in the
notice of public hearing, FDA is engaged in a comprehensive review of
its regulations and policies governing communications by firms about
unapproved uses of approved or cleared medical products, and the
comments it receives will inform FDA's policy development in this area.
    FDA will consider the feedback it receives in all three of these
dockets as the Agency continues to review its policies on firm
communications about medical products, and interested persons may wish
to review the documents FDA has issued in all three dockets before
submitting comments to any of the relevant dockets.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the current thinking of FDA on certain
commonly asked questions regarding firms' communications with payors.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests

or requirements that members of the public submit reports, keep
records, or provide information to a third party. Section 3506(c)(2)(A)
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to
provide a 60-day notice in the Federal Register concerning each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Drug Manufacturer Communications of Health Care Economic
Information to Payors Under FD&C Act Section 502(a); Drug and Device
Manufacturer Communications With Payors Regarding Investigational
Products.
    Description of Respondents: For information that should be included
when HCEI is disseminated to payors, respondents to this collection of
information are firms that manufacture prescription human drug
products, including biological products; for information that should be
included with communications with payors about investigational
products, respondents to this collection of information are firms that
manufacture prescription human drug products, including biological
products, and medical devices.
    Burden Estimate: This draft guidance includes recommendations
regarding information that firms should include in HCEI for
prescription drugs if they choose to disseminate such materials (``HCEI
materials'') to payors, in accordance with section 502(a).
Specifically, FDA recommends that various aspects of study design and
methodology of an economic analysis (i.e., type of analysis, modeling
technique, patient population, perspective/viewpoint, treatment
comparator, time horizon, outcome measures, cost estimates, and
assumptions); factors that limit generalizability of an economic
analysis; limitations to an economic analysis; and sensitivity
analyses, if applicable, be included in HCEI materials disseminated to
payors to allow for informed decision-making and to help ensure that
the HCEI is not false or misleading.
    Furthermore, FDA recommends that firms include other information
when disseminating HCEI materials, as applicable, to provide a balanced
and complete presentation. Such information includes a statement of the
FDA-approved indication of the drug and a copy of the most current FDA-
approved labeling. Under section 502(a), firms must also include a
conspicuous and prominent statement to describe any material
differences between the HCEI and the FDA-approved labeling. HCEI
materials should also disclose whether certain studies or data sources
were omitted from an economic analysis and how such selective inclusion
of studies or data sources may alter the conclusions presented in the
analysis. Moreover, FDA recommends that HCEI materials disclose
important risk information associated with the approved use of the
drug, and pursuant to section 502(a), must disclose any additional risk
information related to assumptions that vary from the approved
labeling. Finally, HCEI materials should disclose potential financial
or affiliation biases to the extent reasonably known by firms at the
time of dissemination.
    If firms choose to make communications to payors about
investigational products, FDA recommends that firms include a clear
statement with their communications that the product is under
investigation and that the safety or effectiveness of the product has
not been established. In addition, FDA recommends providing information
related to the stage of product development (e.g., the phase of
clinical trial in which a product is being studied and how it relates
to the overall product development plan). Moreover, FDA recommends that
firms provide followup information to payors if previously communicated
information becomes outdated as a result of significant changes or as a
result of new information regarding the product or its review status.
    Based on the post-marketing submissions of promotional materials
using Form FDA 2253 received in calendar year (CY) 2015 for
prescription drugs, FDA estimates that approximately 400 firms will
disseminate 4,000 distinct HCEI materials annually. FDA estimates that
it will take firms approximately 20 hours to compile and draft the
information that this draft guidance recommends should be included if
they choose to disseminate HCEI materials to payors.
    Based on the number of prescription drugs and devices approved/
cleared in CY 2015, FDA estimates that approximately 520 firms will
prepare 1,040 distinct communications of information to payors about
their investigational products annually. FDA estimates that it will
take firms approximately 0.5 hours to compile and draft the information
that this draft guidance recommends should be provided with
communications to payors about investigational products. In addition,
FDA estimates that approximately half of the firms will spend
approximately 2 hours to compile and provide 520 distinct
communications of followup information regarding previously
communicated information to payors about their investigational products
annually.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
               Type of information                  Number of     responses per   Total annual          Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when                400                10         4,000  20........................................        80,000
 firms choose to disseminate HCEI materials to
 payors about prescription drugs under section
 502(a).
Recommended information to be included when                520                 2         1,040  0.5 (30 minutes)..........................           520
 firms choose to disseminate pre-approval
 communications about investigational drugs or
 devices to payors.

Follow up information to payors regarding                  260                 2           520  2.........................................         1,040
 previously communicated information about
 investigational drugs and devices.
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................  ............  ................  ............  ..........................................        81,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 314.81(b)(3)(i) (Form FDA 2253) have been approved under OMB
control number 0910-0001.

III. Other Issues for Consideration

    Although section 502(a) is specific to approved drugs and section
III.A of this draft guidance addresses firms' communications of HCEI to
payors only about approved drugs, FDA is interested in whether similar
principles to those outlined in that section should apply to firms'
communications of HCEI to payors about approved/cleared devices or
whether different principles should be considered. FDA is specifically
interested in identifying principles that, if applied to communications
of HCEI about approved/cleared devices, could help ensure that such
information is truthful and non-misleading and aids payors in making
informed selection and/or coverage and reimbursement decisions about
these products. FDA is interested in comments from interested parties
on any of the topics addressed in this draft guidance and specifically
requests comments from interested parties on the extent to which the
principles provided in section III.A could be applicable to
communications of HCEI about approved/cleared devices. To the extent
that interested parties believe that different considerations should
apply to medical devices or that guidance is needed on additional
issues with respect to medical device firms' communications of HCEI
about approved/cleared medical devices to payors, FDA is interested in
input on those topics as well.
    FDA is also seeking comments from interested parties regarding
communications of HCEI about animal drugs. Although FDA recognizes that
the audience for HCEI about animal drugs may be different from that
identified in section III.A as a result of differences in how payment
decisions are made for animal drugs, FDA is interested in learning the
extent to which the principles provided in section III.A could be
applicable to communications of HCEI about animal drugs with
appropriate audiences for such information. To the extent that
commenters believe that different considerations should apply to animal
drugs or that guidance is needed on additional issues with respect to
animal drug firms' communications of HCEI about approved new animal
drugs to appropriate audiences, FDA is interested in input on those
topics as well.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: January 6, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01011 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 7, 2010 (Volume 75, Number 194)]
[Notices]
[Page 62121-62122]
[DOCID:fr07oc10-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13811-000]

Osprey V, LLC; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

September 30, 2010.
    On July 12, 2010, Osprey V, LLC filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Emery Mills Dam
Project to be located at the Emery Mills Dam, on the Mousam River, in
York County, Maine. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of: (1) The existing 29.3-foot-
high, 210-foot-long Emery Mills Dam; (2) an existing 1,005-acre
impoundment with a normal water surface elevation of 482 feet National
Geodetic Vertical Datum; (3) an existing 8-foot-diameter, 28-foot-long
drainage conduit; (4) a new in-line bulb turbine and generator with an
installed capacity of 450 kilowatts; (5) a new approximately 700-foot-
long, 7.2 or

12.47-kilovolt transmission line; and (6) appurtenant facilities. The
project would have an estimated annual generation of 3,000 megawatt-
hours.
    Applicant Contact: Hoon Won, 275 River Road, P.O. Box 202,
Woolwich, ME 04579;<PHONE_NUMBER>.
    FERC Contact: Brandon Cherry,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-
filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13811) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25254 Filed 10-6-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 23, 2008 (Volume 73, Number 101)]
[Notices]
[Page 30176-30178]
[DOCID:fr23my08-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57831; File No. SR-ISE-2008-39]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change To Amend its Schedule of Fees To Establish Fees for Transactions
in Options on Five Premium Products

May 16, 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 May 9, 2008, International Securities Exchange, LLC (``ISE'' or
the ``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 prepared by ISE. The Exchange has
designated this proposal as one establishing or changing a member due,
fee, or other charge imposed by ISE 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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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

    ISE is proposing to amend its Schedule of Fees to establish fees
for transactions in options on five Premium Products.\5\ The text of
the proposed rule

change is available at http://www.ise.com, the principal offices of the
Exchange, and the Commission's Public Reference Room.
---------------------------------------------------------------------------

    \5\ Premium Products is defined in the Schedule of Fees as the
products enumerated therein.
---------------------------------------------------------------------------

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

    In its filing with the Commission, 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. 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 Exchange is proposing to amend its Schedule of Fees to
establish fees for transactions in options on the CurrencyShares\SM\
Australian Dollar Trust (``FXA''), the CurrencyShares\SM\ British Pound
Sterling Trust (``FXB''), the CurrencyShares\SM\ Euro Trust (``FXE''),
the CurrencyShares\SM\ Japanese Yen Trust (``FXY'') \6\ and the iShares
MSCI Taiwan Index Fund (``EWT'').\7\ The Exchange represents that FXA,
FXB, FXE, FXY and EWT are eligible for options trading because they
constitute ``Exchange-Traded Fund Shares,'' as defined by ISE Rule
502(h).
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    \6\ CurrencyShares\SM\ Australian Dollar Trust,
CurrencyShares\SM\ British Pound Sterling Trust, CurrencyShares\SM\
Euro Trust, and CurrencyShares\SM\ Japanese Yen Trust are service
marks of their respective owner(s). Rydex Distributors, Inc., an
affiliate of Rydex Investments and Rydex Specialized Products, is
the distributor of Rydex funds. Rydex Specialized Products LLC, d/b/
a Rydex Investments (``Rydex''), is the sponsor of the
CurrencyShares\SM\ Australian Dollar Trust (``FXA''), the
CurrencyShares\SM\ British Pound Sterling Trust (``FXB''), the
CurrencyShares\SM\ Euro Trust (``FXE'') and the CurrencyShares\SM\
Japanese Yen Trust (``FXY''). Rydex has not licensed or authorized
ISE to (i) engage in the creation, listing, provision of a market
for trading, marketing, and promotion of options on FXA, FXB, FXE
and FXY or (ii) to use and refer to any trademarks or service marks
in connection with the listing, provision of a market for trading,
marketing, and promotion of options on FXA, FXB, FXE and FXY or with
making disclosures concerning options on FXA, FXB, FXE and FXY under
any applicable federal or state laws, rules or regulations. Rydex
does not sponsor, endorse, or promote such activity by ISE, and is
not affiliated in any manner with ISE.
    \7\ iShares[supreg] is a registered trademark of Barclays Global
Investors, N.A. (``BGI''), a majority owned subsidiary of Barclays
Bank PLC. ``MSCI Taiwan Index'' is a service mark of Morgan Stanley
Capital International (``MSCI'') and has been licensed for use for
certain purposes by BGI. All other trademarks and service marks are
the property of their respective owners. iShares MSCI Taiwan Index
Fund (``EWT'') is not sponsored, endorsed, issued, sold or promoted
by MSCI. BGI and MSCI have not licensed or authorized ISE to (i)
engage in the creation, listing, provision of a market for trading,
marketing, and promotion of options on EWT or (ii) to use and refer
to any of their trademarks or service marks in connection with the
listing, provision of a market for trading, marketing, and promotion
of options on EWT or with making disclosures concerning options on
EWT under any applicable federal or state laws, rules or
regulations. BGI and MSCI do not sponsor, endorse, or promote such
activity by ISE, and are not affiliated in any manner with ISE.
---------------------------------------------------------------------------

    All of the applicable fees covered by this filing are identical to
fees charged by the Exchange for all other Premium Products.
Specifically, the Exchange is proposing to adopt an execution fee and a
comparison fee for all transactions in options on FXA, FXB, FXE, FXY
and EWT.\8\ The amount of the execution fee and comparison fee for
products covered by this filing shall be $0.15 and $0.03 per contract,
respectively, for all Public Customer Orders \9\ and Firm Proprietary
orders. The amount of the execution fee and comparison fee for all ISE
Market Maker transactions shall be equal to the execution fee and
comparison fee currently charged by the Exchange for ISE Market Maker
transactions in equity options.\10\ Finally, the amount of the
execution fee and comparison fee for all non-ISE Market Maker
transactions shall be $0.37 and $0.03 per contract, respectively.\11\
Further, since options on FXA, FXB, FXE, FXY and EWT are multiply-
listed, the Exchange's Payment for Order Flow fee shall apply to all
these products. The Exchange believes the proposed rule change will
further the Exchange's goal of introducing new products to the
marketplace that are competitively priced.
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    \8\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2008, these fees
will also be charged to Linkage Principal Orders (``Linkage P
Orders'') and Linkage Principal Acting as Agent Orders (``Linkage P/
A Orders''). The amount of the execution fee charged by the Exchange
for Linkage P Orders and Linkage P/A Orders is $0.24 per contract
side and $0.15 per contract side, respectively. See Securities
Exchange Act Release No. 56128 (July 24, 2007), 72 FR 42161 (August
1, 2007) (SR-ISE-2007-55).
    \9\ Public Customer Order is defined in Exchange Rule 100(a)(39)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(38) as a person or entity that is
not a broker or dealer in securities.
    \10\ The execution fee is currently between $.21 and $.12 per
contract side, depending on the Exchange Average Daily Volume, and
the comparison fee is currently $.03 per contract side.
    \11\ The amount of the execution and comparison fee for non-ISE
Market Maker transactions executed in the Exchange's Facilitation
and Solicitation Mechanisms is $0.16 and $0.03 per contract,
respectively.
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    Further, the Exchange proposes to remove IXK from its Schedule of
Fees.\12\
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    \12\ This Premium Product was recently delisted and no longer
trades on the Exchange. Thus, the Exchange proposes to remove it
from its fee schedule.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of section 6 of the Act,\13\ in general, and
furthers the objectives of section 6(b)(4),\14\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 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 proposed rule change has been designated as a fee
change pursuant to section 19(b)(3)(A)(ii) of the Act \15\ and Rule
19b-4(f)(2) \16\ thereunder, because it establishes or changes a due,
fee, or other charge imposed on members by ISE. Accordingly, the
proposal is effective upon filing with the Commission. At any time
within 60 days of the filing of the 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.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-ISE-2008-39 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-ISE-2008-39. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-ISE-2008-39 and should be
submitted on or before June 13, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-11523 Filed 5-22-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: February 13, 2009 (Volume 74, Number 29)]
[Notices]
[Page 7238-7239]
[DOCID:fr13fe09-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). The
meeting will be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 19, 2009, from 8
a.m. to 5 p.m.
    Location: Marriott Conference Centers, UMUC Inn and Conference
Center by Marriott, 3501 University Blvd., East, Adelphi, MD. The hotel
telephone number is<PHONE_NUMBER>.
    Contact Person: Elaine Ferguson, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512533. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 22-
406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson
Pharmaceutical Research & Development, L.L.C., for the proposed
indication for use in prophylaxis of deep vein thrombosis and pulmonary
embolism in patients undergoing hip replacement surgery or knee
replacement surgery.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 5, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before February 25, 2009. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine

the speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by February 26, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Elaine Ferguson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 4, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-3089 Filed 2-12-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Notices]
[Page 20394]
[FR Doc No: 2021-07946]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4584-DR; Docket ID FEMA-2021-0001]

Washington; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Washington (FEMA-4584-DR), dated February 4, 2021, and
related determinations.

DATES: This amendment was issued March 19, 2021.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Washington is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of February 4, 2021.

Ferry County for Public Assistance.

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

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07946 Filed 4-16-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 62 (Thursday, March 31, 2022)]
[Notices]
[Page 18785]
[FR Doc No: 2022-06785]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-1442-000]

EdSan 1B Group 3, 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
EdSan 1B Group 3, 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 April 14, 2022.
    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://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. 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 protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: March 25, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-06785 Filed 3-30-22; 8:45 am]
BILLING CODE 6717-01-P