[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49705-49708]
[FR Doc No: 2016-17822]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78392; File No. SR-NASDAQ-2016-098]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Modify the Complimentary
Services Offered to Certain New Listings

July 22, 2016.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 11, 2016, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the complimentary services offered
to certain new listings.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Nasdaq offers complimentary services to companies listing on the
Nasdaq Global and Global Select Markets in connection with an initial
public offering, upon emerging from bankruptcy, or in connection with a
spin-off or carve-out from another company (``Eligible New Listings'')
and to companies that switch their listing from the New York Stock
Exchange (``NYSE'') to the Nasdaq Global or Global Select Markets
(``Eligible Switches'' and, together with Eligible New Listings,
``Eligible Companies'').\3\ Nasdaq believes that this program offers
valuable services to newly listing companies, designed to help ease the
transition of becoming a public company or switching markets, makes
listing on Nasdaq more attractive to these companies, and also provides
Nasdaq Corporate Solutions \4\ the opportunity to demonstrate the value
of its services and forge a relationship with the company. Eligible
Companies receive a whistleblower hotline, investor relations Web site,
press release distribution services, interactive webcasting, and market
analytic tools, and may receive a market surveillance service.\5\ Based
on Nasdaq's experience with the program and competitive changes,\6\
Nasdaq proposes to modify its offering as described below.
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    \3\ See Exchange Act Release No. 65963 (December 15, 2011), 76
FR 79262 (December 21, 2011) (SR-NASDAQ-2011-122) (adopting IM-5900-
7) (the ``Original Filing''); Exchange Act Release No. 72669 (July
24, 2014), 79 FR 44234 (July 30, 2014) (SR-NASDAQ-2014-058)
(adopting changes to IM-5900-7). These adopting releases are
collectively referred to as the ``Prior Filings.''
    \4\ In November 2015, the name of NASDAQ OMX Corporate Solutions
was changed to Nasdaq Corporate Solutions to reflect the rebranding
of the holding company from NASDAQ OMX to Nasdaq, Inc. This change
is reflected in the amended rule language.
    \5\ Only Eligible Companies with a market capitalization of $750
million or more receive the market surveillance service. This
service is being renamed in this filing ``stock surveillance'' to
better reflect its purpose.
    \6\ See Exchange Act Release No. 76127 (October 9, 2015), 80 FR
62584 (October 16, 2015) (SR-NYSE-2015-36) (modifying the services
offered by NYSE to certain companies). See also Exchange Act Release
No. 77401 (March 17, 2016), 81 FR 15585 (March 23, 2016) (SR-
NYSEMKT-2016-12) (adopting a rule allowing NYSE MKT to offer certain
newly listed companies services).
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    First, Nasdaq currently offers Eligible Companies that have a
market capitalization of $750 million or more a stock surveillance
tool, through which an analyst attempts to determine who is buying and
selling the company's stock. While any public company can use this
offering, which is designed to enhance the company's investor relations
activity, it may not be an appropriate fit for some companies, such as
those that are closely held or otherwise have low liquidity or low
volume. Other companies may prioritize different investor relations
tools over stock surveillance. These companies therefore are more
likely to derive value from a different market advisory service offered
by Nasdaq Corporate Solutions. Accordingly, in order to make the
package more attractive to these companies, Nasdaq proposes to allow
companies eligible for this service to choose from the existing stock
surveillance offering or, instead, to choose other alternatives, which
are also designed to help companies identify current owners, potential
buyers or sellers of their stock, or otherwise enhance their investor
relations efforts. Specifically, instead of the existing offering,
companies would be allowed to choose: (i) A global targeting package,
where an investor targeting specialist will help focus the company's
investor relations efforts on appropriate investors, tailor messaging
to those investors' interests and measure the company's impact on their
holdings; (ii) monthly ownership analytics and event driven targeting,
which provide a monthly shareholder analysis and tracking report, which
an analyst will help interpret during a monthly call, and a shareholder
targeting plan around one event each year, such as a roadshow or
investor conference; \7\ or (iii) an annual perception study designed
to identify how the company is perceived by key stakeholders and
provide the company with actionable recommendations for enhancing its
perception in the market. These alternative market advisory services
are similar in that they all assist a company's investor relations
efforts by providing information about current or potential investors
to the company, but are designed to be valuable to companies based on
their needs at differing times. The approximate retail value of the
proposed new services ranges from $35,000 to $46,000 per year, as
compared to the approximate retail

value of $51,000 of the existing stock surveillance tool.\8\
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    \7\ To fully utilize this service, the company will also have to
subscribe to, and separately pay for, certain third party
information, such as position reports from the Depositary Trust
Corporation.
    \8\ Nasdaq also proposes to update the description of the stock
surveillance tool to clarify that it is a single, dedicated analyst
who provides that service, as opposed to the team approach used for
the proposed alternative market advisory tools, and to note that the
analyst attempts to identify institutional buyers and sellers in the
company's stock.
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    Second, Nasdaq proposes to create a new tier of services for
Eligible Companies with a market capitalization of $5 billion or more.
As noted in the Prior Filings, Nasdaq believes that it is appropriate
to offer different services based on a company's market capitalization
given that larger companies generally will need more and different
governance, communication and intelligence services.\9\ The listing of
these companies also attracts the most attention and therefore enhances
Nasdaq's image as a listing venue to the benefit of Nasdaq and all
other Nasdaq-listed companies. Based on Nasdaq's experience, Nasdaq has
concluded that companies with a market capitalization of $5 billion or
more have more complex investor relations functions and frequently have
more shareholders and a greater change in their shareholdings, and
therefore can benefit from, and are more likely to purchase at the end
of the complimentary period, investor targeting or perception studies
in addition to surveillance services. As such, Nasdaq proposes to offer
these companies the choice of a second market advisory tool.\10\
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    \9\ Exchange Act Release No. 65963, 76 FR at 79265.
    \10\ In describing the value of the services in the rule text,
Nasdaq presumed that a company would use stock surveillance, which
has an approximate retail value of $51,000, and global targeting,
which has an approximate retail value of $40,000. A company using
the stock surveillance tool would be unlikely also to use the
monthly ownership analytics and event driven targeting because there
is considerable overlap between these services. Companies could, of
course, select different combinations of the four offered services
that do not overlap, but these other combinations would have lower
total approximate retail values.
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    Third, Nasdaq has determined to enhance the value of the package
offered to Eligible Switches. NYSE recently modified the ongoing
services it offers its listed companies, claiming to increase the value
of those services.\11\ As a result, while most companies pay
substantially lower listing fees on Nasdaq, some companies considering
whether to switch to Nasdaq nonetheless will need a greater incentive
to forego the services offered by NYSE, which are now valued higher by
NYSE. Accordingly, Nasdaq proposes to increase the number of users of
the market analytic tool to three users for Eligible Switches with a
market capitalization of $750 million or more but less than $5 billion
and to four users for Eligible Switches with a market capitalization of
$5 billion or more.\12\ In addition, Nasdaq proposes to increase the
term of the complimentary services from three to four years for any
Eligible Switch with a market capitalization of $750 million or
greater. This restores some features and the term of complimentary
services that was previously in effect for such companies.\13\
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    \11\ Exchange Act Release No. 76127, supra.
    \12\ This service has a retail value of approximately $29,000
per year for two users, $40,000 for three users, and $51,000 for
four users.
    \13\ Prior to July 2014, Nasdaq offered market analytic tools
for four users to all Eligible Companies. In addition, Nasdaq
offered Eligible Switches (but not other companies) with a market
capitalization of $500 million or more four years of complimentary
services. The 2014 changes, as well as the changes proposed in this
filing to restore some of those services, reflects the competition
among exchanges for listings. Securities Exchange Act Release No.
72669, 79 FR at 44235.
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    The proposed rule change would also update the values and
descriptions of the services offered as follows. The approximate retail
value of the investor relations Web site would be updated from $15,000
to $16,000, the market analytic tool for two users from $30,000 to
$29,000, and the stock surveillance tool from $50,000 to $51,000.\14\
In addition, the proposed rule change will eliminate rounding in the
total retail value of the services offered each category of Eligible
Company. The description of the market analytic tool would be changed
to reflect the addition of mobile access to the users of that service
and to add the value of that offering for three and four users ($40,000
and $51,000, respectively). The ``Interactive Webcasting'' service
would be renamed ``Audio Webcasting'' to reflect better the voice-only
nature of the service, which is delivered through a platform branded
with the company's name and logo that allows real-time questions from
the audience. The four audio webcasts also would be described as a
``package'' to reflect better the basis for approximate retail value
provided.\15\ In addition, Nasdaq proposes to rename the current
``Press Release'' service to ``Disclosure Services,'' to better reflect
the availability of EDGAR and XBRL services, and to specify that these
services are provided as an annual stipend usable with Nasdaq Corporate
Solutions.\16\ Nasdaq also proposes to delete the reference to factors
affecting the number of press releases available because the revised
rule would explicitly state that it is an annual stipend and would
emphasize disclosure services generally rather than just press
releases.
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    \14\ The Commission has previously held that such updates are
required by the Act. Exchange Act Release No. 72669, 79 FR at 44236.
    \15\ Four separately purchased webcasts would cost more than
four purchased together as a package. The approximate retail value
provided is, and always has been, based on the purchase of such a
package.
    \16\ These are changes to reflect the way the service has always
been offered.
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    Where a company has a choice among different complimentary services
under the revised rule, it must make its selection when it first begins
to use a complimentary service. A company will not be permitted to
subsequently change to a different complimentary service offered in the
package. Of course the company can discontinue using a service at any
time without penalty and can also elect to purchase from Nasdaq
Corporate Solutions a service alternative that was previously declined
or a comparable service from another competitor.
    Nasdaq will implement this rule filing upon approval. Any company
receiving services under the terms of the Prior Filings on the date of
approval may elect to receive services under the revised terms in this
proposed rule filing (even if those services were not available at the
time the company listed on Nasdaq). If a company elects to receive
services under the proposed rules, the services that the company is
eligible to receive will be determined based on its status and market
capitalization at the time of its original listing. The length of time
that services are available to the company under the revised package
will be calculated from the company's original listing date. In this
manner, the rule will be applied prospectively, from approval.
    Finally, the proposed rule change would modify the introductory
note to IM-5900-7 to reference the historical changes to the program
and explain the impact of the revisions to companies that are already
listed. The rule would also be reorganized to enhance its readability
and usability.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of section 6 of the Act,\17\ in general, and sections
6(b)(4), 6(b)(5), and 6(b)(8), in particular, in that the proposal is
designed, among other things, to provide for the equitable allocation
of reasonable dues, fees, and other charges among Exchange members and
issuers and other persons using its facilities and to promote just and
equitable principles of trade, and is not

designed to permit unfair discrimination between issuers, and in that
the rules of the Exchange do not impose any burden on competition not
necessary or appropriate in furtherance of the purposes of the Act. In
the Prior Filings, the Commission determined that existing IM-5900-7 is
consistent with these provisions of the Act.\18\ Nothing proposed
herein changes that conclusion. Nasdaq faces competition in the market
for listing services,\19\ and competes, in part, by offering valuable
services to companies, including services that ease the companies'
transition to being public or listed on a new exchange. Under the
proposed changes, these services would be available for a small number
of all public companies \20\ and would remain available only for a
short period of two to four years, as in the Original Filing.
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    \17\ 15 U.S.C. 78f.
    \18\ Exchange Act Release No. 65963, 76 FR at 79267; Exchange
Act Release No. 72669, 79 FR at 44234.
    \19\ The Justice Department has noted the intense competitive
environment for exchange listings. See ``NASDAQ OMX Group Inc. and
IntercontinentalExchange Inc. Abandon Their Proposed Acquisition Of
NYSE Euronext After Justice Department Threatens Lawsuit'' (May 16,
2011), available at http://www.justice.gov/atr/public/press_releases/2011/271214.htm.
    \20\ For example, in 2014 there were 309 total IPOs in the U.S.
and Nasdaq listed 189 of them; 147 qualified for services under IM-
5900-7. In 2015, there were 196 total IPOs in the U.S. and Nasdaq
listed 143 of them; 98 qualified for services under IM-5900-7. Two
exchange switches qualified for services under IM-5900-7 in 2014 and
five qualified in 2015. In contrast, according to FactSet, there are
approximately 13,000 public companies in the U.S. on June 29, 2016,
including more than 5,000 listed on exchanges.
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    Under the existing rule, Nasdaq offers companies with a market
capitalization of $750 million or more a stock surveillance service and
Nasdaq has justified why providing this service to such companies is
not unfairly discriminatory in the Prior Filings. Nasdaq proposes to
allow these companies to continue to receive this service or, at their
election, to choose a different market advisory service with a lower
retail value, but which may be more meaningful to the company. The
addition of this flexibility does not change Nasdaq's fees nor how
those fees are allocated among issuers and other persons using Nasdaq's
facilities, and it does not unfairly discriminate against any issuer,
because any issuer currently eligible to receive the higher value stock
surveillance service would only receive a lower value service if the
issuer voluntarily determines that the other service is more valuable
to it based on its circumstances. Nasdaq believes that by allowing
companies the ability to choose an appropriate market advisory tool,
instead of offering just stock surveillance, the package will be more
enticing. Therefore, this change will enhance competition among listing
exchanges, rather than impose any burden on that competition. In
addition, by providing companies the ability to choose a more
meaningful market advisory tool, Nasdaq believes that these companies
will have a better experience with the applicable tool; as a result,
the companies are more likely to continue to use their chosen service.
The ability to choose could create additional users of the service
class and enhance competition among service providers.
    Nasdaq also proposes to allow Eligible Companies with a market
capitalization of $5 billion or more to receive an additional market
advisory service. As noted above, Nasdaq has concluded that companies
with a market capitalization of $5 billion or more have more complex
investor relations functions and frequently have more shareholders and
face greater changes in their shareholdings. These companies therefore
can benefit from additional market advisory services and are more
likely to purchase additional services at the end of the complimentary
period. There is also enhanced competition for listing of these larger
companies and offering them an additional market advisory service
reflects that competition and the greater fees they generally pay.
Nasdaq believes that this enhanced need, the increased likelihood that
the company will purchase the service at the end of the complimentary
period, the increased competition for these listings, and the greater
fees generally paid by these companies form an equitable and reasonable
basis to distinguish these issuers; as a result, Nasdaq does not
believe that this change unfairly discriminates between issuers. Nasdaq
also believes that by allowing certain companies the ability to choose
an additional market advisory tool, the package will be more enticing
and therefore will enhance competition among listing exchanges, rather
than impose any burden on that competition. In addition, by providing
companies the ability to use an additional market advisory tool, Nasdaq
believes that these companies are more likely to continue to use their
chosen service on an ongoing basis when the complimentary period is
over. This ability to choose could create additional users of the
service class and enhance competition among service providers.
    Nasdaq previously offered market analytic tools for four users to
all Eligible Companies but reduced that to two users based on Nasdaq's
experience with company use of the service.\21\ Upon further
consideration, Nasdaq believes that allowing a third user of its market
analytics tools to Eligible Switches with a market capitalization of
$750 million or more and a fourth user for Eligible Switches with a
market capitalization of $5 billion or more better addresses Nasdaq's
prior experience and is appropriate and not unfairly discriminatory.
Larger companies often have more complex investor relations functions
and therefore can benefit from additional market analytic user seats.
Offering these companies additional user seats based on their size and
needs therefore enables Nasdaq to compete better for listings, which is
a nondiscriminatory reason to distinguish among issuers. In addition,
Nasdaq believes that it is appropriate to distinguish Eligible Switches
from other Eligible New Listings because Eligible Switches generally
have larger investor relations teams already in place and therefore can
benefit from the additional user seats. On the other hand, many
Eligible New Listings work with investment banks and other firms that
provide ongoing support for a period after their listing while the
company's investor relations programs mature, and these companies
therefore have less need for the additional user seats. In addition,
Eligible Switches forego services paid for by their former exchange and
larger companies forego more services.\22\ Therefore, Nasdaq believes
that it is equitable and not unfairly discriminatory to offer these
additional user seats only to Eligible Switches and not to Eligible New
Listings and to base the number of additional seats on the Eligible
Switches' size.
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    \21\ Securities Exchange Act Release No. 72669, supra.
    \22\ While NYSE bases its service tiers for currently listed
companies on shares outstanding, as described in the Prior Filings,
Nasdaq believes that companies with higher market capitalizations
also generally will have more shares outstanding.
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    The proposed change to reinstate the four-year term of services
provided to Eligible Switches with a market capitalization of $750
million or more restores the term of complimentary services that was in
effect for these companies prior to the 2014 changes.\23\ This change
reflects Nasdaq's ongoing assessment of the competitive market for
listings and does not place any unnecessary burden on that competition.
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    \23\ Exchange Act Release No. 65963, 76 FR 79262.
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    The adjustments proposed to reflect changes in the fair market
values of the services offered do not meaningfully affect the
allocation of Nasdaq's fees and

therefore also do not impact the Commission's prior conclusions. These
changes, in fact, were found to be necessary by the Commission in the
Prior Filings.\24\ Similarly, the changes to rename certain services to
better reflect the service offered, refer to Nasdaq Corporate Solutions
and reorganize the rule are clarifying changes, which have no impact on
fees and how they are allocated or on competition.
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    \24\ Exchange Act Release No. 72669, 79 FR at 44236.
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    Nasdaq believes that it is not unfairly discriminatory to offer the
revised service package only to currently listed companies that are
receiving services at the time of the proposal's approval, and not to
other currently listed companies. Companies receiving complimentary
services are still in the process of sampling Nasdaq Corporate
Solutions' offering and both the companies and Nasdaq Corporate
Solutions will benefit from the ability of the company to utilize the
revised services. Moreover, because Nasdaq Corporate Solutions
continues to provide the complimentary services to these companies,
extending their term and providing additional seats and advisory
services is a seamless process. On the other hand, companies that are
not currently receiving complimentary services from Nasdaq Corporate
Solutions will have either entered into binding contractual agreements
with Nasdaq Corporate Solutions and other providers for the specific
services they require or determined that they do not wish to purchase
the services. Extending the benefits of the revised rule to such
companies would cause them to have duplicative services to what they
have already contracted or provide them with the option for a service
that they have already concluded they do not want. Accordingly,
providing the benefit of the changes only to those companies receiving
services when the proposed rule change is approved is not unfairly
discriminatory.

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. As described in the
statutory basis section, above, the proposed rule change responds to
competitive pressures in the market for listings. Nasdaq believes the
proposed changes will result in a more enticing package for potential
listings and therefore will enhance competition among listing
exchanges. The proposed changes to allow companies the ability to
choose a more meaningful market advisory tool will provide companies a
better experience with these tools, the proposed change to allow
certain companies to receive two market advisory tools will expose
eligible companies to additional service options. As a result, Nasdaq
believes that when the complimentary period ends these companies are
more likely to continue to use the Nasdaq Corporate Solutions service
or a competing service, whereas otherwise they may not be exposed to
the value of these services and therefore may not purchase any. This
will create additional users of the service class and enhance
competition among service providers. In addition, other service
providers can also offer similar services to companies, thereby
increasing competition to the benefit of those companies and their
shareholders. Accordingly, Nasdaq does not believe the proposed rule
change will impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-NASDAQ-2016-098 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2016-098. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2016-098 and should
be submitted on or before August 18, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
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    \25\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-17822 Filed 7-27-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16285-16290]
[FR Doc No: 2011-6792]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2002-F-0198] (formerly Docket No. 2002F-0316)

Food Additives Permitted for Direct Addition to Food for Human
Consumption; Bacteriophage Preparation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections and denial of requests for a
hearing and stay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is responding to
objections and is denying requests that it has received for a hearing
on the final rule that amended the food additive regulations to provide
for the use of a bacteriophage preparation as an antimicrobial agent
against Listeria monocytogenes on ready-to-eat (RTE) meat and poultry
products. After reviewing the objections to the final rule and the
requests for a hearing, the Agency has concluded that the objections do
not raise issues of material fact that justify a hearing or otherwise
provide a basis for revoking the amendment to the regulation. FDA also
is denying the request for a stay of the effective date of the final
rule.

DATES: Effective date of the final rule published in the Federal
Register of August 18, 2006 (71 FR 47729) confirmed: August 18, 2006.

FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA published a notice in the Federal Register of July 22, 2002 (67
FR 47823), announcing the filing of food additive petition, FAP 2A4738,
by Intralytix Inc., to amend the food additive regulations by providing
for the safe use of a

mixture of bacteriophages as an antimicrobial agent against L.
monocytogenes on foods, including fresh meat products, fresh poultry,
and poultry products. On December 18, 2003, the petitioner amended the
petition to limit the petitioned use only to RTE meat and poultry
products. In response to this petition, FDA issued a final rule in the
Federal Register of August 18, 2006 (71 FR 47729), approving the use of
the bacteriophage preparation on RTE meat and poultry products. This
rule will be referred to in this document as the ``bacteriophage final
rule.'' The preamble to the final rule advised that objections to the
final rule and requests for a hearing were due within 30 days of the
publication date (i.e., by September 18, 2006).

II. Objections, Requests for a Hearing, and Request for a Stay of
Effective Date

    Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(f)) provides that, within 30 days after
publication of an order relating to a food additive regulation, any
person adversely affected by such order may file objections, specifying
with particularity the provisions of the order ``* * * deemed
objectionable, stating reasonable grounds therefor, and requesting a
public hearing upon such objections * * *.'' FDA may deny a hearing
request if the objections to the regulation do not raise genuine and
substantial issues of fact that can be resolved at a hearing (Community
Nutrition Institute v. Young, 773 F.2d 1356, 1364 (DC Cir. 1985), cert.
denied, 475 U.S. 1123 (1986)).
    Under the food additive regulations at 21 CFR 171.110, objections
and requests for a hearing are governed by part 12 (21 CFR part 12) of
FDA's regulations. Under Sec.  12.22(a), each objection must meet the
following conditions: (1) Must be submitted on or before the 30th day
after the date of publication of the final rule; (2) must be separately
numbered; (3) must specify with particularity the provision of the
regulation or proposed order objected to; (4) must specifically state
each objection on which a hearing is requested; failure to request a
hearing on an objection constitutes a waiver of the right to a hearing
on that objection; and (5) must include a detailed description and
analysis of the factual information to be presented in support of the
objection if a hearing is requested; failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection.
    Following publication of the bacteriophage final rule, FDA received
more than 70 objections within the 30-day objection period. All but one
of these submissions expressed general opposition to the use of the
bacteriophage preparation on RTE meat and poultry products; however, no
evidence was submitted in support of these objections. As stated
previously, under section 409(f)(1) of the FD&C Act, objections must
``[specify] with particularity the provisions of the order deemed
objectionable, stating reasonable grounds therefor * * *.'' These
submissions did not provide reasonable grounds and identified no
substantive issue to which the Agency can respond. Therefore, these
submissions are denied and will not be considered further. The
submission raising specific objections was a letter from Food & Water
Watch (FWW) with six objections. The FWW letter sought a revocation of
the bacteriophage final rule and requested a hearing on the issues
raised by each objection. The letter also requested that the regulation
be stayed pending a public hearing of the scientific issues. These
objections are addressed in section IV of this document.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request
for a hearing are set out in Sec.  12.24(b). Under that regulation, a
hearing will be granted if the material submitted by the requester
shows, among other things, the following: (1) There is a genuine and
substantial factual issue for resolution at a hearing; a hearing will
not be granted on issues of policy or law; (2) the factual issue can be
resolved by available and specifically identified reliable evidence; a
hearing will not be granted on the basis of mere allegations or denials
or general descriptions of positions and contentions; (3) the data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
requester; a hearing will be denied if the data and information
submitted are insufficient to justify the factual determination urged,
even if accurate; (4) resolution of the factual issue in the way sought
by the person is adequate to justify the action requested; a hearing
will not be granted on factual issues that are not determinative with
respect to the action requested (e.g., if the action would be the same
even if the factual issue were resolved in the way sought); (5) the
action requested is not inconsistent with any provision in the FD&C Act
or any FDA regulation; and (6) the requirements in other applicable
regulations, e.g., 21 CFR 10.20 and Sec. Sec.  12.21 and 12.22, and in
the notice issuing the final regulation or the notice of opportunity
for hearing are met.
    A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing'' (Costle v.
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), reh. denied,
446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning,
Inc., 412 U.S. 609, 620-621 (1973)). An allegation that a hearing is
necessary to ``sharpen the issues'' or to ``fully develop the facts''
does not meet this test (Georgia Pacific Corp. v. U.S. Environmental
Protection Agency, 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing
request fails to identify any factual evidence that would be the
subject of a hearing, there is no point in holding one. In judicial
proceedings, a court is authorized to issue summary judgment without an
evidentiary hearing whenever it finds that there are no genuine issues
of material fact in dispute and a party is entitled to judgment as a
matter of law. (See Rule 56, Federal Rules of Civil Procedure.) The
same principle applies in administrative proceedings. (See Sec.
12.28.)
    A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact concerning which a meaningful
hearing might be held (Pineapple Growers Association v. FDA, 673 F.2d
1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection
are, even if true, legally insufficient to alter the decision, the
Agency need not grant a hearing (see Dyestuffs & Chemicals, Inc. v.
Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911
(1960)). A hearing is justified only if the objections are made in good
faith and if they ``draw in question in a material way the
underpinnings of the regulation at issue'' (Pactra Industries v.
Consumer Product Safety Commission, 555 F.2d 677, 684 (9th Cir. 1977)).
A hearing need not be held to resolve questions of law or policy (see
Citizens for Allegan County, Inc. v. Federal Power Commission, 414 F.2d
1125, 1128-29 and n.5 (D.C. Cir. 1969); Sun Oil Co. v. Federal Power
Commission, 256 F.2d 233, 240-41 (5th Cir.), cert. denied, 358 U.S. 872
(1958)).
    Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were adequately raised and
considered in an earlier proceeding. Once an issue has been so raised
and considered, a party cannot raise that same issue in a later
proceeding without new evidence. The various judicial doctrines dealing
with finality can be validly applied to the administrative process. In
explaining

why these principles ``self evidently'' ought to apply to an Agency
proceeding, the U.S. Court of Appeals for the District of Columbia
Circuit wrote: ``The underlying concept is as simple as this: Justice
requires that a party have a fair chance to present his position. But
overall interests of administration do not require or generally
contemplate that he will be given more than one fair opportunity.''
Retail Clerks Union, Local 1401 v. National Labor Relations Board, 463
F.2d 316, 322 (DC Cir. 1972). (See Costle v. Pacific Legal Foundation,
supra at 215-220. See also Pacific Seafarers, Inc. v. Pacific Far East
Line, Inc., 404 F.2d 804 (DC Cir. 1968), cert. denied, 393 U.S. 1093
(1969).)
    In summary, a hearing request must present sufficient credible
evidence to raise a material issue of fact and the evidence must be
adequate to resolve the issue as requested and to justify the action
requested.

IV. Analysis of Objections and Response to Hearing Requests

    The FWW submission raises six objections based on issues that they
believe to be factual and requests a hearing based on these objections.
FDA addresses each of the objections in the following paragraphs, as
well as the evidence and information filed in support of each,
comparing each objection and the information submitted in support of it
to the standards for granting a hearing in Sec.  12.24.

A. FWW's Assertion That FDA Failed To Follow Its Own Guidelines

    FWW claims that FDA failed to follow its own guidelines for
assessing the safety of food additives. Specifically, FWW states that
FDA did not ``certify'' that it followed the procedures stated in
current publications of the National Academy of Sciences/National
Research Council (NAS/NRC) when reviewing the bacteriophage petition,
or if different procedures were used, FDA did not ``certify'' that they
are as reliable as the NAS/NRC procedures, as FWW states is required by
Sec.  170.20 (21 CFR 170.20). FWW also contends that FDA did not comply
with the testing set forth in its own guidance entitled ``Toxicological
Principles for the Safety Assessment of Food Ingredients,'' otherwise
known as FDA's Redbook, or establish a 100-fold safety factor for the
additive as set forth in 21 CFR 170.22. If a different safety factor
was used, FWW asserts that FDA did not provide evidence to justify a
different safety factor. FWW also questions the relevance and
applicability of the various studies relied on by the petitioner to
show safety because of either: (1) Deficiencies with how the studies
were conducted, (2) the studies investigated efficacy rather than
safety, or (3) the substance tested is not the same bacteriophage that
is the subject of the petition.
    Contrary to what FWW appears to assert, FDA notes that the Agency
does not ``certify'' that the procedures used in evaluating a food
additive petition either followed the current NAS/NRC procedures or
were as reliable as those procedures. Section 170.20 sets forth the
general scientific principles that FDA uses in evaluating a food
additive petition and cites the principles and procedures stated in
current publications of the NAS/NRC as a guide that the Agency uses in
its safety evaluations of food additives. Nevertheless, FDA has
consistently taken the position that many scientifically valid types of
data may properly support a finding that the proposed use of a food
additive will cause ``no harm'' to consumers. Moreover, Sec.  170.20(a)
specifically states that ``A petition will not be denied, however, by
reason of the petitioner's having followed procedures other than those
outlined in the publications of the National Academy of Sciences-
National Research Council if, from available evidence, the Commissioner
finds that the procedures used give results as reliable as, or more
reliable than, those reasonably to be expected from the use of the
outlined procedures.'' Similarly, NAS/NRC acknowledges in the
conclusions of its document regarding procedures for evaluating the
safety of food chemicals that the document's purpose is to ``guide and
stimulate--not replace--informed professional and administrative
judgment'' (Ref. 1).
    FDA did not request the petitioner to carry out studies recommended
in NAS/NRC guidelines because the bacteriophages that are the active
component of the food additive infect L. monocytogenes exclusively, and
not mammalian cells. (See discussion at 71 FR 47729 at 47730). As such,
traditional animal testing of the additive as recommended by NAS/NRC
for food chemicals, is neither necessary nor helpful to demonstrate
that the petitioned use of the additive is safe.
    Regarding the use of safety factors, the use of a safety factor is
intended to account for the uncertainty of extrapolating animal
toxicity data to humans. Because bacteriophages do not infect mammals,
the use of a safety factor is unnecessary to provide adequate assurance
of safety.
    Similarly, due to the nature of this food additive, there is no
need to assign a concern level as set forth in the Redbook. FDA's
Redbook provides guidance that represents the Agency's current thinking
on the information needed for the safety assessment of food
ingredients. As with any Agency guidance, the Redbook does not bind the
petitioner or the Agency to follow specific procedures that are
recommended. Alternative approaches are permissible if such approaches
satisfy the requirement of the applicable statute and regulations.
Importantly, the statute does not prescribe the safety tests to be
performed but leaves that determination to the discretion and
scientific expertise of FDA. Not all food additives require the same
amount or type of testing. The testing and data necessary to establish
the safety of an additive will vary depending on the type and
characteristics of a particular additive and its intended use. Concern
levels are used to determine the recommended toxicity tests for an
additive. It was unnecessary to assign a concern level in the present
case, because FDA's primary concern about the subject additive was the
safety of potential residual components from the host organism, L.
monocytogenes, and not the bacteriophages themselves.
    One such residue of concern was Listeriolysin O (LLO), an exotoxin
produced by the host organism. To address this concern, the petitioner
analyzed the bacteriophage preparation for LLO and was unable to detect
it using a method sensitive to 5 hemolytic units per milliliter (HU/
ml). Even when the food additive was concentrated 10-fold, the
petitioner still did not detect any hemolytic activity. Although LLO
was not detected in the bacteriophage preparation, FDA established a
specification of 5 HU/ml for the maximum amount of LLO permitted in the
bacteriophage preparation as a condition of safe use, which is the
limit of detection for the method provided by the petitioner. FDA
concluded that the potential residues of LLO that may be found in the
food additive are negligible (i.e., 5 HU/ml or less) and do not pose a
safety concern for the use of the food additive as an antimicrobial
agent on RTE meat and poultry products. Furthermore, as discussed in
the bacteriophage final rule, the presence of any small amount of LLO
in the bacteriophage preparation may be mitigated by the following
factors: Inactivation of LLO by cholesterol that is present in RTE meat
and poultry products; inactivation of LLO by the low stomach pH; and
inactivation of orally consumed LLO by human defense mechanisms (e.g.,
normal intestinal microflora and cell-mediated immunity reactions) and
degradation by

proteolytic enzymes in the diet or in the stomach. FDA concluded that
reliable alternative methods from NRC/NAS procedures were used to
establish the safety of the bacteriophage preparation for its use on
RTE meat and poultry products, and that the data considered for this
regulation, when evaluated in its entirety, are sufficient to support
the safety of the bacteriophage preparation for that use.
    FWW's submission provides no evidence that FDA failed to follow its
own guidelines for assessing the safety of food additives. The FWW
submission does not raise a genuine and substantial issue of fact and
does not provide any specifically identified reliable evidence that, if
established at a hearing, would be adequate to demonstrate that FDA
acted in violation of its governing statutes and regulations. Thus, a
hearing is not justified based on this objection (Sec.  12.24(b)(1),
(b)(2), and (b)(3)).

B. Inactivation of LLO By Stomach Acid and Cholesterol

    FWW contends that FDA relies on conjecture in concluding that foods
treated with a bacteriophage preparation are safe for human
consumption. Specifically, FWW asserts that FDA's conclusion that any
residual LLO will be inactivated by factors such as cholesterol in the
meat or poultry, acidity within the stomach, and proteolytic enzymes
present in the food or in the stomach is based on unsupported
assumptions and not experimental data. Regarding the inactivation of
LLO by cholesterol, FWW's asserts that FDA's conclusion about
mitigation of LLO by cholesterol was not based on any data on the
levels of cholesterol in meat necessary to inactivate LLO, and that the
mechanism for the inactivation of LLO by cholesterol is ``not yet fully
understood by researchers.'' FWW also states that there is a need for a
more thorough study to investigate the reaction of certain sensitive
population groups to this bacteriophage preparation.
    As stated in the bacteriophage final rule, the toxicity of LLO has
been shown to be significantly reduced--by as much as 200- to 2,000-
fold--following pre-incubation of LLO with added cholesterol in vitro,
based on results of a study conducted by Jacobs et al (Ref. 2). The
results showed that there is almost no hemolytic if LLO is pretreated
with cholesterol at 1 milligram/100 grams (mg/100g). It is well
established that there are relatively high concentrations of
cholesterol in RTE meat and poultry products (approximately 38 to 156
mg/100 g (Ref. 3)). Therefore, since the bacteriophage preparation is
to be used on RTE meat and poultry products, and these products contain
significant amounts of cholesterol, the findings from Jacobs et al.
directly support FDA's conclusion about inactivation of LLO by
cholesterol in RTE meat and poultry products. While the mechanism by
which added cholesterol inhibits LLO may not be fully understood, that
does not undermine the evidence that supports the Agency's conclusion.
    Regarding inactivation of LLO by acidity, the data considered by
FDA in its review of the petition indicate that LLO has activity only
within a pH range between 4.9 and 8 while losing activity at a pH
outside this range, especially in very acidic (low pH) or very alkaline
(high pH) environments. Since the pH inside the stomach is normally
between 1.0 and 3.5 (Ref. 4), the acidic environment in the stomach
would be a defense against any residual LLO from the use of the
additive. No data were submitted by FWW to the contrary, nor was any
information provided that would justify the need for studies to
investigate the reaction of certain sensitive population groups to the
bacteriophage preparation. Because FWW provided no evidence to support
these contentions, FDA is denying the request for a hearing on these
issues; a hearing will not be granted on the basis of mere allegations
or denials or general positions and contentions (Sec.  12.24(b)(2)).

C. FWW's Contention That Petitioner's Efficacy Studies Are Inadequate

    FWW contends that the results of the efficacy studies for the
bacteriophage preparation submitted by the petitioner are inadequate to
show that the preparation will sufficiently control L. monocytogenes in
RTE meat and poultry products. In addition, FWW points out that some
other methods for killing bacteria achieve a greater log reduction of
bacteria than the bacteriophage preparation.
    During its evaluation of FAP 2A4738, FDA consulted with the Food
Safety and Inspection Service (FSIS) of the U.S. Department of
Agriculture (USDA), consistent with 21 CFR 171.1(n) and with a
memorandum of understanding (MOU) between the two Agencies for
reviewing the safety of substances used in the production of meat and
poultry products. Under the MOU, FDA is responsible for reviewing an
ingredient's safety, and USDA/FSIS is responsible for evaluating its
suitability. (MOU 225-00-2000; see also 65 FR 51758 at 51759, August
25, 2000). Suitability relates to the effectiveness of the ingredient
in performing the intended purpose of use and the assurance that the
conditions of use will not result in an adulterated product or one that
misleads consumers. As we stated in the bacteriophage final rule, ``FDA
recognizes that there may be meat or poultry products considered RTE
for which use of the additive may not be suitable within the meaning of
those statutes. This regulation addresses only the safety standard
under section 409 of the Federal Food, Drug, and Cosmetic Act and does
not address requirements for suitability administered by the USDA.''
(71 FR 47729 at 47731). FSIS concurred with the issuance of FDA's final
rule.
    FDA is denying the request for a hearing on this point because a
hearing will not be granted unless there is a genuine and substantial
factual issue to be resolved (Sec.  12.24(b)(1)), and resolution of the
factual issue in the way sought is adequate to justify the action
requested (Sec.  12.24(b)(4)).

D. FWW's Assertion That Key Research Used to Support the Rule Has Not
Been Published in Peer-Reviewed Journals

    FWW asserts that key research submitted by the petitioner in
support of their additive was not published in peer-reviewed journals,
which they claim is required under Sec.  170.31(i) (21 CFR 170.3(i)).
Specifically, FWW is referring to the definition of safe or safety
which is defined in Sec.  170.3(i) as ``* * * a reasonable certainty in
the minds of competent scientists that the substance is not harmful
under the intended conditions of use. * * *''
    FWW has misinterpreted Sec.  170.3(i). This regulation does not
require that in order to establish safety, the research submitted by a
petitioner in support of a food additive must be published in a peer-
reviewed journal. This regulation states that ``Safety may be
determined by scientific procedures or by general recognition of
safety.'' Importantly, scientific procedures are defined under Sec.
170.3(h) as `` * * * human, animal, analytical, and other scientific
studies, whether published or unpublished, appropriate to establish the
safety of a substance.'' Therefore, FDA does not require the key
research submitted by a petitioner in support of a food additive be
published in a peer-reviewed journal to establish safety. This
objection does not raise a genuine and substantial issue of fact for
resolution at a hearing. FDA is denying the request for a hearing on
this point because a hearing will not be granted if there is no genuine
and substantial factual issue to be resolved (Sec.  12.24(b)(1)).

E. FWW's Contention That FDA Did Not Adhere to Its Requirements on
Making Information Publicly Available

    FWW contends that the Agency did not follow the requirements in
Sec.  171.1(h) (21 CFR 171.1(h)) for making information publicly
available. They cite Sec.  171.1(h)(1), which states: ``The following
data and information in a food additive petition are available for
public disclosure, unless extraordinary circumstances are shown, after
the notice of filing of the petition is published in the Federal
Register * * *.'' FWW states that FDA did not publicly disclose the
releasable information from FAP 2A4738 after the notice of filing of
the petition published in the Federal Register as required under Sec.
171(h)(1). FWW also states ``as of the submission of these objections,
FDA has still not made much of this information, including much of this
petition, available.''
    FWW misinterprets Sec.  171.1(h)(1). That paragraph does not mean
that the releasable data and information in a petition are publicly
disclosed when the notice of filing publishes, but merely that the
information in the petition is available for public disclosure. Before
the information in a petition is actually disclosed, the Agency has to
purge all data and information that are protected from disclosure.
Because this is a labor intensive process, FDA does not preemptively
disclose the information in a petition at this time, but rather
releases it in response to requests made under the Freedom of
Information Act (FOIA). To disclose the information in a petition
before a request is received would not be an efficient use of Agency
resources.
    In the case of FAP 2A4738, the notice of filing was published in
the Federal Register of July 22, 2002, at which time the releasable
information in the petition was available for public disclosure through
the Agency's FOIA process. The final rule for this petition published
in the Federal Register of August 18, 2006, and the period for
submitting objections to this rule ended on September 18, 2006. Prior
to the beginning of the objection period, FDA had not processed any
FOIA requests for this information. The petition therefore had not been
previously redacted.
    On September 7, 2006, arrangements were made for FWW to go to FDA's
offices to review the petition, including specific sections in which
the organization had expressed a particular interest. On September 8,
2006, FWW came to FDA's offices and reviewed releasable parts of the
petition. At the end of their visit, FWW left with approximately 250
pages of documents. In addition, an FOIA request from Wenonah Hauter of
FWW (dated August 31, 2006 and received and logged by FDA's Freedom of
Information Staff on September 5, 2006) was processed, and the
information sent to FWW on February 9, 2007.
    The objection provides no evidence to support the contention that
FDA did not follow Sec.  171.1(h) regarding releasable information from
FAP 2A4738. FDA is denying the request for a hearing on this point
because a hearing will not be granted if there is no genuine and
substantial factual issue to be resolved (Sec.  12.24(b)(1)).

F. FWW's Contention That FDA Did Not Provide Adequate and Timely Notice
of the Standards Used To Evaluate the Petition

    FWW contends that FDA did not provide timely notice of the
standards it used for evaluating the petition and how the data
justifies the Agency's conclusion. Specifically, FWW contends that FDA
made available the memoranda referenced in the bacteriophage final rule
and select portions of the petition only after much pleading on the
13th and 21st day, respectively, after the start of the statutorily
required 30-day objection period.
    On August 17, 2006, the date the bacteriophage final rule was
placed on public display and 1 day before the rule published in the
Federal Register, the four references cited in the final rule were also
placed on public display in the petition docket. However, after
realizing that some of the references contained confidential
information, FDA immediately removed them from the docket to redact any
confidential information. The redacted references were placed back in
the docket on August 31, 2006.
    The Agency was first contacted by FWW on August 18, 2006, about the
unavailability of the four references listed in the bacteriophage final
rule. FWW was informed that the review memos had been taken off the
Agency's Web site to be purged of confidential information. While the 4
references cited in the bacteriophage final rule were unavailable to
FWW for 13 days after the publication of the final rule, FWW did obtain
them with more than half the 30-day period for objection still left.
    With respect to the select portions of the petition that FWW
objects to having received 21 days after the start of the 30-day
objection period, we understand this objection to refer to the portions
of the petition that FWW examined in FDA's offices on September 8,
2006. These portions of the petition were not among the four references
cited in the bacteriophage final rule and placed on public display as
part of the petition docket. As is discussed previously, it would not
be an efficient use of Agency resources to prepare the entire petition
for release in advance of any requests to view the petition. However,
FDA was nonetheless able to redact significant portions of the petition
in an expedited manner and provide them for FWW's review on September
8, 2006.
    FDA is denying the request for a hearing on this point because a
hearing will not be granted unless there is a genuine and substantial
factual issue to be resolved (Sec.  12.24(b)(1)), and resolution of the
factual issue in the way sought is adequate to justify the action
requested (Sec.  12.24(b)(4)). Furthermore, a hearing is justified only
if the objections ``draw in question in a material way the
underpinnings of the regulation at issue'' (Pactra Industries v.
Consumer Product Safety Commission, 555 F.2d at 684), which is not the
case with this objection.

V. Summary and Conclusions

    Section 409 of the FD&C Act requires that a food additive be shown
to be safe prior to marketing. Under Sec.  170.3(i), a food additive is
``safe'' if ``* * * there is a reasonable certainty in the minds of
competent scientists that the substance is not harmful under the
intended conditions of use.* * *'' In the final rule approving the use
of a Listeria-specific bacteriophage preparation for treating RTE meat
and poultry products, FDA concluded that the data presented by the
petitioner to establish safety of the additive demonstrate that the use
of the bacteriophage preparation is safe under the conditions of use
stated in the regulation. The petitioner has the burden to demonstrate
the safety of the additive in order to gain FDA approval. (See, e.g.,
Silverman v. Foreman, 631 F.2d 969, 972 (DC Cir. 1980).) Once FDA makes
a finding of safety, the burden shifts to an objector, who must come
forward with evidence that calls into question FDA's conclusion. (See
section 409(f)(1) of the FD&C Act.)
    None of the objections received contained evidence to present a
genuine and substantial issue of fact. Nor has the objector established
that the Agency overlooked significant information in reaching its
conclusion. Therefore, the Agency has determined that the objections
that requested a hearing do not raise any substantial issue of fact
that would justify an evidentiary hearing (Sec.  12.24(b)).
Accordingly, FDA is not making any changes in response

to the objections and is denying the requests for a hearing. In
addition, FWW's request for a stay of the effectiveness of the August
18, 2006, regulation until a hearing is held is moot because FDA is
denying the hearing request. FDA is confirming August 18, 2006, as the
effective date of the regulation.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday.
    1. ``Evaluating the Safety of Food Chemicals,'' National Research
Council, National Academy of Sciences, Washington DC, p. 55.
    2. Jacobs, T., A. Darji, N. Frahm, et al., ``Listeriolysin O:
Cholesterol Inhibits Cytolysis But Not Binding to Cellular Membranes,''
Molecular Microbiology, 28:1081-1089, 1998.
    3. U.S. Department of Agriculture Nutritive Value of Foods, Home
and Garden Bulletin Number 72, USDA, Agricultural Research Service.
    4. Guyton, A.C., J.E. Hall, Textbook of Medical Physiology (9th
ed.) Philadelphia: W.B. Saunders Co., p. 817, 1996.

    Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6792 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 20, 2009 (Volume 74, Number 53)]
[Notices]
[Page 11938]
[DOCID:fr20mr09-54]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER99-2284-009, etc.]

AEE 2, L.L.C, et al.; Notice of Filing

March 12, 2009.

------------------------------------------------------------------------
                                                          Docket Nos.
------------------------------------------------------------------------
AEE 2, L.L.C.........................................     ER99-2284-009
AES Creative Resources, L.P..........................     ER99-1773-009
AES Eastern Energy, L.P..............................     ER99-1761-005
Indianapolis Power & Light Company...................     ER00-1026-016
AES Ironwood, L.L.C..................................     ER01-1315-005
AES Red Oak, L.L.C...................................     ER01-2401-011
AES Huntington Beach, L.L.C..........................     ER98-2184-014
AES Redondo Beach, L.L.C.............................     ER98-2186-015
AES Placerita, Inc...................................       ER00-33-011
Condon Wind Power, LLC...............................      ER05-442-003
AES Alamitos, Inc....................................     ER98-2185-014
Storm Lake Power Partners II, LLC....................     ER99-1228-007
Lake Benton Power Partners, LLC......................     ER97-2904-008
Mountain View Power Partners, LLC....................      ER01-751-010
                                                           ER01-751-012
------------------------------------------------------------------------

Notice of Filing

    Take notice that on February 25, 2009, AEE 2, L.L.C., AES Creative
Resources, L.P., AES Eastern Energy, L.P., Indianapolis Power & Light
Company, AES Ironwood, L.L.C., AES Red Oak, L.L.C., AES Huntington
Beach, L.L.C., AES Redondo Beach, L.L.C., AES Placerita, Inc., Condon
Wind Power, LLC, AES Alamitos, Inc., Storm Lake Power Partners II, LLC,
Lake Benton Power Partners, LLC, and Mountain View Power Partners, LLC,
filed supplemental information to their compliance filing.
    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 March 23, 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-6068 Filed 3-19-09; 8:45 am]


[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13664-13665]
[FR Doc No: 2015-05892]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending February 7, 2014

    The following Applications for Certificates of Public Convenience
and

Necessity and Foreign Air Carrier Permits were filed under Subpart B
(formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 302. 201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2015-0012.
    Date Filed: February 2, 2015.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: February 23, 2015.
    Description: Application of T'way Air Co., Ltd. (``T'way Air'')
requesting a foreign air carrier permit and an exemption authorizing
T'way Air to engage in: (1) Scheduled foreign air transportation of
persons, property and mail from points behind the Republic of Korea,
via the Republic of Korea and intermediate points, to a point or points
in the United States and beyond; (2) charter foreign air transportation
of persons, property and mail between any point or points in the
Republic of Korea and any point or points in the United States, and
beyond to any point or points in a third country or countries; and (3)
other charter foreign air transportation.
    Docket Number: DOT-OST-2015-0014.
    Date Filed: February 2, 2015.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: February 23, 2015.
    Description: Application of LIMA NY Corp. requesting authority to
engage in scheduled passengers operations as a commuter air carrier
operating daily service between the East Hampton Airport and New York
Skyports in New York City, New York.
    Docket Number: DOT-OST-1999-6663 and DOT-OST-2011-0076.
    Date Filed: February 2, 2015.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: February 23, 2015.
    Description: Application of United Parcel Service Co. (``UPS'')
requesting the Department amend its certificate to include authority to
operate scheduled foreign air transportation of property and mail
between IAH and MTY. UPS also requests exemption authority pursuant to
the Department's streamlined licensing procedures, in order to commence
this service while the Department considers its certificate amendment
request.

Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2015-05892 Filed 3-13-15; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8072-8073]
[FR Doc No: 2018-03715]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-463-000]

Notice of Schedule for Environmental Review of the Okeechobee
Lateral Pipeline Project Florida Southeast Connection, LLC

    On August 22, 2017, Florida Southeast Connection, LLC (FSC) filed
an application to construct and operate certain natural gas pipeline
facilities. The Federal Energy Regulatory Commission (Commission) is
considering this application in Docket No. CP17-463-000 for a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act (NGA). The proposed project is known as the
Okeechobee Lateral Pipeline Project (Project), and would connect FSC's
mainline system with the Florida Power & Light Company's (FPL)
Okeechobee Clean Energy Center (OCEC). The Project would be capable of
transporting up to 400 million cubic feet per day of natural gas to the
OCEC.
    This Notice of Schedule for Environmental Review indicates the
anticipated date for the Commission staff's issuance of an
environmental assessment (EA) for this proposal. The issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's EA.

Schedule for Environmental Review

Issuance of EA--March 16, 2018
90-day Federal Authorization Decision Deadline--June 14, 2018

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    FSC requests authorization to construct and operate approximately
5.2 miles of 20-inch-diameter natural gas transmission pipeline and
associated facilities including an inspection tool launcher and a
receiver and a meter station in Okeechobee County, Florida. As
described above, this lateral pipeline would connect FSC's mainline
system with FPL's OCEC. FSC anticipates construction would require four
to five months.

Background

    On October 24, 2017, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Okeechobee Lateral
Pipeline Project and Request for Comments on Environmental Issues
(NOI). The NOI was sent to affected landowners; federal, state, and
local government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. In response to the NOI, the Commission
received comments from the Treasure Coast Democratic Environmental
Caucus, Seminole Tribe of Florida, Sierra Club, and the Economic
Council of Okeechobee County. The primary issues raised by the
commentors concern air quality, cumulative impacts, potential future
projects and connected actions, cultural resources, purpose and need,
alternatives, and greenhouse gas and upstream emissions.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs

at (866) 208-FERC or on the FERC website (www.ferc.gov). Using the
eLibrary link, select General Search from the eLibrary menu, enter the
selected date range and Docket Number excluding the last three digits
(i.e., CP17-463), and follow the instructions. For assistance with
access to eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY
(202) 502-8659, or at [email protected]. The eLibrary link on
the FERC website also provides access to the texts of formal documents
issued by the Commission, such as orders, notices, and rule makings.

    Dated: February 16, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-03715 Filed 2-22-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Rules and Regulations]
[Pages 7955-7956]
[FR Doc No: 2010-3428]

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

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1077]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Interim rule.

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

SUMMARY: This interim rule lists communities where modification of the
Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because
of new scientific or technical data. New flood insurance premium rates
will be calculated from the modified BFEs for new buildings and their
contents.

DATES: These modified BFEs are currently in effect on the dates listed
in the table below and revise the Flood Insurance Rate Maps (FIRMs) in
effect prior to this determination for the listed communities.
    From the date of the second publication of these changes in a
newspaper of local circulation, any person has ninety (90) days in
which to request through the community that the Assistant Administrator
for Mitigation reconsider the changes. The modified BFEs may be changed
during the 90-day period.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Kevin C. Long, Acting Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street SW., Washington, DC 20472,
(202) 646-2820.

SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each
community in this interim rule. However, the address of the Chief
Executive Officer of the community where the modified BFE
determinations are available for inspection is provided.
    Any request for reconsideration must be based on knowledge of
changed conditions or new scientific or technical data.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required to either adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, together with the floodplain management
criteria required by 44 CFR 60.3, are the minimum that are required.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own, or pursuant to policies established by the
other Federal, State, or regional entities. The changes in BFEs are in
accordance with 44 CFR 65.4.
    National Environmental Policy Act. This interim rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This interim rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This interim rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This interim rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

0
Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

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

Sec.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Date and name of
          State and county             Location and Case No.   newspaper where notice      Chief executive           Effective date of        Community
                                                                    was published       officer of  community          modification              No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
California: Shasta..................  City of Shasta Lake (09- July 20, 2009; July     Ms. Carol Martin, City  July 10, 2009...............       060758
                                       09-0170P)                27, 2009, Record        Manager, City of
                                                                Searchlight.            Shasta Lake, P.O. Box
                                                                                777, Shasta Lake, CA
                                                                                96019.
Colorado: El Paso...................  City of Colorado         July 8, 2009; July 15,  The Honorable Lionel    June 30, 2009...............       080060
                                       Springs (09-08-0556P)    2009; El Paso County    Rivera, Mayor, City
                                                                Advertiser and News.    of Colorado Springs,
                                                                                30 South Nevada
                                                                                Avenue, Colorado
                                                                                Springs, CO 80903.
Maryland: Montgomery................  Unincorporated areas of  July 30, 2009; August   The Honorable Isiah     July 24, 2009...............       240049
                                       Montgomery County (09-   6, 2009; Montgomery     Leggett, Montgomery
                                       03-0599P)                County Sentinel.        County Executive,
                                                                                Executive Office
                                                                                Building, 101 Monroe
                                                                                Street, 2nd Floor,
                                                                                Rockville, MD 20850.
Ohio: Lorain........................  City of Avon (08-05-     January 12, 2009;       The Honorable James A.  December 31, 2008...........       390348
                                       2056P)                   January 19, 2009;       Smith, Mayor, City of
                                                                Morning Journal.        Avon, 36080 Chester
                                                                                Road, Avon, OH 44011.
Oklahoma: Comanche..................  City of Lawton (08-06-   July 20, 2009; July     The Honorable John      July 15, 2009...............       400049
                                       1958P)                   27, 2009; Lawton        Purcell, Mayor, City
                                                                Constitution.           of Lawton, 3006
                                                                                Northeast Muse
                                                                                Circle, Lawton, OK
                                                                                72507.

Texas:
    Fort Bend.......................  Unincorporated areas of  July 23, 2009; July     The Honorable Robert    July 17, 2009...............       480228
                                       Fort Bend County (09-    30, 2009; Fort Bend     E. Hebert, PhD, Fort
                                       06-1930P)                Sun.                    Bend County Judge,
                                                                                301 Jackson Street,
                                                                                Richmond, TX 77469.
    Fort Bend.......................  Fort Bend County L.I.D.  July 23, 2009; July     The Honorable Epifanio  July 17, 2009...............       481594
                                       7 (09-06-       30, 2009; Fort Bend     Salazar, Chairman,
                                       1930P)                   Sun.                    Board of Directors,
                                                                                Fort Bend County
                                                                                L.I.D. 7,
                                                                                1300 Post Oak
                                                                                Boulevard, Suite
                                                                                1400, Houston, TX
                                                                                77027.
    Fort Bend.......................  City of Sugarland (09-   July 23, 2009; July     The Honorable James A.  July 17, 2009...............       480234
                                       06-1930P)                30, 2009; Fort Bend     Thompson, Mayor, City
                                                                Sun.                    of Sugar Land, P.O.
                                                                                Box 110, Sugar Land,
                                                                                TX 77487.
    Travis..........................  City of Pflugerville     July 30, 2009; August   The Honorable Jeff      December 4, 2009............       481028
                                       (09-06-0609P)            6, 2009; Austin         Coleman, Mayor, City
                                                                American Statesman.     of Pflugerville, P.O.
                                                                                Box 589,
                                                                                Pflugerville, TX
                                                                                78691.
    Travis..........................  Unincorporated areas of  July 30, 2009; August   The Honorable Samuel    December 4, 2009............       481026
                                       Travis County (09-06-    6, 2009; Austin         T. Biscoe, Travis
                                       0609P)                   American Statesman.     County Judge, 314
                                                                                West 11th Street,
                                                                                Suite 520, Austin, TX
                                                                                78701.
    Webb............................  City of Laredo (08-06-   July 10, 2009; July     The Honorable Raul G.   November 16, 2009...........       480651
                                       2270P)                   17, 2009; Laredo        Salinas, Mayor, City
                                                                Morning Times.          of Laredo, 1110
                                                                                Houston Street,
                                                                                Laredo, TX 78040.
    Webb............................  City of Laredo (08-06-   July 9, 2009; July 16,  The Honorable Raul G.   November 10, 2009...........       480651
                                       2721P)                   2009; Laredo Morning    Salinas, Mayor, City
                                                                Times.                  of Laredo, 1110
                                                                                Houston Street,
                                                                                Laredo, TX 78040.
    Webb............................  Unincorporated areas of  August 4, 2009; August  The Honorable Danny     July 28, 2009...............       481059
                                       Webb County (09-06-      11, 2009; Laredo        Valdez, Webb County
                                       1293P)                   Morning Times.          Judge, 1000 Houston
                                                                                Street, 3rd Floor,
                                                                                Laredo, TX 78040.
Wisconsin:
    Dane............................  Unincorporated areas of  July 24, 2009; July     The Honorable Kathleen  July 15, 2009...............       550077
                                       Dane County (09-05-      31, 2009; Wisconsin     M. Falk, Dane County
                                       0486P)                   State Journal.          Executive, City
                                                                                County Building, Room
                                                                                118, 210 Martin
                                                                                Luther King Jr.
                                                                                Boulevard, Madison,
                                                                                WI 53703.
    Dane............................  Village of De Forest     July 24, 2009; July     The Honorable Jeff      July 15, 2009...............       550082
                                       (09-05-0486P)            31, 2009; Wisconsin     Miller, Village
                                                                State Journal.          President, Village of
                                                                                De Forest, 306 De
                                                                                Forest Street, De
                                                                                Forest, WI 53532.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Sandra K. Knight,
Deputy Assistant Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2010-3428 Filed 2-22-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 24 (Thursday, February 5, 2015)]
[Notices]
[Page 6567]
[FR Doc No: 2015-02320]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the South Texas Regional Airport at Hondo, Texas

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the South Texas Regional Airport at Hondo under the
provisions of Section 125 of the Wendell H. Ford Aviation Investment
Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or before March 9, 2015.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Ed Agnew, Manager, Federal
Aviation Administration, Southwest Region, Airports Division, Texas
Airports Development Office, ASW-650, Fort Worth, Texas 76137.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Jeff Litchfield, City Manager, at the
following address: 1600 Avenue M, Hondo, Texas 78861.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Mekhail, Program Manager,
Federal Aviation Administration, Texas Airports Development Office,
ASW-650, 2601 Meacham Boulevard, Fort Worth, Texas 76137, Telephone:
(817) 222-5663, email<EMAIL_ADDRESS>fax:<PHONE_NUMBER>.
The request to release property may be reviewed in person at this same
location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the South Texas Regional Airport at
Hondo under the provisions of the AIR 21.
    The following is a brief overview of the request:
    The City of Hondo requests the release of 25.855 acres of
aeronautical airport property. The property is located south of Runway
35L and just north of the railroad tracks. The property to be released
will be sold and revenues shall be used for the operation and
maintenance at the airport. Any person may inspect the request in
person at the FAA office listed above under FOR FURTHER INFORMATION
CONTACT.
    In addition, any person may, upon request, inspect the application,
notice and other documents relevant to the application in person at the
South Texas Regional Airport at Hondo, telephone number<PHONE_NUMBER>.

    Issued in Fort Worth, Texas, on January 29, 2015.
Lacey Spriggs,
Acting Manager, Airports Division.
[FR Doc. 2015-02320 Filed 2-4-15; 8:45 am]
BILLING CODE 4910-13-P