[Federal Register: May 1, 2007 (Volume 72, Number 83)]
[Notices]
[Page 23866-23867]
[DOCID:fr01my07-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55663; File No. SR-Amex-2007-39]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Add Additional Exceptions to Rule 126A-AEMI Relating to the Generation
of Intermarket Sweep Orders

April 24, 2007.
    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 April 20, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. Amex has filed this proposal pursuant to Section 19(b)(3)(A)
of the Act \3\ and Rule 19b-4(f)(5) thereunder,\4\ which renders it
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(5).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Amex proposes to adopt changes to Rule 126A--AEMI in order to fully
conform the list of circumstances described therein with additional
exceptions (a) Listed in Rule 611(b) of Regulation NMS \5\ or (b)
separately granted by the Commission pursuant to exemptive orders
issued pursuant to Rule 611(d) of Regulation NMS.\6\ The following
resultant changes to Rule 126A--AEMI are proposed: (i) Addition of the
``stopped order'' exception specified under Rule 611(b)(9) of
Regulation NMS; \7\ (ii) addition of an exception for ``qualified
contingent trades''; \8\ and (iii) addition of an exception for certain
``sub-penny trade-throughs.'' \9\
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    \5\ 17 CFR 242.611(b).
    \6\ 17 CFR 242.611(d).
    \7\ 17 CFR 242.611(b).
    \8\ See Securities Exchange Act Release No. 54389 (August 31,
2006), 71 FR 52829 (September 7, 2006).
    \9\ See Securities Exchange Act Release No. 54678 (October 31,
2006), 71 FR 65018 (November 6, 2006).
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    The text of the proposed rule change is available on Amex's Web
site at http://www.amex.com, at the Exchange's principal office, and at

the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange is currently operating, and has adopted rules in
connection with the operation of, its new hybrid market trading
platform for equity products and exchange traded funds, designated as
AEMISM (the Auction and Electronic Market Integration
platform). Rule 126A--AEMI is the Exchange's effectuation of Rule 611
of Regulation NMS (``Order Protection Rule''), whereby trading centers
are required to ``establish, maintain, and enforce written policies and
procedures that are reasonably designed to prevent trade-throughs on
that trading center of protected quotations in NMS stocks,'' subject to
certain exceptions. Rule 126A--AEMI, in relevant part, currently
requires AEMI to generate an intermarket sweep order to any away market
displaying a protected quotation simultaneously with the execution of a
transaction on the Amex that would constitute a trade-through, except
when one or more of eight circumstances--all contemplated in Rule 611
of Regulation NMS \10\--exist.
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    \10\ 17 CFR 242.611(b).
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    The current proposed changes are intended to expand the list of
exceptional circumstances in Rule 126A--AEMI to include: (i) An
additional exception from Rule 611(b)(9) of Regulation NMS \11\
pertaining to certain ``stopped orders'' for which the Amex had, at the
time of receipt of the order, guaranteed an execution at no worse than
a specified price; \12\ (ii) an additional exception for ``qualified
contingent trades''; \13\ and (iii) an additional exception for certain
``sub-penny trade-throughs.''\14\
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    \11\ 17 CFR 242.611(b)(9).
    \12\ Although Rule 109--AEMI prohibits granting or accepting a
stop with respect to a security traded in AEMI, this exemption may
still be applicable in certain situations such as error corrections.
    \13\ See Securities Exchange Act Release No. 54389 (August 31,
2006), 71 FR 52829 (September 7, 2006).
    \14\ See Securities Exchange Act Release No. 54678 (October 31,
2006), 71 FR 65018 (November 6, 2006).
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    The Exchange asserts that the proposal to effect the foregoing
changes to the AEMI trading system does not significantly affect the
protection of investors or the public interest, does not impose any
significant burden on competition, and does not have the effect of
limiting the access to or availability of the system.

2. Statutory Basis
    The proposed rule change is designed to be consistent with
Regulation NMS, as well as consistent with Section 6(b) of the Act,\15\
in general, and furthers the objectives of Section 6(b)(5)
thereunder,\16\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and national market system and, in
general, to protect investors and the public interest.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change will impose no burden on competition that
is not necessary or appropriate in furtherance of the purposes of the
Act.

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

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

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

    Because the proposed rule change does not: (1) Significantly affect
the protection of investors or the public interest; (2) impose any
significant burden on competition; and (3) have the effect of limiting
the access to or availability of an existing order entry or trading
system of the Exchange, the foregoing rule change has become effective
immediately pursuant to Section 19(b)(3)(A)(iii) of the Act \17\ and
Rule 19b-4(f)(5) thereunder.\18\ At any time within 60 days of the
filing of such proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in the furtherance of the
purposes of the Act.
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    \17\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \18\ 17 CFR 240.19b-4(f)(5).
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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 at http://www.sec.gov/rules/sro.shtml.
; or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-Amex-2007-39 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 No. SR-Amex-2007-39. 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. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File No. SR-Amex-2007-39 and should be submitted on or before May 22,
2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-8225 Filed 4-30-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: May 2, 2007 (Volume 72, Number 84)]
[Notices]
[Page 24341-24343]
[DOCID:fr02my07-107]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27804; 812-13255]

Hill Physicians Medical Group, Inc.; Notice of Application

April 26, 2007.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTIONS: Notice of application for an order under section 3(b)(2), or,
alternatively, under section 6(c) of the Investment Company Act of 1940
(the ``Act'').

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Applicant: Hill Physicians Medical Group, Inc. (``Hill Physicians'').
    Summary of Application: Applicant seeks an order under section
3(b)(2) of the Act declaring it to be primarily engaged in a business
other than that of investing, reinvesting, owning, holding or trading
in securities or, alternatively, under section 6(c) of the Act granting
it an exemption from all provisions of the Act and the rules and
regulations thereunder. Applicant is in the business of providing or
arranging to provide physician services in Northern California to
individual enrollee members of various health plans, including health
maintenance organizations (``HMOs'') and other third party payors
(collectively, ``Health Plans'').

DATES: Filing Dates: The application was filed on January 18, 2006, and
amended on January 29, 2007.

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 applicant with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on May 21, 2007, and should be accompanied by proof of
service on applicant, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, 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, Securities and Exchange Commission, 100 F Street,
NE, Washington, DC 20549-1090. Applicant, c/o Paul A. Stewart, Esq.,
Foley and Lardner LLP, One Maritime Plaza, 6th Floor, San Francisco, CA
94111.

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, at
(202) 551-6811, or Janet M. Grossnickle, Branch Chief, at (202) 551-
6821 (Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Branch, 100 F Street, NE, Washington, DC,
20549-0102 (tel.<PHONE_NUMBER>).

Applicant's Representations

    1. Formed in 1983, Hill Physicians is a physician's independent
practice association organized as a California for-profit private
professional medical corporation. Applicant represents that its shares
can only be held by medical Providers (as defined below) and that the
shares confer procedural rights to the Providers that hold them, not
economic rights.\1\ There is no trading market for Hill Physicians'
stock. The non-transferable shares may only be sold to and redeemed by
Hill Physicians at a price not to exceed the original issuance price of
the share. Applicant further states that no dividends have ever been
paid on its shares and none are expected to be paid.
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    \1\ Hill Physicians only has one class of stock. Each
shareholder Provider may hold only one share of Hill Physicians'
stock.
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    2. Hill Physicians provides or arranges to provide physician
services through California licensed practicing physicians
(``Providers'') to members of Health Plans in northern California.
Applicant states that these services are provided pursuant to a written
contract with each Health Plan. Under each contract, Hill Physicians is
obligated to provide the covered physician services that individual
enrollee members of a Health Plan may later need. Hill Physicians is
paid by the Health Plans on a fixed fee or ``capitated'' basis, meaning
that Hill Physicians is paid monthly in advance a flat per member fee
for each Health Plan member assigned to Hill Physicians. The capitation
rates are set in advance, typically for two-year periods, and the
payment covers all physician and certain ancillary services that any or
all of the Health Plan members may need. The Providers, each of whom
has signed substantially identical independent contractor agreements
with Hill Physicians, provide the services at their individual offices.
The Providers then send bills for payment to Hill Physicians, rather
than the Health Plans. Hill Physicians pays the Providers mostly on a
fee for service, not capitated, basis, as and when Provider bills are
submitted to it.
    3. This payment structure means that Hill Physicians bears the
economic risk

that its payments to Providers for medical services will exceed the
fixed amounts it receives from the Health Plans. Applicant states that
it maintains a substantial amount of invested reserves, including
investment securities, to manage this risk. Applicant further states
that the accumulation of cash and investments is an inherent part of
its business structure because of the regularity of the capitation
payments it receives and the delayed and uncertain amount of the
payments it makes to Providers. Applicant also represents that it
maintains its investment portfolio to meet California regulatory
requirements.
    4. Applicant states that it is registered with, and subject to
regulatory oversight by, the Medical Board of California. Applicant
states that it is a ``risk bearing organization'' within the meaning of
the California Health and Safety Code and it is subject to regulation
of its solvency by California's Department of Managed Healthcare.
Applicant also states that it is required by law, regulation and
governmental policy to maintain positive levels of working capital and
tangible net equity.

Applicant's Legal Analysis

    1. Section 3(a)(1)(A) of the Act defines the term ``investment
company'' to include an issuer that is or holds itself out as being
engaged primarily, or proposes to engage primarily, in the business of
investing, reinvesting or trading in securities. Section 3(a)(1)(C) of
the Act further defines an investment company as an issuer that is
engaged or proposes to engage in the business of investing,
reinvesting, owning, holding or trading in securities, and owns or
proposes to acquire investment securities having a value in excess of
40 percent of the value of the issuer's total assets (exclusive of
Government securities and cash items) on an unconsolidated basis.
Applicant states that it has not held itself out as being engaged
primarily in the business of investing, reinvesting or trading in
securities within the meaning of section 3(a)(1)(A) of the Act.
Applicant states that it would fall within the definition of investment
company under section 3(a)(1)(C) of the Act because more than 40
percent of its total assets consist of investment securities as defined
in section 3(a)(2) of the Act.
    2. Rule 3a-1 under the Act provides an exemption from the
definition of investment company if no more than 45 percent of a
company's total assets consist of, and not more than 45 percent of its
net income over the last four quarters is derived from, securities
other than Government securities and securities of majority-owned
subsidiaries and companies primarily controlled by it. Applicant states
that it has not been able to rely on rule 3a-1 because its securities
comprise a large percentage of its total assets.
    3. Section 3(b)(2) of the Act provides that, notwithstanding
section 3(a)(1)(C), the Commission may issue an order declaring an
issuer to be primarily engaged in a business other than that of
investing, reinvesting, owning, holding or trading in securities
directly, through majority-owned subsidiaries, or controlled companies
conducting similar types of businesses. Applicant requests an order
under section 3(b)(2) of the Act declaring that it is primarily engaged
in a business other than that of investing, reinvesting, owning,
holding or trading in securities, and therefore is not an investment
company as defined in the Act. In determining whether an issuer is
``primarily engaged'' in a non-investment company business under
section 3(b)(2), the Commission considers the following factors: (a)
The company's historical development, (b) its public representations of
policy, (c) the activities of its officers and directors, (d) the
nature of its present assets (the ``Asset Factor''), and (e) the
sources of its present income (the ``Income Factor'').\2\
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    \2\ Tonopah Mining Company of Nevada, 26 SEC 426, 427 (1947).
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    4. Recently, the Commission set forth its belief that it is
appropriate for HMOs to determine whether they are primarily engaged in
a non-investment business for purposes of section 3(b)(2) without
considering the Asset Factor provided that they met certain
conditions.\3\ Generally, the Commission indicated that the Asset
Factor need not be considered by an HMO that (a) provides or arranges
for the provision of health care services to subscribers or enrollees
of the HMO; (b) is licensed under the laws of a state as a health care
service plan, a health care service contractor, a health maintenance
organization or a similar health plan company, and is subject to
supervision by the insurance commissioner or a similar official; (c)
allocates, manages and uses its investment securities in a manner
consistent with its business as an HMO and in accordance with an
investment policy adopted by its board of directors; and (d) bears a
substantial amount of the risk that covered health care costs of the
subscribers or enrollees of its health care products will differ from
the prepaid or periodic charges paid by or on behalf of such persons
(``underwriting risk''). In connection with the Income Factor, the
Commission also clarified that an HMO may consider the sources of its
present revenues so long as it derives substantially all of its total
revenues from health care operations.
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    \3\ PacifiCare of Arizona, Inc. et al., Investment Company Act
Rel. Nos. 26643 (Oct. 25, 2004) (notice) and 26679 (Nov. 22, 2004)
(order).
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    5. Applicant submits that it satisfies the criteria for the
issuance of an order under section 3(b)(2) because the facts show that
Hill Physicians is primarily engaged in providing physician and related
health care services, and not in the business of investing,
reinvesting, owning, holding or trading in securities.

a. Historical Development

    Applicant states that it was formed in 1983 as an independent
practice association for the express purpose of providing or arranging
to provide physician services and that all of its activities since
formation have been devoted to this purpose. Applicant also states that
it intends to continue to be primarily engaged in the business of
providing physician and related health care services.

b. Public Representations of Policy

    Applicant states that all of the annual reports, internet postings,
press releases and written communications it has issued have related to
its business of providing physician services. Applicant also states
that it has never held itself out as an investment company within the
meaning of the Act and has never made any public representations that
would indicate that it is in any business other than providing or
arranging to provide physician services. Applicant represents that it
has not issued any press release, advertising, promotional piece or
other communication concerning its holdings of investment securities or
its capital investment policies, or concerning any potential for profit
or appreciation in value relating to its own shares.

c. Activities of Officers and Directors

    Applicant represents that neither the directors nor the officers of
Hill Physicians devote any significant part of their time to Hill
Physicians' investment process. Applicant states that the members of
its board of directors (``Board'') are all practicing physicians and
were part of its physician network prior to serving on the Board.
Applicant states that all of its directors and officers devote
substantially all of their time spent on Hill Physicians matters on its
business of providing or arranging to provide physician services.
Applicant estimates that the Board and its executive committee spends

approximately 20% of its time on each of strategy, operations,
membership and quality improvement, 15% of its time on education,
technology and all other topics and 5% of its time on finance,
including less than 1% on investment matters. The Board's involvement
with respect to the investment portfolio consists of adopting an
investment policy and reviewing periodic reports from its unaffiliated
investment adviser and broker. Only three out of approximately 420
employees devote a de minimis amount of time to supporting Hill
Physicians' investment process.\4\
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    \4\ Hill Physicians itself has no employees. Its management team
and substantially all management services it requires are provided
by a management company, PriMed Management Consulting Services, Inc.
(``PriMed''). PriMed is compensated on the basis of cost plus
incentives related to revenue growth, operating results and
administrative efficiency and its compensation is not affected by
the performance or value of Hill Physicians' investment securities.
PriMed is owned by Hill Physicians, Catholic Healthcare West and the
individuals who serve as Hill Physicians' chief executive officer
and chief operating officer.
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d. Nature of Assets

    Applicant states that it owns no fixed assets and has a relatively
small asset base because it is a service organization whose workforce
consists solely of independent contractor physicians working out of
their own offices. Further, Applicant maintains a substantial amount of
liquid assets, including investment securities, to: (a) Manage the risk
that the aggregate capitated payments it receives from Health Plans
will not adequately cover the actual amounts paid to Providers for
services rendered; (b) ensure its ability to make timely payments
during months when Hill Physicians' payment obligations to Providers
for their services significantly exceed its month capitation revenue;
(c) meet the statutory or regulatory requirements with respect to its
cash-to-claims ratio, working capital and tangible net equity; and (d)
cover its payment obligations to Providers and its operating expenses.
Accordingly, Hill Physicians' cash, investment securities and accounts
receivable comprised 83.2% of its total assets as of September 30,
2006, and it owned investment securities on that date representing
approximately 65.9% of its total assets excluding Government securities
and cash items. Applicant does not invest or trade in securities for
speculative purposes.

e. Sources of Income

    Applicant states that 49% of its total income for the four fiscal
quarters ended September 30, 2006 combined was derived from investment
securities. Applicant states that this percentage is much higher than
historical levels because of a non-recurring investment gain
transaction and the realization of accumulated gains when a new
investment advisor adjusted the portfolio, selling most of the
marketable securities. Hill Physicians anticipates that approximately
35% of its net income after taxes will be derived from investment
securities in the future as it retains earnings for the purpose of
providing operating capital and accumulates resources to strengthen
infrastructure, e.g., implementing electronic medical records and
practice management systems in Providers' offices.
    Applicant believes, however, that its sources of revenue are more
representative of its activity as an operating company than its sources
of income. Applicant states that income generation is not integral to
its business because it, as an independent medical practice
association, essentially acts as a ``cooperative'' for the benefit of
the Providers. Applicant asserts that independent practice associations
try to maximize the revenues they receive and fairly distribute them to
the participating medical service providers. If Hill Physicians chooses
not to retain earnings (and in years when it sustained operating
losses), earnings from investment securities could represent all of its
total income. Applicant states that revenues from the provision of
physicians' services have always represented over 99 percent of its
gross revenue, while revenues from investments constituted the
remaining less than one percent. Applicant does not expect that the
percentage of its total revenue derived from investment securities
would ever represent other than an insignificant part of its total
revenues.
    6. As discussed more fully in the application, Applicant believes
that it shares with HMOs the characteristics necessary to permit a
determination of its primary business without regard to the nature of
its assets. Hill Physicians provides or arranges to provide health care
services to enrollees of Health Plans in return for capitation
payments. While not licensed under state law as a health care service
plan, health care service contractor, HMO or similar health plan
company, Hill Physicians is subject to similar regulation by the
California agency that regulates Health Plans and by the Medical Board
of California. Hill Physicians allocates, manages and uses its
investment securities in a manner consistent with its business of
providing or arranging to provide physician services to members of
Health Plans, and its Board has approved its investment policies.
Applicant further argues that it meets the last condition because it
bears the entire underwriting risk for payments to Providers, none of
which is transferred to, or shared with, a third party under any
contracts or other arrangements. Accordingly, Applicant submits that
its primary business for purposes of section 3(b)(2) of the Act should
be determined without considering the nature of its assets.
    7. Applicant asserts that its sources of revenues, its historical
development, its public representations of policy and the activities of
its officers and directors, as discussed in the application,
demonstrate that it is engaged primarily in a health care, and not in
an investment, business, and thus satisfies the criteria for issuing an
order under section 3(b)(2) of the Act.
    8. In the alternative to exemptive relief under section 3(b)(2),
Hill Physicians requests an order under section 6(c) of the Act
exempting it from all provisions of the Act.\5\ Applicant states that
it has no public shareholders since it is privately held by its
shareholder physicians and there is no trading market in its
nontransferable shares. Applicant further states that there is no
financial gain incentive associated with ownership of its shares.
Furthermore, applicant believes that it is not the type of company the
Act was designed to regulate and that compliance with the Act would be
unnecessary, expensive and incompatible with its primary business of
delivering health care. Consequently, Hill Physicians submits that the
requested exemption is necessary and appropriate in the public
interest, is consistent with the protection of investors, and is
consistent with the purposes of the Act.
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    \5\ Section 6(c) provides, in relevant part, that the Commission
may issue a conditional or unconditional exemption from any
provisions of the Act or rule thereunder if the exemption is
``necessary or appropriate in the public interest'' and is
``consistent with the protection of investors and the purposes
fairly intended by the policy and provisions of [the Act].''

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-8353 Filed 5-1-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: July 23, 2009 (Volume 74, Number 140)]
[Notices]
[Page 36482]
[DOCID:fr23jy09-31]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6885-009-CA]

Cinnamon Ranch Hydroelectric Project; Notice of Availability of
Environmental Assessment

July 16, 2009.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR part
380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has
reviewed the application for a subsequent license for the Cinnamon
Ranch Hydroelectric Project, and has prepared an Environmental
Assessment. The operating project is located on Pellisier Creek, Middle
Creek, and Birch Creek, in the Hammil Valley area of Mono County, near
the Town of Benton, California. The project occupies 0.13 acre of U.S.
Forest Service lands within the Inyo National Forest and 7.53 acres of
lands administered by the Bureau of Land Management.
    The EA contains the staff's analysis of the potential environmental
impacts of the project and concludes that relicensing the project would
not constitute a major Federal action that would significantly affect
the quality of the human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,
(202) 502-8659.
    You may also register online at http://www.ferc.gov/
esubscribenow.htm to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support at<EMAIL_ADDRESS>or toll-free
at 1-866-208-3676, or for TTY,<PHONE_NUMBER>.
    Please contact Gaylord Hoisington by telephone at<PHONE_NUMBER> or
by e-mail at<EMAIL_ADDRESS>if you have any questions.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-17506 Filed 7-22-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12692-12696]
[FR Doc No: 2021-04472]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1228]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Multiple
Indications in Direct-to-Consumer Television Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by April 5, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Study of Multiple Indications in Direct-to-
Consumer Television Advertisements.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Study of Multiple Indications in Direct-to-Consumer Television
Advertisements

OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health.
    Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that are most
central to our mission, focusing in particular on three main topic
areas: (1) Advertising features, including content and format; (2)
target populations; and (3) research quality. Through the evaluation of
advertising features, we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and

understanding of prescription drug risks and benefits. Focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience, and our focus on research quality aims at maximizing the
quality of research data through analytical methodology development and
investigation of sampling and response issues. This study will inform
the first topic area, advertising features, including content and
format.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The
website includes links to the latest Federal Register notices and peer-
reviewed publications produced by our office. The website maintains
information on studies we have conducted, dating back to a direct-to-
consumer (DTC) survey conducted in 1999.
    A number of prescription drugs are approved for multiple
indications. These indications can be similar in certain respects
(e.g., diabetic peripheral neuropathy and fibromyalgia, which are both
conditions that manifest in pain) or very different from one another
(e.g., diabetic peripheral neuropathy and generalized anxiety
disorder). If a drug is approved for multiple indications, sponsors
choose whether to promote only one of those indications in DTC
television advertising, or multiple indications in the same television
advertisement. We are unaware of any quantitative research that
addresses how presenting multiple indications in one advertisement
affects consumers' processing of drug information. Some research
suggests that presenting more than one indication in a television
advertisement, regardless of the similarity of the indications, may
increase the cognitive load on consumers, thus decreasing their
understanding of the drug's indications (Refs. 1-3).
    When more than one indication is presented, the similarity or
dissimilarity of the indications may affect participants' ability to
remember and understand the indications. If this is the case, it is not
clear whether similarity would have a positive or negative effect in
the multimodal context of a television advertisement (e.g., Refs. 4 and
5).
    This study will provide preliminary information on whether
consumers face challenges when multiple indications are promoted in a
single television advertisement. The study also will explore whether
similarity of the indications affects participants' likelihood to
recall and understand the indications, and whether its effect would be
positive or negative.
    We propose to test three types of fictional DTC television
advertisements--one that promotes a single indication, one that
promotes an indication plus a similar indication, and one that promotes
an indication plus a dissimilar indication--in two different medical
conditions (table 1).

              Table 1--Study Design: 1 x 3 Factorial Experiment Repeated in Two Medical Conditions
----------------------------------------------------------------------------------------------------------------
                                                                    Indication 1 plus a     Indication 1 plus a
                                             Indication 1           similar indication    dissimilar  indication
----------------------------------------------------------------------------------------------------------------
Study 1: Diabetic peripheral          DPN.......................  DPN + fibromyalgia....  DPN + generalized
 neuropathy (DPN).                                                                         anxiety disorder.
Study 2: Rheumatoid arthritis (RA)..  RA........................  RA + psoriatic          RA + ulcerative
                                                                   arthritis.              colitis.
----------------------------------------------------------------------------------------------------------------

    We plan to conduct two pretests (one for each main study) and two
main studies not longer than 20 minutes, administered via internet
panel, to test the experimental manipulations and pilot the main study
procedures. Participants will be randomly assigned to view one study
advertisement and then complete a questionnaire that assesses recall
and comprehension of the drug's benefits and risks, benefit and risk
perceptions, attitudes, and behavioral intentions. We will also measure
covariates such as demographics and health literacy. Taking into
account prior research, it is our hypothesis that participants will be
more likely to correctly recall and understand the first indication
when it is presented alone, compared with when it is presented with a
second (similar or dissimilar) indication. We will explore whether
similarity of the indications affects participants' likelihood to
recall and understand the indications. We will also explore the effects
of the indication presentation on benefit and risk perceptions,
attitudes toward the drug and the indication information, and
intentions to look for more information and ask a doctor about the
drug.
    For all phases of this research, we will recruit adult volunteers
18 years of age or older. For Pretest 1 and Study 1, we will recruit
participants who self-report being diagnosed with diabetes (N = 60 in
Pretest 1 and N = 402 in Study 1). For Pretest 2 and Study 2, we will
recruit participants who self-report being diagnosed with rheumatoid
arthritis (N = 60 in Pretest 2 and N = 402 in Study 2). We will exclude
individuals who work for the Department of Health and Human Services or
work in the healthcare, marketing, or pharmaceutical industries. We
will also exclude pretest participants from the main studies, and
participants will not be able to participate in both Studies 1 and 2.
With these sample sizes, we will have sufficient power to detect small-
sized effects in Studies 1 and 2. For the burden estimate, we include
an additional 10% over our target number of valid completes to account
for some overage.
    In the Federal Register of July 6, 2020 (85 FR 40296), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four comments that were PRA-
related.
    Within the four submissions, FDA received multiple comments that
the Agency has addressed below. For brevity, some public comments are
paraphrased and therefore may not reflect the exact language used by
the commenter. We assure commenters that the entirety of their comments
was considered even if not fully captured by our paraphrasing in this
document.
    (Comment) One comment suggested several ideas for other study
designs, including: (1) Studying consumer reactions to actual
advertisement campaigns; (2) studying consumer reactions to watching a
DTC television advertisement and then viewing a related website; and
(3) studying advertisements for multiple indications with different
risk profiles. Another comment suggested another study idea:

Studying a drug with multiple indications for the same disease.
    (Response) We appreciate these alternate study ideas. As this is
the first study on this topic, we acknowledge our study cannot answer
every research question. We believe these alternate study ideas could
be candidates for future research, and we encourage stakeholders to
conduct research in this area.
    (Comment) One comment recommended using Crohn's or ulcerative
colitis rather than leukemia as the dissimilar indication in Study 2 to
avoid confusion with adverse effects of common RA medications.
    (Response) Based on this comment, we plan to use ulcerative colitis
rather than leukemia as the dissimilar indication in Study 2.
    (Comment) Three comments noted that care should be taken to reduce
confounding variables in the study stimuli in terms of length, order
and presentation of indications, background and actor profiles,
advertisement quality, and audio and visual effects.
    (Response) We can confirm that care has been taken to ensure that
we do not have any unintentional confounds across the study conditions.
The advertisements use the same actors, scenes, audio and visual
effects and all other design and content features to ensure that all
elements are consistent across experimental conditions. We also used
the same setting, actors, and advertisement concept across Study 1 and
Study 2 to minimize differences across the two studies. The only aspect
that will change is the manipulated content (i.e., script and
superimposed text relaying the indications).
    (Comment) One comment requested that we clarify how we are defining
similar versus dissimilar indications.
    (Response) The similar indications have similar clinical
manifestations: In Study 1, nerve-related pain for diabetic peripheral
neuropathy and fibromyalgia, and in Study 2, joint pain for rheumatoid
arthritis and psoriatic arthritis. The dissimilar indications have
dissimilar clinical manifestations: In Study 1, nerve-related pain for
diabetic peripheral neuropathy and anxiety for generalized anxiety
disorder, and in Study 2, joint pain for rheumatoid arthritis and
abdominal pain and diarrhea for ulcerative colitis.
    (Comment) One comment recommended stratification across conditions
for demographics and several health characteristics.
    (Response) Typically, stratified randomization is used if there are
prognostic variables that correlate with outcome measures and
researchers are concerned about such factors not being evenly
distributed across groups (Ref. 6). We have no reason to expect that
the aforementioned factors would have a strong association with the
outcome measures, nor do we have reason to believe that we will not
achieve adequate balance of prognostic variables given the large sample
size proposed for this study (Ref. 6). Random assignment will help to
produce groups which are, on average, probabilistically similar to each
other. Because randomization eliminates most other sources of
systematic variation, we can be reasonably confident that any effect
that is found is the result of the intervention and not some
preexisting differences between the groups (Ref. 7). However, we have
included questions about demographics and health characteristics, which
will enable us to assess their association with our outcomes and
statistically control for them if necessary.
    (Comment) One comment noted that the sample size per cell should be
at least 75 participants.
    (Response) We conducted power analyses to determine sample size. We
plan to have 134 participants per cell in each study, for a total of
402 participants per study.
    (Comment) One comment noted that recruiting participants with only
the primary indication could bias results because participants will be
more familiar with their own medical condition. Instead, it suggested
that for each study condition we recruit a sample that matches that
study condition (e.g., recruiting participants with diabetic peripheral
neuropathy or fibromyalgia for the second study condition in Study 1).
    (Response) We agree that participants may know more about their own
medical condition than the other medical conditions advertised.
However, we believe the alternate design offered in the comment would
make results difficult to interpret as it would be unclear whether
differences were due to the advertisement manipulations or to the
different samples. Instead, we plan to keep the original design. We do
not plan to compare participants' recall, recognition, or comprehension
of the primary indication to the second indication (which may lead to
the bias noted in the comment). Rather, we plan to compare
understanding across the experimental conditions. For instance, we are
testing the hypothesis that participants (with diabetes in Study 1 and
rheumatoid arthritis in Study 2) who see the first indication alone
will be more likely to recall, recognize, and comprehend the first
indication compared with participants (with diabetes in Study 1 and
rheumatoid arthritis in Study 2) who see the first indication and a
second (similar or dissimilar) indication. As another example, we would
expect that recall, recognition, and comprehension of the second
indication would be higher when the second indication is mentioned in
the advertisement compared with when it is not (e.g., participants are
more likely to know the drug is also indicated for fibromyalgia when
the advertisement mentions the fibromyalgia indication). We will
measure participants' familiarity with treatments for each medical
condition and assess whether they have been diagnosed with each medical
condition. We can use these variables to explore differences among
participants. A future study could examine how individuals suffering
from fibromyalgia or generalized anxiety, or from psoriatic arthritis
or ulcerative colitis (which are secondary indications in the current
study) may interpret these advertisements.
    (Comment) One comment suggested recruiting participants with
diabetic peripheral neuropathy specifically rather than diabetes in
Study 1, while another comment noted that diabetic peripheral
neuropathy is underdiagnosed and therefore may present recruitment
challenges.
    (Response) We plan to retain the diabetes sample for Study 1 to aid
recruitment. We will ask participants if they experience diabetes-
related pain and whether they have been diagnosed with diabetic
peripheral neuropathy.
    (Comment) One comment noted concern about the chosen indications
because medical conditions can differ from one another in several ways
(e.g., prevalence, treatment options) and suggested considering public
awareness of the medical conditions.
    (Response) We agree that medical conditions vary; this is
unavoidable in a study of this kind. To account for this, we plan to
conduct two studies using different medical conditions to determine
whether the effects replicate across studies. We will measure
participants' familiarity with treatments for the medical conditions in
each study.
    (Comment) One comment suggested asking participants if they were
familiar with the fictitious drug and terminating participants who say
yes.
    (Response) It is unlikely that many participants will claim to be
familiar with the fictional brand name. However, past research has
noted the human tendency to falsely recognize content

(Ref. 8). While theoretically interesting, the fact that people may
falsely recognize our brand should not threaten the internal validity
of the current study. Random assignment should guard against systematic
differences among groups in terms of false recognition tendency.
Nonetheless, we appreciate this concern and in response, we have added
a question to the survey to measure familiarity with the brand, which
we can then explore in auxiliary analyses, but we do not think
participants with false brand familiarity should be removed from the
study. Our study sample includes those with rheumatoid arthritis for
one of the studies (a condition with lower prevalence in the United
States, about 0.6 percent of the population). Excluding those with
false recognition would impose additional burden on recruitment.
    (Comment) One comment suggested that the questionnaire should
include the statement ``Based on the ad you just saw . . .'' before
each question.
    (Response) We include this statement and similar language
throughout the questionnaire.
    (Comment) One comment suggested we measure unaided awareness of the
indications, aided awareness of the indications, likelihood to go to
the branded drug website to learn more about the drug, and likelihood
to ask their doctor about the drug.
    (Response) We measure unaided awareness of the indications (benefit
recall) in Question 2, aided awareness of the indications (benefit
recognition) in Question 3, and likelihood to look for more information
about the drug and ask their doctor about the drug in Questions 16 and
17.
    (Comment) One comment suggested deleting Questions 2 and 13 in
favor of Questions 3 and 14 because these open-ended questions may be
difficult for respondents to answer.
    (Response) Questions 2 and 13 measure unaided recall of drug
benefits and risks whereas Questions 3 and 14 measure recognition of
drug benefits and risks. We agree that recall is more difficult than
recognition. We plan to retain Questions 2 and 13 but will assess their
utility in cognitive interviews and pretesting.
    (Comment) One comment suggested using consistent scales on the
questionnaire.
    (Response) Most questionnaire items have true/false/don't know or
yes/no/don't know response options. Some items are validated measures
with Likert-type scales; for these, we have used the response options
from the validated measures.
    (Comment) Two comments suggested removing or revising questions 7-
10 because participants do not have the medical expertise to say
whether someone is a good candidate for a drug. Instead, the comments
suggested asking whether the drug is appropriate for them.
    (Response) These questions are intended to measure participants'
comprehension of the indications as communicated in the advertisements.
DTC advertisements can drive consumers to ask their doctors about a
drug, so it is important to know whether the drug indication is
accurately communicated to consumers. We used similar questions about
being a ``good candidate'' in another study (OMB control number 0910-
0885). In cognitive interviews, participants were able to answer the
questions and they understood that the questions were asking about the
drug information in the advertisement. We also tested language, such as
whether it would be appropriate for the person to ask their doctor
about the drug, but participants found this language to be wordy and
unnecessary. We do not plan to change these questions at this time, but
we will assess participants' ability to answer these questions in
cognitive interviews and pretesting.
    (Comment) Two comments suggested deleting or revising several items
(Questions 16, 17, 21-24, 26, 27 in one comment, Questions 18-27 in the
other) because responses to these items may be influenced by the
particular stimuli used and by factors other than those being studied.
    (Response) These items measure intentions, attitudes, and
perceptions. We agree that several factors can influence these
outcomes. However, random assignment to conditions allows us to
determine whether the experimental manipulation is responsible for
differences in these outcomes across conditions. We will retain these
items and assess their utility in cognitive interviews and pretesting.
    (Comment) One comment suggested combining Questions 30 through 33
into one item and asking it at the beginning of the questionnaire.
    (Response) We combined questions Q31 and Q32 into one item and
moved the item to the screener.
    (Comment) One comment suggested we ask participants if they have
been diagnosed with the indicated medical conditions (diabetic
neuropathy, fibromyalgia, etc.).
    (Response) These questions are included on the questionnaire.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 1 and 2 screener....................             264               1             264  0.083 (5 minutes).........................              22
Pretest 1 and 2.............................             132               1             132  0.333 (20 minutes)........................              44
Main Study 1 and 2 screener.................           1,770               1           1,770  0.083 (5 minutes).........................             147
Main Study 1 and 2..........................             885               1             885  0.333 (20 minutes)........................             295
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             508
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Mayer, R.E. and R. Moreno (2003), ``Nine Ways to Reduce Cognitive
Load in Multimedia Learning.'' Educational Psychologist, 38(1), 43-
52.
2. Mutlu-Bayraktar, D., V. Cosgun, and T.

Altan (2019), ``Cognitive Load in Multimedia Learning Environments:
A Systematic Review.'' Computers & Education, 141, 103618.
3. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al. (2018),
``Serious and Actionable Risks, Plus Disclosure: Investigating an
Alternative Approach for Presenting Risk Information in Prescription
Drug Television Advertisements.'' Research in Social and
Administrative Pharmacy, 14(10), 951-963.
4. Jiang, Y.V., H.J. Lee, A. Asaad, and R. Remington (2016),
``Similarity Effects in Visual Working Memory.'' Psychonomic
Bulletin & Review, 23(2), 476-482.
5. Oberauer, K. and E.B. Lange (2008), ``Interference in Verbal
Working Memory: Distinguishing Similarity-Based Confusion, Feature
Overwriting, and Feature Migration.'' Journal of Memory and
Language, 58(3), 730-745.
6. Friedman, L.M., C.D. Furberg, and D.L. DeMets (1998),
Fundamentals of Clinical Trials. New York, NY: Spring Science-
Business Media, LLC.
7. Fisher, R.A. (1937), The Design of Experiments. Edinburgh, United
Kingdom: Oliver and Boyd.
8. Southwell, B.G. and R. Langteau (2008), ``Age, Memory Changes,
and the Varying Utility of Recognition as a Media Effects Pathway''.
Communication Methods and Measures, 2, 100-114.

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04472 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Rules and Regulations]
[Pages 66454-66456]
[FR Doc No: 2021-25469]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0288; Airspace Docket No. 21-AGL-6]
RIN 2120-AA66

Amendment of Area Navigation (RNAV) T-348 and Establishment of T-
409; Northcentral United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends RNAV route T-348 and establishes RNAV route
T-409 in the northcentral United States. This action expands the
availability of RNAV routing in support of transitioning the National
Airspace

System (NAS) from ground-based to satellite-based navigation.

DATES: Effective date 0901 UTC, January 27, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. FAA Order JO 7400.11F is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of FAA Order JO 7400.11F at NARA,
email: [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jesse Acevedo, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the 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 modifies the route structure as necessary to preserve
the safe and efficient flow of air traffic within the NAS.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2021-0288, in the Federal Register (86 FR 24798; May 10, 2021),
amending T-348 and establishing T-409. The proposed action expands the
availability of RNAV routing in support of transitioning the NAS from
ground-based to satellite-based navigation. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal. No comments were received.
    United States Area Navigation T-routes are published in paragraph
6011 of FAA Order JO 7400.11F, dated August 10, 2021, and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV routes listed in this document will be published subsequently
in FAA JO Order 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by amending RNAV route T-348 and
establishing RNAV route T-409. This action is necessary to support the
FAA's Next Generation Air Transportation System efforts to transition
of the NAS from ground-based to satellite-based navigation.
    The RNAV route actions are described below.
    T-348: T-348 extends between the BRAIN, MN, waypoint (WP) and the
LUNGS, WI, WP. This action extends the route between the LESNR, SD, WP
and the BRAIN, MN, WP. As a result of this route segment addition, the
BRAIN WP will remain in place, but will no longer be referenced in the
legal description. The new route flows from the LESNR WP, through the
TECUD, SD, fix and Sioux Falls, SD, VOR/Tactical Air Navigation
(VORTAC), to the GRSIS, MN, WP, onward. The resulting RNAV route
extends between the LESNR WP and the LUNGS WP.
    T-409: T-409 is a new RNAV route that extends between the LLUKY,
NE, WP and the Pierre, SD, VORTAC. For RNAV equipped aircraft, this
route mitigates the loss of the V-71 airway segments removed on
September 10, 2020, due to the decommissioning of the Winner, SD, VOR.
Non-equipped aircraft can request ATC radar vectors to fly around or
through the area or take advantage of any adjacent VOR Federal airways.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

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
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, will 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 of amending RNAV T-348 and
establishing RNAV T-409, in support of efforts transitioning the NAS
from ground-based to satellite-based navigation, qualifies for
categorical exclusion under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points). As such, this action is not expected to result in any
potentially significant environmental impacts. In accordance with FAA
Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the
FAA has reviewed this action for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis. Accordingly, the FAA
has determined that no extraordinary circumstances exist that warrant
preparation of an environmental assessment or environmental impact
study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration 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 14 CFR 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 JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

 Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-348 LESNR, SD to LUNGS, WI [Amended]

LESNR, SD                                       WP                             (Lat. 43[deg]29'16.49'' N, long. 099[deg]45'41.00'' W)
TECUD, SD                                       FIX                            (Lat. 43[deg]32'54.48'' N, long. 097[deg]51'42.23'' W)
Sioux Falls, SD (FSD)                           VORTAC                         (Lat. 43[deg]38'58.14'' N, long. 096[deg]46'52.02'' W)
GRSIS, MN                                       WP                             (Lat. 43[deg]38'45.54'' N, long. 094[deg]25'21.17'' W)
FOOLS, MN                                       WP                             (Lat. 43[deg]46'58.20'' N, long. 092[deg]35'44.93'' W)
GABDE, MN                                       WP                             (Lat. 43[deg]38'50.04'' N, long. 092[deg]18'26.46'' W)
KRRTR, IA                                       WP                             (Lat. 43[deg]16'18.12'' N, long. 091[deg]22'30.62'' W)
Madison, WI (MSN)                               VORTAC                         (Lat. 43[deg]08'41.41'' N, long. 089[deg]20'22.91'' W)
LUNGS, WI                                       WP                             (Lat. 43[deg]02'43.66'' N, long. 088[deg]56'54.86'' W)

                                                                      * * * * * * *
T-409 LLUKY, NE to Pierre, SD (PIR) [New]

LLUKY, NE                                       WP                             (Lat. 42[deg]29'20.26'' N, long. 098[deg]38'11.44'' W)
ADEDY, SD                                       FIX                            (Lat.43[deg]03'05.06'' N, long. 099[deg]17'41.35'' W)
LESNR, SD                                       WP                             (Lat. 43[deg]29'16.49'' N, long. 099[deg]45'41.00'' W)
Pierre, SD (PIR)                                VORTAC                         (Lat. 44[deg]23'40.40'' N, long. 100[deg]09'46.11'' W)

* * * * *

    Issued in Washington, DC, on November 17, 2021.
Michael R. Beckles,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-25469 Filed 11-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Notices]
[Page 71474]
[FR Doc No: 2012-28993]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Seventeenth Meeting: RTCA Special Committee 224, Airport Security
Access Control Systems

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 224, Airport Security
Access Control Systems.

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SUMMARY: The FAA is issuing this notice to advise the public of the
seventeenth meeting of the RTCA Special Committee 224, Airport Security
Access Control Systems.

DATES: The meeting will be held December 13, 2012 from 9:00 a.m.-4:00
p.m.

ADDRESSES: The meeting will be held at RTCA, 1150 18th Street NW.,
Suite 910, Washington, DC, 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 224. The agenda will
include the following:

December 13, 2012

 Welcome/Introductions/Administrative Remarks
 Review/Approve Summary of Sixteenth Meeting
 Updates from TSA (as required)
 Section Reports
 Times and Place of Next Meeting
 Other Business
 Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on November 15, 2012.
Richard F. Gonzalez,
Management Analyst, Business Operations Group, ANG-A12, Federal
Aviation Administration.
[FR Doc. 2012-28993 Filed 11-29-12; 8:45 am]
BILLING CODE 4910-13-P